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RECRUITING
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

2026-05-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

barzolvolimab

Subcutaneous Administration

OTHER

Standard of Care

Observational/Standard of Care

Locations (34)

Cahaba Dermatology & Skin Health Center, LLC

Birmingham, Alabama, United States

Center for Dermatology & Plastic Surgery - Avacare

Scottsdale, Arizona, 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

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

Institute for Asthma and Allergy

Wheaton, Maryland, United States

Respiratory Medicine Research Institute of Michigan PLC

Ypsilanti, Michigan, United States

Michigan Center for Research Co., LLC (or Profound Research LLC at Clarkson Medical Group as listed in Suvoda)

Clarkson, 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

Rainey & Finklea San Antonio (RFSA) Dermatology

San Antonio, Texas, United States

Cornerstone Dermatology

Coorparoo, QSL, Australia

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

Razgrad, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Pulmovision

Sofia, Bulgaria

Evidence Based Medical Educator Inc.

Toronto, Ontario, Canada

Joel Liem Medicine Professional Corporation

Windsor, Ontario, Canada

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

Gdansk, Poland

EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

Wroclaw, Poland

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Durban, KwaZulu-Natal, South Africa

University of Cape Town Lung Institute (UCTLI)

Mowbray, Western Cape, South Africa

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Universitario de La Plana

Villarreal de Huerva, Spain