Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05263505
Status:
TERMINATED
Last Update Posted:
2023-11-07
First Post:
2022-02-16
Brief Title:
Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 60000 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None