A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
← catalyst calendarNCT06455202 · readout ≤ 73 d
Sponsored by Celldex Therapeutics (industry) · CLDX — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
976actual
Sites
245
Countries
Australia, Bulgaria, Canada +19
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-07-19 | actual | When the study began enrolling |
| Primary completion | Oct 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-06-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Spontaneous Urticaria
Interventions
- Biological: barzolvolimab
- Biological: Matching placebo
Primary outcome
what the primary-completion date above is the date OFMean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
measured From Day 1 (first dose) to Day 85 (Week 12)
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