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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
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513208-32-00
Acronym
CDX0159-12
Enrollment
521
Registered
2024-11-05
Start date
2024-12-16
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Spontaneous Urticaria

Brief summary

Mean change from baseline in UAS7 at Week 12

Detailed description

Mean change from baseline in ISS7 and HSS7 at Week 12, Percent of participants with UAS7 = 0 at Week 12, Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12, Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12., Percent of participants with UAS7 ≤ 6 at Week 12, Mean change from baseline in UAS7 at Week 4, Mean change from baseline in UAS7 at Week 24, Percent of participants with UAS7 = 0 at Week 24

Interventions

Sponsors

Celldex Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in UAS7 at Week 12

Secondary

MeasureTime frame
Mean change from baseline in ISS7 and HSS7 at Week 12, Percent of participants with UAS7 = 0 at Week 12, Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12, Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12., Percent of participants with UAS7 ≤ 6 at Week 12, Mean change from baseline in UAS7 at Week 4, Mean change from baseline in UAS7 at Week 24, Percent of participants with UAS7 = 0 at Week 24

Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026