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Clinical Trials in the USA / NCT06445023
Active, not recruiting Phase 3

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

NCT06445023 · tracked via the Priya Life Science USA tracker
Sponsor
Celldex Therapeutics
Phase
Phase 3
Started
2024-07-11
Last updated
2026-03-25

Condition(s) studied

Chronic Spontaneous Urticaria

Investigational drug(s) / intervention(s)

barzolvolimab →Matching placebo

barzolvolimab: Subcutaneous Administration

Matching placebo: Matching placebo Subcutaneous Administration

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (235)

FacilityCityRegionStatus
Cahaba Dermatology Skin Health Center Birmingham Alabama
First OC Dermatology - Fountain Valley Fountain Valley California
310 Clinical Research Inglewood California
Dermatology Research Associates Los Angeles California
Focus Clinical Research - Los Angeles Los Angeles California
Cura Clinical Research Oxnard California
Allergy and Asthma Consultants Redwood City California
Acclaim Clinical Research San Diego California
West Dermatology Research Center San Diego California
Therapeutics Clinical Research San Diego California
Orso Health, Inc. Torrance California
Integrated Research of Inland, Inc. Upland California
Western States Clinical Research Inc Wheat Ridge Colorado
Encore Medical Research Boynton Beach Boynton Beach Florida
Direct Helpers Research Center Hialeah Florida
GSI Clinical Research Margate Florida
International Dermatology Research Inc - Miami Miami Florida
Miami Dade Medical Research Institute, LLC Miami Florida
Sarasota Clinical Research Sarasota Florida
GCP Global Clinical Professionals, LLC St. Petersburg Florida
Paradigm Clinical Research Boise Boise Idaho
Endeavor Health Skokie Illinois
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave Indianapolis Indiana
DS Research of Kentucky, LLC Louisville Kentucky
Allergy and Asthma Specialists PSC Owensboro Kentucky
Clinical Trials Management LLC - Southshore Office Metairie Louisiana
Johns Hopkins Asthma and Allergy Center Baltimore Maryland
DermAssociates, LLC Rockville Maryland
Institute For Asthma and Allergy Wheaton Maryland
David Fivenson MD Dermatolgy PLLC Ann Arbor Michigan
Resp Medicine Research Institute of MI Ypsilanti Michigan
Dermatolgy and Skin Cancer Center Lee's Summit Missouri
MediSearch, LLC Saint Joseph Missouri
Montana Medical Research Missoula Montana
Excel Clinical Research - Las Vegas Las Vegas Nevada
Allergy Partners of N.J., P.C. Ocean City New Jersey
Finger Lakes Medical Research, PLLC Cortland New York
Sadick Research Group New York New York
Bexley Dermatology Research Bexley Ohio
Apex Clinical Research Canton Ohio

+ 195 more sites — see the full list on the official registry below.

More Celldex Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06445023 on ClinicalTrials.gov ↗ ← All trials in the USA