[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-spontaneous-urticaria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-spontaneous-urticaria":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,46,73,103,126,151,181,202,222,253,271,293,317,342,363],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100609825","phase-2-a-study-to-learn-about-ritlecitinib-for-the-potential-treatment-of-chronic-spontaneous-urticaria-in-adults-100609825",false,"NCT07219615","A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.","A PHASE 2B RANDOMIZED, DOUBLE-BLIND, 12-WEEK PLACEBO-CONTROLLED STUDY WITH A 12-WEEK DOUBLE-BLIND EXTENSION PERIOD TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH CHRONIC SPONTANEOUS URTICARIA","Inclusion Criteria:\n\nAge:\n\n1. 18 years of age or older (or the minimum legal adult age as defined per local regulations, whichever is greater) at screening.\n\n   Disease Characteristics:\n2. Participants must meet the following Chronic Spontaneous Urticaria (CSU) criteria:\n\n   a. Chronic spontaneous urticaria diagnosis for ≥3 months at the time of screening (with the onset date assessed by the Investigator based on all available records) b. Diagnosis of CSU inadequately controlled by second generation antihistamine (sgAH) at the time of randomization, defined as: (i) The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of sgAH during this time period.\n\n(ii) Participants must have been on a sgAH at locally approved dose or higher for treatment of CSU for at least 7 consecutive days before screening assessment of UAS7 and ISS7 is initiated.\n\n(iii) Urticaria Activity Score 7 (UAS7) ≥16 (range 0-42) and an Itch Severity Score 7 (ISS7) ≥8 (range: 0-21) during the 7 days prior to randomization Day 1 c. Participants must complete at least 5 Urticaria Activity Score (UAS) eDiary entries during the 7 days immediately preceding randomization (Day 1) to confirm eligibility. If this requirement is not met due to documented, limited circumstances such as technical issues or short-term illness, the screening period may be extended only for the number of days necessary to allow completion of 5 UAS entries within any 7-day window. This extension period must not exceed 7 days.\n\nd. Anti-Immunoglobulin E-naïve (IgE-naïve) and Anti-Immunoglobulin E-experienced (Anti-IgE-experienced) participants. Anti-IgE-experienced participants are defined as meeting any of the following criteria confirmed by the Site Investigator: (i) Did not adequately respond to the approved dosage of an anti-IgE therapy (eg, omalizumab 300 mg Q4W or an alternate approved anti-IgE therapy) for at least 3 months, as assessed by the Investigator (ii) Could not tolerate an anti-IgE therapy (iii) Stopped an anti-IgE therapy for any reason, eg, loss of access e. Anti-IgE-experienced participants must have stopped anti-IgE therapy for at least 16 weeks, or 5 half-lives, whichever is longer, prior to randomization Day 1\n\nExclusion Criteria:\n\nMedical Conditions:\n\n1. Medical conditions pertaining to CSU and other diseases\u002Fconditions affecting the skin\n\n   * Urticaria is solely due to inducible urticaria.\n   * Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals or angioedema symptoms, including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to Complement 1 (C1) inhibitor deficiency).\n   * Any other active skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigold, dermatitis herpetiformis, senile pruritus, etc.).\n2. History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy\u002Fhypersensitivity to any component (including excipients) of the study intervention.\n3. General Infection History:\n\n   * Having a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.\n   * Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1.\n   * Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.\n4. Specific Viral Infection History\n\n   * History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.\n   * Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.\n   * Have a known immunodeficiency disorder (including positive serology for HIV at screening) or a first-degree relative with a hereditary immunodeficiency (unless known negative carrier status).\n5. Other Medical Conditions\n\n   * Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (eg, untreated hyperthyroidism or hypothyroidism), pulmonary, cardiovascular, psychiatric, immunologic\u002Frheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator or Pfizer (or designee), the participant is inappropriate for entry into this study, or unwilling\u002Funable to comply with study procedures and lifestyle requirements.\n   * Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating, or progressive.\n   * Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening.\n   * Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.\n   * Have a history of any lymphoproliferative disorder such as Epstein-Barr Virus (EBV)-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.\n   * Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery. Participants with elective surgery scheduled to occur during the study can only be enrolled with approval of the sponsor.\n6. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Any psychiatric condition including recent or active suicidal ideation or behavior that protocol-defined criteria.\n\n   Prior\u002FConcomitant Therapy:\n7. Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol defined timelines.\n\n   Prior\u002FConcurrent Clinical Study Experience:\n8. Previous administration of an investigational product (drug or vaccine) within 8 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.\n\n   Diagnostic Assessments:\n9. Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.\n10. Screening standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.\n\n    Other Exclusion Criteria:\n11. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of chronic spontaneous urticaria (CSU) that is not effectively treated by antihistamines which are used to stop the body's \"allergy alarm system\" from overreacting. Chronic spontaneous urticaria is a disease that causes itchy hives and swellings in the deep layers of skin and fatty tissue just underneath the skin that come and go without a clear reason.\n\nThis study will look at both the 50 milligrams (mg) once daily (QD) oral dose and 100 milligrams (mg) once daily (QD) oral dose and compare them to placebo (pill with no active medicine).\n\nThis study is seeking participants who:\n\n* Are 18 years of age or older\n* Have a diagnosis of chronic spontaneous urticaria for 3 months or more that has not been controlled well with antihistamine treatment.\n* Do not have any other skin conditions associated with chronic itching or itching caused mainly by known triggers.\n* Are willing to stop all other treatments that they may be taking for chronic spontaneous urticaria other than a second-generation antihistamine (sgAH).\n\nAbout 150 participants will take part in this study. Participants will be chosen by chance, like drawing names out of a hat, to receive either the 50 mg dose or 100 mg dose or placebo, taken by mouth once daily for 12 weeks( Period A). Thereafter the participants on 50 mg and 100 mg will continue on their doses while the participants receiving placebo will be switched to 100mg for an additional 12 weeks (Period B). The 2 doses of ritlecitinib in this study will be compared to each other and to the placebo. This will help to see if the 50 mg and\u002For 100 mg dose of ritlecitinib is safe and effective.\n\nParticipants will be in this study for about 8 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:\n\n* Physical examinations,\n* Hearing tests,\n* Blood tests,\n* X-ray,\n* ECG (electrocardiogram),\n* Participants will also be asked to complete questionnaires every day about their chronic spontaneous urticaria in an electronic diary.",[26],"Chronic Spontaneous Urticaria",[28,29,30,31,32],"Hives","CSU","Urticaria","Chronic Hives","Itch","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2025-10-30",{"date":41,"type":20},"2027-04-23",{"name":43,"class":44},"Pfizer","INDUSTRY",69,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100643203","remibrutinib-in-real-world-clinical-practice---a-germany-sub-study-reassert-100643203","NCT07642557","Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)","Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study (REASSERT) - Local Adaptation in Germany From Global Umbrella Protocol (CLOU064A2402)","Inclusion Criteria:\n\n7.2.1 Inclusion criteria Patients must meet all the following criteria to be eligible for inclusion in this study.\n\n1. Patients with a confirmed diagnosis of primary CSU by the treating physician.\n2. Aged at least 18 years on the date of enrollment.\n3. Written informed consent of the patient to participate in the study and willingness to complete full follow-up period of 24 months.\n4. Cohort-specific observational inclusion criteria:\n\n   1. Cohort 2: Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label.\n   2. Cohort3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. Note, occasional steroid rescue medication is out of scope for cohort definition. If a patient had been on continuous steroids for at least 3 weeks during treatment history, they will be included in cohort 3.\n\nExclusion Criteria:\n\nPatients are excluded if they meet any of the following criteria:\n\n1. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with remibrutinib.\n2. Patients within the safety follow-up phase of a previous interventional or non-interventional study.\n3. Patients who received remibrutinib at any time in the past.\n4. Patients not capable or willing to continuously provide ePRO\u002FeDiary data via electronic means throughout the duration of the study.\n5. Patients who are treated with remibrutinib outside of the local label.","100 Years",{"count":55,"type":20},470,"OBSERVATIONAL","Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to escalate\u002Fswitch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.",[26],[60,61,26,62],"Remibrutinib","Non-Interventional Study","Second-generation H1 antihistamine","NOT_YET_RECRUITING","2026-06-09",{"date":66,"type":37},"2026-06-11",{"date":68,"type":20},"2026-07-10",{"date":70,"type":20},"2029-05-31",{"name":72,"class":44},"Novartis Pharmaceuticals",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100491309","phase-3-24-weeks-double-blind-randomized-placebo-controlled-trial-to-evaluate-efficacy-pk-safety-of-lou064-in-adolescents-12---18-with-csu-and-inadequate-response-to-h1-antihistamine-followed-by-optional-3-years-open-label-extension-and-an-optional-3-years-safety-long-term-treatment-free-follow-up-100491309","NCT05677451","24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - \u003C18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up","A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years","Key