barzolvolimab
Sponsors
Celldex Therapeutics Inc., Celldex Therapeutics
Conditions
Atopic DermatitisChronic Inducible UrticariaChronic Spontaneous UrticariaCold UrticariaCold-Induced UrticariaCold-Induced Urticaria and Symptomatic DermographismEosinophilic EsophagitisPrurigo Nodularis
Phase 2
A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
CompletedNCT05368285
Start: 2022-05-19End: 2024-12-20Updated: 2025-03-26
A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
CompletedNCT05405660
Start: 2022-06-28End: 2025-09-12Updated: 2025-11-06
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
CompletedNCT05774184
Start: 2023-06-01End: 2026-01-23Updated: 2026-01-30
A Study of Barzolvolimab in Patients With Prurigo Nodularis
Active, not recruitingNCT06366750
Start: 2024-04-12End: 2027-03-01Updated: 2026-01-30
CDX0159-08: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The “EvolvE” Study)
CompletedCTIS2024-512767-30-00
Start: 2023-09-28End: 2025-09-17Target: 23Updated: 2025-06-01
CDX0159-10: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Prurigo Nodularis
Active, not recruitingCTIS2023-510279-80-00
Start: 2024-09-25Target: 78Updated: 2025-10-27
CDX0159-07: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose ranging Study to Assess the Efficacy and Safety of CDX 0159 in Patients with Chronic Inducible Urticaria
CompletedCTIS2024-516988-87-00
Start: 2022-11-09End: 2025-09-12Target: 114Updated: 2025-09-12
A Study of Barzolvolimab in Patients With Atopic Dermatitis
Active, not recruitingNCT06727552
Start: 2024-12-18End: 2027-05-01Updated: 2026-03-27
Phase 3
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Active, not recruitingNCT06445023
Start: 2024-07-11End: 2027-04-01Updated: 2026-03-25
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
Active, not recruitingNCT06455202
Start: 2024-07-19End: 2027-04-01Updated: 2026-03-25
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ – CSU1)
RecruitingCTIS2024-513208-32-00
Start: 2024-12-16Target: 521Updated: 2025-07-21
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ – CSU2)
RecruitingCTIS2024-513210-36-00
Start: 2025-04-04Target: 528Updated: 2026-01-16
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
RecruitingNCT07256392
Start: 2025-11-25End: 2028-09-01Target: 1370Updated: 2026-03-31
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)
RecruitingNCT07266402
Start: 2026-01-15End: 2028-10-01Target: 240Updated: 2026-03-27
A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants with Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13 (EMBARQ-CSU LTE)
Not yet recruitingCTIS2025-522878-36-00
Target: 174Updated: 2026-03-17
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)
Not yet recruitingCTIS2025-522583-32-00
Target: 80Updated: 2026-03-25