[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-to-severe-atopic-dermatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-to-severe-atopic-dermatitis":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,68,92,115,136,157,179,199,221,241],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100641772","phase-2-pharmacokinetics-safety-and-efficacy-of-nemolizumab-in-participants-aged-6-to-23-months-with-moderate-to-severe-atopic-dermatitis-100641772",false,"NCT07660835","Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Moderate-to Severe Atopic Dermatitis","A Multicenter, Open-Label, Single-Group Clinical Study to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab in Pediatric Subjects (Aged 6 to 23 Months) With Moderate-to-Severe Atopic Dermatitis Not Adequately Controlled With Topical Therapy","NemoBaby","Inclusion Criteria\n\n* Participants greater than and equal to (\\>=) 6 to less than (\\\u003C) 24 months of age at the screening visit.\n* Diagnosis of AD according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit.\n* Eczema Area and Severity Index (EASI) score \\>= 16 at both screening and baseline visits.\n* Investigator's Global Assessment (IGA) score \\>= 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both screening and baseline visits.\n* AD involvement \\>= 10 percent (%) of body surface area (BSA) at both screening and baseline visits. (Note: BSA to be derived from the SCORing Atopic Dermatitis (SCORAD).)\n* Weekly average of worst scratch\u002Fitch Numeric Rating Scale (WSI-NRS) score of at least 4 at both screening and baseline visits as assessed by the parent(s)\u002Fcaregiver:\n\n  * Screening WSI-NRS score will be determined by a single WSI-NRS assessment (score ranging from 0 to 10) for the 24-hour period immediately preceding the screening visit.\n  * Baseline WSI-NRS score will be determined based on the average of daily WSI-NRS scores (score ranging from 0 to 10) during the 7 days immediately preceding baseline (rounding not permitted). A minimum of 4 daily scores out of the 7 days immediately preceding baseline is required for this calculation. For participants who do not have at least 4 daily scores reported during the 7 days immediately preceding the planned enrollment date, enrollment should be postponed until this requirement is met, without exceeding the maximum screening duration of 4 weeks.\n* Documented history by a physician and\u002For investigator of inadequate response to existing topical AD medications or use of systemic therapies for control of the disease (within 6 months before the screening visit).\n* Participant's parent(s)\u002Fcaregiver willing and able to comply with all time commitments and procedural requirements of the clinical study protocol.\n* Participant's parent(s)\u002Fcaregiver understand and sign a parental Informed Consent Form (ICF) before any study-related procedures are performed.\n* Participant's parent(s)\u002Fcaregiver agree to apply a moisturizer daily from the screening visit and liberally as needed throughout the study; if applying a prescribed topical corticosteroid (TCS) prior to study enrollment, agree to continue at the same stable dose from screening and throughout the study as determined appropriate by the investigator.\n\nExclusion Criteria\n\n* Body weight \\\u003C 5 Kilograms (kg).\n* Child in Care: a child placed under the control or protection of an agency, organization, institution, or entity by courts or government authorities under applicable law or regulation.\n* Cutaneous infection within 1 week before the baseline visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit. Participants may be rescreened once the infection has resolved.Note: A participant with mild, localized superficial infection may be included based on investigator discretion.\n* Having received any of the following treatments within the specified timeframe before the baseline visit:\n\nCoal tar products - 2 weeks Topical Janus kinase (JAK) inhibitor - 2 weeks Topical phosphodiesterase-4 (PDE-4) inhibitor - 2 weeks Medium and higher potency TCS - 2 weeks Topical calcineurin inhibitor (TCI) - 2 weeks Topical medications with occlusive dressings (e.g., wet wraps) - 2 weeks Systemic corticosteroids (inhaled and intraocular permitted) - 4 weeks Immunosuppressive or immunomodulatory drugs (e.g., cyclosporine A, oral tacrolimus, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, JAK inhibitors) - 4 weeks or 5 half-lives (whichever is longer) Biologics and biosimilars (e.g., etanercept, adalimumab, infliximab, omalizumab) - 8 weeks or 5 half-lives (whichever is longer) Dupilumab - 10 weeks Live (attenuated) vaccine - 4 weeks Alternative medicine for AD (e.g., traditional Chinese medicine) - 2 weeks For participants with planned live (attenuated) vaccination during the study, consultation with a pediatrician will determine whether vaccination should be postponed until study completion or administered before study start without compromising health. Inactivated vaccines (e.g., diphtheria, tetanus, pertussis (DPT), hepatitis A, hepatitis B, inactivated polio vaccine (IPV), haemophilus influenzae type B, meningococcal, pneumococcal, influenza) are permitted.