Center for Clinical Studies | Clear Lake-Webster, TX
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About
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.
Full description
The purpose of this study is to assess the efficacy and safety of barzolvolimab (CDX-0159) in adults with prurigo nodularis.
There is a screening period of approximately 28 days, a 24-week double-blind treatment period and a 16-week follow-up period after treatment. Participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg, or placebo Q4W.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Males and females, ≥18 years of age.
Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Key Exclusion Criteria
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Primary purpose
Allocation
Interventional model
Masking
120 participants in 3 patient groups, including a placebo group
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Central trial contact
Celldex Therapeutics
Data sourced from clinicaltrials.gov
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