[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atopic-dermatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atopic-dermatitis":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,159,0,25,[9,51,76,88,115,141,162,187,209,230,254,281,307,331,352,375,400,422,453,483,502,526,546,569,597],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053852","phase-1-evaluating-the-safety-and-tolerability-of-baricitinib-in-patients-with-job-syndrome-with-lupus-like-disease-andor-atopic-dermatitis-100053852",false,"NCT07262983","Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and\u002For Atopic Dermatitis","A Pilot Study to Evaluate the Safety and Tolerability of Baricitinib in Patients With Job s Syndrome With Lupus-like Disease and\u002For Atopic Dermatitis","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Must be able to understand and provide informed consent or assent.\n2. Aged \\>=12 years.\n3. Documented STAT3 variant causing hyper-IgE syndrome.\n4. Enrollment in NIH protocol 00-I-0159, Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES).\n\n   a. Presence of SLE and\u002For AD as follows: SLE patients should meet either Systemic Lupus International Collaborating Clinics (SLICC) or 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) SLE classification criteria. AD is defined as EASI tool score \\>=16 and body surface area tool score of 10% at screening.\n5. Ability to take oral medication and be willing to adhere to the study intervention regimen.\n6. For individuals on glucocorticoids, the dose must be less than 10 mg daily and stable for the 30 days prior to Day 0.\n7. For individuals on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, the dose must have been stable for 90 days prior to Day 0. The maximum allowed dose is hydroxychloroquine 400 mg\u002Fday or 6.5 mg\u002Fkg\u002Fday, whichever is greater. The maximum allowed dose for chloroquine phosphate is 500 mg daily, and for quinacrine is 100 mg daily.\n8. Individuals may be on lipid-lowering medications if initiated at least 90 days prior to Day 0, and the dose must be stable for 30 days prior to Day 0.\n9. Individuals of reproductive potential must agree to use at least one highly effective method of contraception when engaging in sexual activities that can result in pregnancy while on study drug. Acceptable methods of contraception include:\n\n   * Intrauterine device (IUD)\n   * Bilateral tubal ligation\n   * Abstinence\n   * Vasectomized partner\n   * Hormonal contraception used in combination with barrier method: progestogen containing (oral, intravaginal, transdermal) or progestogen-only (oral, injectable, implantable) starting 30 days prior to initiation of baricitinib\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known history of hypersensitivity to baricitinib or other JAK inhibitors.\n2. Current or recent use of any investigational drug\u002Fintervention (within 6 months or 5 half-lives, whichever is longer, prior to Day 0) except for COVID-19 vaccines or therapies that have been granted an FDA emergency authorization.\n3. Scheduled to participate in another clinical study involving an investigational drug during the course of this study.\n4. Use of systemic immunosuppressive or immune-modulating agents within 90 days prior to Day 0, except systemic steroids \\\u003C=10 mg of prednisone equivalent per day.\n5. Current or prior treatment with rituximab in the 6 months prior to Day 0.\n6. Current treatment with methotrexate, mycophenolate mofetil, other less common immunomodulatory drugs such as those falling into the class of disease-modifying antirheumatic drugs (DMARDs), belimumab, and other immunosuppressive biologics not otherwise specified herein. Participants previously on methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or belimumab, other immunosuppressive biologics, or DMARDs should have been withdrawn from the drug for at least 90 days prior to Day 0.\n7. Treatment with cyclophosphamide and pulse methylprednisolone within 6 months prior to Day 0.\n8. Hypercholesterolemia: Values after 8- to 12-hour fasting blood specimen: total cholesterol \\>250 mg\u002FdL or LDL \\>180 mg\u002FdL or hypertriglyceridemia (triglyceride \\>300 mg\u002FdL) within 90 days prior to Day 0.\n9. History of alcohol or drug abuse within 6 months prior to Day 0.\n10. Presence of 1 or more of the following clinically significant laboratory abnormalities:\n\n    1. Serum ALT \\>=3 times ULN.\n    2. Serum total bilirubin \\>=2 times ULN.\n    3. ANC \\\u003C=750 cells\u002FmicroL.\n    4. Hemoglobin \\\u003C=9.0 g\u002FdL.\n    5. Platelet count \\\u003C=100,000\u002FmicroL.\n    6. Serum creatinine \\>=2 times ULN.\n11. Planned or anticipated major surgical procedure during the study.\n12. Plans to receive any live vaccines within 1 month of the anticipated first dose of baricitinib.\n13. Known or suspected immune-dysregulatory disorders besides Job s syndrome, lupus-like disease, and\u002For AD.\n14. Active invasive opportunistic infections (eg, non-TB mycobacterial infections, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, aspergillosis) despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged infections suggesting an immune-compromised status as judged by the investigator.\n15. Known active TB. Participants with treated LTB will be eligible to participate. Participants with untreated LTB will not be excluded but will be evaluated by an infectious disease consultant and may become eligible for trial based on infectious disease consultant recommendations.\n16. Infection with HIV.\n17. Untreated infection with hepatitis B or C.\n18. Unwillingness to receive prophylactic entecavir (or similar), only for individuals with evidence of clearance of hepatitis B with positive hepatitis B core and surface antibody and negative hepatitis B surface antigen and PCR.\n19. BK or JC viremia at screening visit.\n20. Active infection that requires the use of oral or intravenous antimicrobials that remains unresolved at least 14 days prior to the administration of the first dose of study medication.\n21. Individuals with active renal or central nervous system disease or a high activity level in any organ system (except articular) that requires immediate immunosuppressive therapy as determined by the investigator.\n22. History of cancer, with the exceptions of basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix, provided the participant is in remission and curative therapy was completed at least 12 months prior to screening. History of other malignancies are also permitted provided that the individual is in remission and curative therapy was completed at least 5 years prior to screening.\n23. Planned or anticipated use of any prohibited medications and procedures during the study.\n24. Pregnancy or current breastfeeding.\n25. Currently receiving hemodialysis or peritoneal dialysis.\n26. Past or current medical problems or findings from physical examination, electrocardiogram, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risk from participation in the study, may interfere with the individual s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. These may include, but are not limited to:\n\n    1. Known coronary artery aneurysm.\n    2. Known history of arterial or venous thrombosis or at high risk for clotting disorder.\n    3. Known history of PE or DVT in the past.\n    4. Psychiatric illness or history of medical non-compliance that the study team feels will make the individual unlikely to complete the study.\n    5. Significant impairment of major organ function (lung, heart, liver, kidney) or any condition that, in the opinion of the investigator, would jeopardize the individual s safety following exposure to the study drug.\n27. Individuals with known increased risk factors for MACE including a history of:\n\n    1. Ischemic heart disease (eg, history of acute myocardial infarction).\n    2. Heart failure.\n    3. Cardiomyopathy.\n    4. Severe valvular heart disease.\n    5. Significant arrhythmias.\n    6. Chronic renal failure.\n    7. Cerebrovascular accident or transient ischemic attack.\n    8. Uncontrolled diabetes mellitus.\n    9. Uncontrolled hypertension.\n    10. Current smokers or former smokers with less than 3 years since complete cessation and\u002For \\>20 pack-years of smoking history.\n28. History of idiopathic GI perforation or diverticulitis with high risk of perforation.\n29. Treatment with strong organic anion transporter 3 inhibitors (OAT3) (eg, probenecid) due to drug interactions.\n30. Uncontrolled thyroid disease as per principal investigator or medically responsible investigator.","ALL","12 Years","120 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Background:\n\nAutosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system. It can cause skin and lung infections and problems with blood vessels, connective tissues, and bones. People with HIES often have lupus-like disease or atopic dermatitis (skin rash). Researchers want to know if a drug approved to treat other immune system diseases (baricitinib) can help people with HIES.\n\nObjective:\n\nTo test baricitinib in people with HIES with lupus-like disease or skin rash.\n\nEligibility:\n\nPeople aged 12 years and older with HIES with lupus-like disease or skin rash.\n\nDesign:\n\nParticipants will have 5 clinic visits, 4 remote visits, and 2 phone visits in 9 months.\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have tests of the speed and pressure of blood flow through their body: Blood pressure cuffs will be placed on each arm and leg; electrodes will be placed on the wrists and a microphone on the chest.\n\nThe study has a 3-month lead-in period. Participants will not take the study drug during this time. They will continue with their usual medical care. They will have 2 phone calls with the study team.\n\nBaricitinib is a tablet taken by mouth. Participants will take 1 or 2 tablets by mouth every day for 6 months. They will start with a low dose and may increase to a higher dose.\n\nBlood and urine tests will be repeated during each study visit. Other tests may also be repeated during some visits. A skin sample may also be taken....",[28,29,30,31,32],"Hyper IgE Syndrome From STAT3 Mutation","Job s Syndrome","HIES","Lupus","Atopic Dermatitis",[28,34,30,31,32,35,36,37],"Job s syndrome","Lupus-like Disease","JAK Inhibition","Janus Kinases","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":22},"2026-07-16",{"date":46,"type":22},"2030-10-01",{"name":48,"class":49},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":50},"100053281","phase-1-a-clinical-study-of-hrs-8797-in-healthy-participants-100053281","NCT07698756","A Clinical Study of HRS-8797 in Healthy Participants","A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect Following Single and Multiple Oral Doses of HRS-8797 Tablets in Healthy Subjects","Inclusion Criteria:\n\n1. Healthy men and women aged 18 to 55 years old at informed consent signing\n2. Male body weight ≥50 kg , female ≥45 kg; BMI 18 to 28 kg\u002Fm² at screening and baseline\n3. Have no clinically significant abnormalities at screening and baseline\n4. Fertile females and males with fertile female partners: effective contraception consent, and sustained until 4 weeks after the last dose (abstinence or highly effective contraception); no sperm\u002Fegg donation\n\nExclusion Criteria:\n\n1. A history or current severe diseases of multiple systems, or other diseases interfering with trial results.\n2. Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial.\n3. Blood donation\u002Fsevere blood loss (≥400 mL) within 3 months, blood transfusion within 4 weeks before screening; planned blood donation during the trial.\n4. History of drug abuse\u002Fdependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned\n5. participation during the trial; within 5 half-lives of a prior drug (whichever is longer).\n6. Smoking history (≥5 cigarettes\u002Fday) within 4 weeks before screening; inability to abstain from tobacco during the trial;\n7. Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening.\n8. Special dietary requirements and inability to comply with the unified diet.\n9. Difficulty in swallowing\u002Fvenous blood collection; intolerance to intensive blood sampling.\n10. Other circumstances deemed unsuitable for trial participation by Researcher.",true,"18 Years","55 Years",{"count":62,"type":22},74,[25],"The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants.",[32],"NOT_YET_RECRUITING","2026-07-07",{"date":41,"type":42},{"date":70,"type":22},"2026-07",{"date":72,"type":22},"2027-01",{"name":74,"class":75},"Chengdu Suncadia Medicine Co., Ltd.","INDUSTRY",{"id":77,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":26,"conditions":80,"keywords":81,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":87,"locationsCount":50},"100613161",{"count":21,"type":22},[25],[28,29,30,31,32],[28,34,30,31,32,35,36,37],"2026-07-01",{"date":84,"type":42},"2026-07-02",{"date":67,"type":22},{"date":46,"type":22},{"name":48,"class":49},{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":95,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100554828","phase-1-targeted-investigation-of-microbiome-2-treat-atopic-dermatitis-time-2-100554828","NCT06504160","Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)","Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9","Inclusion Criteria:\n\nEach individual must meet all of the following criteria at Screening to be eligible for enrollment as a study participant:\n\n1. Participant and\u002For parent\u002Flegal guardian must be able to understand and provide informed consent and assent (if applicable).\n2. Male or female participant 6 years of age or older.\n3. Meet ADRN Standard Diagnostic Criteria for active AD.\n\n   Each individual must meet all of the following criteria at Baseline to be eligible for enrollment as a study participant:\n4. Have at least 7 cm2 of lesional skin within the upper extremities, lower extremities, and\u002For trunk. Lesions on the face, neck, hands, feet, and intertriginous areas do not count toward the required area, as samples may not be taken from these areas. The required area may be one contiguous area or may be comprised of multiple areas with a compliant total area.\n5. Have at least 3% body surface area of AD involvement as indicated by derived total area of involvement score during SCORAD assessment.\n6. Have an IGA score of two or greater.\n7. Each potential participant who can become pregnant must meet either of the following criteria prior to randomization to be eligible for enrollment as a study participant.\n\n   1. Willing to remain abstinent from intercourse that may result in a pregnancy.\n   2. Willing to use an FDA-approved method of contraception for the duration of study participation. Acceptable methods include the following:\n\n      * Permanent sterilization of partner\n      * Long-acting reversible contraceptives (e.g., intrauterine devices or systems, implantable rods, contraceptive injections) when used as directed for at least 7 days prior to Baseline.\n      * Short-acting hormonal contraceptives (e.g., oral contraceptive pills, patch, vaginal ring) when used as directed for at least 30 days prior to Baseline\n      * Barrier methods (e.g., condoms; diaphragm, sponge, or cervical cap with spermicide)\n8. Have obtained negative pregnancy test results during both the Screening and Baseline Visits.\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria at Screening or Baseline are not eligible for enrollment as study participants:\n\n1. Inability or unwillingness to give written informed consent or comply with study protocol.\n2. Has self-reported as pregnant or lactating during the Screening or Baseline Visit, or is pregnant as indicated by a positive pregnancy test result obtained at the Screening or Baseline Visit.\n3. Sensitivity to or difficulty tolerating Dove® fragrance-free bar soap, Cetaphil® lotion, alcohol-based cleaners, clobetasol and fluocinonide ointments, triamcinolone ointment, hydrocortisone ointment, glycerol, hydroxyethylcellulose or soy products.\n4. Known recalcitrance to topical steroids, including class 1 steroids, within 6 months of the Screening Visit.\n5. History of serious life-threatening reaction to tape or adhesives.\n6. Known allergy to all antibiotics to which S. hominis A9 is sensitive. These include ampicillin-sulbactam, cefazolin, cefoxitin, clindamycin, daptomycin, doxycycline, levofloxacin, linezolid, minocycline, moxifloxacin, mupirocin, nitrofurantoin, oxacillin, rifampin, trimethoprim-sulfamethoxazole, and vancomycin.\n7. Has a major defect in the epidermal barrier such as open wounds or genodermatoses (e.g., Netherton's syndrome).\n8. Is immunocompromised (e.g., Human Immunodeficiency Virus (HIV)\u002FAcquired Immunodeficiency Syndrome (AIDS), Wiskott-Aldrich Syndrome) or has an immune system disorder (e.g., autoimmune disease).\n9. Has current malignant disease (except non-melanoma skin cancer in an area not affected by treatment).\n10. Has a history of psychiatric disease or history of alcohol or drug abuse that, in the opinion of the study investigator, would interfere with the ability to comply with the study protocol.\n11. Ongoing participation in another investigational trial or use of investigational drugs within 8 weeks, or five half-lives (if known), whichever is longer, of the Screening Visit.\n12. Treatment with non-steroid systemic immunosuppressant within 6 months of the Screening Visit.\n13. Treatment with any biologic, including dupilumab, within 16 weeks of the Screening Visit.\n14. Treatment with oral or injectable therapy for AD (excluding oral steroids) within five half-lives (if known) or 16 weeks before the Screening Visit, whichever is longer.\n15. Treatment with oral retinoids (e.g., isotretinoin) within 60 days of the Screening Visit.\n16. Treatment with allergen immunotherapy within 30 days of Screening Visit.\n17. Has close contacts (e.g., spouse, children, or members in the same household) who have severe barrier defects or are immunocompromised.\n18. May, in the opinion of the investigator, have difficulty tolerating the medication washout requirements for topical AD treatments, prescription moisturizers, antibiotics, oral steroid therapies, and phototherapy ahead of Baseline.\n19. Past or current medical conditions or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.\n\n    Individuals who meet any of the following criteria at Baseline are not eligible for enrollment as study participants:\n20. Have more than 30% body surface area of AD involvement, as indicated by the derived total area of involvement score during SCORAD assessment.\n21. Active bacterial, viral, or fungal skin infections, except for onychomycosis and tinea pedis.\n22. Any noticeable breaks or cracks in the skin on the target areas of investigational product application, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection.\n\n    a. At the investigator's discretion, participants with minor breaks, cracks, or excoriations on body areas not eligible for sampling during the trial may be enrolled, provided there is no evidence of infection and investigational product is not applied to these areas until healed.\n23. Use of topical AD treatments - including steroids and calcineurin inhibitors - on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within seven days of the Baseline Visit.\n24. Treatment with prescription moisturizers classified as medical device (e.g., Atopiclair®, MimyX®, Epiceram®, etc.) on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within seven days of the Baseline Visit.\n25. Use of any systemic microbialª within fourteen days of the Baseline Visit, or use of any topical antimicrobial on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within fourteen days of the Baseline Visit.\n\n    a. Antimicrobials include antibiotics, antifungals, antiparasitics, and antivirals. Certain systemic antivirals that do not exhibit systemic anti-inflammatory effects may be permitted with prior approval from a protocol co-chair).\n26. Within the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), and trunk, use of topical products - prescription or over-the-counter, all formulations - not specified per protocol, within seven days of the Baseline Visit.\n27. Use of systemic corticosteroid therapies for any indication within 28 days of the Baseline Visit.\n28. Use of systemic corticosteroid therapies for treatment of an asthma exacerbation within 3 months of the Baseline Visit.\n29. Require a dose greater than 880 mcg\u002Fday of fluticasone propionate or equivalent inhaled corticosteroid to maintain asthma control, at the time of the Baseline Visit.\n30. Any phototherapy for skin disease (such as narrow band ultraviolet B \\[NBUVB\\], ultraviolet B \\[UVB\\], ultraviolet A1 \\[UVA1\\], psoralen + UVA \\[PUVA\\]) or regular use (more than 2 visits per week) of a tanning bed within 28 days of the Baseline Visit.","6 Years",{"count":97,"type":22},86,[25],"This is a Phase 1b, randomized, placebo\u002Fvehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and pediatric participants with atopic dermatitis.\n\nThe primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial two-week period of co-treatment with topical corticosteroids (TCS). The primary efficacy objective of this study is to assess the ability of ShA9, compared to placebo (vehicle), to prolong the period of atopic dermatitis control over 12 weeks after conclusion of an initial two-week period of co-treatment with TCS.",[32],[102,103,104,105,106,107],"atopic dermatitis","eczema","ADRN","TIME-2","microbiome","Staphylococcus hominis",{"date":84,"type":42},{"date":110,"type":42},"2025-05-22",{"date":112,"type":22},"2027-02-05",{"name":48,"class":49},8,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100593206","phase-2-a-long-term-safety-and-efficacy-study-evaluating-apg777-in-atopic-dermatitis-100593206","NCT07003425","A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis","A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777","Inclusion Criteria:\n\n* Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol\n* Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777\n* Use the same non-prescription non-medicated emollient\u002Fmoisturizer of their choice from the last day of the Parent Study and throughout the LTE study\n\nExclusion Criteria:\n\n* Participants who have developed an AE while participating in the Parent Study, which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient\n* Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study\n* Use of any of the prohibited medications from Screening Visit (Visit 1) of the LTE study\n* Presence of dermatologic conditions and\u002For comorbidities that might confound the diagnosis of AD and\u002For interfere with study assessments\n\nNote: Additional protocol defined Inclusion\u002FExclusion criteria may apply",{"count":123,"type":22},350,[125],"PHASE2","This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).