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

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ClinicalTrials.gov Identifier: NCT05399368
Recruitment Status : Recruiting
First Posted : June 1, 2022
Last Update Posted : December 15, 2022
Sponsor:
Information provided by (Responsible Party):
RAPT Therapeutics, Inc.

Study Description
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Brief Summary:
Phase 2 study of RPT193 in adults with atopic dermatitis

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: RPT193 Other: Placebo Phase 2

Detailed Description:
Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 7, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Clinical efficacy [ Time Frame: 16 weeks ]
    % change in Eczema Area Severity Index (EASI)

  2. Safety as measured by adverse events [ Time Frame: 16 weeks ]
    Incidence of treatment-emergent adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05399368


Contacts
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Contact: Trial Manager 650-489-9000 clinical.trials@rapt.com

Locations
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Sponsors and Collaborators
RAPT Therapeutics, Inc.
More Information
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Responsible Party: RAPT Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05399368    
Other Study ID Numbers: RPT193-02
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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