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Clinical Trials in India / NCT06455202
Active, not recruiting Phase 3

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

NCT06455202 · tracked via the Priya Life Science India tracker
Sponsor
Celldex Therapeutics
Phase
Phase 3
Started
2024-07-19
Last updated
2026-03-25

Condition(s) studied

Chronic Spontaneous Urticaria

Investigational drug(s) / intervention(s)

barzolvolimabMatching 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 (245)

FacilityCityRegionStatus
Allervie Clinical Research - Cullman Cullman Alabama
Research Solutions of Arizona PC Litchfield Park Arizona
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd. Scottsdale Arizona
Center for Dermatology & Plastic Surgery Scottsdale Arizona
Kern Research, Inc. Bakersfield California
UCLA Clinical Trials Contracts & Strategic Relations Los Angeles California
California Allergy and Asthma Medical Group Los Angeles California
LA Universal Research Center, Inc. Los Angeles California
Allergy and Asthma Associates of Southern Cal Mission Viejo California
Huntington Asthma & Allergy Center Pasadena California
Apex Clinical Research San Diego California
WR-MCCR San Diego California
University Clinical Trials San Diego California
Clinical Science Institute Santa Monica California
Raffi Tachdjian MD, Inc Santa Monica California
Clarity Dermatology, PLLC Castle Rock Colorado
Asthma and Allergy Associates Colorado Springs Colorado
Driven Research LLC Coral Gables Florida
Palm Beach Dermatology Group Delray Beach Florida
Dolphin Medical Research Doral Florida
South FL Clinical Research LLC Miami Florida
Dade Florida Clinical Research Center Miami Florida
Deluxe Health Center Miami Lakes Florida
Revival Clinical Research Orlando Florida
International Clinical Research - FL LLC Sanford Florida
D&H Tamarac Research Center, LLC Tamarac Florida
Advanced Clinical Research Institute (ACRI) - Florida Tampa Florida
Deluxe Health Center Tampa Florida
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research Tampa Florida
University of South Florida Tampa Florida
Olympian Clinical Research Tampa Florida
Lane Dermatology Research - Centricity - PPDS Columbus Georgia
Skin Care Physicians of Georgia Macon Georgia
Treasure Valley Medical Research Boise Idaho
Rush University Medical Center Chicago Illinois
Sneeze Wheeze and Itch Associates LLC Normal Illinois
The Indiana Clinical Trials Center, PC Plainfield Indiana
South Bend Clinic South Bend Indiana
University of Kansas Medical Center Kansas City Kansas
Equity Medical Bowling Green Kentucky

+ 205 more sites — see the full list on the official registry below.

More Celldex Therapeutics trials in India

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 NCT06455202 on ClinicalTrials.gov ↗ ← All trials in India