Study Stopped
Study on clinical hold by FDA
An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis
A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis
1 other identifier
interventional
229
2 countries
59
Brief Summary
Phase 2 study of RPT193 in adults with atopic dermatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2022
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
June 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2024
CompletedResults Posted
Study results publicly available
February 25, 2026
CompletedMarch 23, 2026
March 1, 2026
2 years
May 26, 2022
May 21, 2025
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD
% change in Eczema Area Severity Index (EASI) from baseline at Week 16
16 weeks
Secondary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
16 weeks
Study Arms (4)
RPT193 400 mg
EXPERIMENTALRPT193 400 mg oral tablet administered daily for 16 weeks
RPT193 200 mg
EXPERIMENTALRPT193 200 mg oral tablet administered daily for 16 weeks
RPT193 50 mg
EXPERIMENTALRPT193 50 mg oral tablet administered daily for 16 weeks
Placebo
PLACEBO COMPARATORMatching placebo oral tablet administered daily for 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244, United States
Perseverance Research Center
Scottsdale, Arizona, 85254, United States
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Grimes Center
Los Angeles, California, 90036, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Wallace Medical Group
Los Angeles, California, 90056, United States
Velocity Clinical Research
North Hollywood, California, 91606, United States
Integrative Skin Science and Research
Sacramento, California, 95815, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Clinical Trials Research Institute
Thousand Oaks, California, 91320, United States
Foxhall Research Center
Washington D.C., District of Columbia, 20016, United States
Driven Research LLC
Coral Gables, Florida, 33134, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134, United States
Palm Beach Dermatology Group
Delray Beach, Florida, 33484, United States
GSI Clinical Research
Margate, Florida, 33063, United States
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172, United States
Forcare Clinical Research
Tampa, Florida, 33613, United States
Skin Care Physicians of Georgia
Macon, Georgia, 31217, United States
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060, United States
Georgia Skin & Cancer Clinic
Savannah, Georgia, 31419, United States
University Dermatology and Vein Clinic
Darien, Illinois, 60561, United States
Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center
Indianapolis, Indiana, 46202, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
The Indiana Clinical Trials Center PC
Plainfield, Indiana, 46168, United States
Skin Sciences PLLC
Louisville, Kentucky, 40217', United States
DelRicht Research
Baton Rouge, Louisiana, 70809, United States
Schweiger Dermatology Group, PC Research Division
Columbia, Maryland, 21044, United States
MetroBoston Clinical Partners
Brighton, Massachusetts, 02135, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169, United States
Fivenson Dermatology
Ann Arbor, Michigan, 48103, United States
St. Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, 49085, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Advanced Dermatology of the Midlands
Omaha, Nebraska, 68144, United States
Skin Specialists PC (Schlessinger MD)
Omaha, Nebraska, 68144, United States
Schweiger Dermatology Group
Verona, New Jersey, 07044, United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11415, United States
JUVA Skin & Laser Center
New York, New York, 10022, United States
Ichan School of Medicine at Mount Sinai
New York, New York, 10029, United States
Markowitz Medical, PLLC
New York, New York, 10128, United States
Optima Research - Boardman
Boardman, Ohio, 44512, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Arlington Research Center Inc.
Arlington, Texas, 76011, United States
DermResearch
Austin, Texas, 78759, United States
Studies in Dermatology, LLC
Cypress, Texas, 77433, United States
Dermatology Treatment and Research Center
Dallas, Texas, 75230, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Acclaim Dermatology
Sugar Land, Texas, 77479, United States
Complete Dermatology
Sugar Land, Texas, 77479, United States
Jordan Valley Dermatology Center
South Jordan, Utah, 84095, United States
West End Dermatology Associates
Richmond, Virginia, 23233, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M7G1, Canada
LEADER Research
Hamilton, Ontario, L8L 3C3, Canada
Red Maple Trials Inc.
Ottawa, Ontario, K1H 1E4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
A limitation of the study is the small sample size due to the early termination of the study.
Results Point of Contact
- Title
- Jennifer Nicholson
- Organization
- RAPT Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2022
First Posted
June 1, 2022
Study Start
June 7, 2022
Primary Completion
May 24, 2024
Study Completion
May 24, 2024
Last Updated
March 23, 2026
Results First Posted
February 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share