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ENROLLING BY INVITATION
NCT07256392
PHASE3

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Sponsor: Celldex Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.

Official title: A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1370

Start Date

2025-11-25

Completion Date

2028-09

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

BIOLOGICAL

barzolvolimab

Subcutaneous Administration

OTHER

Standard of Care

Observational/Standard of Care

Locations (63)

Cahaba Dermatology & Skin Health Center, LLC

Birmingham, Alabama, United States

Medical Research of Arizona

Scottsdale, Arizona, United States

Center for Dermatology & Plastic Surgery - Avacare

Scottsdale, Arizona, United States

Kern Research

Bakersfield, California, United States

Allergy and Asthma Associates of Southern California - Laguna Niguel - CRN

Laguna Niguel, California, United States

Dermatology Research Associates

Los Angeles, California, United States

LA Universal Research Center, Inc.

Los Angeles, California, United States

Encore Medical Research of Boynton Beach LLC

Boynton Beach, Florida, United States

Dolphin Medical Research

Doral, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Deluxe Health Center

Miami Lakes, Florida, United States

Sarasota Clinical Research

Sarasota, Florida, United States

Advanced Clinical Research Institute (ACRI) - Florida

Tampa, Florida, United States

Centricity Research Columbus Dermatology

Columbus, Georgia, United States

Endeavor Health

Skokie, Illinois, United States

The South Bend Clinic - Avacare

South Bend, Indiana, United States

John Hopkins University

Baltimore, Maryland, United States

Institute for Asthma and Allergy

Wheaton, Maryland, United States

Michigan Center for Research Co., LLC

Clarkston, Michigan, United States

Respiratory Medicine Research Institute of Michigan PLC

Ypsilanti, Michigan, United States

Midwest Clinical Research

St Louis, Missouri, United States

Montana Medical Research, Inc.

Missoula, Montana, United States

Bexley Dermatology Research

Bexley, Ohio, United States

Toledo Institute for Clinical Research

Toledo, Ohio, United States

Portland Allergy and Asthma

Clackamas, Oregon, United States

Clinical Partners LLC

Johnston, Rhode Island, United States

Western Sky Medical Research

El Paso, Texas, United States

Rainey & Finklea San Antonio (RFSA) Dermatology

San Antonio, Texas, United States

Conexa Investigación Clínica S.A.

CABA, Buenos Aires F.D., Argentina

Aprillus Asistencia e Investigacion de Arcis Salud SRL

CABA, Buenos Aires F.D., Argentina

Instituto de Especialidades de la Salud Rosario - Clínica del Tórax

Rosario, Sante Fe, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Sante Fe, Argentina

Clinica Mayo de Urgencias

San Miguel de Tucumán, Tucumán Province, Argentina

Cornerstone Dermatology

Coorparoo, QSL, Australia

The Alfred Hospital - Kern

Melbourne, Victoria, Australia

Outpatient Clinic for IP for Specialized Outpatient Medical Care in Allergology-Dr.Cholak

Razgrad, Bulgaria

Medical Center Iskar EOOD

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

Sofia, Bulgaria

Medical Center Pulmovision

Sofia, Bulgaria

Lima's Excellence In Allergy And Dermatology Research (Leader) Inc.

Hamilton, Ontario, Canada

Lynderm Research Inc

Markham, Ontario, Canada

Evidence Based Medical Educator Inc.

Toronto, Ontario, Canada

Joel Liem Medicine Professional Corporation

Windsor, Ontario, Canada

CHRU Nantes Hôtel Dieu

Nantes, France

Hospital A. Syggros

Athens, Greece

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Poland

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

Krakow, Poland

MICS Centrum Medyczne Toruń

Torun, Poland

Klinika Ambroziak Dermatologia

Warsaw, Poland

Ginemedica Sp. z o.o.

Wroclaw, Poland

EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

Wroclaw, Poland

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University of Cape Town Lung Institute (UCTLI)

Mowbray, Western Cape, South Africa

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Suwon, South Korea

Hospital General Universitario Dr. Balmis

Alicante, Spain

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Madrid, Spain

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Villarreal de Huerva, Spain

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