\n\nThe LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.\n\nThis study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.",[32],[32,129,130,131],"APG777","Safety","Efficacy","2026-06-30",{"date":82,"type":42},{"date":135,"type":42},"2025-05-14",{"date":137,"type":22},"2029-12",{"name":139,"class":75},"Apogee Therapeutics, Inc.",61,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":58,"sex":17,"minAge":59,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100578221","phase-1-a-study-of-bbt001-in-healthy-volunteers-hvs-and-in-adult-patients-with-atopic-dermatitis-ad-100578221","NCT06808477","A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)","A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and AD Patients","Key Inclusion Criteria (Part A, B, C, D)\n\n1. Age of 18-65 years.\n2. Body mass index between 18-32 kg\u002Fm², capped at 120 kg.\n3. Negative pregnancy tests for women of childbearing potential.\n4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.\n5. Non-smokers, healthy current smokers (≤5 cigarettes\u002Fday), or ex-smokers.\n6. Adequate contraception use (for men and women of childbearing potential).\n7. No clinically significant abnormalities or history of relevant diseases.\n\nKey Inclusion Criteria (Parts C and E only)\n\n1. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.\n2. Moderate to severe atopic dermatitis\n3. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3\n4. Atopic lesions cover ≥10% of body surface area (BSA)\n5. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.\n\nKey Exclusion Criteria for (Part A, B, C, D)\n\n1. Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg), immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections.\n2. History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.\n3. Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.\n4. Positive drug\u002Falcohol tests or abnormal vital signs at screening or Day -1.\n5. Abnormal Electrocardiogram (ECG) findings\n6. History of drug\u002Falcohol abuse in the past 2 years.\n7. Donated \\>500mL blood within 2 months of screening.\n8. History of severe allergic reactions or hypersensitivity.\n\nKey Exclusion Criteria for (Parts C and E only)\n\n1. Skin diseases other than atopic dermatitis, significant tattoos, or scarring.\n2. Receipt of immunoglobulin or blood products within 30 days.\n3. Atopic dermatitis with ocular symptoms or chronic ocular steroid use.\n4. Chronic pruritus from conditions other than atopic dermatitis.\n5. Acute\u002Ftreated infections or chronic skin infections.\n6. Current use of sedating antihistamines or corticosteroids.","65 Years",{"count":150,"type":22},198,[25],"This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).",[32],{"date":82,"type":42},{"date":156,"type":42},"2025-02-27",{"date":158,"type":22},"2027-02-06",{"name":160,"class":75},"Bambusa Therapeutics",7,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":58,"sex":17,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":173,"conditions":174,"keywords":178,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":50},"100247843","natural-history-and-genetics-of-food-allergy-and-related-conditions-100247843","NCT02504853","Natural History and Genetics of Food Allergy and Related Conditions","* GENERAL INCLUSION CRITERIA:\n\nAll participants must meet the following criteria:\n\n1. Be 2 to 99 years-old at the time of enrollment for participants who will be seen at the NIH CC; be 0 (newborn) to 99 years-old at the time of enrollment for participants who will submit mail-in samples or participate in telehealth visits. Only viable neonates will be enrolled.\n2. Willing to allow storage of blood, buccal swabs, saliva, nasal swabs, stool samples, and other clinically appropriate tissue specimens for future use in medical research\n3. Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives\n\nADDITIONAL INCLUSION CRITERIA FOR AFFECTED PARTICIPANTS\n\nIn addition to the general criteria listed above, affected participants must meet 1 of the following criteria:\n\n1. Have a clinical history of an immediate hypersensitivity reaction to food(s) and be sensitized to food allergen(s) (as evidenced by positive SPT or allergen-specific IgE testing)\n2. Be sensitized (as evidenced by positive SPT or allergen-specific IgE testing) to food allergen(s) but have no overt clinical history of IgE-mediated symptoms when they eat that food(s)\n3. Have a suspected genetic or congenital disorder potentially associated with food allergy or related condition, as determined by the principal investigator (PI) or associate investigators (AIs)\n4. Have a diagnosis of eosinophilic esophagitis (EoE), or clinical suspicion for EoE as determined by the principal investigator (PI) or associate investigators (AIs)\n5. Have a history of atopic dermatitis based on self-report or physician assessment.\n\nADDITIONAL INCLUSION CRITERIA FOR UNAFFECTED RELATIVES:\n\nIn addition to the general criteria listed above, unaffected relatives must meet the following criteria:\n\n1. Be a relative of an affected participant\n2. Be unaffected by food allergy (as determined by clinical history and\u002For allergy testing) or be unaffected by the genetic condition under study\n\nADDITIONAL INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS\n\nIn addition to the general criteria listed above, healthy volunteers must meet the following criteria:\n\n1. Be unrelated to an affected participant\n2. Be unaffected by food allergy (as determined by clinical history and\u002For allergy testing) or be unaffected by the genetic condition under study\n\nADDITIONAL PROCEDURE- SPECIFIC INCLUSION CRITERIA:\n\nThe following additional inclusion criteria apply for participants undergoing leukapheresis:\n\n1. Age \\>= 18 years\n2. Stable hematologic parameters (definition: white blood cell count \\> 2,500\u002FmicroL, hemoglobin \\> 10 g\u002FdL, and platelet count \\> 75,000\u002FmicroL)\n\nGENERAL EXCLUSION CRITERIA:\n\nParticipants will be excluded for any of the following:\n\n* Presence of conditions that, in the judgment of the investigator or the referring physician, may put the participant at undue risk or make them unsuitable for participation in the study.\n* Inability to participate for the duration of the study.\n* The PI deems that participation in the study would not be expected to advance the study goals.\n\nADDITIONAL PROCEDURE- SPECIFIC EXCLUSION CRITERIA\n\nAdditional exclusion criteria apply for unaffected relatives and healthy volunteers who are undergoing endoscopy with biopsies for research purposes. Unaffected relatives and healthy volunteers will be excluded from participating in this procedure if they meet any of the following criteria:\n\n1. uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s Physical Status Classification System (https:\u002F\u002Fjournals.lww.com\u002Fanesthesiologyopen\u002Ffulltext\u002F2026\u002F04000\u002Famerican\\_society\\_of\\_anesthesiologists\\_statement\\_on.2.aspx)\n2. history of adverse reaction to conscious sedation or general anesthesia required for endoscopy\n3. hemoglobin \\\u003C 11 g\u002FdL\n4. platelet count \\\u003C 100,000 microL\n5. PT INR \\>1.3 or PTT prolonged by \\> 3 seconds\n6. pregnant or breastfeeding\n7. viral screens positive for HIV or hepatitis B or C\n8. severe unstable myocardial ischemia or cardiomyopathy\n9. severe hypoxemia due to chronic pulmonary disease\n10. recent abdominal surgery\n11. anticoagulant therapy that cannot be interrupted\n12. history of reflux disease within the last 3 years or use of acid-suppression medication (including over-the-counter medications such as Tums, Rolaids, Zantac, Prilosec OTC, or Prevacid OTC) within the last 2 months\n13. chronic GI or immunologic disease\n14. clinically indicated EGD or colonoscopy within the past 12 months\n15. use of systemic or inhaled corticosteroids within the past 4 months\n16. have a history of EGID including EoE\n17. younger than 18 years of age","1 Day","99 Years",{"count":171,"type":22},1800,"OBSERVATIONAL","Background:\n\n\\- About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them.\n\nObjective:\n\n\\- To learn more about the causes and effects of food allergy and related conditions.\n\nEligibility:\n\n* People ages 2 99 who have food allergy and\u002For a related genetic or other condition\n* Their relatives\n* Healthy relatives and volunteers\n\nDesign:\n\n* Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer.\n* Participants will be screened with medical history, physical exam, and questionnaires.\n* Participants may have the following:\n* Blood tests\n* Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop.\n* Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm.\n* X-rays\n* Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour.\n* EGD and colonoscopy: Biopsies are taken from the gastrointestinal system.\n* Tiny biopsies of skin\n* Photographs of the body\n* Collection of cells through:\n* Swab of nose, inside of cheek, or skin\n* Gentle skin scrape\n* Tape stripping: piece of tape is put on the skin and pulled off.",[175,176,32,177],"Food Allergy","Loeys-Dietz Syndrome","Eosinophilic Esophagitis",[177,176,32,179,180],"TGFbeta","Natural History",{"date":82,"type":42},{"date":183,"type":42},"2015-07-29",{"date":185,"type":22},"2027-06-15",{"name":48,"class":49},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":58,"sex":17,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":50},"100534433","corevitas-international-adolescent-atopic-dermatitis-ad-drug-safety-and-effectiveness-registry-100534433","NCT06238765","CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry","Inclusion Criteria:\n\n* To be eligible to participate in this registry, an individual must meet all the following criteria:\n\n  1. Has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified healthcare provider\n  2. Is 10 - 15 years of age at the time of enrollment.\n  3. Subject has initiated or is initiating an enrollment-eligible medication at the time of enrollment\n\n     Exclusion Criteria:\n* An individual who meets any of the following criteria will be excluded from participation in the registry:\n\n  1. Is participating or planning to participate in a blinded clinical trial for an AD drug.\n  2. Is unwilling or unable to provide standing height measurements.","10 Years","15 Years",{"count":196,"type":22},1500,"Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.",[32],"2026-06-25",{"date":201,"type":42},"2026-06-29",{"date":203,"type":42},"2023-12-02",{"date":205,"type":22},"2099-12-31",{"name":207,"class":208},"CorEvitas","NETWORK",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100615299","this-study-is-a-non-interventional-disease-registry-of-adolescent-and-adult-patients-with-atopic-dermatitis-who-initiate-or-switch-any-systemic-treatment-100615299","NCT07290803","This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment","Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments","ARMADA-AD","Inclusion Criteria:\n\n* Patients aged more than or equal to (≥) 12 years at the time of consent.\n* Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.