Barzolvolimab versus placebo for adults with cold-induced urticaria and symptomatic dermographism not controlled by H1-antihistamines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, double-blind, placebo-controlled trial enrolling adults with cold-induced urticaria (ColdU) or symptomatic dermographism (SD) who remain symptomatic on stable second-generation H1-antihistamines. After up to 4 weeks of screening, participants are randomized to receive barzolvolimab or placebo during a 24-week double-blind treatment period (initial 450 mg dose then 150 mg every 4 weeks for active arm). Following that, there is a 28-week period in which all participants receive open-label barzolvolimab 300 mg every 8 weeks, and then a 16-week safety follow-up. Efficacy will be compared between randomized arms and safety/tolerability monitored throughout.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cahaba Dermatology & Skin Health Center, LLC
  Birmingham, Alabama, United States Recruiting
• One of a Kind Clinical Research Center, LLC
  Scottsdale, Arizona, United States Recruiting
• Kern Research, Inc.
  Bakersfield, California, United States Recruiting
• One of a Kind Clinical Research Center
  Napa, California, United States Recruiting
• Allergy & Asthma Consultants
  Redwood City, California, United States Recruiting
• Amicis Research Center
  Sherman Oaks, California, United States Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Celldex Therapeutics
• Email: clinicaltrials@celldex.com
• Phone: 844-723-9363

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.