\n\n* Participants who, after a full 16-week treatment course with dupilumab, experienced worsening of AD or failed to achieve minimal improvement (e.g., \\\u003C= 10% reduction in EASI or no reduction in IGA).\n* History of lymphoproliferative disease or malignancy of any organ system before the screening visit.\n* History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or any study treatment excipients.\n* Known or suspected primary immunodeficiency.\n* History of, or current confounding skin condition (e.g., Netherton syndrome, psoriasis, contact dermatitis, dermatitis herpetiformis, erythroderma, ichthyosis, scabies) that may interfere with study assessments.\n* Any medical condition (e.g., serious cardiac, hepatic, pulmonary \\[including uncontrolled asthma\\], or hematologic disease) or clinically relevant laboratory abnormality during screening that may place the participant at significant risk or interfere with study assessments (e.g., poor venous access or needle phobia). Note: Laboratory tests with abnormal results may be repeated once during screening; the last value will determine eligibility.\n\nUncontrolled asthma defined as one or more of the following:\n\n* Asthma exacerbation requiring hospitalization since birth (\\\u003C=12 months of age) or within the preceding 12 months (\\>12 months of age)\n* Daytime asthma symptoms \\>2 times per week during the preceding 3 months\n* Nighttime awakenings \\>2 times per month during the preceding 3 months\n* Asthma exacerbation requiring oral corticosteroids or additional Short-Acting\n* Beta-Agonist (SABA) inhalers \\>2 times per week during the preceding 3 months\n\n  * Planned or expected major surgical procedure during the clinical study.\n  * Planned or anticipated use of prohibited medications during the study.\n  * Currently participating or participated in another clinical study of an investigational drug or device within the past 8 weeks (or 5 half-lives, whichever is longer) before the screening visit, or currently in an exclusion period from a previous clinical study.","ALL","6 Months","23 Months",{"count":21,"type":22},35,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The primary objective of the study is to assess the pharmacokinetics (PK) and safety of nemolizumab in pediatric participants (aged 6-23 months) with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical treatments.",[28],"Moderate-to-Severe Atopic Dermatitis","NOT_YET_RECRUITING","2026-06-16",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":22},"2026-06-30",{"date":37,"type":22},"2028-07-15",{"name":39,"class":40},"Galderma R&D","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100587889","phase-1-phase-1a1b-study-of-trb-061-in-healthy-participants--patients-with-atopic-dermatitis-100587889","NCT06934252","Phase 1a\u002F1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis","A Phase 1a\u002F1b Randomized, Double-Blind, Placebo-Controlled, 3-Part Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Doses of TRB-061 in Healthy Participants and in Patients With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent.\n2. Body weight ≥50 kg and a body mass index (BMI)between 18.5 and 35.0 kg\u002Fm², inclusive.\n3. Participant is in good general health as determined by the investigator, based on medical history, physical examination, and clinical laboratory tests.\n4. For healthy participants (SAD and MAD): no clinically significant abnormalities in ECGs at screening.\n5. For participants in Phase 1b: Confirmed diagnosis of AD with onset of symptoms at least 1 year prior to Screening.\n6. Must be nonpregnant and nonlactating with negative pregnancy tests at screening and prior to dosing.\n7. Must be a non-smoker or ≤5 cigarettes per week for the past 6 months (SAD\u002FMAD only).\n8. For participants in Phase 1b: Moderate-to-severe AD at Screening and at Day 1 visit\n9. Agrees to abstain from the use of tetrahydrocannabinol (THC)-containing products while on study.\n\nExclusion Criteria:\n\n1. History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the participant at risk or interfere with study results.\n2. History or presence of any condition requiring systemic immunosuppressive or immunomodulatory therapy within a defined period before screening.\n3. Use of any biologic agent (e.g., monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before Day 1.