drugset / Trial / NCT05263505

Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

NCT05263505

RandomizedParallel-groupDouble-blindTreatment

Summary

Ocular mucous membrane pemphigoid (MMP) is an autoimmune, scarring conjunctivitis that can lead to vision loss and permanent disability. It is a rare disorder with an estimated incidence of 1 in 60,000. There are currently no FDA-approved medications for the treatment of mucous membrane pemphigoid, highlighting a clear unmet need. At present, moderate to severe disease requires off-label use of potent immunosuppressive agents, such as oral anti-proliferatives (methotrexate, azathioprine, and mycophenolate), rituximab (RTX) or cyclophosphamide (CyC). Recently, Janus kinase (JAK) inhibition with baricitinib or tofacitinib been reported to be successful in one case of ocular MMP. This is a randomized, single-masked, two-arm study of baricitinib vs anti-proliferatives for ocular MMP.

Timeline

Start
2022-02-21
Primary completion
2023-09-11
Completion
2023-09-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azathioprine Small molecule 2 mg/kg
Subject Baricitinib Small molecule 4 mg
Comparator Methotrexate Small molecule 20 mg
Comparator Mycophenolate Sodium Unknown 1 g