[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cold-urticaria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cold-urticaria":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":16,"minAge":17,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":5},"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).",true,"75 Years",{"count":64,"type":20},72,[66],"PHASE1","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.",[69,27,29,26],"Healthy Subjects",[71,72,73,74,75,76,77,78,79,80,81,82,83,84],"Urticaria","Skin diseases","Mast cells","Bispecific antibody","GTX-B001","Infusion","Single Ascending Dose","Healthy subjects","Safety","Pharmacokinetics","Pharmacodynamics","Cold urticaria","Intravenous","symptomatic dermographism","2026-01-28",{"date":87,"type":44},"2026-01-30",{"date":89,"type":44},"2025-10-06",{"date":91,"type":20},"2027-08",{"name":93,"class":51},"Granular Therapeutics Limited"]