A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Last updated: February 18, 2025
Sponsor: Celldex Therapeutics
Overall Status: Active - Recruiting

Phase

3

Condition

Hives (Urticaria)

Urticaria

Treatment

barzolvolimab

Matching placebo

Clinical Study ID

NCT06445023
CDX0159-12
2024-513208-32-00
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Males and females, >/= 18 years of age.

  2. Diagnosis of chronic spontaneous urticaria (CSU) >/= 6 months.

  3. CSU despite the use of a stable regimen of second generation non-sedatingH1-antihistamine as defined by:

  4. The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite theuse of non-sedating H1-antihistamines.

  5. Must be on a stable regimen of second generation non-sedating H1-antihistaminefor >/= 4 weeks prior to study treatment.

  6. UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to treatment.

  7. Normal blood counts and liver function tests.

  8. Both males and females of child-bearing potential must agree to use highly effectivecontraceptives during the study and for 150 days after treatment.

  9. Willing and able to complete a daily symptom electronic diary and comply with studyvisits.

  10. Participants with and without prior biologic experience are eligible.

Exclusion

Key Exclusion Criteria:

  1. Women who are pregnant or nursing.

  2. Chronic inducible urticaria that would confound the study endpoints.

  3. Other diseases associated with urticaria.

  4. Active pruritic skin condition in addition to CSU.

  5. Medical condition that would cause additional risk or interfere with studyprocedures.

  6. Known HIV, hepatitis B or hepatitis C infection.

  7. Vaccination of a live vaccine within 2 months prior to study treatment (subjectsmust agree to avoid live vaccinations during the study). Inactivated vaccines areallowed such as seasonal influenza injection or COVID-19 vaccine.

  8. History of anaphylaxis

  9. Prior treatment with barzolvolimab

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Study Design

Total Participants: 915
Treatment Group(s): 2
Primary Treatment: barzolvolimab
Phase: 3
Study Start date:
July 11, 2024
Estimated Completion Date:
April 30, 2027

Study Description

This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose.

There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period.

Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

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