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Randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy and safety of barzolvolimab in patients with chronic spontaneous urticaria who continue to experience symptoms despite treatment with antihistamines.
THE PURPOSE OF THIS RESEARCH STUDY IS TO TEST THE ACTUAL EFFICACY OF BARZOLVOLIMAB AT 2 DIFFERENT DOSE LEVELS AND TO DETERMINE IF IT HELPS PEOPLE WITH CSU. BARZOLVOLIMAB HAS BEEN TESTED IN 2 STUDIES OF HEALTHY VOLUNTEERS AND 2 STUDIES OF PATIENTS WITH CSU.
Technical Summary
- PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BARZOLVOLIMAB IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA WHO CONTINUE TO EXPERIENCE SYMPTOMS DESPITE TREATMENT WITH H1 ANTIHISTAMINES (EMBARQ - CSU2)
- Code EudraCT: 2024-513210-36-00
- Protocol number: CDX0159-13
- Promoter: Celldex Therapeutics
- Molecule/Drug: Barzolvolimab
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