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

A Two-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate-to-Severe Pruritus in Adult Subjects With Atopic Dermatitis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Part A of this study includes a 12-week Double-blind Treatment Period and a 52-week Open-label Extension Period. Subjects will be randomized to receive oral difelikefalin 0.25 mg tablets BID plus TCS cream, difelikefalin 0.5 mg tablets BID plus TCS cream, placebo tablets BID plus TCS cream or placebo tablets BID plus vehicle cream. Part B of this study includes a 12-week Double-blind Treatment Period and 52-week Open-label Extension Period. Subjects will be randomized to receive oral difelikefalin 0.25 mg or 0.5 mg tablets BID plus TCS cream or oral placebo tablets BID plus TCS cream. Part A results at week 12 will inform Part B. Subjects who participated in Part A of the study may not participate in Part B. All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Conditions

• Pruritus
• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	difelikefalin 0.25 mg	Oral difelikefalin 0.25 mg tablets administered twice daily
DRUG	difelikefalin 0.5 mg	Oral difelikefalin 0.5 mg tablets administered twice daily
DRUG	TCS Cream	TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
DRUG	Placebo	Oral Placebo tablets administered twice daily
DRUG	Vehicle Cream	Vehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Timeline

• Start date: 2022-08-16
• Primary completion: 2024-02-02
• Completion: 2024-02-02
• First posted: 2022-05-24
• Last updated: 2024-02-22

Locations

61 sites across 1 country: United States

Regulatory

• FDA-regulated drug study