A Study of CDX-0159 in Patients With Chronic Inducible Urticaria (NCT05405660) | Clinical Trial Compass
CompletedPhase 2
A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
United States196 participantsStarted 2022-06-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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)
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.
What they're measuring
1
Percentage of patients with a negative provocation test at week 12
✕. 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.