A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Ruxolitinib 0.15% Cream QD; Ruxolitinib 0.5% Cream QD; Ruxolitinib 1.5% Cream QD; Ruxolitinib 1.5% Cream BID; Triamcinolone 0.1% Cream BID; Vehicle Cream BID
Intervention description: Ruxolitinib 0.15% cream QD; Ruxolitinib 0.5% cream QD; Ruxolitinib 1.5% cream QD; Ruxolitinib 1.5% cream BID; Triamcinolone 0.1% cream BID; Vehicle cream BID
Intervention MeSH terms: Triamcinolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Atopic dermatitis; eczema; pruritus; Janus kinase (JAK) inhibitors

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.
    

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).