\n4. Participation in another investigational drug trial within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before Day 1.\n5. History of hypersensitivity or allergic reaction to any component of the study drug or placebo formulation.\n6. Known active or latent tuberculosis (TB) infection. or history of incomplete TB treatment.\n7. Positive test at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) RNA, or human immunodeficiency virus (HIV).\n8. Active infection or history of serious infections within 4 weeks prior to Day 1.\n9. Clinically significant ECG abnormalities (e.g., QTcF\\>470 ms) or other cardiac risk factors.\n10. Abnormal and clinically significant laboratory values at screening.\n11. Use of live vaccines within 4 weeks before Day 1.\n12. Use of systemic corticosteroids, immunosuppressants, or immunomodulatory drugs within protocol-defined washout periods (Part 3 only).\n13. Recent history of alcohol or drug abuse as defined per protocol.\n14. Use of tobacco\u002Fnicotine products beyond protocol-allowed limits (SAD and MAD).\n15. Positive cotinine test at check-in (SAD\u002FMAD only).\n16. Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study.\n17. Any medical or psychiatric condition that, in the opinion of the Investigator or Sponsor's medical monitor, would place the participant at risk, interfere with study participation, or interfere with the interpretation of study results.\n18. Surgery within the past 90 days prior to dosing as determined by the Investigator or Sponsor's medical monitor to be clinically relevant or planned surgery to be performed during the study and 30 days after the last dose of study drug",true,"18 Years","70 Years",{"count":52,"type":22},115,[54],"PHASE1","This Phase 1a\u002F1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). The number of dosing cohorts may be increased or decreased in Part 1 (SAD) or Part 2 (MAD).\n\nPart 1 (SAD): Healthy participants receiving single doses of TRB-061 or placebo.\n\nPart 2 (MAD): Healthy participants receiving multiple doses (3 doses over 8 weeks) of TRB-061 or placebo.\n\nPart 3 (Phase 1b): Participants with moderate-to-severe AD receiving repeated doses (4 doses over 12 weeks) of TRB-061 or placebo.",[57],"Moderate-to-severe Atopic Dermatitis","RECRUITING","2026-06-15",{"date":30,"type":33},{"date":62,"type":33},"2025-05-02",{"date":64,"type":22},"2028-02-29",{"name":66,"class":40},"TRex Bio, Inc.",15,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":48,"sex":17,"minAge":49,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100635898","phase-1-a-3-part-study-of-syx-5219-in-healthy-volunteers-and-participants-with-atopic-dermatitis-100635898","NCT07558668","A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis","A Multi-part, FiH Study in Healthy Participants and Participants With Atopic Dermatitis (AD) to Assess the Safety, Tolerability, Pharmacokinetics (PK) of Single & Multiple Ascending Doses and Selected Dose of SYX-5219 (AD Participants).","Inclusion Criteria:\n\nParts 1 \\& 2\n\n* Healthy male and female participant, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of 18-32 kg\u002Fm2.\n* Female participant of non-childbearing potential or female of childbearing potential that is sexually abstinent.\n* No clinically significant abnormalities in laboratory, vital signs or ECG measurements.\n\nPart 3\n\n* Male and female participants with clinically confirmed diagnosis of active AD, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of ≤40 kg\u002Fm2.\n* Meet minimum AD entry criteria;\n\n  * AD covering ≥10% of the body surface area (BSA) at screening and baseline.\n  * Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.\n  * Validated Investigator's Global Assessment (vIGA) score of ≥ 3 (moderate) at screening and baseline.\n  * Peak Pruritus NRS score of ≥ 4 at screening and baseline.\n\nExclusion Criteria:\n\nParts 1 \\& 2\n\n• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.\n\nPart 3\n\n* 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.\n* Has medical history as stated in the main study exclusion criteria.\n* Received treatment(s) as stated in the main study exclusion criteria.","65 Years",{"count":77,"type":22},149,[54],"The purpose of this study is to evaluate the study drug, SYX-5219, in a multi-part First-in-Human (FiH) study to be conducted in healthy volunteers and participants with Atopic Dermatitis (AD). The objectives of this study are to determine the safety, tolerability and levels of SYX-5219 in the blood and urine when SYX-5219 is given in each part of the study (SAD, MAD, Food Effect and Participants with AD).