\n* Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)\n* Signed informed consent for registry participation by the patient or parent\u002Flegal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.\n\nExclusion Criteria:\n\n* Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.\n* Insufficient understanding of the study by the patient and\u002For parent\u002Fguardian.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":218,"type":22},1000,"The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.\n\nThe study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.",[32],"2026-06-24",{"date":199,"type":42},{"date":224,"type":42},"2025-11-17",{"date":226,"type":22},"2034-01-30",{"name":228,"class":75},"Sanofi",59,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":238,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100540041","phase-3-a-trial-to-evaluate-the-efficacy-and-safety-of-tralokinumab-in-combination-with-topical-corticosteroids-in-children-and-infants-with-moderate-to-severe-atopic-dermatitis-100540041","NCT06311682","A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis","A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to \u003C12 Years) and Infants (Age 6 Months to \u003C2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to \u003C12 Years) and Open-label and Single-group for Infants (Age 6 Months to \u003C2 Years)","TRAPEDS 2","Inclusion Criteria:\n\n* Age 6 months to \\\u003C12 years at screening.\n* Body weight ≥9 kg at screening.\n* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.\n* History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 months for subjects aged 6 months to \\\u003C6 years at screening.\n* Documented inadequate response to mid-strength TCS within 6 months before the screening visit.\n* AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD.\n* An EASI score of ≥16 at screening and baseline.\n* An IGA score of ≥3 at screening and baseline.\n* A Child Worst Itch NRS average score of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score of ≥4 (subjects aged \\\u003C6 years at screening) during the week prior to baseline.\n\nExclusion Criteria:\n\n* Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinase inhibitors (JAK) within 1 week prior to baseline.\n* Treatment with bleach baths within 1 week prior to baseline.\n* Treatment with the immunomodulatory medications systemic immunosuppressive\u002Fimmunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors) and systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery) within 4 weeks prior to baseline.\n* Use of tanning beds or phototherapy within 4 weeks prior to baseline.\n* Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit.\n* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis.\n* Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks before the baseline visit.\n* History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.","6 Months","11 Years",{"count":241,"type":22},195,[243],"PHASE3","The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \\[SC\\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.\n\nThe study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.\n\nThe children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.",[32],{"date":199,"type":42},{"date":248,"type":42},"2024-06-10",{"date":250,"type":22},"2028-04-28",{"name":252,"class":75},"LEO Pharma",72,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":268,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100545992","phase-3-a-study-of-upadacitinib-in-adult-participants-with-moderate-to-severe-atopic-dermatitis-and-inadequate-response-to-dupilumab-100545992","NCT06389136","A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab","A Phase 3b\u002F4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)","Switch-Up","Inclusion Criteria:\n\n* Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria.\n* Participant meets all the following disease activity criteria at Baseline Visit:\n\n  * Eczema Area and Severity Index (EASI) score \\>= 12;\n  * validated Investigator´s Global Assessment for AD (vIGA-AD) score \\>= 3;\n  * Body surface area (BSA) involvement of \\>= 10% in a majority of subjects (\\>= 50% of the overall study population)\n  * Baseline weekly average of daily Worst Pruritus-Numerical Rating Scale (WP-NRS) \\>= 4. Note: The Baseline weekly average of daily WP-NRS will be calculated from the 7 consecutive days immediately preceding the Baseline Visit. A minimum of 4 daily scores out of the 7 days is needed.\n  * Inadequate response to dupilumab treatment after at least 4 months of current use.\n  * Particpant has applied a topical emollient (an additive-free, bland emollient moisturizer) twice daily for at least 7 days before the Baseline Visit and for the duration of the study. Note: Subject may use prescription moisturizers or moisturizers containing ceramide, urea, filaggrin degradation products or hyaluronic acid if such moisturizers were initiated before the Screening visit.\n\nExclusion Criteria:\n\n* Meeting any of the following conditions at Baseline:\n\n  * Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or would interfere with assessment of AD lesions;\n  * Two or more past episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;\n  * One or more past episodes of disseminated herpes simplex (including eczema herpeticum);\n  * HIV infection defined as confirmed positive anti- HIV Ab test;\n  * Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV);\n  * Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual);\n  * For Japan: Positive result of beta-D-glucan (screening for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period;\n  * Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral\u002Fintramuscular anti-infectives within 14 days prior to the Baseline Visit;\n  * Chronic recurring infection and\u002For active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study;\n  * COVID-19 infection: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild\u002Fmoderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status.\n* At Baseline any of the following medical diseases or disorders:\n\n  * Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery or venous thromboembolism;\n  * Any unstable clinical condition which, in the opinion of the investigator would put the subject at risk by participating in the protocol;\n  * Diagnosed active parasitic infection, suspected or high risk of parasitic infection unless clinical (and if necessary) laboratory assessment have ruled out active infection before randomization;\n  * History of an organ transplant which requires continued immunosuppression;\n  * History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and\u002For other products in the same class;\n  * History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;\n  * Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery including sleeve gastrectomy; subjects with a history of gastric banding\u002Fsegmentation are not excluded;\n  * History of malignancy except for successfully treated NMSC or localized carcinoma in situ of the cervix.","63 Years",{"count":264,"type":22},200,[243],"Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD.\n\nUpadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide.\n\nThe study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[32],[269,270,271],"Upadacitinib","Rinvoq","ABT-494","2026-06-23",{"date":199,"type":42},{"date":275,"type":42},"2024-06-14",{"date":277,"type":22},"2027-03",{"name":279,"class":75},"AbbVie",127,{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":58,"sex":17,"minAge":288,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":4,"leadSponsor":305,"locationsCount":50},"100103147","studies-of-skin-microbes-in-healthy-people-and-in-people-with-skin-conditions-100103147","NCT00605878","Studies of Skin Microbes in Healthy People and in People With Skin Conditions","Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients","* INCLUSION CRITERIA:\n\nInclusion Criteria for all groups\n\nMust have a primary care professional who will continue standard of care\u002Fevaluation in tandem with the protocol to whom information and recommendations can be communicated.\n\nInclusion Criteria for Group 1: Healthy Volunteers\n\nAdult males or females aged 18-50 at time of enrollment.\n\nInclusion Criteria for Group 2: AD patients\n\nA. Confirmed diagnosis of AD (UK Working Party s Diagnostic Criteria)24\n\nB. Moderate to severe AD SCORAD greater than or equal to 25(25)\n\nC. Greater than or equal to 1 affected antecubital (or popliteal) fossae at time of enrollment to serve as a target site.\n\nInclusion Criteria for Group 3: Healthy (pediatric) Controls\n\nA. Males or females 2-18 years of age.\n\nInclusion Criteria for Groups 4, 5, \\& 6: AD\u002FHIES\u002FWAS\u002FDOCK8 patients\n\nA. Must have mutation-proven diagnosis, with or without eczematous dermatitis.\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for all groups:\n\n1. Any subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants \\\u003C 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.\n2. Any subjects who have cancer, and are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies within the previous 6 months.\n3. Any subject with a history of bone marrow transplant or gene therapy.\n\nExclusion Criteria specific for Group 2: AD patients\n\nA. Unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to body site sampling. Unable to temporarily discontinue use of topical steroids or calcineurin inhibitors for greater than or equal to 7 days to small areas of skin intended for sampling. (Topical therapies\u002Femollients for AD may be continued to non-adjacent, nontarget sites.)\n\nB. Underlying immunodeficiency, either as primary disease or secondary to treatment.\n\nExclusion Criteria specific for Groups 4, 5, \\& 6: HIES\u002FWAS\u002FDOCK8 patients:\n\nA. Unable to remain off topical steroids and emollients for preferably 7 days but at least 24 hours prior to body site sampling.\n\nExclusion Criteria specific for Groups 1 \\& 3: Healthy Volunteers and Healthy (pediatric) Controls:\n\nA. Any subjects with unstable or uncontrolled or chronic medical conditions requiring treatment or hospitalization. Individual determinations will be made at the discretion of the medical investigator.\n\nB. Underlying immunodeficiency, either as primary disease or secondary to treatment.\n\nC. Other documented chronic dermatologic disease, such as AD or psoriasis that may interfere with evaluation of the cutaneous microbiome. Common transient conditions, such as acne, are permissible.\n\nD. Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals.\n\nE. Subjects with asthma.\n\n5\\. Any female with symptoms and\u002For serum hormone levels consistent with perimenopause","2 Years","100 Years",{"count":291,"type":22},530,"This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.\n\nHealthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40 years of age may be eligible for this study.\n\nWe also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to AD.\n\nEligible participants undergo the following tests and procedures:\n\n* Medical family and medication history\n* Skin examination\n* Blood tests (research blood as well as serum IgE, and complete blood count)\n* Skin samples to analyze microbes. Samples are obtained by the following methods: swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal) of a small skin sample less than 1\u002F4-inch (5 mm) in diameter.