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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT03011892
Eligibility Criteria:
Inclusion Criteria:
* Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
* Participants with a history of AD for at least 2 years.
* Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
* Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline.
* Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
Exclusion Criteria:
* Participants with evidence of active acute or chronic infections.
* Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline.
* Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
* Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis).
* Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.
* Participants with cytopenias at screening, defined as:
* Leukocytes \< 3.0 × 10\^9/L.
* Neutrophils \< lower limit of normal.
* Hemoglobin \< 10 g/dL.
* Lymphocytes \< 0.8 × 10\^9/L
* Platelets \< 100 × 10\^9/L.
* Participants with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease (ESRD) on dialysis or at least 1 of the following:
* Serum creatinine \> 1.5 mg/dL.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.
* Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).
* Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03011892
Study Brief:
Protocol Section:
NCT03011892