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

ID#: NCT05399368

Age: 18 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: June 07, 2022

End Date: September 01, 2023

Contact Information:
Trial Manager
Summary: Phase 2 study of RPT193 in adults with atopic dermatitis

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