Complete Announced during: Premarket · announced Tue 7:09a ET (premarket); before = Mon close; first trade Tue 7:10a ET; time = SEC 8-K acceptance
Celldex Therapeutics (Nasdaq: CLDX) reported topline results from a Phase 3 trial of barzolvolimab in chronic spontaneous urticaria on September 22, 2026. The company said the trial met its primary endpoint. ClinicalTrials.gov lists 963 enrolled participants (NCT06445023).
Trial details
- Drug
- BarzolvolimabType Biological Route subcutaneous
- Treats
- Studied as a treatment for chronic spontaneous urticaria.Condition Chronic Spontaneous Urticaria
- Patients
- 963 patients (actual enrollment)4 arms · 235 sites in 21 countries
- Phase
- Phase 3
- Design
- Randomized, quadruple-blind, parallel-group
- Primary endpoint
- Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) (From Day 1 (first dose) to Day 85 (Week 12))
- Key secondary endpoints
- Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
- Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
- Percentage of participants with UAS7 = 0 at Week 12
- Result
- Met endpointBoth Phase 3 trials met the primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at Week 12, and all key secondary endpoints, demonstrating clinically meaningful and statistically significant improvements in disease activity.
- Safety
- Barzolvolimab was well-tolerated through the 24 week placebo controlled treatment period with a favorable safety profile consistent with prior Phase 2 experience.
- Sponsor
- Celldex Therapeutics Nasdaq: CLDX
- Dates
- Study start Jul 11, 2024Primary completion Oct 2026 (anticipated)Announced Sep 22, 2026, 7:09 AM ET (SEC 8-K filing time)
- Trial ID
- NCT06445023 ClinicalTrials.gov
About this trial
This randomized, quadruple-blind, parallel-group Phase 3 trial (NCT06445023) tested Barzolvolimab in Chronic Spontaneous Urticaria. Studied as a treatment for chronic spontaneous urticaria. It enrolled 963 patients across 4 arms at 235 sites in 21 countries. The primary endpoint was Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) (From Day 1 (first dose) to Day 85 (Week 12)). Celldex Therapeutics reported that the trial met its primary endpoint. The study started on Jul 11, 2024 and is expected to reach primary completion in Oct 2026.
Sources
- Source: SEC EDGAR 8-K (EX-99.1)
- ClinicalTrials.gov record: NCT06445023
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