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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06455202

Public ClinicalTrials.gov record NCT06455202. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 1:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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-CSU2)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06455202
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Celldex Therapeutics
Industry
Enrollment
976 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 19, 2024 (Actual)
Primary completion
Oct 2026 (Estimated)
Completion
Apr 2027 (Estimated)
Last update posted
Mar 25, 2026

2024 – 2027

United States locations

U.S. sites
63
U.S. states
24
U.S. cities
50
Facility City State ZIP Site status
Allervie Clinical Research - Cullman Cullman Alabama 35058 —
Research Solutions of Arizona PC Litchfield Park Arizona 85340 —
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd. Scottsdale Arizona 85258 —
Center for Dermatology & Plastic Surgery Scottsdale Arizona 85260 —
Kern Research, Inc. Bakersfield California 93301 —
UCLA Clinical Trials Contracts & Strategic Relations Los Angeles California 90024 —
California Allergy and Asthma Medical Group Los Angeles California 90025 —
LA Universal Research Center, Inc. Los Angeles California 90057 —
Allergy and Asthma Associates of Southern Cal Mission Viejo California 92691 —
Huntington Asthma & Allergy Center Pasadena California 91107 —
Apex Clinical Research San Diego California 92120 —
WR-MCCR San Diego California 92120 —
University Clinical Trials San Diego California 92123 —
Clinical Science Institute Santa Monica California 90404 —
Raffi Tachdjian MD, Inc Santa Monica California 90404 —
Clarity Dermatology, PLLC Castle Rock Colorado 80109 —
Asthma and Allergy Associates Colorado Springs Colorado 80907 —
Driven Research LLC Coral Gables Florida 33134 —
Palm Beach Dermatology Group Delray Beach Florida 33484 —
Dolphin Medical Research Doral Florida 33172 —
South FL Clinical Research LLC Miami Florida 33165 —
Dade Florida Clinical Research Center Miami Florida 33173 —
Deluxe Health Center Miami Lakes Florida 33014 —
Revival Clinical Research Orlando Florida 32807 —
International Clinical Research - FL LLC Sanford Florida 32771 —
D&H Tamarac Research Center, LLC Tamarac Florida 33321 —
Advanced Clinical Research Institute (ACRI) - Florida Tampa Florida 33607 —
Deluxe Health Center Tampa Florida 33607 —
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research Tampa Florida 33609 —
University of South Florida Tampa Florida 33613 —
Olympian Clinical Research Tampa Florida 33615 —
Lane Dermatology Research - Centricity - PPDS Columbus Georgia 31904 —
Skin Care Physicians of Georgia Macon Georgia 31217 —
Treasure Valley Medical Research Boise Idaho 83706 —
Rush University Medical Center Chicago Illinois 60612 —
Sneeze Wheeze and Itch Associates LLC Normal Illinois 61761 —
The Indiana Clinical Trials Center, PC Plainfield Indiana 46168 —
South Bend Clinic South Bend Indiana 46617 —
University of Kansas Medical Center Kansas City Kansas 66160-8500 —
Equity Medical Bowling Green Kentucky 42104 —
Allergy & Asthma Associates Lexington Kentucky 40509 —
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS Baton Rouge Louisiana 70808 —
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS Towson Maryland 21204 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Derm Institute of Western Michigan Caledonia Michigan 49316 —
Clarkston Skin Research - Clarkston Clarkston Michigan 48346 —
Midwest Clinical Research, LLC St Louis Missouri 63141 —
Washington University School of Medicine St Louis Missouri 63141 —
Skin Specialists PC Omaha Nebraska 68144 —
Hudson-Essex Allergy Belleville New Jersey 07109 —
Impact Medical / Circuit Clinical Paramus New Jersey 07652 —
Impact Medical / Circuit Clinical Riverdale New Jersey 07457 —
Equity Medical LLC New York New York 10023 —
OptiSkin Medical New York New York 10128 —
Optima Research Boardman Ohio 44512 —
Optimed Research Ltd - ClinEdge - PPDS Columbus Ohio 43235 —
Penn State Health Milton Hershey Med Cen Hershey Pennsylvania 17033 —
Clinical Partners LLC Johnston Rhode Island 02919 —
Western Sky Medical Research El Paso Texas 79932 —
Austin Institute for Clinical Research, Inc. Pflugerville Texas 78660 —
Rainey & Finklea San Antonio Dermatology San Antonio Texas 78213 —
Allergy Associates of Utah - Sandy Murray Utah 84107 —
Kalo Clinical Research West Valley City Utah 84120 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 182 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06455202, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 25, 2026 · Synced Oct 26, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06455202 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →