A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Summary

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous Urticaria

Timeline

Start

2022-05-19

Primary completion

2023-09-28

Completion

2024-12-20

Outcome

Met primary endpoint

paper There was significant improvement in mean (95% confidence interval) change from baseline to week 12 in UAS7 PMID 41747871 ↗

paper in UAS7 in barzolvolimab-treated patients compared to patients who received placebo (75 mg every 4 weeks: -6.60 [-10.71, -2.49] P = .0017 PMID 41747871 ↗

release “Results from a placebo controlled Phase 2 study in CSU demonstrated that barzolvolimab met the primary endpoint” celldex.com ↗

release “this Phase 2 study of barzolvolimab in patients with moderate to severe CSU refractory to antihistamines, including patients with biologic-refractory disease, met its primary endpoint” celldex.com ↗

release “Barzolvolimab met all primary and secondary endpoints at 12 weeks in the Company’s Phase 2 study in CSU.” celldex.com ↗

release “Barzolvolimab achieved the primary efficacy endpoint of the study—a statistically significant mean change from baseline to Week 12 in UAS7” celldex.com ↗

Publications

• Metz M, Mitha E, Leflein J, Talreja N, Gotua M, Krasowska D, Peter J, Anderson J, Young D, Heath-Chiozzi M, Paradise E, Greenberg S, Bernstein JA. Randomized dose-finding study of anti-KIT barzolvolimab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol. 2026 Feb 24:S0091-6749(26)00129-6. doi: 10.1016/j.jaci.2026.02.018. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	barzolvolimab	Monoclonal antibody	75 mg	Subcutaneous
Subject	barzolvolimab	Monoclonal antibody	150 mg	Subcutaneous
Subject	barzolvolimab	Monoclonal antibody	300 mg	Subcutaneous

Indications