\n\nThe study will be split into up to 3 parts as follows:\n\n* Part 1 - Single Ascending Dose (SAD) and Food Effect in healthy volunteers\n* Part 2 - Multiple Ascending Dose (MAD) in healthy volunteers\n* Part 3 - Multiple Dose in Participants with AD - enrolling up to 45 males and females with a confirmed diagnosis of AD of at least 6 months, evaluating multiple dose administrations of SYX-5219 or placebo daily over a period of 42 days.",[81],"Moderate to Severe Atopic Dermatitis","2026-04-22",{"date":84,"type":33},"2026-04-30",{"date":86,"type":33},"2025-02-26",{"date":88,"type":22},"2026-09-30",{"name":90,"class":40},"Sitryx Therapeutics Ltd",14,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100609206","phase-2-a-study-to-investigate-the-efficacy-and-safety-of-shr-1905-in-patients-with-moderate-to-severe-atopic-dermatitis-100609206","NCT07211542","A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis","A Randomized, Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of SHR-1905 Injection in Patients With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. The subjects have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the researcher, understand and are willing to strictly abide by the requirements of this clinical research protocol to complete the study.\n2. At the time of signing the informed consent, the subjects are ≥ 18 years old and ≤ 75 years old, male or female.\n3. Have atopic dermatitis at screening.\n\nExclusion Criteria:\n\n1. Hypersensitivity to the study drug or any ingredient in the study drug.\n2. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of Atopic Dermatitis (AD).\n3. Has malignancy or has a history of malignancy.\n4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial.\n5. Females who are pregnant or lactating.","75 Years",{"count":101,"type":22},75,[25],"This trial was designed to evaluate the efficacy and safety of SHR-1905 in patients with moderate-to-severe atopic dermatitis.",[57],"2026-04-02",{"date":107,"type":33},"2026-04-08",{"date":109,"type":33},"2025-11-07",{"date":111,"type":22},"2027-02",{"name":113,"class":40},"Guangdong Hengrui Pharmaceutical Co., Ltd",1,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":99,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":4},"100631556","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ak139-in-patients-with-moderate-to-severe-atopic-dermatitis-100631556","NCT07502222","A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Able to understand the study and voluntarily sign the ICF.\n2. Atopic dermatitis (AD) diagnosed at least 6 months before screening.\n3. Eczema Area and Severity Index (EASI) score ≥16, Investigator's Global Assessment (IGA) score ≥3, and Body surface area (BSA) involvement ≥10% at both screening and baseline.\n4. A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline.\n5. Inadequate response or intolerance to prior topical therapy for AD.\n6. The patients agree to use highly effective contraception methods from the moment of signing of the ICF to 90 days after the last dose of the investigational product.\n\nExclusion Criteria:\n\n1. Acute onset of AD within the first 4 weeks of randomization.\n2. Received systemic corticosteroids, immunosuppressive\u002Fimmunomodulatory drugs, phototherapy or other systemic therapies used for AD within the 4 weeks before randomization.\n3. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)\n4. Received or planned to receive live vaccine treatment within the 12 weeks before randomization or during the study period.\n5. Received allergen specific immunotherapy within the 12 weeks before randomization.\n6. Have a history of allergies to any component of AK139 and\u002For severe allergic reactions to monoclonal antibodies.",{"count":123,"type":22},168,[25],"This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.",[28],"2026-03-25",{"date":129,"type":33},"2026-03-30",{"date":131,"type":22},"2026-04-07",{"date":133,"type":22},"2028-01-10",{"name":135,"class":40},"Akeso",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":99,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100628705","phase-2-a-multicenter-randomized-double-blind-placebo-controlled-phase--clinical-study-to-evaluate-the-efficacy-and-safety-of-cms-d001-in-adult-patients-with-moderate-to-severe-atopic-dermatitis-100628705","NCT07465120","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n* Aged 18-75 years, willing to sign the ICF\n* Clinical diagnosis of AD (Hanifin \\& Rajka criteria) for ≥1 year\n* At screening and baseline, EASI score ≥ 16 points, IGA ≥ 3, BSA ≥ 10%, Itch NRS ≥ 4\n* Documented history of inadequate response to topical corticosteroids (TCS) or -topical calcineurin inhibitors (TCI).\n* Subject has applied a topical emollient (moisturizer) daily for at least 7 days prior to the Baseline Visit.\n\nExclusion Criteria:\n\n* Other active skin conditions that may interfere with AD assessment.\n* History of a serious bacterial, fungal, or viral infection requiring hospitalization or intravenous antimicrobial therapy within 3 months prior to the first dose.