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

Phase 2

Terminated

• Conditions: Atopic Dermatitis
• Interventions: Drug: RPT193; Other: Placebo

• Registration Number: NCT05399368
• Lead Sponsor: RAPT Therapeutics, Inc.

Brief Summary

Phase 2 study of RPT193 in adults with atopic dermatitis

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Study Start: 2022-06-07
• Primary Completion: 2024-05-24
• Study Completion: 2024-05-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 229

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RPT193 400 mg	RPT193	RPT193 400 mg oral tablet administered daily for 16 weeks
RPT193 200 mg	RPT193	RPT193 200 mg oral tablet administered daily for 16 weeks
RPT193 50 mg	RPT193	RPT193 50 mg oral tablet administered daily for 16 weeks
Placebo	Placebo	Matching placebo oral tablet administered daily for 16 weeks

Primary Outcome Measures

Name	Time	Method
Clinical efficacy	16 weeks	% change in Eczema Area Severity Index (EASI)
Safety as measured by adverse events	16 weeks	Incidence of treatment-emergent adverse events

Trial Locations

Locations (59)

Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center; 🇺🇸 Indianapolis, Indiana, United States

Wallace Medical Group; 🇺🇸 Los Angeles, California, United States

Clinical Science Institute; 🇺🇸 Santa Monica, California, United States

Grimes Center; 🇺🇸 Los Angeles, California, United States

California Dermatology & Clinical Research Institute; 🇺🇸 Encinitas, California, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Clinical Trials Research Institute; 🇺🇸 Thousand Oaks, California, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Skin Care Physicians of Georgia; 🇺🇸 Macon, Georgia, United States

Marietta Dermatology Clinical Research, Inc.; 🇺🇸 Marietta, Georgia, United States

Georgia Skin & Cancer Clinic; 🇺🇸 Savannah, Georgia, United States

JUVA Skin & Laser Center; 🇺🇸 New York, New York, United States

Forest Hills Dermatology Group; 🇺🇸 Kew Gardens, New York, United States

MetroBoston Clinical Partners; 🇺🇸 Brighton, Massachusetts, United States

Markowitz Medical, PLLC; 🇺🇸 New York, New York, United States

Optima Research - Boardman; 🇺🇸 Boardman, Ohio, United States

Clinical Trial Network; 🇺🇸 Houston, Texas, United States

Acclaim Dermatology; 🇺🇸 Sugar Land, Texas, United States

Studies in Dermatology, LLC; 🇺🇸 Cypress, Texas, United States

Arlington Research Center Inc.; 🇺🇸 Arlington, Texas, United States

First OC Dermatology; 🇺🇸 Fountain Valley, California, United States

The Indiana Clinical Trials Center PC; 🇺🇸 Plainfield, Indiana, United States

University Dermatology and Vein Clinic; 🇺🇸 Darien, Illinois, United States

Ichan School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Apex Clinical Research Center; 🇺🇸 Mayfield Heights, Ohio, United States

Complete Dermatology; 🇺🇸 Sugar Land, Texas, United States

Jordan Valley Dermatology Center; 🇺🇸 South Jordan, Utah, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States

LEADER Research; 🇨🇦 Hamilton, Ontario, Canada

Red Maple Trials Inc.; 🇨🇦 Ottawa, Ontario, Canada

Schweiger Dermatology Group; 🇺🇸 Verona, New Jersey, United States

Grekin Skin Institute; 🇺🇸 Warren, Michigan, United States

Schweiger Dermatology Group, PC Research Division; 🇺🇸 Columbia, Maryland, United States

Medisearch Clinical Trials; 🇺🇸 Saint Joseph, Missouri, United States

Dermatology Treatment and Research Center; 🇺🇸 Dallas, Texas, United States

Palm Beach Dermatology Group; 🇺🇸 Delray Beach, Florida, United States

Perseverance Research Center; 🇺🇸 Scottsdale, Arizona, United States

Lenus Research & Medical Group, LLC; 🇺🇸 Sweetwater, Florida, United States

DelRicht Research; 🇺🇸 Baton Rouge, Louisiana, United States

Arkansas Research Trials, LLC; 🇺🇸 North Little Rock, Arkansas, United States

Driven Research LLC; 🇺🇸 Coral Gables, Florida, United States

Florida Academic Centers Research and Education, LLC; 🇺🇸 Coral Gables, Florida, United States

Beacon Clinical Research, LLC; 🇺🇸 Quincy, Massachusetts, United States

St. Joseph Dermatology and Vein Clinic; 🇺🇸 Saint Joseph, Michigan, United States

Health Concepts; 🇺🇸 Rapid City, South Dakota, United States

GSI Clinical Research; 🇺🇸 Margate, Florida, United States

Foxhall Research Center; 🇺🇸 Washington, District of Columbia, United States

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States

Cahaba Dermatology and Skin Health Center; 🇺🇸 Birmingham, Alabama, United States

Skin Sciences PLLC; 🇺🇸 Louisville, Kentucky, United States

Forcare Clinical Research; 🇺🇸 Tampa, Florida, United States

Fivenson Dermatology; 🇺🇸 Ann Arbor, Michigan, United States

Advanced Dermatology of the Midlands; 🇺🇸 Omaha, Nebraska, United States

DermResearch; 🇺🇸 Austin, Texas, United States

Progressive Clinical Research; 🇺🇸 San Antonio, Texas, United States

West End Dermatology Associates; 🇺🇸 Richmond, Virginia, United States

Skin Specialists PC (Schlessinger MD); 🇺🇸 Omaha, Nebraska, United States

Velocity Clinical Research; 🇺🇸 North Hollywood, California, United States

SimcoDerm Medical and Surgical Dermatology Center; 🇨🇦 Barrie, Ontario, Canada