Study to Evaluate the Safety and Tolerability of AC-1101 Topical Gel in Patients with Granuloma Annulare

Exclusion Criteria

• •1. Patients with active malignancy will not be permitted to enroll in the proposed study. Patients with a history of treated nonmelanoma skin cancer will be eligible to enroll.
• •2. Patients under treatment with biologics or other systemic immunosuppressive medications (e.g., methotrexate (MTX), mycophenolate) within the last 3 months.
• •3. Presence of any clinically significant abnormality at physical examination, clinically significant abnormal laboratory assessment or positive test for hepatitis B (HBs-Ag), hepatitis C (HCV-Ab), or HIV found during medical screening.
• •4. History of allergic reactions to tofacitinib or other related drugs, or to any excipient in the formulation.
• •5. Positive pregnancy test at screening. If a woman becomes pregnant during the study, she will stop the study medication and be removed from the study. She will be urged to follow up with her Primary Care Physician or obstetrician-gynecologist. The study doctors will ask to follow the pregnancy to its outcome.
• •6. Women of childbearing potential who are unable or unwilling to use birth control (oral pills, rings or patches are not permitted) while taking the medication.
• •7. Pregnant or breast-feeding women.
• •8. Current active smokers.
• •9. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving drug or device administration.
• •10. History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening.
• •11. Positive QuantiFERON®-TB indicating possible tuberculosis infection.
• •12. Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the study.
• •13. History of clinically significant opportunistic infection, e.g., invasive fungal infections or pneumocystis pneumonia.
• •14. Serious local infection, e.g., cellulitis, abscess, or systemic infection, e.g., septicemia, within 3 months prior to screening.
• •15. Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis, such as Acetaminophen (2g in 24-hour period) because they are judged unlikely to affect the PK profile of the study drug or subject safety:
• •1. Prescription medications within 14 days prior to the first dosing with the exception of on-going medications to treat existing comorbid disorders, as judged by the Investigator.
• •2. Topical medications inlcuding antibiotics or corticosteriod applied to the designated treatment area.
• •3. Depot injection or implant of any drug within 3 months prior to the first dosing.
• •4. Any drugs known to significantly induce or inhibit hepatic drug metabolism via the CYP3A4 and CYP2C19 enzymes within 30 days prior to first dosing.
• •16. Fever associated with a symptomatic viral or bacterial infection, within 2 weeks prior to the first dosing.
• •17. Subjects with a personal history of significant coronary heart disease, heart failure, and/or cerebrovascular disease.
• •18. Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.