Summary:
A Phase 2, Controlled Study to Evaluate the Safety and Efficacy of study drug Phosphate Cream (Triamcinolone 0.1% Cream) Applied Topically to Adults With Atopic Dermatitis. The total duration will be up to 20 weeks.
Qualified Participants Must:
• Be adult men and women between 18 and 70 years of age
•
Have been diagnosed with AD for at least 2 years
•
Have an IGA score of 2 to 3 at screening and baseline
•
Subjects with 3% to 20% BSA of AD involvement, excluding the face and intertriginous areas, at screening and baseline
Key Exclusion Criteria:
- Subjects with evidence of active acute or chronic infections.
- Use of topical treatments for AD (other than bland emollients) within 1 week 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 severely impaired liver function (Child-Pugh Class C) or end-stage renal disease on dialysis or at least 1 of the following:
- Positive serology test results for hepatitis B surface antigen or core antibody, or for hepatitis C virus antibody with detectable hepatitis C RNA at screening.
- 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).
Qualified Participants May Receive:
Compensation for study participation time and travel.