Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT05399368
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05399368
Study Brief:
Protocol Section:
NCT05399368