drugset / Trial / NCT05387707
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2022-08-16
- Primary completion
- 2024-02-02
- Completion
- 2024-02-02
Outcome
Outcome not reported
Stopped: “In Part A of the study, oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Difelikefalin | Protein / enzyme biologic | 0.25 mg | Oral |
| Subject | Difelikefalin | Protein / enzyme biologic | 0.5 mg | Oral |