Living with chronic spontaneous urticaria, or hives, can be incredibly challenging, especially when standard treatments like antihistamines don’t provide relief. This study is exploring a new treatment called barzolvolimab for adults who continue to experience symptoms despite taking these medications. The study involves around 915 participants who will be randomly assigned to receive either barzolvolimab or a placebo, which is a treatment with no active ingredients. Over a 24-week period, researchers will closely monitor how well barzolvolimab works compared to the placebo. The main focus will be on measuring changes in the severity of hives over time. If barzolvolimab proves effective, it could be a game-changer for many people who feel stuck with their symptoms, offering a new option for managing this frustrating condition.
Can a new treatment finally help those suffering from chronic hives?
Plain Language Summary
What this means for you:
Barzolvolimab could be a new hope for adults struggling with chronic spontaneous urticaria. What this means for you:
Barzolvolimab could be a new hope for adults struggling with chronic spontaneous urticaria. View Original Abstract ↓
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