NCT06445023

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 963 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 description

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.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
BIOLOGICAL	barzolvolimab	Subcutaneous Administration
BIOLOGICAL	Matching placebo	Matching placebo Subcutaneous Administration

Timeline

• Start date: 2024-07-11
• Primary completion: 2026-10-01
• Completion: 2027-04-01
• First posted: 2024-06-06
• Last updated: 2026-03-25

Locations

235 sites across 21 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Malaysia, Peru, Poland, Portugal, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study