[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-inducible-urticaria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-inducible-urticaria":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,84,113],{"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":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100613423","phase-3-a-study-to-investigate-efficacy-safety-and-tolerability-of-barzolvolimab-versus-placebo-in-adults-with-cold-induced-urticaria-and-symptomatic-dermographism-inadequately-controlled-by-h1-antihistamines-embarq---coldu-and-sd-100613423",false,"NCT07266402","A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)","Key Inclusion Criteria:\n\n1. Males and females, \\>\u002F= 18 years of age.\n2. Diagnosis of cold induced urticaria or symptomatic dermographism \\>\u002F= 3 months.\n3. Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:\n\n   1. The presence of hives for \\>\u002F= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.\n   2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \\>\u002F= 4 weeks prior to study treatment.\n   3. Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 15 °C and \\\u003C 37 °C using the TempTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test.\n   4. Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test.\n4. Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening\n5. Normal blood counts and liver function tests.\n6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for ≥ 150 days after treatment.\n7. Willing and able to complete a daily symptom electronic diary and comply with study visits.\n8. Participants with and without prior biologic experience are eligible.\n\nKey Exclusion Criteria:\n\n1. Women who are pregnant or nursing.\n2. Clearly defined cause for chronic urticaria.\n3. Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.\n4. Medical condition that would cause additional risk or interfere with study procedures.\n5. Known HIV, hepatitis B or hepatitis C infection.\n6. Vaccination with a live vaccine within 30 days prior to screening (subjects must agree to avoid vaccination with a live vaccine during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.\n7. History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water).\n8. Prior treatment with barzolvolimab\n\nThere are additional criteria that your study doctor will review with you to confirm you are eligible for the study.","ALL","18 Years",{"count":19,"type":20},240,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.",[26,27,28,29],"Chronic Inducible Urticaria","Cold Urticaria","Cold-Induced Urticaria","Symptomatic Dermographism",[31,32,33,34,35,36,37,38,39],"Chronic Inducible urticaria","cold urticaria","cold-induced urticaria","ColdU","symptomatic dermographism,","SD","barzolvolimab","CDX0159","CDX-0159","RECRUITING","2026-06-30",{"date":43,"type":44},"2026-07-01","ACTUAL",{"date":46,"type":44},"2026-01-15",{"date":48,"type":20},"2028-10",{"name":50,"class":51},"Celldex Therapeutics","INDUSTRY",73,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"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":63,"type":20},98,[65],"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.",[26,68],"Chronic Spontaneous Urticaria",[70,71,72,73],"First-in-Human","Single Ascending Dose","Multiple Ascending Dose","Healthy Participant","2026-04-17",{"date":76,"type":44},"2026-04-21",{"date":78,"type":44},"2026-04-01",{"date":80,"type":20},"2026-11",{"name":82,"class":51},"Enanta Pharmaceuticals, Inc",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"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":92,"type":20},105,[94],"PHASE2","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).",[26,68],[26,68,98,99,100,101,102,27,34,29,36],"BLU-808","CIndU","CSU","Chronic Urticaria","CU","2026-02-16",{"date":105,"type":44},"2026-02-17",{"date":107,"type":44},"2025-05-28",{"date":109,"type":20},"2026-12-31",{"name":111,"class":51},"Blueprint Medicines Corporation",47,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":60,"sex":16,"minAge":17,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100606885","phase-1-a-phase-1-study-of-gtx-b001-in-healthy-subjects-and-patients-with-chronic-inducible-urticaria-100606885","NCT07181369","A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Tolerability, Pharmacokinetic, Pharmacodynamic, and Preliminary Efficacy Trial of GTX-B001 in Healthy Volunteers (Part A) and Patients With Chronic Inducible Urticaria (Part B)","CHILL-MC","Key inclusion Criteria (Part A):\n\n* The subject is between 18 and 55 years of age (both inclusive) at the date of screening.\n* The subject is in good general health based on the medical history, physical examination and the results of vital signs, electrocardiogram and clinical laboratory, as judged by the investigator.\n\nKey inclusion Criteria (Part B):\n\n* The subject is between 18 and 75 years of age (both inclusive) at the date of screening\n* A history of signs and\u002For symptoms of ColdU or SD experienced ≥ 3 months prior to screening.\n* For ColdU patients, a positive provocation test during screening and baseline, using the TempTest® device.\n* For SD patients, a positive provocation test with at least 3 pins during screening and baseline, using the FricTest® device.\n* Inadequate control of ColdU or SD by second generation H1-antihistamine (sgAH) as defined as the presence of itch and hives following a trigger (e.g. cold or scratching, respectively) within the last 6 weeks prior to screening in spite of use of a sgAH.\n* A Urticaria Control Test (UCT) score of \\\u003C 12 at screening.\n\nKey exclusion Criteria (Parts A \\& B):\n\n* Presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine disease or disorder that would interfere with the patient's safety or the interpretation of trial results in the judgment of the investigator.\n* Treatment with an investigational drug or intervention for any condition within three months of screening, or concurrent participation in another clinical trial in which an investigational drug is administered.\n* Treatment with immunomodulating therapy (e.g., intravenous or intramuscular immunoglobulins, systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus, mycophenolate mofetil, hydroxychloroquine, infliximab, adalimumab, etanercept, etc.) within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.\n* Use of any monoclonal antibody or therapeutic protein within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.\n* History of anaphylaxis, autoimmune disorders requiring more than topical medication, or asthma requiring regular use of inhaled medication within the past 5 years, unless, in the opinion of the Investigator, the condition is not considered clinically significant and is unlikely to affect subject safety or study outcomes.\n\nAdditionally for Part B:\n\n* Disease with symptoms of urticaria or angioedema other than Chronic Urticaria (CU), for example urticaria vasculitis, erythema multiforme, mastocytosis, or drug-induced urticaria. Patients with concomitant Chronic Spontaneous Urticaria (CSU) or other forms of Chronic Inducible Urticaria (CIndU) are eligible provided that symptoms at screening are consistent with ColdU or SD and that ColdU or SD is the dominant form of CU.\n* Any other skin disease associated with chronic itching that might influence in the investigators' opinion of the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or psoriasis.\n* Receipt of any biologic therapy for urticaria control (e.g. omalizumab, dupilumab, ligelizumab, etc.) within three months of screening (whether on-label or off-label).","75 Years",{"count":123,"type":20},72,[65],"This is a first-in-human study aimed at determining the safety of a single dose of GTX-B001 in healthy participants and in people with chronic inducible urticaria.",[127,27,29,26],"Healthy Subjects",[129,130,131,132,133,134,71,135,136,137,138,139,140,141],"Urticaria","Skin diseases","Mast cells","Bispecific antibody","GTX-B001","Infusion","Healthy subjects","Safety","Pharmacokinetics","Pharmacodynamics","Cold urticaria","Intravenous","symptomatic dermographism","2026-01-28",{"date":144,"type":44},"2026-01-30",{"date":146,"type":44},"2025-10-06",{"date":148,"type":20},"2027-08",{"name":150,"class":51},"Granular Therapeutics Limited",2]