\n* History of a bacterial, fungal, or viral infection requiring oral antimicrobial therapy within 4 weeks prior to the first dose.\n* Active infection or acute illness within 7 days prior to the first dose.\n* Chronic or recurrent infectious diseases at screening or baseline that may increase safety risks.\n* Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.\n* History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation.\n* History of malignant tumour within 5 years before screening.\n* Previous or current autoimmune diseases.\n* Positive results of confirmatory test for hepatitis B, hepatitis C, human\n* immunodeficiency virus (HIV) or syphilis.\n* Allergic to any component of the investigational drug.",{"count":143,"type":22},160,[25],"This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial, aiming to evaluate the efficacy, safety, and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis, as well as to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CMS-D001 and its major metabolites (as applicable) in participants with moderate to severe atopic dermatitis, so as to provide a basis for the dosage of the Phase III confirmatory clinical trial.",[81],"2026-03-08",{"date":149,"type":33},"2026-03-11",{"date":151,"type":22},"2026-03-20",{"date":153,"type":22},"2027-05-31",{"name":155,"class":40},"Dermavon Holdings Limited",28,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":99,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":114},"100621460","phase-3-evaluation-of-the-efficacy-and-safety-of-oral-lw402-tablets-for-the-treatment-of-patients-with-moderate-to-severe-atopic-dermatitis-100621460","NCT07370909","Evaluation of the Efficacy and Safety of Oral LW402 Tablets for the Treatment of Patients With Moderate-to-Severe Atopic Dermatitis","A Multi-center, Randomized, Double Blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of LW402 Tablets in Patients With Moderate-to-severe Atopic Dermatitis.","Inclusion Criteria:\n\n* Subjects voluntarily provided informed consent and agreed to participate in the study.\n* Gender: no restrictions; Age: 18 to 75 years inclusive (as of the date of signing the informed consent form).\n* At screening, subjects met the Hanifin-Rajka diagnostic criteria for atopic dermatitis (AD) (Appendix 4) and had a documented AD history of ≥1 year prior to screening.\n* At screening and baseline visits, subjects were required to have moderate-to-severe atopic dermatitis (AD) with all three of the following criteria satisfied:\n\n  * Total AD lesion area ≥ 10% of body surface area (BSA)\n  * Investigator's Global Assessment (IGA) score ≥ 3\n  * Eczema Area and Severity Index (EASI) score ≥ 16\n\nExclusion Criteria:\n\n* Subjects with a documented history of hypersensitivity to Janus kinase (JAK) inhibitors.\n* Subjects with current or a history of autoimmune diseases other than atopic dermatitis (AD) (e.g., systemic lupus erythematosus \\[SLE\\], inflammatory bowel disease \\[IBD\\], Felty's syndrome, scleroderma, inflammatory myopathy, other connective tissue diseases, overlap syndrome) or other skin conditions that may interfere with AD assessment (e.g., contact dermatitis, psoriasis).",{"count":165,"type":22},480,[167],"PHASE3","This Phase 3, double-blind (sponsor-open), multicenter, placebo-controlled study aims to evaluate the efficacy and safety of oral LW402 tablets in patients with moderate to severe atopic dermatitis.",[81],"2026-01-27",{"date":172,"type":33},"2026-01-29",{"date":174,"type":22},"2026-01-30",{"date":176,"type":22},"2028-12-31",{"name":178,"class":40},"Shanghai Longwood Biopharmaceuticals Co., Ltd.",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":99,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":4},"100619394","phase-2-a-phase-ii-study-of-qls12010-capsules-in-adults-with-moderate-to-severe-atopic-dermatitis-100619394","NCT07344051","A Phase II Study of QLS12010 Capsules in Adults With Moderate to Severe Atopic Dermatitis","A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. At screening, the diagnosis of atopic dermatitis (AD) shall meet the Hanifin-Rajka criteria, with a duration of AD ≥ 1 year prior to baseline;\n2. At screening and baseline: Eczema Area and Severity Index (EASI) score ≥ 16 points, Investigator's Global Assessment (IGA) score ≥ 3 points, and body surface area (BSA) affected by AD ≥ 10%;\n3. At baseline: Weekly mean score of Pruritus Numerical Rating Scale (PP NRS) ≥ 4 points (with daily PP NRS scores recorded on at least 4 days within the 1 week prior to baseline);\n\nExclusion Criteria:\n\n1. Participants with other medical conditions (excluding AD) that, as determined by the investigator, may interfere with the evaluation of efficacy or safety in this study, including but