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

Inclusion Criteria:

- Subjects diagnosed with atopic dermatitis as defined by the Hanifin and Rajka
criteria.

- Subjects with a history of atopic dermatitis for at least 2 years.

- Subjects with an Investigator's Global Assessment score of 2 to 3 at screening and
baseline.

- Subjects with body surface area of atopic dermatitis involvement, excluding the face
and intertriginous areas, of 3% to 20% at screening and baseline.

- Subjects who agree to discontinue all agents used to treat atopic dermatitis from
screening through the final follow-up visit.

Exclusion Criteria:

- Subjects with evidence of active acute or chronic infections.

- Use of topical treatments for atopic dermatitis (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).

- Subjects with other dermatologic disease besides atopic dermatitis whose presence or
treatments could complicate the assessment of disease (eg, psoriasis).

- Subjects with a history of other diseases besides dermatologic disorders (eg, other
autoimmune diseases) taking treatments that could complicate assessments.

- Subjects 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.

- Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal
disease on dialysis or at least 1 of the following:

- Serum creatinine > 1.5 mg/dL.

- Alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of
normal.

- Subjects 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).

- Subjects who have previously received Janus kinase inhibitors, systemic or topical
(eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).