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Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

NCT05263505 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-11-07

Study results available
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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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2023-09-11
Completion
2023-09-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05263505 on ClinicalTrials.gov