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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06445023

Public ClinicalTrials.gov record NCT06445023. 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 Nov 6, 2026, 3:52 PM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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-CSU1)

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
NCT06445023
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Celldex Therapeutics
Industry
Enrollment
963 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 11, 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
58
U.S. states
24
U.S. cities
53
Facility City State ZIP Site status
Cahaba Dermatology Skin Health Center Birmingham Alabama 35244 —
First OC Dermatology - Fountain Valley Fountain Valley California 92708 —
310 Clinical Research Inglewood California 90301 —
Dermatology Research Associates Los Angeles California 90045 —
Focus Clinical Research - Los Angeles Los Angeles California 91307 —
Cura Clinical Research Oxnard California 93030 —
Allergy and Asthma Consultants Redwood City California 94063 —
Acclaim Clinical Research San Diego California 92120 —
West Dermatology Research Center San Diego California 92121 —
Therapeutics Clinical Research San Diego California 92123 —
Orso Health, Inc. Torrance California 90505 —
Integrated Research of Inland, Inc. Upland California 91786 —
Western States Clinical Research Inc Wheat Ridge Colorado 80033 —
Encore Medical Research Boynton Beach Boynton Beach Florida 33436 —
Direct Helpers Research Center Hialeah Florida 33012 —
GSI Clinical Research Margate Florida 33063 —
International Dermatology Research Inc - Miami Miami Florida 33144 —
Miami Dade Medical Research Institute, LLC Miami Florida 33176 —
Sarasota Clinical Research Sarasota Florida 34239 —
GCP Global Clinical Professionals, LLC St. Petersburg Florida 33705 —
Paradigm Clinical Research Boise Boise Idaho 83709 —
Endeavor Health Skokie Illinois 60077 —
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave Indianapolis Indiana 46250 —
DS Research of Kentucky, LLC Louisville Kentucky 40241 —
Allergy and Asthma Specialists PSC Owensboro Kentucky 42301 —
Clinical Trials Management LLC - Southshore Office Metairie Louisiana 70006 —
Johns Hopkins Asthma and Allergy Center Baltimore Maryland 21224 —
DermAssociates, LLC Rockville Maryland 20850 —
Institute For Asthma and Allergy Wheaton Maryland 20902 —
David Fivenson MD Dermatolgy PLLC Ann Arbor Michigan 48103 —
Resp Medicine Research Institute of MI Ypsilanti Michigan 48197 —
Dermatolgy and Skin Cancer Center Lee's Summit Missouri 64064 —
MediSearch, LLC Saint Joseph Missouri 64506 —
Montana Medical Research Missoula Montana 59808 —
Excel Clinical Research - Las Vegas Las Vegas Nevada 90301 —
Allergy Partners of N.J., P.C. Ocean City New Jersey 07712 —
Finger Lakes Medical Research, PLLC Cortland New York 13045 —
Sadick Research Group New York New York 10075 —
Bexley Dermatology Research Bexley Ohio 43209 —
Apex Clinical Research Canton Ohio 44718 —
Bernstein Clinical Research Center, LLC Cincinnati Ohio 45236 —
Wright State Physicians Fairborn Ohio 45324 —
Auni Allergy Findlay Ohio 45840 —
Apex Clinical Research Center Mayfield Heights Ohio 44124 —
Toledo Institute of Clinical Research Toledo Ohio 43617 —
Allergy Asthma and Clinical Research Center Oklahoma City Oklahoma 73120 —
Portland Allergy and Asthma Clackamas Oregon 97015 —
Oregon Medical Research Center Portland Oregon 97201 —
Clinical Research Philadelphia, LLC Philadelphia Pennsylvania 18114 —
National Allergy and Asthma Research, LLC - CRN - PPDS North Charleston South Carolina 29420 —
Alina Clinical Trials Dallas Texas 75225 —
Zenos Clinical Research Dallas Texas 75230 —
Epic Clinical Research Lewisville Texas 75057 —
VAST Clinical Research - Plano Plano Texas 75033 —
STAAMP Research, LLC - CRN San Antonio Texas 78229 —
Allergy and Asthma Care of Waco Waco Texas 76712 —
University of Utah - MidValley Dermatology - PPDS Murray Utah 84107 —
Premier Clinical Research Spokane Washington 99202 —

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 177 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06445023, 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 Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06445023 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →