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

Last updated: April 29, 2026
Sponsor: Celldex Therapeutics
Overall Status: Active - Recruiting

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

  • Cornerstone Dermatology

    Coorparoo, QSL 4151
    Australia

    Active - Recruiting

  • EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

    Wroclaw, 54-144
    Poland

    Active - Recruiting

  • Cahaba Dermatology & Skin Health Center, LLC

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • Center for Dermatology & Plastic Surgery - Avacare

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Center for Dermatology & Plastic Surgery - Avacare

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • LA Universal Research Center, Inc.

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles 5368361, California 5332921 90045
    United States

    Site Not Available

  • Encore Medical Research of Boynton Beach LLC

    Boynton Beach, Florida 33436
    United States

    Active - Recruiting

  • Direct Helpers Research Center

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Deluxe Health Center

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Sarasota Clinical Research

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Advanced Clinical Research Institute (ACRI) - Florida

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Direct Helpers Research Center

    Hialeah 4158476, Florida 4155751 33012
    United States

    Site Not Available

  • Deluxe Health Center

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Site Not Available

  • Advanced Clinical Research Institute (ACRI) - Florida

    Tampa 4174757, Florida 4155751 33607
    United States

    Site Not Available

  • Centricity Research Columbus Dermatology

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Centricity Research Columbus Dermatology

    Columbus 4188985, Georgia 4197000 31904
    United States

    Site Not Available

  • Endeavor Health

    Skokie, Illinois 60026
    United States

    Active - Recruiting

  • The South Bend Clinic - Avacare

    South Bend, Indiana 46617
    United States

    Active - Recruiting

  • Institute for Asthma and Allergy

    Wheaton, Maryland 20902
    United States

    Active - Recruiting

  • Institute for Asthma and Allergy

    Wheaton 4373349, Maryland 4361885 20902
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan PLC

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • 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

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

    Clarkson 4381419, Missouri 4398678 48346
    United States

    Site Not Available

  • Montana Medical Research, Inc.

    Missoula, Montana 59808
    United States

    Active - Recruiting

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Active - Recruiting

  • Toledo Institute for Clinical Research

    Toledo, Ohio 43617
    United States

    Active - Recruiting

  • Bexley Dermatology Research

    Bexley 4506487, Ohio 5165418 43209
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.