: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Inducible Urticaria

  • STATUS
    Recruiting
  • End date
    Oct 22, 2024
  • participants needed
    180
  • sponsor
    Celldex Therapeutics
Updated on 22 October 2022

Summary

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.

Description

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Inducible Urticaria (Cold Urticaria [ColdU] or Symptomatic Dermographism [SD]) who remain symptomatic despite the use of H1-antihistamines.

There is a screening period of up to 4 weeks, followed by a 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.

Details
Condition Chronic Inducible Urticaria
Treatment Matching Placebo, barzolvolimab
Clinical Study IdentifierNCT05405660
SponsorCelldex Therapeutics
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females, >/= 18 years of age
Diagnosis of chronic ColdU or SD >/= 3 months
Diagnosis of ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by
Recurrent pruritic wheals with or without angioedema due to ColdU or SD for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines
Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment and agree to stay on through trial
UCT < 12 during the 14 days prior to treatment
Positive provocation test
for ColdU patients: developing a wheal at the test site within 10 min after using TempTest® at any temperature at both screening (Visit 1) and randomization (Visit 3)
for SD patients: developing a wheal at the test site within 10 min after using FricTest® with ≥ 3 pins at both screening (Visit 1) and randomization (Visit 3)
Both males and females of child-bearing potential must agree to use highly effective
contraceptives during the study and for 150 days after treatment
Willing and able to complete a daily symptom electronic diary and comply with study visits

Exclusion Criteria

Women who are pregnant or nursing
Active Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD that may interfere with study assessments
Active, pruritic skin condition in addition to CIndU
Medical condition that would cause additional risk or interfere with study procedures
Known active HIV, hepatitis B or hepatitis C infection
Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine
History of anaphylaxis
There are additional criteria that your study doctor will review with you to confirm you
are eligible for the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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