Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

Conditions

• Cicatrizing Conjunctivitis
• Mucous Membrane Pemphigoid

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Feb 21, 2022

Status verified

Oct 2023

Primary completion

Sep 11, 2023

Completion

Sep 11, 2023

Study Design

Enrollment

2 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Baricitinib
  4mg daily
• Active Comparator: Antiproliferative
  methotrexate, azathioprine, or mycophenolate

Primary Outcome Measure

Treatment Response [ Time Frame: 8 weeks ]

Locations (1)

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