[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Celldex Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100618373","phase-1-a-study-of-cdx-622-in-participants-with-mild-to-moderate-asthma-100618373",false,"NCT07330778","A Study of CDX-622 in Participants With Mild to Moderate Asthma","An Open-Label, Single-Dose Study to Assess the Safety, Pharmacodynamics, and Pharmacokinetics of CDX-622 in Adults With Mild to Moderate Asthma","Key Inclusion Criteria:\n\n1. Males and females, ≥ 18 years of age\n2. Diagnosis of mild to moderate asthma for at least 12 months\n3. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal\n4. Airway reversibility ≥ 12% and 200 mL improvement in FEV1\n5. Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment\n6. Willing and able to comply with all study requirements and procedures\n\nKey Exclusion Criteria:\n\n1. Females who are pregnant or nursing\n2. Pulmonary disease other than asthma\n3. Systemic diseases with elevated eosinophils other than asthma\n4. Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months\n5. History of needing ventilator support due to asthma\n6. Current nasal polyps\n7. Severe or uncontrolled asthma\n8. History of smoking or vaping within the past 6 months\n9. Tuberculosis, hepatitis B or C virus, or HIV\n10. Immunomodulating biologic therapies within the past 3 months for non-extended half-life biologics.\n11. Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab\n\nAdditional protocol defined inclusion and exclusion criteria could apply.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.",[26],"Mild to Moderate Asthma",[28,29,30],"Asthma","Mild to moderate","CDX-622","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2026-06-01",{"date":39,"type":20},"2027-03",{"name":41,"class":42},"Celldex Therapeutics","INDUSTRY",4,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"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","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.",{"count":52,"type":20},240,[54],"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.",[57,58,59,60],"Chronic Inducible Urticaria","Cold Urticaria","Cold-Induced Urticaria","Symptomatic Dermographism",[62,63,64,65,66,67,68,69,70],"Chronic Inducible urticaria","cold urticaria","cold-induced urticaria","ColdU","symptomatic dermographism,","SD","barzolvolimab","CDX0159","CDX-0159",{"date":72,"type":35},"2026-07-01",{"date":74,"type":35},"2026-01-15",{"date":76,"type":20},"2028-10",{"name":41,"class":42},73,""]