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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271514
• Other study ID #: RPT193-01
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2019
• Est. completion date: April 26, 2021

Study information

• Verified date: September 2021
• Source: RAPT Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• RPT193
Antagonist of the CCR4 chemokine receptor
• Placebo
Matching placebo

Locations

Country	Name	City	State
Netherlands	PRA	Groningen
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	DermResearch, Inc.	Austin	Texas
United States	DelRicht Research	Baton Rouge	Louisiana
United States	MetroBoston Clinical Partners LLC	Brighton	Massachusetts
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Clinical Trials Management,LLC	Metairie	Louisiana
United States	Lenus Research & Medical Group	Miami	Florida
United States	Sadick Research Group LLC	New York	New York
United States	Central Sooner Research	Norman	Oklahoma
United States	Progressive Clinical Research PA	San Antonio	Texas
United States	University Clinical Trials, Inc	San Diego	California
United States	Perseverance Research Center LLC	Scottsdale	Arizona
United States	ForCare Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
RAPT Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)