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

Last updated: June 26, 2026
Sponsor: Celldex Therapeutics
Overall Status: Active - Enrolling

Phase

3

Condition

Hives (Urticaria)

Urticaria

Treatment

Standard of Care

barzolvolimab

Clinical Study ID

NCT07256392
CDX0159-17
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Written informed consent

  2. Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12or CDX0159-13).

  3. Both males and females of child-bearing potential must agree to use highly effectivecontraceptives when receiving barzolvolimab treatment and for 150 days aftertreatment.

  4. Willing and able to comply with all study requirements and procedures, includingcompletion of a daily symptom electronic diary.

Exclusion

Key Exclusion Criteria:

  1. Active pruritic skin condition in addition to CSU.

  2. Medical condition that would cause additional risk or interfere with studyprocedures.

  3. Participants without at least one documented UAS7 score from Weeks 64-68 of theCDX0159-12 or CDX0159-13 trials.

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Study Design

Total Participants: 1370
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase: 3
Study Start date:
November 25, 2025
Estimated Completion Date:
September 30, 2028

Study Description

This is a global, multicenter, long-term extension phase 3b study to determine the time to disease worsening or treatment failure in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods the phase 3 clinical trials.

The study will consist of 2 Groups: Group 1 (Observation Group), comprising participants whose UAS7 score is less than 16 at entry and Group 2 (Barzolvolimab Retreatment Group) comprising participants whose UAS7 score is 16 or greater.

Participation in this trial will last for approximately 52 weeks for participants assigned to Group 1 (Observation Group) and who do not receive barzolvolimab during the trial. Participants assigned to Group 1 who require barzolvolimab rescue during the trial will be in the trial for up to 68 weeks. Participants assigned to Group 2 (Barzolvolimab Retreatment Group), trial participation will last for approximately 68 weeks from the start of treatment (Day 1).

Connect with a study center

  • Aprillus Asistencia e Investigacion de Arcis Salud SRL

    CABA, Buenos Aires F.D. 1406
    Argentina

    Site Not Available

  • Conexa Investigación Clínica S.A.

    CABA, Buenos Aires F.D. 1012
    Argentina

    Site Not Available

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Sante Fe S2000DEJ
    Argentina

    Site Not Available

  • Instituto de Especialidades de la Salud Rosario - Clínica del Tórax

    Rosario, Sante Fe 2000
    Argentina

    Site Not Available

  • Clinica Mayo de Urgencias

    San Miguel de Tucumán, Tucumán Province 4000
    Argentina

    Site Not Available

  • Cornerstone Dermatology

    Coorparoo, QSL 4151
    Australia

    Site Not Available

  • The Alfred Hospital - Kern

    Melbourne, Victoria 3004
    Australia

    Site Not Available

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

    Razgrad, 7200
    Bulgaria

    Site Not Available

  • Medical Center Hera EOOD

    Sofia, 1510
    Bulgaria

    Site Not Available

  • Medical Center Iskar EOOD

    Sofia, 1000
    Bulgaria

    Site Not Available

  • Medical Center Pulmovision

    Sofia, 1756
    Bulgaria

    Site Not Available

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

    Sofia, 1606
    Bulgaria

    Site Not Available

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

    Hamilton, Ontario L8L 3C3
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Evidence Based Medical Educator Inc.

    Toronto, Ontario M5G1E2
    Canada

    Site Not Available

  • Joel Liem Medicine Professional Corporation

    Windsor, Ontario N8X 2G1
    Canada

    Site Not Available

  • CHRU Nantes Hôtel Dieu

    Nantes, 44093
    France

    Site Not Available

  • Hospital A. Syggros

    Athens, 16121
    Greece

    Site Not Available

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

    Gdansk, 80-546
    Poland

    Site Not Available

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

    Krakow, 31-011
    Poland

    Site Not Available

  • MICS Centrum Medyczne Toruń

    Torun, 87-100
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953
    Poland

    Site Not Available

  • EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

    Wroclaw, 54-144
    Poland

    Site Not Available

  • Ginemedica Sp. z o.o.

    Wroclaw, 50-414
    Poland

    Site Not Available

  • Worthwhile Clinical Trials

    Benoni, Gauteng 1501
    South Africa

    Site Not Available

  • About Allergy

    Pretoria, Gauteng 0181
    South Africa

    Site Not Available

  • Global Clinical Trials (Pty) Ltd - Pretoria

    Pretoria, Gauteng 0157
    South Africa

    Site Not Available

  • Synapta Clinical Research Centre

    Durban, KwaZulu-Natal 4001
    South Africa

    Site Not Available

  • University of Cape Town Lung Institute (UCTLI)

    Mowbray, Western Cape 7700
    South Africa

    Site Not Available

  • Ajou University Hospital

    Suwon, 16499
    South Korea

    Site Not Available

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Clinico San Carlos - Lopez Bran

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario de La Plana

    Villarreal de Huerva, 12540
    Spain

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813414
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 404
    Taiwan

    Site Not Available

  • Cahaba Dermatology & Skin Health Center, LLC

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Center for Dermatology & Plastic Surgery - Avacare

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Medical Research of Arizona

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Kern Research

    Bakersfield, California 93301
    United States

    Site Not Available

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

    Laguna Niguel, California 92677
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • LA Universal Research Center, Inc.

    Los Angeles, California 90057
    United States

    Site Not Available

  • Encore Medical Research of Boynton Beach LLC

    Boynton Beach, Florida 33436
    United States

    Site Not Available

  • Dolphin Medical Research

    Doral, Florida 33172
    United States

    Site Not Available

  • Direct Helpers Research Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Deluxe Health Center

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Sarasota Clinical Research

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Advanced Clinical Research Institute (ACRI) - Florida

    Tampa, Florida 33607
    United States

    Site Not Available

  • Centricity Research Columbus Dermatology

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Endeavor Health

    Skokie, Illinois 60026
    United States

    Site Not Available

  • The South Bend Clinic - Avacare

    South Bend, Indiana 46617
    United States

    Site Not Available

  • John Hopkins University

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Institute for Asthma and Allergy

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Michigan Center for Research Co., LLC

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan PLC

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

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

    Clarkson, Missouri 48346
    United States

    Active - Recruiting

  • Midwest Clinical Research

    St Louis, Missouri 63141
    United States

    Site Not Available

  • Montana Medical Research, Inc.

    Missoula, Montana 59808
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Toledo Institute for Clinical Research

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Portland Allergy and Asthma

    Clackamas, Oregon 97015
    United States

    Site Not Available

  • Clinical Partners LLC

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Western Sky Medical Research

    El Paso, Texas 79912
    United States

    Site Not Available

  • Rainey & Finklea San Antonio (RFSA) Dermatology

    San Antonio, Texas 78213
    United States

    Site Not Available

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