Inclusion Criteria:\n\n* Male and female adolescent participants aged \\>= 12 to \\\u003C 18 years of age at the time of signing the informed consent\n* CSU duration for \\>= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation)\n* Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as:\n* The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines\n* UAS7 score (range 0 - 42) \\>= 16, ISS7 score (range 0 - 21) \\>= 6 and HSS7 score (range 0 - 21) \\>= 6 during the 7 days prior to randomization (Day 1)\n* Documentation of hives within three months before randomization (either at screening and\u002For at randomization; or documented in the participants' medical history)\n\nKey Exclusion criteria:\n\n* Previous use of remibrutinib or other BTK inhibitors\n* Significant bleeding risk or coagulation disorders\n* History of gastrointestinal bleeding\n* Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg\u002Fd or clopidogrel up to 75 mg\u002Fd. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited\n* History or current hepatic disease\n* Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant\n* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes\n* Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria\n* Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria\n* Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","12 Years","17 Years",{"count":83,"type":20},100,[85],"PHASE3","The purpose of this trial is:\n\n1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \\\u003C 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines\n2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment\n3. to collect safety data in this population for up to three years after the last dose of study treatment",[26],[89,90,91,92,93],"BTK inhibitor","Chronic spontaneous urticaria","Urticaria activity score","Hives severity score","Itch severity score","2026-06-04",{"date":96,"type":37},"2026-06-05",{"date":98,"type":37},"2023-07-11",{"date":100,"type":20},"2032-03-30",{"name":72,"class":44},66,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100639664","phase-2-a-clinical-trial-of-hrs-3095-in-patients-with-chronic-spontaneous-urticaria-100639664","NCT07613866","A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HRS-3095 in Patients With Chronic Spontaneous Urticaria","Inclusion Criteria:\n\n1. Participants must be between 18 and 70 years of age, inclusive, at the time of signing the Informed Consent Form (ICF), with no restriction on gender.\n2. Participants must have a history of chronic spontaneous urticaria (CSU) with a disease duration of at least 6 months prior to screening.\n3. Participants must be diagnosed with H1-antihistamine-inadequately-controlled CSU at screening, defined as: having had persistent symptoms of pruritus and wheals for ≥6 weeks prior to screening, despite regular use of second-generation H1-antihistamines during that period.\n4. At randomization, the UAS7 score must be ≥16 (range: 0-42) and the HSS7 score ≥ 8 (range: 0-21).\n5. Participants must have been on a stable dose of the specified second-generation H1-antihistamine for at least 3 days prior to the first UAS score at screening.\n6. Participants must be willing and able to complete logbook entries as required during the study and must have no missing daily UAS scores during the 7 days before randomization.\n7. Participants must voluntarily sign the Informed Consent Form (ICF) before any study-related procedures, be able to communicate effectively with the investigator, and be willing to strictly adhere to the requirements of the study protocol.\n8. Female participants of childbearing potential or male participants with a female partner of childbearing potential must agree to avoid donating sperm or ova and must agree to take highly effective contraceptive measures from the time of signing the ICF until 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Any skin disease that could interfere with study assessment (e.g., chronic inducible urticaria, urticarial vasculitis, atopic dermatitis, psoriasis).\n2. Use of systemic or topical medications with therapeutic or immunomodulatory effects on the study disease during the relevant washout period prior to screening.\n3. Use of investigational drugs or medical devices within 8 weeks or 5 half-lives (if known), whichever is longer, or within 30 days (for small molecules) prior to screening.\n4. Vaccination or exposure to live or attenuated vaccines within 3 months prior to screening or participation in a vaccine-related clinical trial within 3 months prior to randomization.\n5. History or current coagulation-related risk (e.g., bleeding diathesis, coagulopathy, GI bleeding with clinical significance, antiplatelet or anticoagulant use, history of thrombosis or thromboembolic events, or increased risk of thrombosis).\n6. History of liver disease or current treatment for liver disease (e.g., hepatitis, cirrhosis, liver failure).\n7. History of systemic antimicrobial use or presence of superficial skin infection (e.g., impetigo) within 4 weeks prior to screening.\n8. History of malignancy or current malignancy (excluding completely resected and recurrence-free basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia).\n9. Major surgery performed within 3 months prior to randomization or planned during the study.\n10. Serious concomitant disease or any condition judged by the investigator to make the participant unsuitable for study participation.\n11. Abnormal findings in vital signs, physical examination, laboratory tests, ECG, chest X-ray\u002FCT, or abdominal ultrasound during screening that have clinical significance and may affect study validity or participant safety.\n12. Pregnant or breastfeeding women.\n13. Allergy to the study drug or any of its components.\n14. History of alcohol abuse within 6 months prior to screening (e.g., \\> 14 units\u002Fweek) or history of illicit drug abuse within 6 months prior to screening.\n15. Any condition judged by the investigator that may affect the safety or efficacy evaluation of the study drug or participant compliance with the study procedures or diary.","70 Years",{"count":112,"type":20},190,[23],"The study is being conducted to evaluate the efficacy, and safety of HRS-3095 with Chronic Spontaneous in adults, and to explore the reasonable dosage of HRS-3095 for Chronic Spontaneous Urticaria.",[26],"2026-05-22",{"date":118,"type":37},"2026-05-29",{"date":120,"type":20},"2026-07",{"date":122,"type":20},"2027-03",{"name":124,"class":44},"Chengdu Suncadia Medicine Co., Ltd.",2,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":134,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100624329","a-real-world-study-of-remibrutinib-in-chronic-spontaneous-urticaria-patients-100624329","NCT07408219","A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients","RELIEF: Remibrutinib in Chronic Spontaneous Urticaria: Early Real World Effectiveness and Satisfaction Survey","RELIEF","Inclusion criteria:\n\nHealthcare provider (HCP) participants eligible to refer patients for inclusion in this study must meet all the following criteria:\n\n1. Have an active medical license and be board certified\u002Fboard eligible allergist or dermatologist in the US. Nurse practitioners and physician assistant practicing in allergy and dermatology are eligible.\n2. Manage CSU patients within their practice.\n3. Enrolled in the research network or are referred HCPs who agree to participate.\n4. Have the requisite patient population based on study inclusion\u002Fexclusion criteria.\n\n   Patients eligible for inclusion in this study must meet all of the following criteria:\n5. ≥ 18 years of age.\n6. Diagnosed with CSU by an HCP.\n7. Have received a prescription for remibrutinib or dupilumab and are expected to initiate treatment.\n8. Have access to an electronic device with internet capabilities.\n9. Able to read and understand English.\n10. Willing and able to provide consent for study participation.\n\nExclusion criteria:\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Unable to procure remibrutinib or dupilumab (through samples, commercially or patient assistance program).\n2. Exposure to oral corticosteroid treatment in 14 days prior to consent.\n3. Exposure to oral corticosteroid treatment in 14 days prior to initiating treatment with remibrutinib or dupilumab.\n4. Prior participation in a remibrutinib or dupilumab clinical trial.\n5. Cognitive impairment that impacts the patient's ability to participate.",{"count":135,"type":20},350,"This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients using validated patient reported outcome (PRO) tools.",[26],[90,60,139,140,141],"Dupilumab","Urticaria control test","Urticaria control test 7 day recall","2026-05-06",{"date":144,"type":37},"2026-05-11",{"date":146,"type":37},"2026-01-17",{"date":148,"type":20},"2026-09-30",{"name":72,"class":44},1,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":158,"sex":16,"minAge":17,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":150},"100634532","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-single-and-multiple-doses-of-edp-978-in-healthy-adults-100634532","NCT07540910","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults","A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human, Phase 1 Study of Orally Administered EDP-978 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-978 Pharmacokinetics in Healthy Adult Participants","Inclusion Criteria:\n\n* An informed consent document signed and dated by the subject.\n* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.\n\nExclusion Criteria:\n\n* Clinically relevant evidence or history of illness or disease.\n* Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit\n* Pregnant or nursing females.\n* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.\n* A positive urine drug screen at screening or Day -1.\n* Current tobacco smokers or use of tobacco within 3 months prior to screening.\n* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).\n* History of regular alcohol consumption.\n* Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.",true,"65 Years",{"count":161,"type":20},98,[163],"PHASE1","This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.",[166,26],"Chronic Inducible Urticaria",[168,169,170,171],"First-in-Human","Single Ascending Dose","Multiple Ascending Dose","Healthy Participant","2026-04-17",{"date":174,"type":37},"2026-04-21",{"date":176,"type":37},"2026-04-01",{"date":178,"type":20},"2026-11",{"name":180,"class":44},"Enanta Pharmaceuticals, Inc",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":150},"100620495","remibrutinib-in-real-world-clinical-practice-100620495","NCT07358364","Remibrutinib in Real-world Clinical Practice","Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study","REASSERT","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of primary CSU by the treating physician.