CDX0159-12 Enrolling

Research Trial for Chronic Spontaneous Urticaria 1 (72 Weeks)-CA


Treatment: Injection Age: 18 Years


Who Can Participate?

Males or females, ≥ 18 years of age with chronic spontaneous urticaria (CSU) may be eligible to participate.

 

Inclusion Criteria:

      • Diagnosis of CSU for 6 months or more
      • CSU resistant to a stable dose and regimen containing a second-generation H1 antihistamine (H1AH), as defined by the following:
      • Recurrent pruritic wheals (itchy bumps) with or without angioedema (swelling in deeper layers of skin) for ≥ 6 weeks at any time prior to screening despite treatment with a H1AH
      • Must have been on a stable dose and regimen containing a second-generation H1AH at approved or increased dose as background therapy for the treatment of CSU for ≥ 4 weeks prior to randomization

 

Participant Info:

      • No cost to participate or receive treatment
      • Regular visits with study doctors who specialise in treating chronic spontaneous urticaria
      • Will receive investigational injected treatment (active study drug) or placebo
      • Reimbursement for study-related expenses may be provided

 

How Long Will The Study Last?

      • 72 weeks (19 study visits)

Participating Locations

COUNTRY
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Canada

Participating Experts

No Doctors Found

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The following information is from ClinicalTrials.gov

Last Update Posted: January 29, 2025

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)

ClinicalTrials.gov ID

NCT06445023

Sponsor

Celldex Therapeutics

Study Description

  • Brief Summary:

    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.

  • Condition or Disease:

    Chronic Spontaneous Urticaria

  • Intervention/Treatment:

    Biological: barzolvolimab Biological: barzolvolimab Biological: barzolvolimab,Biological: Matching placebo Biological: barzolvolimab,Biological: Matching placebo
  • Phase:

    PHASE 3

  • Ages Eligible for Study:

    18 Years and older (ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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