Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)

Phase 2 Completed 126 enrolled Cara Therapeutics, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.

Timeline

Start: 2021-01-11
Primary completion: 2022-05-18
Completion: 2022-06-30

Publications

Kim BS, Bissonnette R, Nograles K, Munera C, Shah N, Jebara A, Cirulli J, Goncalves J, Lebwohl M; KOMFORT Trial Investigators. Phase 2 Trial of Difelikefalin in Notalgia Paresthetica. N Engl J Med. 2023 Feb 9;388(6):511-517. doi: 10.1056/NEJMoa2210699.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Difelikefalin	Protein / enzyme biologic	2 mg	Oral

Indications

No indication recorded.