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NCT07256392 · ClinicalTrials.gov registry record · Phase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
A Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Celldex Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,370
- Enrollment target
- 9
- Study locations
NCT07256392 is a Phase 3 study of Chronic Spontaneous Urticaria that is actively recruiting participants, run by Celldex Therapeutics. The registered enrollment target is 1,370 participants, roughly in line with the 1,351-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target. The trial reports 9 study locations across 7 states.
The verdict
NCT07256392, a Phase 3 study of Chronic Spontaneous Urticaria, is actively recruiting participants, sponsored by Celldex Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,370 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.
Conditions Studied
Interventions
- OTHER Standard of Care
- BIOLOGICAL barzolvolimab
Study Locations (9)
Florida
- Direct Helpers Research Center - Hialeah
- Deluxe Health Center - Miami Lakes
- Advanced Clinical Research Institute (ACRI) - Florida - Tampa
Arizona
- Center for Dermatology & Plastic Surgery - Avacare - Scottsdale
California
- Dermatology Research Associates - Los Angeles
Georgia
- Centricity Research Columbus Dermatology - Columbus
Maryland
- Institute for Asthma and Allergy - Wheaton
Missouri
- Michigan Center for Research Co., LLC (or Profound Research LLC at Clarkson Medical Group as listed in Suvoda) - Clarkson
Ohio
- Bexley Dermatology Research - Bexley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,370 participants |
| Start Date | 2025-11-25 |
| Est. Completion | 2028-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07256392
The ClinicalTrials.gov registry entry for NCT07256392 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,370 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 1,351-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target. The listed sponsor is Celldex Therapeutics, which has 42 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT07256392 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT07256392 about?
NCT07256392 is a clinical study titled "Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria". The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment ...
What is the current status of trial NCT07256392?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,370 participants. The study started on 2025-11-25. Estimated completion is 2028-09.
What conditions does trial NCT07256392 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT07256392?
The interventions under investigation include: Standard of Care (OTHER), barzolvolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07256392?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07256392 being conducted?
This trial has 9 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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