\n* Aged at least 18 years on the date of enrolment.\n* Written informed consent of the patient to participate in the study (according to country specifications) and willingness to complete full follow-up period of 24 months.\n* Cohort-specific observational inclusion criteria:\n\n  * Cohort 1: Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision (independent of study enrolment) to escalate sgH1-AH treatment.\n  * Cohort 2: Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrolment) to switch to remibrutinib treatment as per local label.\n  * Cohort 3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrolment) to switch to remibrutinib treatment as per local label. Note, occasional steroid rescue medication is out of scope for cohort definition. If a patient had been on continuous steroids for at least three weeks during treatment history, they will be included in cohort 3.\n\nNote: Candidate patients must not have initiated the next escalated treatment step (i.e. up dosed AH for cohort 1, or remibrutinib for cohorts 2 and 3) prior to their enrolment to ensure the baseline visit captures their clinical status before treatment escalation.\n\nExclusion Criteria:\n\n* Currently enrolled in a clinical trial or on any experimental treatment.\n* Patients within the safety follow-up phase of a previous interventional or non-interventional study.\n* Patients who received remibrutinib as an investigational medical product during a remibrutinib interventional study or MAP\u002FPSDS at any time in the past.\n* Patients not capable or willing to continuously provide ePRO\u002FeDiary data via electronic means throughout the duration of the study.\n* Patients who are treated with remibrutinib outside of the local label.",{"count":190,"type":20},3280,"Prospective, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate\u002Fswitch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.",[26],[60,61,26,62],"2026-04-13",{"date":196,"type":37},"2026-04-16",{"date":198,"type":37},"2026-02-02",{"date":200,"type":20},"2031-10-30",{"name":72,"class":44},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":150},"100617245","a-study-to-describe-the-real-world-effectiveness-safety-and-patterns-of-use-of-dupilumab-in-patients-with-chronic-spontaneous-urticaria-100617245","NCT07316114","A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria","A Prospective Observational Study of Patients Receiving Dupilumab for Chronic Spontaneous Urticaria","DEDICATION","Inclusion Criteria:\n\n* Patients aged 12 years or older at the time of informed consent\u002Fassent.\n* Physician decision to treat the patient with dupilumab for chronic spontaneous urticaria (CSU) made prior to and independently of the patient's participation in the study.\n* Patient is able to understand and complete study-related questionnaires.\n* Patients and\u002For parent\u002Flegally authorized representative provide voluntary informed consent and\u002For assent to participate in the study before inclusion in the study.\n\nExclusion Criteria:\n\n* Patients who have a contraindication to dupilumab according to the approved prescribing information label.\n* Any condition that the treating physician or virtual Investigator believes may interfere with the patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments.\n* Patients currently participating in any interventional clinical trial.\n* Prior use of dupilumab within 6 months of the baseline assessment.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":211,"type":20},400,"This is a decentralized study designed to describe the real-world effectiveness, safety, and patterns of use of dupilumab in patients with chronic spontaneous urticaria (CSU). This study will be conducted in the United States and will collect data available from participants' medical files, other items routinely collected during disease management in clinical practice, and patient-reported outcomes related to disease, work productivity, quality of life, and CSU-related hospitalizations.\n\nParticipation in this study is the patient's own choice and is entirely voluntary. The treating physician prescribes dupilumab treatment as part of routine care, independently of the study. Once the decision to prescribe dupilumab is made by the treating physician, patients can self-screen and will be contacted by the Virtual Research Coordination Center to determine potential study eligibility. Patients will be enrolled if they provide an informed consent and meet all inclusion criteria and none of the exclusion criteria.\n\nThe duration of the study for each participant is 24 months. All patients will be followed for 24 months or until death, loss to follow-up, or withdrawal, whichever occurs first.",[26],{"date":215,"type":37},"2026-04-14",{"date":217,"type":37},"2026-03-18",{"date":219,"type":20},"2029-11-22",{"name":221,"class":44},"Sanofi",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100587670","phase-2-study-of-blu-808-in-chronic-inducible-urticaria-cindu-and-chronic-spontaneous-urticaria-csu-100587670","NCT06931405","Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)","A Phase 2 Study to Evaluate the Safety, Tolerability, and Clinical Activity of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria","Key Inclusion Criteria:\n\n* Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.\n* Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.\n\nKey Exclusion Criteria:\n\n* Part A: Any active urticaria that may interfere with study assessments.\n* Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria.\n* Part A and Part B: Any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions.\n* Part A and Part B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results.\n* Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation.\n* Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.",{"count":230,"type":20},105,[23],"This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).",[166,26],[166,26,235,236,29,237,238,239,240,241,242],"BLU-808","CIndU","Chronic Urticaria","CU","Cold Urticaria","ColdU","Symptomatic Dermographism","SD","2026-02-16",{"date":245,"type":37},"2026-02-17",{"date":247,"type":37},"2025-05-28",{"date":249,"type":20},"2026-12-31",{"name":251,"class":44},"Blueprint Medicines Corporation",47,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":259,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":261,"conditions":262,"keywords":263,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":268,"leadSponsor":270,"locationsCount":150},"100620527","remibrutinib-in-real-world-clinical-practice---a-us-sub-study-100620527","NCT07358780","Remibrutinib in Real-world Clinical Practice - a US Sub-study","Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study - a US Sub-study",{"count":260,"type":20},505,"Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate\u002Fswitch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.",[26],[60,61,26,62],"2026-02-10",{"date":266,"type":37},"2026-02-13",{"date":198,"type":37},{"date":269,"type":20},"2029-09-30",{"name":72,"class":44},{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":21,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100623867","phase-3-trial-of-jyb1904-injection-in-adult-patients-with-chronic-spontaneous-urticaria-100623867","NCT07402213","Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines","Inclusion Criteria:\n\n* Male or female participant must be ≥18 years old at the time of signing the informed consent.\n* Participants are diagnosed with CSU for ≥6 months before screening.\n* Participants suffer from itching and hives for at least 6 consecutive weeks at any time before screening.\n* UAS7 (range 0\\~42) ≥16, ISS7 (range 0\\~21) ≥8 during 7 days before randomization.\n* Participants treated with stable dose of second-generation H1 antihistamines (up to 4x approved dose) for at least 6 consecutive weeks before randomization, switching medications, or changing drug dosage or frequency is not allowed within 3 weeks before randomization.\n* Participants have ≥6 days record of UAS7 before randomization.\n\nExclusion Criteria:\n\n* Participants who suffer from inducible urticaria with definite inducements, including urticaria factitia (dermatographism), cold contact, heat contact, solar, pressure, delayed pressure, aquagenic, cholinergic or contact urticaria, etc.\n* Participants who suffer from any other skin diseases with chronic itching, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis, etc.\n* Participants who suffer from other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria or acquired\u002Fdrug-induced urticaria.\n* Participants who are contraindicated or hypersensitive to antihistamines or any of its component (such as fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine).\n* History of anaphylactic shock.",{"count":279,"type":20},180,[85],"This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.",[26],[29],"2026-02-03",{"date":286,"type":37},"2026-02-11",{"date":288,"type":20},"2026-03-31",{"date":290,"type":20},"2028-04-28",{"name":292,"class":44},"Jemincare",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":300,"enrollmentInfo":4,"targetDuration":4,"studyType":301,"phases":4,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":312,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":316,"locationsCount":4},"100452378","global-managed-access-program-cohort-for-remibrutinib-in-adult-patients-with-chronic-spontaneous-urticaria-100452378","NCT05170724","Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria","Managed Access Program (MAP) Cohort Treatment Plan CLOU064A2002M to Provide Access to Remibrutinib for Adult Patients With Chronic Spontaneous Urticaria (CSU)","Inclusion Criteria:\n\nPatients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:\n\n1. Adult male and female subjects (≥ 18 years) who are able and willing to provide written informed consent prior to enrolling in the cohort.\n2. CSU diagnosis for ≥ 6 months (defined as onset of CSU with supporting documentation).\n3. Diagnosis of CSU refractory to H1-AH at locally label approved doses and to omalizumab (where applicable), as assessed by the treating physician, using one of the following tools: UAS7, UCT or DLQI\n4. Not eligible or able to enroll in a clinical trial or no relevant clinical trials available\n\nExclusion Criteria:\n\nPatients eligible for this Treatment Plan must not meet any of the following criteria:\n\n1. Previous premature discontinuation from a remibrutinib clinical trial for any reason\n2. History of hypersensitivity to remibrutinib or its excipients or to other BTK inhibitors\n3. Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria\n4. Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria\n5. Any other skin disease associated with chronic itching that might influence in the physician's opinion the treatment effect, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis\n6. Use of prohibited concomitant treatment\n7. Known history or evidence of ongoing alcohol or drug abuse within the last 6 months before treatment start\n8. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases\n9. Pregnant or nursing (lactating) women\n10. Women of child-bearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after stopping of program treatment. Highly effective contraception methods include:\n\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n    * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or bilateral tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n    * Male sterilization (at least 6 months prior to screening). For female participants in the program, the vasectomized male partner should be the sole partner for that participant\n    * Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.\n\n    Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). Women are considered not of child-bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential.\n11. History of live attenuated vaccine within 6 weeks prior to treatment start or requirement to receive these vaccinations at any time during treatment with remibrutinib\n12. Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III\u002FIV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the physician's opinion, would compromise the safety of the participant, or otherwise preclude adherence to the treatment plan\n13. Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids\n14. Hematology parameters before treatment start:\n\n    * Hemoglobin: \\\u003C 10 g\u002Fdl\n    * Platelets: \\\u003C 100 000\u002Fmm3\n    * Leucocytes: \\\u003C 3 000\u002Fmm3\n    * Neutrophils: \\\u003C 1 500\u002Fmm3\n15. Significant bleeding risk or coagulation disorders\n16. History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring hospitalization or blood transfusion)\n17. Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg\u002Fd or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid + clopidogrel) is prohibited.\n18. Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC))\n19. History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 before treatment start\n20. History of renal disease, creatinine level above 1.5x ULN, or estimated Glomerular Filtration Rate (eGFR) \\\u003C45ml\u002Fmin (using the Cockcroft-Gault equation) before treatment start\n21. Evidence of an ongoing Hepatitis C infection (e.g. defined by the detection of hepatitis C-ribonucleic acid (HCV-RNA) at screening) and\u002For an ongoing Hepatitis B infection (defined by the detection of Hepatitis B virus surface antigen (HBsAg) and\u002For hepatitis B virus (HBV)-DNA at screening; participants who are positive for anti-hepatits B core (HBc) antibodies but who are negative for antibodies against HBsAg and HBV-DNA can be included into the program if they agree to monitoring for HBsAg and HBV-DNA re-activation)\n22. Known or suspected ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (e.g. tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and\u002For known positivity for Human Immunodeficiency Virus (HIV) infection. HIV antigen\u002Fantibody tests will be performed to determine HIV status if required according to local regulations.","99 Years","EXPANDED_ACCESS","The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide access to remibrutinib for adult patients with chronic spontaneous urticaria (CSU)",[26],[26,29,305,306,60,307,308,309,30,310,311],"MAP","Managed Access Program","Early Access","Expanded Access","LOU064","Skin Disease","Cohort MAP","AVAILABLE","2025-12-01",{"date":315,"type":37},"2025-12-05",{"name":72,"class":44},{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":150},"100509707","phase-4-extending-omalizumab-treatment-intervals-in-patients-with-chronic-spontaneous-urticaria-100509707","NCT05916937","Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria","Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial","EXOTIC","Inclusion Criteria:\n\n* A diagnosis of CSU according to the EAACI\u002FGA2LEN\u002FEDF\u002FWAO guidelines.\n* Age ≥ 18 years.\n* Omalizumab-naïve prior to initiating treatment with omalizumab.\n* Background treatment with four antihistamines daily.\n* Candidate for omalizumab treatment according to Danish guidelines.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Planned pregnancy within the next 6 months.\n* Weight ≥ 100 kilograms.\n* Presence of any other active skin disease or condition that may interfere with the assessment of CSU, such as atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis.\n* Use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine.\n* Predominantly experience symptoms from chronic inducible urticaria (CIndU).\n* Inability to complete study or comply with study procedures.\n\nPatients with a positive basophil histamine release assay (BHRA) are not eligible for the study. Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.",{"count":326,"type":20},40,[328],"PHASE4","This study is a multicentre, randomized, open-label, non-inferiority clinical trial.