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 – CSU2] (NCT06455202)

The CDX0159-13 study is designed to evaluate the safety and efficacy of Barzolvolimab in adult participants with chronic spontaneous urticaria (CSU) who still have symptoms despite H1-antihistamine treatment. Participants receive either trial medication or a placebo (something that looks like the trial drug but has no effect on the body), both administered as injections under the skin (subcutaneous). The treatment period will be approximately 52 weeks with all participants moved to active treatment (receiving treatment drug) after Week 24.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Professor Johannes S Kern

Key inclusion data

Are 18 years or older

Have been diagnosed with CSU for more than 6 months prior to screening

Still have CSU despite a stable dose of second-generation non-sedating H1-antihistamines

Participants cannot enroll if they have a history of anaphylaxis