Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis (KARE)

Cara Therapeutics

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis; Pruritus

Treatments: Drug: difelikefalin 0.5 mg; Drug: difelikefalin 1.0 mg; Drug: Placebo; Drug: difelikefalin 0.25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04018027

CR845-210501

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, 4-arm, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with atopic dermatitis (AD) and moderate to severe pruritus.

Full description

The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 7 days after the last dose of study drug.

All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.

Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension upon completion of the Week 12 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).

Enrollment: 401 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 at least a 12-month history of AD;
• Subject has chronic itch 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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401 participants in 4 patient groups, including a placebo group

Difelikefalin 0.25 mg

Active Comparator group

Description:

Oral difelikefalin 0.25 mg tablet administered twice daily

Treatment:

Drug: difelikefalin 0.25 mg

Difelikefalin 0.5 mg

Active Comparator group

Description:

Oral difelikefalin 0.5 mg tablet administered twice daily

Treatment:

Drug: difelikefalin 0.5 mg

Difelikefalin 1.0 mg

Active Comparator group

Description:

Oral difelikefalin 1.0 mg tablet administered twice daily

Treatment:

Drug: difelikefalin 1.0 mg

Placebo

Placebo Comparator group

Description:

Oral placebo tablet administered twice daily

Treatment:

Drug: Placebo