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An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis

Sponsor
RAPT Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05399368
Collaborator
(none)
268
Enrollment
22
Locations
4
Arms
14.8
Anticipated Duration (Months)
12.2
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase 2 study of RPT193 in adults with atopic dermatitis

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis

Study Design

Study Type:
Interventional
Anticipated Enrollment :
268 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Double blind
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date :
Jun 7, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: RPT193 400 mg

RPT193 400 mg oral tablet administered daily for 16 weeks

Drug: RPT193
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
Experimental: RPT193 200 mg

RPT193 200 mg oral tablet administered daily for 16 weeks

Drug: RPT193
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
Experimental: RPT193 50 mg

RPT193 50 mg oral tablet administered daily for 16 weeks

Drug: RPT193
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
Placebo Comparator: Placebo

Matching placebo oral tablet administered daily for 16 weeks

Other: Placebo
Nonactive placebo tablet

Outcome Measures

Primary Outcome Measures

  1. Clinical efficacy [16 weeks]

    % change in Eczema Area Severity Index (EASI)

  2. Safety as measured by adverse events [16 weeks]

    Incidence of treatment-emergent adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cahaba Dermatology and Skin Health Center Birmingham Alabama United States 35244
2 Perseverance Research Center Scottsdale Arizona United States 85254
3 Arkansas Research Trials, LLC North Little Rock Arkansas United States 72117
4 California Dermatology & Clinical Research Institute Encinitas California United States 92024
5 Wallace Medical Group Los Angeles California United States 90056
6 Wallace Medical Group Los Angeles California United States 90056
7 Clinical Trials Research Institute Thousand Oaks California United States 91320
8 Driven Research LLC Coral Gables Florida United States 33134
9 Palm Beach Dermatology Group Delray Beach Florida United States 33484
10 Skin Care Physicians of Georgia Macon Georgia United States 31217
11 Marietta Dermatology Clinical Research, Inc. Marietta Georgia United States 30060
12 Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana United States 46250
13 Schweiger Dermatology Group, PC Research Division Columbia Maryland United States 21044
14 MetroBoston Clinical Partners Brighton Massachusetts United States 02135
15 Beacon Clinical Research, LLC Quincy Massachusetts United States 02169
16 Skin Specialists PC (Schlessinger MD) Omaha Nebraska United States 68144
17 Schweiger Dermatology Group Verona New Jersey United States 07044
18 Forest Hills Dermatology Group Kew Gardens New York United States 11415
19 JUVA Skin & Laser Center New York New York United States 10022
20 Studies in Dermatology, LLC Cypress Texas United States 77433
21 Progressive Clinical Research San Antonio Texas United States 78213
22 Jordan Valley Dermatology Center South Jordan Utah United States 84095

Sponsors and Collaborators

  • RAPT Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RAPT Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05399368
Other Study ID Numbers:
  • RPT193-02
First Posted:
Jun 1, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by RAPT Therapeutics, Inc.
atopic dermatitis
Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Eczema

Study Results

No Results Posted as of Aug 16, 2022