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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: RPT193

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • PRA
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Perseverance Research Center LLC
  • California
    • San Diego, California, United States, 92123
      • University Clinical Trials, Inc
  • Florida
    • Miami, Florida, United States, 33172
      • Lenus Research & Medical Group
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • DelRicht Research
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management,LLC
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • MetroBoston Clinical Partners LLC
  • New York
    • New York, New York, United States, 10075
      • Sadick Research Group LLC
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research PA

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RAPT Therapeutics, Inc.
• Investigators: Study Director: Laurence Cheng, MD, PhD, RAPT Therepeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): April 26, 2021

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: RPT193-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No