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

a study on Hives

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by April W. Armstrong, MD, MPH
Headshot of April W. Armstrong
April W. Armstrong

Description

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.

Official Title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)

Details

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.

Keywords

Chronic Spontaneous Urticaria, CDX-0159, barzolvolimab, CSU, urticaria activity score, itch severity score, hives severity score, Urticaria, Chronic Urticaria, barzolvolimab 150 mg, barzolvolimab 300 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Males and females, >/= 18 years of age.
  2. Chronic spontaneous urticaria (CSU) >/= 6 months prior to Screening (Visit 1).

  3. CSU 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 non-sedating H1-antihistamines.
    2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
    3. UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to study treatment.
  4. Normal blood counts and liver function tests.
  5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
  6. Willing and able to complete a daily symptom electronic diary and comply with study visits.
  7. Participants with and without prior biologic experience are eligible.

You CAN'T join if...

  1. Women who are pregnant or nursing.
  2. Chronic urticaria whose predominant manifestation is due to CIndU.
  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 study procedures.
  6. Known HIV, hepatitis B or hepatitis C infection.
  7. Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized 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.

Locations

  • Dermatology Research Associates accepting new patients
    Los Angeles California 90045 United States
  • First OC Dermatology - Fountain Valley accepting new patients
    Fountain Valley California 92708 United States

Lead Scientist at UCLA

  • April W. Armstrong, MD, MPH
    Dr. April Armstrong is Professor and Chief of Dermatology at University of California Los Angeles (UCLA). She oversees and leads the dermatology division, including managing clinical operations and promoting research and education. She also serves as Co-Director for Network Resources at the UCLA Clinical and Translational Research Institute.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celldex Therapeutics
Links
Sign up for this study
ID
NCT06445023
Phase
Phase 3 Hives Research Study
Study Type
Interventional
Participants
Expecting 915 study participants
Last Updated
Contact us about this trial