Status:
TERMINATED
An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis
Lead Sponsor:
RAPT Therapeutics, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Phase 2 study of RPT193 in adults with atopic dermatitis
Detailed Description
Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2024
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT05399368
Start Date
June 7 2022
End Date
May 24 2024
Last Update
June 14 2024
Active Locations (59)
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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