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

NCT05387707 ↗

Phase 3 Terminated 287 enrolled Cara Therapeutics, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Difelikefalin Protein / enzyme biologic 0.25 mg Oral
Subject Difelikefalin Protein / enzyme biologic 0.5 mg Oral

Indications