\n\nThe purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.",[26,331],"Chronic Urticaria, Idiopathic","2025-09-16",{"date":334,"type":37},"2025-09-19",{"date":336,"type":37},"2024-01-12",{"date":338,"type":20},"2025-12-31",{"name":340,"class":341},"Simon Francis Thomsen","OTHER",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":158,"sex":16,"minAge":17,"maxAge":159,"enrollmentInfo":349,"targetDuration":4,"studyType":21,"phases":351,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":361,"locationsCount":150},"100582530","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-hs-10561-capsule-in-healthy-chinese-adults-and-patients-with-chronic-spontaneous-urticaria-100582530","NCT06864507","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.","A Randomized, Double-blind, Placebo-controlled Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.","Inclusion Criteria:\n\n* Written informed consent must be obtained before any assessment is performed.(SD)\n* Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;(SD)\n* Male participants weighing ≥ 50 kg and female participants weighing ≥ 40 kg; body mass index (weight\u002Fsquare of height (kg\u002Fm2)) within the range of 18-30 kg\u002Fm2 (inclusive);(SD)\n* Female participants and male participants (including their female partners) agree to use highly effective methods of contraception from the date of signing the informed consent form until 30 days after the last dose;(SD)\n* Without history of severe respiratory, gastrointestinal (such as inflammatory bowel disease, Crohn's disease, chronic diarrhea, etc.), neurological, circulatory, urinary, endocrine, musculoskeletal, immune system disorders, or a history of tumors prior to screening.(SD)\n* Written informed consent must be obtained before any assessment is performed.(MD and Phase 2)\n* Healthy adults aged 18-65 years (inclusive) at the time of signing the informed consent form;(MD and Phase 2)\n* Have been diagnosed with chronic spontaneous urticaria for ≥6 months at the time of screening;(MD and Phase 2)\n* Female participants and male participants (including their female partners) agree to use highly effective methods of contraception from the date of signing the informed consent form until 30 days after the last dose.(MD and Phase 2)\n\nExclusion Criteria:\n\n* Have clinically significant abnormalities in vital signs, physical examination, laboratory tests, chest X-ray\u002FCT, or abdominal ultrasound during the screening period, which, as assessed by the investigator, may increase the participants' risk or affect the scientific validity of the study;(SD)\n* Females with a positive blood pregnancy test, breastfeeding females, or participants planning to become pregnant during the study period;(SD)\n* Any physiological or psychological condition or disease, as determined by the investigator, that could increase the risk, affect the participants' compliance, or impact the participants' ability to complete the study.(SD)\n* Chronic urticaria with a clear primary or sole trigger (chronic inducible urticaria);(MD and Phase 2)\n* Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria);(MD and Phase 2)\n* Other diseases with symptoms of urticaria or angioedema;(MD and Phase 2)\n* Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results;(MD and Phase 2)\n* Pregnant or nursing (lactating) women.(MD and Phase 2)",{"count":350,"type":20},150,[163,23],"This is a randomized, double-blind, placebo-controlled phase 1\u002F2 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HS-10561 capsule in healthy Chinese adults and patients with chronic spontaneous urticaria.",[26],[90],"2025-03-06",{"date":357,"type":37},"2025-03-07",{"date":359,"type":20},"2025-03-31",{"date":249,"type":20},{"name":362,"class":44},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":21,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":150},"100555226","phase-2-trial-of-jyb1904-in-chronic-spontaneous-urticaria-100555226","NCT06509334","Trial of JYB1904 in Chronic Spontaneous Urticaria.","A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Adult Patients with Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines","Inclusion Criteria:\n\n* Male or female adult subjects (≥18 years of age).\n* Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.\n* Itching and hives lasting ≥ 6 weeks prior to Screening Visit 1.\n* Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 - 21) ≥ 6 within 7 days prior to randomization.\n\nExclusion Criteria:\n\n* Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), cold-contact, heat-contact, solar, pressure, delayed-pressure, water-source, cholinergic, or contact urticaria\n* Any other dermatological condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the opinion of the investigator may affect the study assessment and study results\n* Other conditions with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or acquired\u002Fdrug-induced urticaria.\n* Previous allergic reaction or poor efficacy with omalizumab.\n* Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or any of the ingredients.",{"count":371,"type":20},135,[23],"This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.",[26],"2024-11-26",{"date":377,"type":37},"2024-11-29",{"date":379,"type":37},"2024-08-04",{"date":381,"type":20},"2026-07-15",{"name":292,"class":44}]