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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: Active Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Celldex Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total scor
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 |
What the registry record for NCT06455202 still lists
NCT06455202 is an interventional study that assigns participants to a tested intervention. The registered 976 participants enrollment target is mid-sized for trials with a published cap, below the 1,373-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (29% lower).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
Similar trials for Chronic Spontaneous Urticaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06455202's enrollment target sits among peer trials
976 5th of 18 higher than 14 of 18 other Chronic Spontaneous Urticaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Spontaneous Urticaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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