An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis

NCT ID: NCT05399368

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2024-05-24

Brief Summary

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Phase 2 study of RPT193 in adults with atopic dermatitis

Detailed Description

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Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blind

Study Groups

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RPT193 400 mg

RPT193 400 mg oral tablet administered daily for 16 weeks

Group Type EXPERIMENTAL

RPT193

Intervention Type DRUG

RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17

RPT193 200 mg

RPT193 200 mg oral tablet administered daily for 16 weeks

Group Type EXPERIMENTAL

RPT193

Intervention Type DRUG

RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17

RPT193 50 mg

RPT193 50 mg oral tablet administered daily for 16 weeks

Group Type EXPERIMENTAL

RPT193

Intervention Type DRUG

RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17

Placebo

Matching placebo oral tablet administered daily for 16 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Nonactive placebo tablet

Interventions

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RPT193

RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17

Intervention Type DRUG

Placebo

Nonactive placebo tablet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria
* 12-month history of AD and had no significant flares in AD for at least 4 weeks before screening
* inadequate response to a ≥1 month treatment with topical medications
* Atopic dermatitis covering ≥10% of the body surface area
* EASI score ≥16
* Validated Investigator Global Assessment (VIGA) ≥3
* Use of emollient(s) at least 2x daily for 1 week prior to baseline
* Negative coronavirus disease (COVID)-19 results at screening

Exclusion Criteria

* Uncontrolled moderate-to-severe asthma
* Uncontrolled diabetes
* Stage III or IV cardiac failure
* Severe renal condition
* Major surgery within 8 weeks of screening
* Immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline
* Use of systemic Janus kinase (JAK) inhibitor within 8 weeks of baseline
* Received live or live-attenuated vaccine within 4 weeks of baseline
* Prior receipt of RPT193
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RAPT Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, United States

Site Status

Perseverance Research Center

Scottsdale, Arizona, United States

Site Status

Arkansas Research Trials, LLC

North Little Rock, Arkansas, United States

Site Status

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status

First OC Dermatology

Fountain Valley, California, United States

Site Status

Grimes Center

Los Angeles, California, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Wallace Medical Group

Los Angeles, California, United States

Site Status

Velocity Clinical Research

North Hollywood, California, United States

Site Status

Integrative Skin Science and Research

Sacramento, California, United States

Site Status

Clinical Science Institute

Santa Monica, California, United States

Site Status

Clinical Trials Research Institute

Thousand Oaks, California, United States

Site Status

Foxhall Research Center

Washington D.C., District of Columbia, United States

Site Status

Driven Research LLC

Coral Gables, Florida, United States

Site Status

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, United States

Site Status

Palm Beach Dermatology Group

Delray Beach, Florida, United States

Site Status

GSI Clinical Research

Margate, Florida, United States

Site Status

Lenus Research & Medical Group, LLC

Sweetwater, Florida, United States

Site Status

Forcare Clinical Research

Tampa, Florida, United States

Site Status

Skin Care Physicians of Georgia

Macon, Georgia, United States

Site Status

Marietta Dermatology Clinical Research, Inc.

Marietta, Georgia, United States

Site Status

Georgia Skin & Cancer Clinic

Savannah, Georgia, United States

Site Status

University Dermatology and Vein Clinic

Darien, Illinois, United States

Site Status

Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center

Indianapolis, Indiana, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

The Indiana Clinical Trials Center PC

Plainfield, Indiana, United States

Site Status

Skin Sciences PLLC

Louisville, Kentucky, United States

Site Status

DelRicht Research

Baton Rouge, Louisiana, United States

Site Status

Schweiger Dermatology Group, PC Research Division

Columbia, Maryland, United States

Site Status

MetroBoston Clinical Partners

Brighton, Massachusetts, United States

Site Status

Beacon Clinical Research, LLC

Quincy, Massachusetts, United States

Site Status

Fivenson Dermatology

Ann Arbor, Michigan, United States

Site Status

St. Joseph Dermatology and Vein Clinic

Saint Joseph, Michigan, United States

Site Status

Grekin Skin Institute

Warren, Michigan, United States

Site Status

Medisearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status

Advanced Dermatology of the Midlands

Omaha, Nebraska, United States

Site Status

Skin Specialists PC (Schlessinger MD)

Omaha, Nebraska, United States

Site Status

Schweiger Dermatology Group

Verona, New Jersey, United States

Site Status

Forest Hills Dermatology Group

Kew Gardens, New York, United States

Site Status

JUVA Skin & Laser Center

New York, New York, United States

Site Status

Ichan School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Markowitz Medical, PLLC

New York, New York, United States

Site Status

Optima Research - Boardman

Boardman, Ohio, United States

Site Status

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

Arlington Research Center Inc.

Arlington, Texas, United States

Site Status

DermResearch

Austin, Texas, United States

Site Status

Studies in Dermatology, LLC

Cypress, Texas, United States

Site Status

Dermatology Treatment and Research Center

Dallas, Texas, United States

Site Status

Clinical Trial Network

Houston, Texas, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

Acclaim Dermatology

Sugar Land, Texas, United States

Site Status

Complete Dermatology

Sugar Land, Texas, United States

Site Status

Jordan Valley Dermatology Center

South Jordan, Utah, United States

Site Status

West End Dermatology Associates

Richmond, Virginia, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Site Status

LEADER Research

Hamilton, Ontario, Canada

Site Status

Red Maple Trials Inc.

Ottawa, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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RPT193-02

Identifier Type: -

Identifier Source: org_study_id

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