\n* Nose swabs to analyze microbes.\n* Patients with eczema may have photographs of their skin taken to help monitor the skin rashes.\n\nParticipants may be contacted periodically for follow-up studies. Patients with atopic dermatitis may have additional skin samples collected to examine changes in the skin bacteria over time and during all of the stages of eczema. In addition, patients who have a flare of their eczema are asked to undergo a skin sample collection as soon as possible.",[294,32],"Eczema",[296,180,297,298,299,32,294,300,301],"Skin","Microbiome","Bacteria","Atopic Dermatitis (Eczema)","Health Volunteer","HG",{"date":221,"type":42},{"date":304,"type":42},"2008-01-22",{"name":306,"class":49},"National Human Genome Research Institute (NHGRI)",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":58,"sex":17,"minAge":59,"maxAge":148,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":50},"100633533","phase-1-first-in-human-trial-to-assess-regn20423-in-healthy-adult-participants-and-adult-participants-with-atopic-dermatitis-100633533","NCT07527923","First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis","A Two-Part Phase 1, Randomized, Double-Blind, Placebo-Controlled First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN20423 in Adult Healthy Participants and Adult Participants With Atopic Dermatitis","AURA-AD","Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis\n\nKey Inclusion Criteria:\n\nPart A:\n\n1. Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention\n2. Has a BMI within 18 to 31 kg\u002Fm² (inclusive) at the screening visit\n\n   Part B:\n3. Has a history of AD for at least 6 months at screening\n4. Has EASI score ≥5 at both the screening and baseline visits\n5. Has IGA score ≥2 at both the screening and baseline visits\n\nKey Exclusion Criteria\n\nPart A:\n\n1. Hospitalized (\\>24 hours) for any reason within 30 days prior to the screening visit\n2. Hypersensitivity to the study treatment or any of its excipients\n3. History of clinical parasite infection, except treated trichomoniasis\n4. Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study\n5. History of alcohol or drug abuse as determined by the investigator\n\n   Part B:\n6. Known or suspected history of immunosuppression\n7. Presence of skin comorbidities at screening that may interfere with study assessments\n8. Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list\n9. Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study\n\nNote: Other protocol defined Inclusion\u002F Exclusion criteria apply",{"count":316,"type":22},144,[25],"This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans.\n\nThe study is looking at:\n\n* What side effects REGN20423 might cause\n* How much REGN20423 is in the blood at different times\n* How well REGN20423 works in adults with atopic dermatitis\n* Whether the body makes antibodies against REGN20423\n* How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others\n* What the best dose of REGN20423 is",[320,32],"Healthy Volunteer",[294,322],"Inflammatory skin disease","2026-06-22",{"date":199,"type":42},{"date":326,"type":42},"2026-05-22",{"date":328,"type":22},"2028-06-23",{"name":330,"class":75},"Regeneron Pharmaceuticals",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":50},"100640796","phase-1-hl-300-ointment-in-patients-with-mild-to-moderate-atopic-dermatitis-100640796","NCT07629778","HL-300 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of HL-300 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years at the time of ICF signing, with no gender restriction\n2. Meeting the Hanifin \\& Rajka diagnostic criteria for atopic dermatitis (AD) at screening, with a history of AD ≥ 6 months before screening, and the AD condition judged by the investigator to be stable within 4 weeks prior to ICF signing,.\n3. vIGA-AD score of 2-3 at screening and baseline visits;\n4. EASI score within the range of 5-21 at screening and baseline;\n5. \"Body Surface Area (BSA) affected by AD skin lesions meeting one of the following requirements at screening and baseline visits, with skin lesions suitable for topical treatment:\n\n   * Cohort 1: BSA of 5% to 20%;\n   * Cohort 2: BSA of 15% to 25%. \"\n6. Women of childbearing potential and men willing to use at least one highly effective method of contraception or practice abstinence from the time of informed consent signing until 3 months after the last dose of the investigational product\n7. Those who voluntarily participate in the study and sign the informed consent form\n\nExclusion Criteria:\n\n1. \"Trial participants with any of the following medical histories or abnormal conditions at screening: (1) Skin lesions or abnormalities that may affect the assessment of the investigational product application site; (2) Clinically relevant skin diseases that are contraindicated for the study or affect the assessment of the application site, including but not limited to: psoriasis, acne, skin cancer; (3) Other autoimmune diseases besides AD, such as inflammatory bowel disease, rheumatoid arthritis, where the investigator believes the disease would unfavorably impact the assessment of this study; (4) Current or history of lymphoproliferative disorders, or signs or symptoms suggestive of possible lymphoproliferative disorders, including lymphadenopathy or splenomegaly; (5) Any malignancy, or any history of malignancy within 5 years prior to screening (except for completely resected cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or papillary thyroid carcinoma); (6) History of herpes virus infection within the past 6 months, or recurrent herpes zoster (≥2 episodes), disseminated herpes zoster, disseminated herpes simplex, or current inability to rule out herpes zoster or herpes simplex infection; (7) Systemic infection requiring hospitalization within 12 weeks prior to screening to baseline, or active bacterial, viral, fungal, parasitic, or other infections requiring anti-infective treatment within 4 weeks prior to screening to baseline; (8) Local active infection within 1 week prior to screening to baseline, such as active infected AD, or any superficial skin infection requiring oral or intravenous antibiotic, antifungal, or antiviral medication; (9) History of thrombotic events, including deep vein thrombosis and pulmonary embolism, or high-risk factors for thromboembolism (e.g., immobilization or prolonged bed rest), which is judged by the investigator's comprehensive clinical assessment to be unsuitable for participation in this study; (10) History of significant cardiovascular, neurological, respiratory, hematological, digestive, urinary, immune, or psychiatric diseases that the investigator believes may confound study results or affect drug absorption, distribution, metabolism, and excretion, or place the trial participant at undue risk; (11) History of drug abuse or substance abuse.\"\n2. \"Trial participants who have received any of the following treatments: (1) Use of topical skin products for AD or AD-related skin infections at the study application site within 2 weeks prior to baseline, including but not limited to: topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase 4 (PDE-4) inhibitor ointments, topical antimicrobials, etc.; (2) Use of topical skin products containing chemically active ingredients (including but not limited to vitamin E cream, functional products containing niacinamide\u002Furea\u002Fceramide, excluding emollients without any chemically active ingredients) at the study application site within 1 week prior to baseline; (3) Use of systemic therapeutic drugs for AD within 4 weeks or 5 half-lives (whichever is longer) prior to baseline, including but not limited to systemic anti-infectives, PDE-4 inhibitors, and systemic traditional Chinese medicine or herbal medicines for AD; (4) Use of systemic or topical JAK inhibitors (such as ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib, delgocitinib, upadacitinib, abrocitinib, etc.) within 12 weeks prior to baseline; (5) Use of sedating antihistamines within 2 weeks prior to baseline (Stable use of non-sedating antihistamines is permitted \\[dose stable for 2 weeks or 5 half-lives (whichever is longer) before the first study medication\\]); (6) Use of systemic immunosuppressants or immunomodulators (such as oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine) within 4 weeks or 5 half-lives (whichever is longer) prior to baseline; (7) Use of biologics (such as dupilumab) within 12 weeks or 5 half-lives (whichever is longer) prior to baseline; (8) Use of strong CYP450 inhibitors or inducers within 2 weeks prior to baseline, including but not limited to: nelfinavir, ritonavir, clarithromycin, itraconazole, nevirapine, and barbiturates; (9) Vaccination with live\u002Fattenuated live vaccines within 4 weeks prior to baseline, or planning to receive vaccination during the study period; (10) Sunbathing or phototherapy (including ultraviolet therapy, photochemotherapy, etc.) with AD therapeutic effects within 4 weeks prior to baseline;\"\n3. \"Trial participants with any of the following laboratory and instrumental examination results:\n\n(1) Any significant clinical and laboratory abnormalities that the investigator believes may affect trial participant safety, including but not limited to:\n\n1. White blood cell count (WBC) \\\u003C 3×109\u002FL, absolute neutrophil count (ANC) \\\u003C 1.5×109\u002FL, absolute lymphocyte count (ALC) \\\u003C 0.8×109\u002FL, platelet count (PLT) \\\u003C 100×109\u002FL, hemoglobin (Hb) \\\u003C 100 g\u002FL;\n2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2× ULN, or total bilirubin (TBIL) ≥ 1.5× ULN;\n3. Blood creatinine \\> 1.5× ULN; (2) Confirmed or suspected active tuberculosis, incompletely cured tuberculosis, or active Mycobacterium tuberculosis infection (except for trial participants with documented treatment proving adequate therapy, who may enter this study based on the medical judgment of the investigator and\u002For infectious disease specialist) judged by the investigator and\u002For infectious disease specialist (combining medical history, symptoms, signs, laboratory tests, tuberculosis screening tests, and imaging findings); (3) QT interval corrected by Fridericia formula (QTcF) ≥500 ms in 12-ECG results at screening; (4) Hepatitis B surface antigen (HBsAg) positive; HBsAg negative but hepatitis B core antibody (HBcAb) positive and HBV-DNA above detection limit, or human immunodeficiency virus antibody (HIV) positive, or anti-hepatitis C virus (HCV) antibody positive and HCV-RNA positive, or Treponema pallidum antibody positive (excluding trial participants with negative non-specific syphilis antibody results and judged by the investigator to have a past history of syphilis infection that has been cured);\" 4.Known or suspected allergy to the investigational product or excipients in the investigational product; 5.Female trial participants who are suspected or known to be pregnant, breastfeeding, or planning pregnancy during the trial period; 6.History of major surgery within 4 weeks prior to baseline or planned surgery during the study; 7.Significant blood loss, received blood transfusion, or donated blood (≥400 mL) within 3 months prior to baseline; 8.Participation in other clinical trials within 3 months prior to baseline; 9.Weekly alcohol consumption greater than 14 units within 3 months prior to screening (1 unit of alcohol ≈ 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine); 10.Other conditions judged by the investigator to be unsuitable for participation in the study.","75 Years",{"count":340,"type":22},156,[25,125],"This study is a randomized, double-blind, placebo-controlled, multicenter Phase Ib\u002FII clinical study designed to evaluate the efficacy, safety, and PK characteristics of HL-300 ointment with different concentration regimens for mild-to-moderate AD.",[32],"2026-06-18",{"date":272,"type":42},{"date":347,"type":42},"2026-05-26",{"date":349,"type":22},"2027-12-31",{"name":351,"class":75},"Hangzhou Highlightll Pharmaceutical Co., Ltd",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100614289","phase-2-a-dose-ranging-study-to-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-galvokimig-in-adult-study-participants-with-atopic-dermatitis-100614289","NCT07277660","A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n* Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent\n* Participant has chronic atopic dermatitis (AtD) (according to American Academy of Dermatology Consensus Criteria) that has been present for at least ≥1 year prior to initiating the study (ie, signing of the informed consent form \\[ICF\\]) and with:\n\n  1. validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline\n  2. Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline\n  3. Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline\n  4. ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline\n  5. Documented recent history (within 6 months prior to Screening) of inadequate response to treatment with topical medications, or study participants for whom topical treatments are otherwise medically inadvisable (eg, due to important side effects or safety risks) and who are candidates for systemic therapy\n\nExclusion Criteria:\n\n* Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study\n* Active dermatologic conditions that may confound the diagnosis of AtD or would interfere with assessment of treatment, such as but not limited to scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic or irritant contact dermatitis\n* Presence or family history (first degree) of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)\n* History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline (including herpes zoster) as judged by the investigator\n* Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria\n* Previous treatment with galvokimig\n* Participant has relevant safety events to one or more interleukin (IL)-13 biologic response modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted in discontinuation and change of treatment\n* All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline\n* Treatment with biologic agents must discontinued at least 3 months prior to baseline",{"count":360,"type":22},160,[125],"The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic dermatitis (AtD).",[32],[32,365,366],"Galvokimig,","UCB9741",{"date":323,"type":42},{"date":369,"type":42},"2025-12-29",{"date":371,"type":22},"2028-03-06",{"name":373,"class":75},"UCB Biopharma SRL",66,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":288,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":383,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":50},"100644423","phase-4-opzelura-experience-study-100644423","NCT07661979","Opzelura Experience Study","Inclusion Criteria:\n\n* Patients ≥2 years of age\n* Patients with a current diagnosis of atopic dermatitis that is mild-to-moderate in severity and in ≥2 body areas\n* Patients with up to 20% total body surface area involvement\n* Women of childbearing age taking\u002Fusing a contraceptive\n\nExclusion Criteria:\n\n* Patients without a current diagnosis of atopic dermatitis\n* Patients who are prescribed changing systemic medications or treatments (phototherapy, biologics) for atopic dermatitis\n* Patients who would require use of other topical medications for other diagnoses (tretinoin, clindamycin)\n* Patients with areas of skin with active infection\n* Patients who are pregnant",{"count":382,"type":22},50,[384],"PHASE4","Atopic dermatitis is a common multifactorial skin disease. Topicals are the mainstay of treatment, but adherence to topicals is often abysmal, possibly worsened by the complexity of recommended treatment algorithms. Giving patients a simple, one drug approach may be advantageous.",[32],[388,389,390],"skin atrophy","treatment adherence","topical medications","2026-06-17",{"date":272,"type":42},{"date":394,"type":22},"2026-08",{"date":396,"type":22},"2027-10",{"name":398,"class":399},"Wake Forest University Health Sciences","OTHER",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":148,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"100546666","phase-2-evaluate-efficacy-and-safety-of-repeat-subcutaneous-doses-of-fb825-in-adults-with-moderate-to-severe-atopic-dermatitis-100546666","NCT06397911","Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be included in the study:\n\n1. The subject is male or female between 18 and 65 years of age at the time of giving informed consent.\n2. Body weight equal to or greater than 40 Kg at the time of screening.\n3. The subject has a physician-confirmed diagnosis of moderate-to-severe atopic dermatitis based on 12 months history of symptoms designated by Hanifin and Rajka criteria.\n4. Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visits.\n5. Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3 (5-point scale) at the screening and baseline visits.\n6. ≥10 % body surface area (BSA) of AD involvement at the screening and baseline visits.\n7. Baseline pruritus numerical rating scale (NRS) average score for maximum itch intensity of ≥ 3, based on the average of daily pruritus NRS scores for maximum itch intensity reported during the 7 days prior to randomization.\n8. History of inadequate response to a stable (4 weeks) regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD within 6 months before the screening visit. (The TCS should belong to medium to high potency strength and has been applied for at least 4 weeks or for the maximum duration recommended by product prescribing information.)\n\n   * An inadequate response is defined as the inability to achieve and maintain remission or a low disease activity state (comparable to vIGA-AD 0=clear to 2=mild).\n   * Subjects with systemic treatment for AD in the past 6 months were also considered as inadequate responders to topical treatments.\n9. Patients must be applying stable doses of an additive-free, basic bland emollient twice-daily for at least 1 week immediately before the baseline visit.\n\n   Note: See exclusion criterion #13 for limitations regarding emollients.\n10. Female subjects must have a negative serum pregnancy test at screening. All subjects of childbearing potential and his\u002Fher sexual partner must meet 2 following condition or acceptable methods of birth control throughout the study.\n\n    * Oral, injectable, or implanted hormonal contraceptives\n    * Condom with a spermicidal form, gel, film, cream, or suppository\n    * Occlusive cap (diaphragm or cervical\u002Fvault caps) with a spermicidal foam, gel, film, cream, or suppository\n    * Intrauterine device\n    * Intrauterine system (for example, progestin-releasing coil) or be surgically sterile (i.e., hysterectomy, bilateral tubal ligation, bilateral oophorectomy, or vasectomy)\n    * Postmenopausal (defined as amenorrhea 12 consecutive months and documented serum follicle stimulating hormone level per laboratory standard) Note: The subject must utilize the method of effective contraception during study period as well as 16 weeks or 5 half-lives following the last dosing of FB825.\n11. The subject is able to provide written informed consent.\n12. The subject agrees to and is capable of adhering to scheduled visits, the treatment plan, laboratory tests, other study procedures, and all protocol requirements.\n\nExclusion Criteria:\n\n* Subjects to whom any of the following applies will be excluded from the study:\n\n  1. Female subjects who are pregnant or lactating\n  2. The subject with positive test results for HBeAg or HCV RNA should be excluded as they are indications of active hepatitis B virus and hepatitis C virus replication.\n  3. A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag\u002FAb combo test) at screening or a history of HIV infection.\n  4. The subject has a history of alcohol or drug abuse within one year prior to screening that would impair or risk the patients' full participation in the study, in the opinion of the investigator.\n  5. The subject has a clinically significant, currently active or severe gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory (with the exception of uncomplicated allergic rhinitis and allergic asthma), inflammatory, immunological, endocrine, diabetes, obesity \\[BMI≥35\\] or infectious disease and is ineligible to participate in the study as judged by the investigator.\n  6. The subject has a clinically significant history, as determined by the investigator, of drug allergies or hypersensitivity such as, but not limited to, sulfonamides and penicillin, or a drug allergy witnessed in a previous study with experimental drugs.\n  7. The subject has any history of a previous anaphylactic reaction.\n  8. The subject has any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.\n  9. The subject has received TCS or TCI within 7 days prior to the baseline visit (Day 1).\n  10. The subject has received any immunoglobulin products or blood products within 3 months prior to baseline visit.\n  11. The subject has received a biologic product (including investigational biologic product) within 5 half-lives or 3 months, whichever is longer, before baseline visit.\n  12. The subject has received an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before baseline visit.\n  13. Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period.\n  14. Initiation of treatment of AD with sedative anti-histamine products during the screening period (patients may continue using stable doses of non-sedative anti-histamine).\n  15. The subject is a member of the professional or ancillary personnel involved in the study.\n  16. The subject regular use (≥2 visits per week) of a tanning booth\u002Fparlor within 4 weeks prior to the baseline visit.\n  17. The subject has received cell-based immunotherapy treatment within 3 months prior to baseline visit.\n  18. The subject has used any of the following classes of medication (prescription or over-the-counter) within specific time frames before the study drug treatment:\n\n      * Systemic corticosteroids within 4 weeks.\n      * Leukotriene modifiers within 4 weeks.\n      * Cyclosporine within 4 weeks, or other immunosuppressants (e.g. gold salts, methotrexate, azathioprine) within 4 weeks.\n      * IFN-γ within 12 weeks, or other immunomodulating drugs within 4 weeks.\n      * Allergen immunotherapy within 1 year.\n      * JAK inhibitor within 4 weeks.\n  19. The subject has received phototherapy within 4 weeks before the study drug treatment.\n  20. The subject has received live vaccine within 12 weeks before the study drug treatment.\n  21. The subject has presence of skin comorbidities that may interfere with study assessments.\n  22. The subject has known or suspected history of immunosuppression, including history of opportunistic infections (e.g., TB) per investigator's judgment.