A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

• Status: Completed
• Trial end date: 2018-03-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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).