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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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
RPT193 400 mg	RPT193	RPT193 400 mg 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)

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

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

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

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

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

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

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

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

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

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

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