Back to resultsA First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RPT193
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility 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
Sites / Locations
- Pinnacle Research Group, LLC
- Perseverance Research Center LLC
- University Clinical Trials, Inc
- Lenus Research & Medical Group
- ForCare Clinical Research
- Dawes Fretzin Clinical Research Group, LLC
- DelRicht Research
- Clinical Trials Management,LLC
- MetroBoston Clinical Partners LLC
- Sadick Research Group LLC
- Central Sooner Research
- DermResearch, Inc.
- Progressive Clinical Research PA
- PRA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo
COMPLETED ENROLLMENT -- Expansion Part C - active
COMPLETED ENROLLMENT -- Expansion Part C - placebo
Arm Description
Increasing doses of RPT193 will be administered to healthy volunteers
Matching placebo will be administered to healthy volunteers
Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers
Matching placebo will be administered once/day for 7 days to healthy volunteers
RPT193 will be administered daily for 28 days to patients with atopic dermatitis
Matching placebo will be administered daily for 28 days to patients with atopic dermatitis
Outcomes
Primary Outcome Measures
Incidence of Treatment Emergent Adverse Events
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04271514
First Posted
February 13, 2020
Last Updated
September 28, 2021
Sponsor
RAPT Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04271514
Brief Title
A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
April 26, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAPT Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active
Arm Type
Experimental
Arm Description
Increasing doses of RPT193 will be administered to healthy volunteers
Arm Title
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo will be administered to healthy volunteers
Arm Title
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active
Arm Type
Experimental
Arm Description
Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers
Arm Title
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo will be administered once/day for 7 days to healthy volunteers
Arm Title
COMPLETED ENROLLMENT -- Expansion Part C - active
Arm Type
Experimental
Arm Description
RPT193 will be administered daily for 28 days to patients with atopic dermatitis
Arm Title
COMPLETED ENROLLMENT -- Expansion Part C - placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo will be administered daily for 28 days to patients with atopic dermatitis
Intervention Type
Drug
Intervention Name(s)
RPT193
Intervention Description
Antagonist of the CCR4 chemokine receptor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events
Description
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Time Frame
up to Day 16 (Part A: SAD); up to Day 22 (Part B: MAD); up to Day 43 (Part C)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Cheng, MD, PhD
Organizational Affiliation
RAPT Therepeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Perseverance Research Center LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
University Clinical Trials, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Lenus Research & Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
DelRicht Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Clinical Trials Management,LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
MetroBoston Clinical Partners LLC
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Sadick Research Group LLC
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Progressive Clinical Research PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
PRA
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
We'll reach out to this number within 24 hrs