NCT05263505

Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucous Membrane Pemphigoid
• Cicatrizing Conjunctivitis

Interventions

Type	Name	Description
DRUG	Baricitinib 2 MG [Olumiant]	Two tabs daily
DRUG	Methotrexate	Target dose: 20mg weekly
DRUG	Azathioprine	Target dose: 2mg/kg daily
DRUG	Mycophenolate	Target Dose: 1g twice daily

Timeline

• Start date: 2022-02-21
• Primary completion: 2023-09-11
• Completion: 2023-09-11
• First posted: 2022-03-02
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study