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NCT06445023 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
A Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Celldex Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 963
- Enrollment target
- 20
- Study locations
NCT06445023: Active Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Celldex Therapeutics.
NCT06445023 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 963 participants, below the 1,374-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06445023, 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
- 963 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
- First OC Dermatology - Fountain Valley - Fountain Valley
- 310 Clinical Research - Inglewood
- Dermatology Research Associates - Los Angeles
- Focus Clinical Research - Los Angeles - Los Angeles
- Cura Clinical Research - Oxnard
- Allergy and Asthma Consultants - Redwood City
- Acclaim Clinical Research - San Diego
- West Dermatology Research Center - San Diego
- Therapeutics Clinical Research - San Diego
- Orso Health, Inc. - Torrance
- Integrated Research of Inland, Inc. - Upland
Florida
- Encore Medical Research Boynton Beach - Boynton Beach
- Direct Helpers Research Center - Hialeah
- GSI Clinical Research - Margate
- International Dermatology Research Inc - Miami - Miami
- Miami Dade Medical Research Institute, LLC - Miami
- Sarasota Clinical Research - Sarasota
- GCP Global Clinical Professionals, LLC - St. Petersburg
Alabama
- Cahaba Dermatology Skin Health Center - Birmingham
Colorado
- Western States Clinical Research Inc - Wheat Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 963 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
What the registry record for NCT06445023 still lists
NCT06445023 is an interventional study that assigns participants to a tested intervention. The registered 963 participants enrollment target is mid-sized for trials with a published cap, below the 1,374-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (30% 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.
NCT06445023 names 20 study sites across 4 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT06445023 about?
NCT06445023 is a clinical study titled "A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria". 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 NCT06445023?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 963 participants. The study started on 2024-07-11. Estimated completion is 2027-04.
What conditions does trial NCT06445023 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT06445023?
The interventions under investigation include: barzolvolimab (BIOLOGICAL), Matching placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT06445023?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06445023 being conducted?
This trial has 20 study locations across Alabama, 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 NCT06445023's enrollment target sits among peer trials
963 6th of 18 higher than 13 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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