Last updated on April 2016

Safety Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruritus Associated With Atopic Dermatitis


Brief description of study

Kappa-opioid receptors mediate the sensation of itch in animals and humans. Asimadoline is an orally active, selective kappa-opioid receptor agonist and has demonstrated efficacy in several preclinical pruritus models. The purpose of this Phase 2 study is to evaluate the safety, tolerability and clinical efficacy of asimadoline in patients with pruritus associated with atopic dermatitis.

Detailed Study Description

Asimadoline has been administered to over 1900 human subjects or patients in clinical trials and exhibits an acceptable safety profile. Due to its high selectivity for the kappa-opioid receptor, asimadoline does not produce mu-opioid like side-effects. Results from preclinical models indicate asimadoline significantly reduces the frequency of scratching induced by pruritic agents. This double-blind placebo-controlled clinical study is designed to evaluate the safety, tolerability and clinical efficacy of asimadoline in patients with pruritus associated with atopic dermatitis.

Clinical Study Identifier: NCT02475447

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Axis Clinical Research

Los Angeles, CA United States
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Children's Hospital Los Angeles

Los Angeles, CA United States
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Forefront Dermatology

Carmel, IN United States
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Wake Forest Baptist Health

Winston-Salem, NC United States
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Sylvana Research Associates

San Antonio, TX United States
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Tory Sullivan, MD PA

N Miami Beach, FL United States
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Temple Itch Center

Philadelphia, PA United States
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Medical Research South

Charleston, SC United States
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Park Avenue Dermatology

Orange Park, FL United States
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MediSearch Clinical Trials

St. Joseph, MO United States
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The Dermatology Group

Verona, NJ United States
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Radiant Research, Inc.

Anderson, SC United States
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