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barzolvolimab

·Code: CDX-0159

barzolvolimab: 7 clinical trials tracked.

barzolvolimab evidence translation

What we can confirm

7 tracked trials

No verified listed company relationship

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about barzolvolimab, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 1 study sponsors
Clinical Trial Registry Records (7)

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)

NCT07266402Registry updated 2026-10-07·Phase 3·CLDX
Recruiting

Primary endpoint: Complete response to provocation testing at Week 12

InterventionalRandomizedquadruple240 targetStarted 2026-01Completion 2028-1072 sites · Germany, Lithuania, Poland, South Africa…Celldex Therapeutics

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

NCT07256392Registry updated 2026-10-07·Phase 3·CLDX
Enrolling by invitation

Primary endpoint: Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater.

Interventionalopen1,370 targetStarted 2025-11Completion 2028-09182 sites · Argentina, Australia, Belgium, Bulgaria…Celldex Therapeutics

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Moderate to Severe Atopic Dermatitis

NCT06727552Registry updated 2026-08-11·Phase 2·CLDX
Active, not recruiting

Primary endpoint: Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16

InterventionalRandomizedquadruple131 enrolledStarted 2024-12Completion 2026-1233 sites · United StatesCelldex Therapeutics

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)

NCT06455202Registry updated 2026-03-25·Phase 3·CLDX
Active, not recruiting

Primary endpoint: Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)

InterventionalRandomizedquadruple976 targetStarted 2024-07Completion 2027-0450 sites · United StatesCelldex Therapeutics

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)

NCT06445023Registry updated 2026-03-25·Phase 3·CLDX
Active, not recruiting

Primary endpoint: Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)

InterventionalRandomizedquadruple963 targetStarted 2024-07Completion 2027-0450 sites · United StatesCelldex Therapeutics

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Patients With Prurigo Nodularis

NCT06366750Registry updated 2026-08-04·Phase 2·CLDX
Active, not recruiting

Primary endpoint: Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.

InterventionalRandomizedquadruple140 enrolledStarted 2024-04Completion 2027-0350 sites · Canada, Croatia, Germany, United StatesCelldex Therapeutics

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)

NCT05774184Registry updated 2026-05-27·Phase 2·CLDX
Completed

Primary endpoint: Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).

InterventionalRandomizedquadruple86 enrolledStarted 2023-06Completion 2026-0145 sites · Australia, Canada, Germany, Italy…Celldex Therapeutics