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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 May 19, 2026, 9:07 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)

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

  • Matching placebo Biological
  • barzolvolimab Biological

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 18, 2024
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027
Last update posted
Mar 24, 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 24, 2026 · Synced May 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06455202 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →