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 (KIND-1)

Cara Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Atopic Dermatitis; Pruritus

Treatments: Drug: TCS Cream; Drug: difelikefalin 0.5 mg; Drug: Vehicle Cream; Drug: Placebo; Drug: difelikefalin 0.25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05387707

CR845-310501

Details and patient eligibility

About

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).

Full 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.

Enrollment: 287 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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287 participants in 4 patient groups, including a placebo group

Difelikefalin 0.25 mg tablets plus TCS cream

Experimental group

Description:

Oral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.

Treatment:

Drug: difelikefalin 0.25 mg

Drug: TCS Cream

Difelikefalin 0.5 mg tablets plus TCS cream

Experimental group

Description:

Oral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.

Treatment:

Drug: TCS Cream

Drug: difelikefalin 0.5 mg

Placebo tablets plus TCS cream

Active Comparator group

Description:

Oral placebo tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Treatment:

Drug: Placebo

Drug: TCS Cream

Placebo tablets plus Vehicle cream (Part A only)

Placebo Comparator group

Description:

Oral placebo tablets administered twice daily. Vehicle cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Treatment:

Drug: Placebo

Drug: Vehicle Cream