not limited to psoriasis, seborrheic dermatitis, systemic lupus erythematosus, moderate-to-severe acne, infectious folliculitis, etc.;\n2. History of severe cardiovascular and cerebrovascular diseases occurring within 6 months prior to screening, including but not limited to unstable angina pectoris, New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, cardiomyopathy, cerebral hemorrhage, acute cerebral infarction, etc.;\n3. Participants with a history of prior use of IRAK4 degraders, small-molecule IRAK4 inhibitors, or similar agents;\n4. Participants who have received treatment with other investigational products (IPs) within 3 months or 5 half-lives (whichever is longer) prior to screening;\n5. Pregnant or lactating women, or participants with a positive pregnancy test result at screening;",{"count":143,"type":22},[25],"This trial was designed to evaluate the efficacy and safety of QLS12010 Capsules in adults with moderate-to-severe atopic dermatitis.",[57],"2026-01-07",{"date":192,"type":33},"2026-01-15",{"date":194,"type":22},"2026-04-05",{"date":196,"type":22},"2027-09",{"name":198,"class":40},"Qilu Pharmaceutical Co., Ltd.",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100534475","phase-3-efficacy-and-safety-of-methotrexate-versus-placebo-in-adults-with-atopic-dermatitis-100534475","NCT06239311","Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.","A Phase 3, Randomised, 2-arm, Parallel-group, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Subcutaneous Methotrexate Versus Placebo in Moderate to Severe Atopic Dermatitis.","Inclusion Criteria:\n\n* Woman of childbearing potential must have a negative pregnancy test at the Screening Visit and must agree to use highly effective methods of contraception while taking the investigational medicinal product (IMP) and for 6 months after the last IMP administration. Men must agree to use a condom during intercourse while taking the IMP and for 3 months after the last IMP administration. They must also agree to not donate sperm for the time period starting at the Screening Visit, throughout the entire trial period, and for at least 3 months after the last IMP administration.\n* Diagnosis of atopic dermatitis (AD) at least 12 months prior to the Screening Visit, diagnosed as defined by the Hanifin and Rajka criteria for AD 4.\n* Moderate to severe AD, defined as the following criteria at the Baseline Visit: Eczema Area and Severity Index (EASI) ≥ 16, Investigator Global Assessment (IGA) ≥ 3, Dermatology Life Quality Index (DLQI) ≥ 10\n* Eligible for systemic treatment, ie, documented history (within 12 months prior to Baseline Visit) of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)s or documented systemic treatment for AD (such as cyclosporine (CYC), azathioprine and\u002For mycophenolate mofetil). Inadequate response to TCS or TCI is defined as failure to obtain or maintain a remission or a low activity disease (IGA ≥ 2) despite a daily treatment with a class 2 or class 3 TCS or TCI for 28 days (or the maximal authorised duration according to the Summary of Product Characteristics (SmPC))\n* Treated with a stable dose of topical emollient, for at least 7 consecutive days prior to the Baseline Visit\n* Chest X-ray without clinically relevant abnormalities performed within the last 6 months prior to the Baseline Visit\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n* Willing and able to comply with the protocol requirements for the duration of the trial\n* Covered by health care insurance in accordance with local requirements\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women, or planning to become pregnant, or to breastfeed during the trial\n* Previously treated with MTX\n* Presenting a known hypersensitivity to MTX or folic acid as well as to any of the excipients\n* Presenting ulcers of the oral cavity and known active gastrointestinal ulcer disease\n* Presenting with known blood dyscrasia (haemoglobin \\\u003C 8.0 g\u002FdL or white blood cell count \\\u003C 4000\u002Fmm3 or platelet count \\\u003C 100000\u002Fmm3)\n* Presenting liver impairment and\u002For aspartate transaminase (AST) or alanine aminotransferase (ALT) \\> 2 times the upper limit of normal (ULN), or bilirubin \\> 5 mg\u002FdL (85.5 μmol\u002FL), or a positive result in the FibrotestTM at the Screening Visit\n* Presenting drug or alcohol abuse within the last 12 months\n* Presenting renal impairment (creatinine clearance less than 60 mL\u002Fmin)\n* Presenting serious, acute or chronic infections such as tuberculosis, hepatitis B or C, HIV positive, or other immunodeficiency syndromes\n\n  1. A positive test result at Screening for hepatitis B surface antigen (HBsAg) and\u002For core antibodies (anti-HBc) excludes the patient from trial participation. Patients with positive surface antibodies (anti-HBs) and a history of hepatitis B virus (HBV) vaccination may be included.