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

Description

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.

Conditions

Chronic Spontaneous Urticaria

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Chronic Spontaneous Urticaria
Intervention / Treatment

-

Contacts and Locations

Birmingham

Cahaba Dermatology Skin Health Center, Birmingham, Alabama, United States, 35244

Scottsdale

Clear Dermatology & Aesthetics Center Scottsdale, Scottsdale, Arizona, United States, 85255

Fountain Valley

First OC Dermatology - Fountain Valley, Fountain Valley, California, United States, 92708

Los Angeles

Dermatology Research Associates, Los Angeles, California, United States, 90045

Oxnard

Cura Clinical Research, Oxnard, California, United States, 93030

Redwood City

Allergy and Asthma Consultants, Redwood City, California, United States, 94063

San Diego

West Dermatology Research Center, San Diego, California, United States, 92121

San Diego

Therapeutics Clinical Research, San Diego, California, United States, 92123

Upland

Integrated Research of Inland, Inc., Upland, California, United States, 91786

Wheat Ridge

Western States Clinical Research Inc, Wheat Ridge, Colorado, United States, 80033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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-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 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.
  • 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 study procedures.
  • 6. Known HIV, hepatitis B or hepatitis C infection.
  • 7. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
  • 8. History of anaphylaxis
  • 9. Prior treatment with barzolvolimab

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Celldex Therapeutics,

Study Record Dates

2027-04