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

2019-07-18 10:31:15 | BioPortfolio

Summary

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.

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 in a 1:1:1:1 ratio 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).

Study Design

Conditions

Pruritus

Intervention

difelikefalin 0.25 mg, difelikefalin 0.5 mg, difelikefalin 1.0 mg, Placebo

Status

Not yet recruiting

Source

Cara Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-18T10:31:15-0400

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Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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