\n  2. A positive test result at Screening for hepatitis C (positive hepatitis C virus (HCV) antibody test confirmed with positive hepatitis C RNA test) excludes the patient from trial participation, even if they have received appropriate and effective treatment, due to the risk of reactivation.\n  3. If the interferon-gamma release assay shows a positive result at the Screening Visit the patient may only be included in the trial if the tuberculosis is latent and all of the following 3 conditions are true: (i) Chest X-ray does not show evidence suggestive of active tuberculosis. (ii) There are no clinical signs and symptoms of pulmonary and\u002For extra-pulmonary tuberculosis. (iii) Documented receipt of one of the following prophylactic treatment regimens: Oral daily isoniazid for 6 months or Oral daily rifampin for 4 months or Isoniazid and rifapentine weekly for 3 months. The IMP can only be administered to a participant with a positive test result in the interferon-gamma release assay (or an indeterminate result if only 1 test is done, or 2 indeterminate results if a second test is done after the first indeterminate test result) after the approval of a tuberculosis specialist.\n* Presenting uncontrolled infection, hospitalisation due to uncontrolled infection or treatment with intravenous antibiotics for infection within 2 months prior to the Baseline Visit\n* Presenting a history of malignancy, including solid tumours and haematologic malignancies, except non-melanoma skin cancer (epithelial cell carcinoma or basal cell carcinoma) and cervical carcinoma in situ that have been treated with no evidence of recurrence during the past 5 years\n* Currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of AD (eg. psoriasis, lupus erythematosus, eczema herpeticum)\n* Treated with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the Baseline\n* Treated with TCS, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the Baseline Visit\n* Treated with oral corticosteroids, azathioprine, mycophenolate mofetil, CsA (Ciclosporin A) or any other systemic immunosuppressor \u002F immunomodulator within 4 weeks before the Baseline Visit\n* Treated by specific allergen immunotherapy started within 3 months before the Baseline Visit 17\n* Treated with a monoclonal antibody (including but not limited to dupilumab or tralokinumab) within the last 3 months or 5 times the half-life of the respective monoclonal antibody (whichever is the longer period) or with any JAK (Janus kinase) inhibitors (including but not limited to ruxolitinib, baricitinib, tofacitinib, upadicitinib, or abrocitinib) within the last 4 weeks prior to the Baseline Visit\n* Treated with any parenteral corticosteroid within 6 weeks prior to the Baseline Visit\n* Treated with ultraviolet therapy within 4 weeks prior to the Baseline Visit\n* Received a live (attenuated) vaccine within 4 weeks before the Baseline Visit or planning to be vaccinated with live vaccine during the trial. Please note: Since MTX may have an effect on the immune system, vaccination with live vaccines must not be performed during MTX administration\n* Having a planned surgery during the trial\n* Presenting a clinically significant medical disease that is uncontrolled despite treatment that, in the opinion of the Investigator, is likely to impact the ability to participate in the trial or to impact the trial efficacy or safety assessments\n* Presenting any additional condition that, in the opinion of the Investigator, may interfere with the assessment or may put the participant at risk\n* Protected by the law (adult under guardianship, or hospitalised in a public or private institution for a reason other than this trial, or incarcerated)\n* Persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical trials, and persons, who due to their age, disability or state of health are reliant on care and for that reason accommodated in residential care institutions, that is accommodations providing an uninterrupted assistance for persons who necessitate such assistance, are in a situation of subordination or factual dependency and therefore may require specific protective measures",{"count":207,"type":22},277,[167],"Atopic dermatitis is an ongoing condition that causes skin irritation, redness, and itchiness. Treatments are usually topical - applied to the skin (e.g., moisturisers or medicated creams) - but a wider variety of systemic treatments (that target the whole body) are needed for those whose condition does not improve with topical treatments. Methotrexate, a drug approved for similar conditions such as arthritis and psoriasis, has been shown to improve atopic dermatitis. This randomised, controlled clinical trial will