\n  23. The subject has active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.\n\n      Note: Patients with resolved infection may be rescreened.\n  24. The subject has history of malignancy within 5 years before the screening period, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.\n  25. The subject has planned or anticipated the use of any prohibited medications and procedures during the entire study period.\n  26. The subject has planned or anticipated major surgical procedure during the entire study period.\n  27. High risk of parasite infection. Evidence of parasitic infection designated as having the following two items:\n\n      • Risk factors for parasitic disease include living in an endemic area, experiencing chronic gastrointestinal symptoms, traveling to regions where geohelminthic infections are endemic within the last 6 months, and\u002For having chronic immunosuppression).\n\n      AND\n\n      • Evidence of parasitic colonization or infection found during stool evaluation for ova and parasites.\n\n      Note: stool ova and parasite evaluation will only be conducted in patients with risk factors and an eosinophil count more than twice the upper limit of normal.",{"count":408,"type":22},114,[125],"This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy, pharmacokinetics, and Safety of repeat subcutaneous doses of FB825 in adults with moderate-to-severe atopic dermatitis.",[32],"2026-06-12",{"date":414,"type":42},"2026-06-15",{"date":416,"type":42},"2024-08-08",{"date":418,"type":22},"2027-05-31",{"name":420,"class":75},"Oneness Biotech Co., Ltd.",16,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":58,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":50},"100562149","identification-of-cutaneous-and-blood-biomarkers-predictive-of-response-to-systemic-treatments-during-chronic-inflammatory-skin-diseases-100562149","NCT06599411","Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases","Identification Des Marqueurs Biologiques cutanés et Sanguins prédictifs de réponse Aux Traitements systémiques au Cours Des Maladies cutanées Inflammatoires Chroniques","ImmuneSkinBank","Inclusion Criteria:\n\nPatients:\n\n* Age\\>18 years\n* Informed consent signed by the patient\n* Diagnosis of moderate to severe chronic inflammatory skin disease (IGA score 3 or 4) including: atopic dermatitis, psoriasis, hidradenitis suppurativa, lichen planus, cutaneous lupus, dermatomyositis, cutaneous scleroderma (=morphea), neutrophilic dermatosis, cutaneous granulomatosis, cutaneaous vasculitis, autoimmune bullous dermatosis\n* Or diagnosis of active leprosy (tuberculoid, lepromatous, reversion type 1, reversion type 2, hypersensitivity type 3), excluding pure neurological leprosy. Classification into 5 stages according to the Ridley and Jopling classification \\[1\\], Reversion reaction (type 1 reaction) and leprous erythema nodosum (type 2 reaction).\n\nHealthy controls :\n\n* Age\\>18 years\n* Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants\n* Informed consent signed by the patient\n* Absence of known cutaneous inflammatory disease.\n\nExclusion Criteria:\n\n* Under guardianship or curatorship\n* Pregnant or breastfeeding woman\n* Lack of affiliation with a social security system\n* Current systemic treatment with immunosupressant (including corticosteroid therapy) or an immunomodulator or received within the last 3 months.",{"count":431,"type":22},830,"Chronic inflammatory skin diseases constitute a heterogeneous group of pathologies. They affect the skin but also other organs (joints, lungs, muscles, etc.). Their prognosis and response to treatments is extremely variable. The discovery of prognosis factors will help to precisely guide the treatment regimen and its intensification based on individual markers. The identification of new therapeutic targets is essential to develop new innovative treatments for inflammatory skin diseases.\n\nThe main objective is to identify new cellular or molecular prognostic factors associated with treatment response at 1 year in inflammatory skin diseases.\n\nThe secondary objectives are a better understanding of the pathophysiology of chronic inflammatory skin diseases, the identification of new cellular, molecular and microbiological prognostic factors associated with the clinical state after 10 years of evolution and the identification of prognostic markers of drug toxicity.",[32,434,435,436,437,438,439,440,441,442,443,444],"Psoriasis","Hidradenitis Suppurativa","Lichen Planus","Cutaneous Lupus","Dermatomyositis","Cutaneaous Scleroderma","Neutrophilic Dermatosis","Cutaneous Granulomatosis","Active Leprosy","Autoimmune Bullous Dermatosis","Cutaneous Vasculitis","2026-06-10",{"date":412,"type":42},{"date":448,"type":42},"2025-10-20",{"date":450,"type":22},"2045-10-20",{"name":452,"class":399},"Assistance Publique - Hôpitaux de Paris",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":461,"enrollmentInfo":462,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":464,"conditions":465,"keywords":466,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":480,"locationsCount":482},"100642845","evaluation-of-a-non-invasive-device-for-early-detection-of-atopic-dermatitis-flares-100642845","NCT07645820","Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares","Evaluation of a Non-Invasive Device for Early Detection of Flares in Adults and Adolescents With Atopic Dermatitis","Detect-AD","Inclusion Criteria:\n\nParticipants may be eligible if they:\n\n* Are 12 to 89 years old.\n* Have been diagnosed with atopic dermatitis (eczema).\n* Have had at least one atopic dermatitis flare within the past 2 months.\n* Are willing and able to use the Nevisense Go device at home, complete an electronic symptom diary, and attend study visits.\n* If currently using systemic treatment for atopic dermatitis, have been on the same treatment for at least 3 months and do not plan to change treatment during the study.\n\nExclusion Criteria:\n\nParticipants may not be eligible if they:\n\n* Are unwilling or unable to avoid applying creams, lotions, ointments, or soap to measurement areas for 6 hours before measurements.\n* Do not have suitable skin areas for study measurements.\n* Have another skin condition that may affect study assessments.\n* Are pregnant.","89 Years",{"count":463,"type":22},450,"This study will collect skin measurements from people with atopic dermatitis (AD) using the investigational Nevisense Go device. Participants aged 12 to 89 years with a history of AD flares will use the device at home for about 90 days. Participants will complete device measurements, electronic diary entries, and up to five in-person study visits. The study is based on the idea that changes in skin barrier function may occur before an AD flare becomes visible or symptoms begin. Information collected during the study, including device measurements, diary entries, and investigator assessments, will be used to evaluate whether these changes may help estimate the likelihood of an AD flare before visible signs or symptoms occur.",[32],[467,468,32,294,469,470,471,472,473,474],"Electrical Impedance Spectroscopy","EIS","Flare","Skin barrier function","Flare Prediction","Dermatology","Nevisense Go","Skin Barrier Dysfunction","2026-06-09",{"date":412,"type":42},{"date":478,"type":22},"2026-05-29",{"date":349,"type":22},{"name":481,"class":75},"Castle Biosciences Incorporated",4,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":50},"100642106","phase-2-a-phase-2b-dose-ranging-study-to-evaluate-the-efficacy-and-safety-of-env-294-in-adults-with-moderate-to-severe-atopic-dermatitis-100642106","NCT07643766","A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\nIn order to participate in this study all participants must:\n\n1. Be at least 18 years of age at the time of signing the ICF.\n2. Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.\n3. Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening and\u002For inadequate response to a systemic therapy within 12 months before Screening.\n4. Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria:\n\n   1. A vIGA score of 3 (moderate) or 4 (severe)\n   2. EASI score of ≥16\n   3. Body surface area involvement of ≥10%\n5. Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.\n6. Use a bland emollient daily for at least 1 week prior to Day 1 and agree to continue using that same emollient daily at the same frequency (minimally, once daily) throughout the study.\n7. Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.\n\nExclusion Criteria:\n\nParticipants are excluded if they:\n\n1. Have any clinically significant medical condition or physical\u002Flaboratory\u002FECG\u002Fvital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.\n2. Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.\n3. Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response as determined by the investigator.\n4. Have an ongoing clinically significant skin infection or is receiving treatment for infection that may interfere with assessment of AD as determined by the investigator.\n5. Are pregnant or breastfeeding or are planning to become pregnant during the duration of the study and for 90 days after the last administration of study drug.\n6. Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.",{"count":264,"type":22},[125],"This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.",[32],"2026-06-07",{"date":412,"type":42},{"date":497,"type":22},"2026-06",{"date":499,"type":22},"2028-05",{"name":501,"class":75},"Enveda Therapeutics",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":58,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":514,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":521,"leadSponsor":523,"locationsCount":525},"100627317","phase-4-the-impact-of-dietary-salt-on-the-severity-of-eczema-100627317","NCT07447063","The Impact of Dietary Salt on the Severity of Eczema","iDOSE","Inclusion Criteria:\n\n* Participants ages 18 years\n* Willing and able to undergo non-contrast MRI.\n\nExclusion Criteria:\n\n* Contraindications to MRI (such as cardiac pacemakers, claustrophobia, non-compatible intracranial vascular clips, IUDs, or other implants)\n* A cardiac event in the past 6 months\n* Impaired function of the liver or kidney (glomerular filtration rate \\\u003C60 mL\u002Fmin)\n* Medications that influence sodium excretion (e.g., diuretics or SGLT2 inhibitors)\n* Antibiotic or immunomodulatory medications within the last month\n* Contraindications to sodium tablets\n\n(Topical medications used exclusively on the head\u002Fneck or hands\u002Ffeet (e.g., antifungal nail treatment, antidandruff shampoo, acne cleansers) are acceptable. Topical and systemic eczema treatments are acceptable if the participant has been on a stable dose for at least 2 months and still meets the severity entry criteria. Patients on dupilumab will not be excluded if they have been on dupilumab for at least two months and still meet the disease severity inclusion criteria.)",{"count":510,"type":22},40,[384],"The goal of this clinical trial is to evaluate the feasibility of low-sodium diet to improve eczema severity. The main questions it aims to answer are:\n\n* Does a low-sodium diet improve eczema severity?\n* How does a low-sodium diet impact skin sodium concentration?\n* Is skin sodium concentration associated with eczema severity?