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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT03011892

Run by

Incyte Corporation

People needed

307

Starts

2017-01-09

Expected to finish

2018-03-12

Last updated by the study team

2021-04-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• BURKE PHARMACEUTICAL RESEARCH, 601 W. Commerce — Bryant, Arkansas, United States
• ENCINO RESEARCH CENTER, 16133 Ventura Blvd — Encino, California, United States
• DERMATOLOGY RESEARCH ASSOCIATES,8930 South Sepulveda Blvd — Los Angeles, California, United States
• DERMATOLOGY SPECIALISTS, INC, 3629 Vista Way — Oceanside, California, United States
• INTEGRATED RESEARCH GROUP, INC, 4646 Brockton Avenue — Riverside, California, United States
• SAN LUIS DERMATOLOGY AND LASER CLINIC, 15 Santa Rosa Street — San Luis Obispo, California, United States
• NEW ENGLAND RESEARCH ASSOCIATES LLC, 5520 Park Avenue — Trumbull, Connecticut, United States
• DS RESEARCH, 2241 Green Valley Road — New Albany, Indiana, United States
• THE INDIANA CLINICAL TRIALS CENTER, 824 Edwards Drive — Plainfield, Indiana, United States
• DERMRESEARCH, 1169 Eastern Parkway 2310 — Louisville, Kentucky, United States
• DS RESEARCH, 3810 Springhurst Blvd — Louisville, Kentucky, United States
• ACTIVMED PRACTICES & RESEARCH, INC, 138 Conant Street — Beverly, Massachusetts, United States
• TUFTS MEDICAL CENTER, 800 Washington Street — Boston, Massachusetts, United States
• HENRY FORD HOSPITAL, 3031 West Grand Blvd — Detroit, Michigan, United States
• WASHINGTON UNIVERSITY - DERMATOLOGY, 4921 Parkview Place — St Louis, Missouri, United States
• WASHINGTON UNIVERSITY - DERMATOLOGY, 969 Mason Road — St Louis, Missouri, United States
• ACTIVMED PRACTICES AND RESEARCH, INC, 110 Corporate Drive — Portsmouth, New Hampshire, United States
• HASSMAN RESEARCH INSTITUTE, LLC, 175 Cross Keys Road — Berlin, New Jersey, United States
• DERMATOLOGY CONSULTING SERVICES, PLLC, 2444 North Main Street — High Point, North Carolina, United States
• WAKE RESEARCH ASSOCIATES LLC, 3100 Duraleigh Road — Raleigh, North Carolina, United States
• DERMATOLOGISTS OF GREATER COLUMBUS, 2359 East Main Street — Bexley, Ohio, United States
• RAPID MEDICAL RESEARCH, INC, 3619 Park East Drive — Cleveland, Ohio, United States
• CENTRAL SOONER RESEARCH, 900 North Porter — Norman, Oklahoma, United States
• PARISH DERMATOLOGY, INC, 1845 Walnut Street — Philadelphia, Pennsylvania, United States
• UAB DERMATOLOGY, 2000 6th Avenue South — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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