A Study of CDX-0159 in Patients With Chronic Inducible 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 Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.
Timeline
- Start
- 2022-06-28
- Primary completion
- 2024-06-12
- Completion
- 2025-09-12
Outcome
Met primary endpoint
release “Data from the 196 patients randomized in the study showed that barzolvolimab achieved the primary efficacy endpoint” celldex.com ↗
release “Barzolvolimab is the first drug to achieve success in a large, randomized, placebo-controlled study in chronic inducible urticaria” celldex.com ↗
release “Barzolvolimab met all primary and secondary endpoints at 12 weeks in the Company’s Phase 2 study in ColdU and SD.” celldex.com ↗
release “In the Phase 2 study, all primary and secondary endpoints were met with high statistical significance at 12 weeks” celldex.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | barzolvolimab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | barzolvolimab | Monoclonal antibody | 300 mg | Subcutaneous |