Phase 3 Study Evaluates Barzolvolimab for Chronic Spontaneous Urticaria

Status: ACTIVE_NOT_RECRUITING | Phase: PHASE3 Condition(s): Chronic Spontaneous Urticaria Intervention(s): barzolvolimab (BIOLOGICAL), Matching placebo (BIOLOGICAL) The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo. Detailed: This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms. Primary Outcome(s): Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) Enrollment: 963 (ACTUAL) Lead Sponsor: Celldex Therapeutics Start: 2024-07-11 | Primary Completion: 2026-10