A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis

• ClinicalTrials.gov Identifier: NCT04271514
• Recruitment Status: Completed
• First Posted: February 17, 2020
• Last Update Posted: September 30, 2021
• Sponsor: RAPT Therapeutics, Inc.
• Information provided by (Responsible Party): RAPT Therapeutics, Inc.

Study Description

Brief Summary:

This study is a first-in-human, 3-part, multi-center, Phase 1, randomized, double-blind, placebo-controlled study with RPT193 in up to 64 healthy male and female subjects and 30 male and female patients with atopic dermatitis. RPT193 is an orally-available, potent, and selective antagonist of CCR4.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: RPT193; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Multiple-dose Escalation, and Food Effect Study of RPT193 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
• Actual Study Start Date: August 12, 2019
• Actual Primary Completion Date: April 26, 2021
• Actual Study Completion Date: April 26, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active; Increasing doses of RPT193 will be administered to healthy volunteers	Drug: RPT193; Antagonist of the CCR4 chemokine receptor
Placebo Comparator: COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo; Matching placebo will be administered to healthy volunteers	Drug: Placebo; Matching placebo
Experimental: COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active; Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers	Drug: RPT193; Antagonist of the CCR4 chemokine receptor
Placebo Comparator: COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo; Matching placebo will be administered once/day for 7 days to healthy volunteers	Drug: Placebo; Matching placebo
Experimental: COMPLETED ENROLLMENT -- Expansion Part C - active; RPT193 will be administered daily for 28 days to patients with atopic dermatitis	Drug: RPT193; Antagonist of the CCR4 chemokine receptor
Placebo Comparator: COMPLETED ENROLLMENT -- Expansion Part C - placebo; Matching placebo will be administered daily for 28 days to patients with atopic dermatitis	Drug: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures :

1. Incidence of Treatment Emergent Adverse Events [ Time Frame: up to Day 16 (Part A: SAD); up to Day 22 (Part B: MAD); up to Day 43 (Part C) ]
   Number of participants with abnormal laboratory values and/or adverse events that are related to treatment

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Selected Inclusion Criteria:

Parts A & B (COMPLETED ENROLLMENT):

• Healthy male or female
• 18-55 years of age, inclusive
• At least 50 kg in weight
• BMI: 18.0-30.0 kg/m2, inclusive

Part C (COMPLETED ENROLLMENT):

• Male or female with atopic dermatitis
• 18-65 years of age, inclusive
• BMI between 18.0 (inclusive) and <40.0 kg/m2
• Body surface area (BSA) with AD involvement ≥10%
• Eczema Area and Severity Index (EASI) score ≥12
• Validated Investigator's Global Assessment (vIGA) ≥3
• History of inadequate response to treatment with topical medications, such as corticosteroids or calcineurin inhibitors, or patients for whom topical treatments are otherwise medically inadvisable

Selected Exclusion Criteria:

Parts A & B (COMPLETED ENROLLMENT):

• Use of tobacco products within 60 days prior to drug administration
• History of alcohol abuse or drug addiction
• Positive drug and alcohol screen
• Participation in a drug study within 60 days prior to drug administration
• Donation or loss of more than 100 mL of blood within 60 days prior to drug administration.
• Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to drug administration.

Part C (COMPLETED ENROLLMENT):

• Any serious and/or uncontrolled medical condition
• History of alcohol abuse or drug addiction
• Positive drug and alcohol screen

Contacts and Locations

Locations

United States, Alabama

Pinnacle Research Group, LLC

Anniston, Alabama, United States, 36207

United States, Arizona

Perseverance Research Center LLC

Scottsdale, Arizona, United States, 85254

United States, California

University Clinical Trials, Inc

San Diego, California, United States, 92123

United States, Florida

Lenus Research & Medical Group

Miami, Florida, United States, 33172

ForCare Clinical Research

Tampa, Florida, United States, 33613

United States, Indiana

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

United States, Louisiana

DelRicht Research

Baton Rouge, Louisiana, United States, 70809

Clinical Trials Management,LLC

Metairie, Louisiana, United States, 70006

United States, Massachusetts

MetroBoston Clinical Partners LLC

Brighton, Massachusetts, United States, 02135

United States, New York

Sadick Research Group LLC

New York, New York, United States, 10075

United States, Oklahoma

Central Sooner Research

Norman, Oklahoma, United States, 73071

United States, Texas

DermResearch, Inc.

Austin, Texas, United States, 78759

Progressive Clinical Research PA

San Antonio, Texas, United States, 78213

Netherlands

PRA

Groningen, Netherlands, 9728 NZ

Sponsors and Collaborators

RAPT Therapeutics, Inc.

Investigators

• Study Director: Laurence Cheng, MD, PhD; RAPT Therepeutics, Inc.

More Information

• Responsible Party: RAPT Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04271514
• Other Study ID Numbers: RPT193-01
• First Posted: February 17, 2020
• Last Update Posted: September 30, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases