NCT07266402 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)
| NCT ID | NCT07266402 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Celldex Therapeutics |
| Condition | Chronic Inducible Urticaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 240 participants in total. It began in 2026-01-15 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Key Inclusion Criteria: 1. Males and females, \>/= 18 years of age. 2. Diagnosis of cold induced urticaria or symptomatic dermographism \>/= 3 months. 3. Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by: 1. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines. 2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment. 3. Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 15 °C and \< 37 °C using the TempTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test. 4. Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test. 4. Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening 5. Normal blood counts and liver function tests. 6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for ≥ 150 days after treatment. 7. Willing and able to complete a daily symptom electronic diary and comply with study visits. 8. Participants with and without prior biologic experience are eligible. Key Exclusion Criteria: 1. Women who are pregnant or nursing. 2. Clearly defined cause for chronic urticaria. 3. Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism. 4. Medical condition that would cause additional risk or interfere with study procedures. 5. Known HIV, hepatitis B or hepatitis C infection. 6. Vaccination with a live vaccine within 30 days prior to screening (subjects must agree to avoid vaccination with a live vaccine during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine. 7. History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water). 8. Prior treatment with barzolvolimab There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07266402 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Inducible Urticaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07266402 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 240 participants.
Is NCT07266402 currently recruiting?
Yes, NCT07266402 is actively recruiting participants. Contact the research team at clinicaltrials@celldex.com for enrollment information.
Where is the NCT07266402 trial being conducted?
This trial is being conducted at Birmingham, United States, Scottsdale, United States, Bakersfield, United States, Napa, United States and 11 additional locations.
Who is sponsoring the NCT07266402 clinical trial?
NCT07266402 is sponsored by Celldex Therapeutics. The trial plans to enroll 240 participants.