NCT06455202Phase 3Active not recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2026-10Estimated

Enrollment · participants976Actual

Source updated2026-03-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-02-27 · 3 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~915 participants (planned)~~

+ After

976 participants (actual)

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

Check registry source

Study details

Conditions studied

Chronic Spontaneous Urticaria

Treatments or interventions studied

barzolvolimabBiological
Matching placeboBiological

Primary outcomes · main study measures

Read the study measures

measure: Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score); description: Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.; timeFrame: From Day 1 (first dose) to Day 85 (Week 12)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history