Individuals aged 18 to 80 years (inclusive) with a clinically confirmed diagnosis of active atopic dermatitis (AD), may qualify for this study. Participants must have at least mild AD, covering 20% or less of the body surface area; chronic pruritus/itch (for more than 6 weeks) related to AD; and AD-related pruritus/itch that has not been adequately controlled by topical therapy alone, in the past 3 months. Qualified adults must also agree to use an emollient(s) daily (once or twice daily) throughout the study.
Participants will receive investigational oral medication (active study drug) or placebo, plus a topical corticosteroid or vehicle cream. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Total study duration lasts approximately 70-72 weeks and involves about 15-16 visits to the study centre.
The following information is from ClinicalTrials.gov
Last Update Posted: March 26, 2023
NCT05387707
Cara Therapeutics, Inc.
Brief Summary:
This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD).
Condition or Disease:
Pruritus
Intervention/Treatment:
Drug: difelikefalin 0.25 mgPhase:
Phase 3
Ages Eligible for Study:
18 Years and 80 Years (Adult)
Sexes Eligible for Study:
All
Key Inclusion Criteria:
To be eligible for inclusion into the study, a patient must meet the following criteria:
Subject has clinically confirmed diagnosis of active AD;
Subject has chronic pruritus related to AD;
Subject has moderate to severe pruritus;
Female subject is not pregnant or nursing during any period of the study.
Key Exclusion Criteria:
A patient will be excluded from the study if any of the following criteria are met:
Subject has clinically infected AD;
Subject has pruritus attributed to a cause other than AD;
Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
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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