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

Recruiting in Palo Alto (17 mi)

Overseen byWilliam Damsky, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: TWi Biotechnology, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a special skin-applied gel called AC-1101 on patients with Granuloma Annulare, a specific skin condition. The gel likely works by reducing inflammation or changing the immune response in the skin.

Eligibility Criteria

Inclusion Criteria

Adequate organ function and marrow function meaured at screening (Visit 1) and enrollment (Visit 2) as defined below: Hemoglobin ≥ 12.0 g/dL for male and 10.5 g/dL for female; Absolute neutrophil count ≥ 1,300 /µL; Absolute lymphocytes: 1.0-4.0 x 109/L (1000-4000 cells/mm3) as the reference range; Platelets ≥ 75,000/µL; Total bilirubin ≤ 1.5 x upper normal limit; AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit; eGFR ≥ 60mL/min/1.73m2

Patients with 1-20% BSA of active Granuloma Annulare lesions will be enrolled.

Other subtypes of GA, such as linear, perforating, and subcutaneous will be excluded from the study. If there is suspicion that GA is medication-induced, the patient will not be enrolled. GA in association with human immunodeficiency virus (HIV) or malignancy will be excluded.

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Exclusion Criteria

History of allergic reactions to tofacitinib or other related drugs, or to any excipient in the formulation.

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.

Pregnant or breast-feeding women.

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