Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
← catalyst calendarNCT07256392 · readout ≤ 773 d
Sponsored by Celldex Therapeutics (industry) · CLDX — their whole pipeline →.
Phase
Phase 3
Status
Enrolling by invitation
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
1,370estimated
Sites
96
Countries
Argentina, Australia, Belgium +16
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 | 2025-11-25 | actual | When the study began enrolling |
| Primary completion | Sep 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-29 | 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
- Other: Standard of Care
Primary outcomes
what the primary-completion date above is the date OFTime to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater.
measured From Day 1 (baseline) to Week 52.
Time to disease worsening or treatment failure through Week 52 based on the occurrence of the discontinuation of barzolvolimab in Group 2 due to lack of efficacy or to a treatment related adverse event.
measured From Day 1 (baseline) to Week 52.
Time to disease worsening or treatment failure through Week 52 based on the occurrence of first use of strongly confounding prohibited medication (Group 1 or 2) or use of barzolvolimab in Group 1.
measured From Day 1 (baseline) to Week 52.
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