investigate how effective.",[81],"2025-08-20",{"date":213,"type":33},"2025-08-27",{"date":215,"type":33},"2024-02-27",{"date":217,"type":22},"2027-04",{"name":219,"class":40},"medac GmbH",30,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":99,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":114},"100571655","phase-3-phase-iii-clinical-study-of-vc005-tablets-in-adult-patients-with-moderate-to-severe-atopic-dermatitis-100571655","NCT06723080","Phase III Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n(1）The patient understands and voluntarily signs the Informed Consent Form (ICF), and has the willingness and ability to complete the regular visits,treatment plans, laboratory tests and other experimental procedures required by the program. (2) Male or female patients aged ≥18 and ≤75 years at the time of signing the ICF. (3) Meet Hanifin-Rajka diagnostic criteria at screening and have atopic dermatitis （AD) symptoms for at least 1 year prior to baseline. (4) At screening and baseline, meets criteria for moderately severe AD based on the investigator's assessment of 3 of the following:Eczema area and severity index (EASI) score ≥12;Psoriasis Area Severity Index (IGA) score ≥3;AD involvement in ≥10% of the Body Surface Area (BSA). (5) Recent (within 1 year prior to screening) topical treatment for AD with inadequate or intolerant clinical response, as determined by the investigator\n\nExclusion Criteria:\n\n(1) Inability to swallow the test drug or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunt, or the presence of a gastrointestinal disorder (e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption condition that interferes with the absorption of the drug; (2) Current or history of lymphoproliferative disorders or presence of signs or symptoms suggestive of possible lymphoproliferative disorders of lymphoid tissue, including lymphadenopathy or splenomegaly; malignancies of any kind, or a history of any malignancy within the 5 years prior to Screening (except for completely resected carcinoma in situ of the cervix or non-metastatic squamous cell or basal cell carcinoma of the skin or papillary carcinoma of the thyroid gland); (3) Patients with prior thromboembolism (including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc.) or other high-risk groups prone to thromboembolism; (4) Patients with a history of herpes virus infection within the last 1 month or those with recurrent episodes of herpes zoster (≥2), disseminated herpes zoster, disseminated herpes simplex, or those for whom herpes zoster or herpes simplex infections cannot be excluded at this time;",{"count":165,"type":22},[167],"This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study",[81],"2025-02-07",{"date":234,"type":33},"2025-02-11",{"date":236,"type":33},"2024-12-30",{"date":238,"type":22},"2027-08-30",{"name":240,"class":40},"Jiangsu vcare pharmaceutical technology co., LTD",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":249,"targetDuration":251,"studyType":252,"phases":4,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":265},"100290215","treatgermany-german-national-clinical-registry-for-patients-with-moderate-to-severe-atopic-dermatitis-100290215","NCT03057860","TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis","TREATgermany: German National Clinical Registry: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis","TREATgermany","Inclusion Criteria:\n\n* AD according to the United Kingdom (UK) working party diagnostic criteria\n* Moderate to severe AD\n* Objective SCORAD \\> 20 or Currently anti-inflammatory systemic treatment for AD or Previous anti-inflammatory systemic treatment for AD within past 24 months\n\nExclusion Criteria:\n\n\\-",{"count":250,"type":22},2800,"5 Years","OBSERVATIONAL","About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence.\n\nSome children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy.\n\nSystematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA).\n\nPharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany).\n\nLarge head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative.\n\nIn this situation, clinical registries can provide valuable information for evidence-based clinical decision making.\n\nExtension of TREATgermany to children and adolescents is necessary as\n\n* moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood\n* it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone\n* innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria\n* adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group\n* Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care",[57],"2022-05-03",{"date":257,"type":33},"2022-05-09",{"date":259,"type":33},"2016-02-01",{"date":261,"type":22},"2026-12-31",{"name":263,"class":264},"Technische Universität Dresden","OTHER",3]