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NCT07266402 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
A Phase 3 study of Chronic Inducible Urticaria and Cold Urticaria, sponsored by Celldex Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT07266402: Recruiting Phase 3 study of Chronic Inducible Urticaria and Cold Urticaria, sponsored by Celldex Therapeutics.
NCT07266402 is a Phase 3 study of Chronic Inducible Urticaria and Cold Urticaria that is actively recruiting participants, run by Celldex Therapeutics. The registered enrollment target is 240 participants, above the 174-participant average among 4 other Chronic Inducible Urticaria trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07266402, a Phase 3 study of Chronic Inducible Urticaria and Cold Urticaria, is actively recruiting participants, sponsored by Celldex Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.
Primary Outcome
Proportion of Cold Induced Urticaria \[ColdU\] participants with complete response in Critical Temperature Threshold (CTT) or proportion of Symptomatic Dermographism \[SD\] participants with complete response in Critical Friction Threshold at Week 12. * For ColdU patients, a complete response is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a complete response test is defined as absence of wheals at the provocati
Conditions Studied
Interventions
- DRUG Barzolvolimab
- DRUG Matching Placebo
Study Locations (20)
California
- Kern Research, Inc. - Bakersfield
- One of a Kind Clinical Research Center - Napa
- Allergy & Asthma Consultants - Redwood City
- Amicis Research Center - Sherman Oaks
- FOMAT - Allergy, Asthma & Immunology Medical Group - Ventura
Florida
- Direct Helpers Research Center - Hialeah
- Well Pharma Medical Research, Corp. - Miami
- Deluxe Health Center, LLC - Miami Lakes
- GCP, Global Clinical Professionals - St. Petersburg
- Advanced Clinical Research Institute - Tampa
Kentucky
- Equity Medical, LLC - Bowling Green
- Advanced ENT and Allergy, PLLC - Louisville
Alabama
- Cahaba Dermatology & Skin Health Center, LLC - Birmingham
Arizona
- One of a Kind Clinical Research Center, LLC - Scottsdale
Georgia
- Centricity Research Columbus Dermatology - Columbus
Idaho
- Treasure Valley Medical Research - Boise
Illinois
- Endeavor Health Clinical Trials Center - Skokie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2026-01-15 |
| Est. Completion | 2028-10 |
| Phase | Phase 3 |
What NCT07266402 shows while recruiting
NCT07266402 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 4 other Chronic Inducible Urticaria trials with a reported enrollment target (38% higher).
The record links to 4 conditions, with Chronic Inducible Urticaria appearing as the primary indexed condition, and to 2 interventions - of which Barzolvolimab is the first listed.
NCT07266402 names 20 study sites across 11 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT07266402 about?
NCT07266402 is a clinical study titled "A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)". The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.
What is the current status of trial NCT07266402?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2026-01-15. Estimated completion is 2028-10.
What conditions does trial NCT07266402 study?
This clinical trial studies the following conditions: Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism.
What interventions are being tested in trial NCT07266402?
The interventions under investigation include: Barzolvolimab (DRUG), Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT07266402?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07266402 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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