\n\nResearchers will ask all participant to follow a low-sodium diet, then compare sodium tablets to a placebo (a look-alike substance that contains no drug) to specifically examine the impact of altering sodium intake.\n\nParticipants will:\n\n* Follow a low-salt diet for the duration of the 24-week study\n* Take sodium chloride tablets every day for 5 weeks followed by a placebo every day for 5 weeks after a 2-week washout period, or vice versa\n* Complete up to 4 virtual check-in visits\n* Visit the clinic 4 times to answer questionnaires, provide bio samples, complete dietary recalls, and undergo non-contrast sodium MRI",[294,32],[515,516,517],"sodium","salt","diet","2026-06-05",{"date":475,"type":42},{"date":323,"type":22},{"date":522,"type":22},"2028-05-05",{"name":524,"class":399},"University of California, San Francisco",2,{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":421},"100610139","phase-2-a-long-term-extension-study-to-evaluate-the-safety-and-efficacy-of-afimkibart-ro7790121-in-participants-with-atopic-dermatitis-100610139","NCT07223697","A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis","An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials","Velarite-LTE","Inclusion Criteria:\n\n* Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study\n\nParent Clinical Trial-Specific Criteria:\n\n* Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved =\\> EASI50 response from study baseline\n\nExclusion Criteria:\n\n* Evidence of other skin conditions that would interfere with the assessment of AD\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart",{"count":535,"type":22},120,[125],"This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.",[32],{"date":475,"type":42},{"date":541,"type":42},"2026-01-08",{"date":543,"type":22},"2033-03-01",{"name":545,"class":75},"Hoffmann-La Roche",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":17,"minAge":288,"maxAge":289,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":50},"100523528","phase-2-cardamom-and-topical-roseomonas-in-atopic-dermatitis-100523528","NCT06096857","Cardamom and Topical Roseomonas in Atopic Dermatitis","A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Aged \\>=2 years\n2. Have a documented primary care provider near residence\n3. Fluency in English (applicable to participant or caregiver who will be answering questionnaires)\n4. Clinical diagnosis of AD, as defined by Hanifin and Rajka criteria, that has been present for \\>=3 months before the screening visit\n\n   * Major Criteria: Must have \\>=3 basic features:\n\n     * Pruritus\n     * Typical morphology and distribution (flexural lichenification in adults, facial and extensor eruptions in infants and children)\n     * Chronic or chronically relapsing dermatitis\n     * Personal or family history of atopy (asthma, allergic rhinitis, AD)\n   * Minor Criteria: Must have \\>=3 minor features:\n\n     * Xerosis\n     * Ichthyosis\u002Fpalmar hyperlinearity, keratosis pilaris\n     * Immediate (type 1) skin-test reactivity\n     * Raised serum IgE\n     * Early age of onset\n     * Tendency toward cutaneous infections (especially Staphylococcus aureus and herpes simplex), impaired cell-mediated immunity\n     * Tendency toward non-specific hand or foot dermatitis\n     * Nipple eczema\n     * Cheilitis\n     * Recurrent conjunctivitis\n     * Dennie-Morgan infraorbital fold\n     * Keratoconus\n     * Anterior subcapsular cataracts\n     * Orbital darkening\n     * Facial pallor, facial erythema\n     * Pityriasis alba\n     * Anterior neck folds\n     * Itch when sweating\n     * Intolerance to wool and lipid solvents\n     * Perifollicular accentuation\n     * Food intolerance\n     * Course influenced by environmental or emotional factors\n     * White dermographism, delayed blanch\n5. EASI \\>5 and\u002For an IGA \\>=1 at time of enrollment.\n6. Sexually active participants of childbearing potential must agree to use adequate methods of contraception from the screening visit continuously until 30 days after stopping treatment with the investigational product. Childbearing potential is defined for children as participants who have begun menstruating and for adults as participants who are not surgically sterile (hysterectomy and\u002For tubal ligation) or menopausal (age \\>=45 years plus no menses for 12 consecutive months without an alternative medical cause). Adequate contraception methods include: a barrier method (eg, condom use), oral contraceptive pill, hormonal patch or ring, hormonal injection, parenteral hormonal implant, or an intrauterine device.\n7. Participants and parents\u002Flegal guardians (for minor participants) are willing and able to comply with all study visits and\u002For study-related procedures.\n8. Participants\u002Fparents\u002Fguardians must have the ability to provide informed consent\u002Fassent as applicable.\n9. Willingness to perform visits virtually.\n\nEXCLUSION CRITERIA:\n\n1. Previous treatment of AD:\n\n   * Within 4 weeks prior to the baseline visit with any of the following:\n\n     * Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine\n     * Phototherapy or photochemotherapy for AD\n   * Within 12 weeks prior to the baseline visit with any of the following having been newly initiated:\n\n     * Topical steroids or topical calcineurin inhibitors\n     * Janus kinase (JAK) inhibitors (oral or topical)\n     * Dupilumab or any other biologic agent\n     * Topical PDE4 inhibitor\n     * Emollients containing ceramides, hyaluronic acid, urea or filaggrin degradation products.\n     * Bleach baths\n2. Active infection (chronic or acute) requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the baseline visit.\n3. Superficial skin infection requiring topical treatment within 1 week of baseline visit.\n4. Known or suspected history of immunosuppression or immunodeficiency.\n5. Existence of indwelling central line.\n6. Co-habitation with someone that has a known or suspected history of immunosuppression or immunodeficiency or has a central line.\n7. Any clinically significant laboratory, history, or exam findings that, in the investigator's opinion, would suggest an increased risk to the participant.\n8. Self-reported pregnancy or breastfeeding.\n9. Menstruating females who have not menstruated within 6 weeks prior to screening. Participants who have an intrauterine device or implanted long-term contraceptive agent that prevents them from menstruating regularly will not be excluded.",{"count":535,"type":22},[125],"Background:\n\nAtopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems. No cure exists for AD. Researchers know that people with AD have different kinds of harmless bacteria on their skin than do people without AD. They want to see if adding a harmless bacteria (Roseomonas mucosa) to the skin can help people with AD.\n\nObjective:\n\nTo test a skin treatment that contains R. mucosa and ground cardamom seeds in people with AD.\n\nEligibility:\n\nPeople aged 2 years and older with AD.\n\nDesign:\n\nAll study visits will be remote. Participants will have 5 visits over about 7 months.\n\nParticipants will be screened. Researchers will review their AD and medical history.\n\nParticipants will receive a study product in the mail. The product comes as a powder in single-use packets. Participants will be shown how to mix the powder with water in a single-use spray vial. They will spray the solution onto their skin 2 to 3 times per week for 14 weeks.\n\nHalf of participants will receive the study powder. Half will receive a placebo; the placebo looks just like the study powder but contains no bacteria. They will not know which one they have.\n\nDuring 3 study visits, participants will take a skin swab. They will receive supplies in the mail to rub a cotton swab on their skin and mail it back to the researchers.\n\nParticipants may opt to have pictures taken of their AD.\n\nParticipants will fill out 4 online questionnaires.",[32,294],[294,32,558,559,560,561],"Roseomonas","Cardamom","Itch","Rash",{"date":563,"type":42},"2026-06-08",{"date":565,"type":42},"2024-10-09",{"date":567,"type":22},"2027-01-01",{"name":48,"class":49},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":577,"maxAge":578,"enrollmentInfo":579,"targetDuration":4,"studyType":23,"phases":581,"briefSummary":582,"conditions":583,"keywords":584,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":592,"leadSponsor":594,"locationsCount":596},"100613353","phase-3-a-study-to-investigate-safety-and-efficacy-of-tapinarof-cream-1-in-participants-ages-3-months-to--24-months-with-atopic-dermatitis-100613353","NCT07265479","A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to \u003C 24 Months With Atopic Dermatitis","A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to \u003C 24 Months With Atopic Dermatitis","Adoring","Inclusion Criteria:\n\n* Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to \\\u003C24 months of age at the Screening visit.\n* Clinical diagnosis of atopic dermatitis (AD), AD covering \\>5% Body Surface Area (BSA) and validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4\n* Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities\n* Legal guardian or primary caregiver is able and willing to adhere to protocol requirements\n\nExclusion Criteria:\n\n* Significant neurological disorder or history of seizure\n* Know clinically significant cardiac rhythm or cardiac disorder\n* History of sudden infant death in a sibling\n* Clinically significant chromosome abnormality\n* History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation\n* Diseases that could cause pruritic and\u002For sleep disruption\n* Immunocompromised\n* Current chronic or acute infection requiring treatment\n* Use of prohibited medication(s) or procedure(s)\n* Use of prohibited medications by breastfeeding mother if breastfeeding participant","3 Months","23 Months",{"count":580,"type":22},180,[243],"The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.",[32],[585,294,586,587],"Pediatric Atopic Dermatitis","tapinarof","topical","2026-06-03",{"date":590,"type":42},"2026-06-04",{"date":369,"type":42},{"date":593,"type":22},"2028-01",{"name":595,"class":75},"Organon and Co",47,{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":50},"100620049","phase-4-utilization-of-a-microdevice-for-psoriasis-and-atopic-dermatitis-100620049","NCT07352566","Utilization of a Microdevice for Psoriasis and Atopic Dermatitis","Utilization of a Cutaneous Therapy In Situ Microdevice","Inclusion Criteria:\n\n\\> 18 years of age patients with atopic dermatitis or psoriasis if female patient with child bearing potential (on oral contraceptive pills or intrauterine device for at least 30 days)\n\nExclusion Criteria: None",{"count":605,"type":22},10,[384],"This study is being done to test a microdevice, which is a small device designed to test drugs directly on skin conditions like atopic dermatitis (eczema) and psoriasis.\n\nThe small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. Very small amounts of these medications will be released into the skin (at levels in your body much lower than are typically used). In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. We will also look at how these reactions are connected to genetic information and overall treatment results.",[434,32],"2026-06-01",{"date":588,"type":42},{"date":612,"type":22},"2026-08-01",{"date":614,"type":22},"2030-06-01",{"name":524,"class":399}]