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NCT06455202 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
A Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Celldex Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 976
- Enrollment target
- 20
- Study locations
NCT06455202 is a Phase 3 study of Chronic Spontaneous Urticaria that is active but no longer recruiting, run by Celldex Therapeutics. The registered enrollment target is 976 participants, below the 1,373-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT06455202, a Phase 3 study of Chronic Spontaneous Urticaria, is active but no longer recruiting, sponsored by Celldex Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 976 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
Conditions Studied
Interventions
- BIOLOGICAL barzolvolimab
- BIOLOGICAL Matching placebo
Study Locations (20)
California
- Kern Research, Inc. - Bakersfield
- UCLA Clinical Trials Contracts & Strategic Relations - Los Angeles
- California Allergy and Asthma Medical Group - Los Angeles
- LA Universal Research Center, Inc. - Los Angeles
- Allergy and Asthma Associates of Southern Cal - Mission Viejo
- Huntington Asthma & Allergy Center - Pasadena
- Apex Clinical Research - San Diego
- WR-MCCR - San Diego
- University Clinical Trials - San Diego
- Clinical Science Institute - Santa Monica
- Raffi Tachdjian MD, Inc - Santa Monica
Arizona
- Research Solutions of Arizona PC - Litchfield Park
- Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd. - Scottsdale
- Center for Dermatology & Plastic Surgery - Scottsdale
Florida
- Driven Research LLC - Coral Gables
- Palm Beach Dermatology Group - Delray Beach
- Dolphin Medical Research - Doral
Colorado
- Clarity Dermatology, PLLC - Castle Rock
- Asthma and Allergy Associates - Colorado Springs
Alabama
- Allervie Clinical Research - Cullman - Cullman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 976 participants |
| Start Date | 2024-07-19 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06455202
The ClinicalTrials.gov registry entry for NCT06455202 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 976 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,373-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (29% lower). 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 barzolvolimab is the first listed.
NCT06455202 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT06455202 about?
NCT06455202 is a clinical study titled "A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)". The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
What is the current status of trial NCT06455202?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 976 participants. The study started on 2024-07-19. Estimated completion is 2027-04.
What conditions does trial NCT06455202 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT06455202?
The interventions under investigation include: barzolvolimab (BIOLOGICAL), Matching placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT06455202?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06455202 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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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