Trial Outcomes & Findings for Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid (NCT NCT05263505)

Last Updated: 2023-11-07

Results Overview

Treatment response of ocular inflammation based on conjunctival injection measured by ophthalmologic exam of the palpebral conjunctiva. Each eye is divided into quadrants and each quadrant is scored from 0 (white and quite) to 3 (severe). The score will be the sum of all 4 quadrants for a total score of 0-12 for each eye. A clinically meaningful response will be defined as a ≥30% reduction in the total score for both eyes.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Baricitinib 4mg daily Baricitinib 2 MG \[Olumiant\]: Two tabs daily	Antiproliferative methotrexate, azathioprine, or mycophenolate Methotrexate: Target dose: 20mg weekly Azathioprine: Target dose: 2mg/kg daily Mycophenolate: Target Dose: 1g twice daily
Overall Study STARTED	1	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Baricitinib 4mg daily Baricitinib 2 MG \[Olumiant\]: Two tabs daily	Antiproliferative methotrexate, azathioprine, or mycophenolate Methotrexate: Target dose: 20mg weekly Azathioprine: Target dose: 2mg/kg daily Mycophenolate: Target Dose: 1g twice daily
Overall Study Adverse Event	0	1

Baseline Characteristics

Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Baricitinib n=1 Participants 4mg daily Baricitinib 2 MG \[Olumiant\]: Two tabs daily	Antiproliferative n=1 Participants methotrexate, azathioprine, or mycophenolate Methotrexate: Target dose: 20mg weekly Azathioprine: Target dose: 2mg/kg daily Mycophenolate: Target Dose: 1g twice daily
Treatment Response	1 Participants	0 Participants

Adverse Events

Baricitinib

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Antiproliferative

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Baricitinib n=1 participants at risk 4mg daily Baricitinib 2 MG \[Olumiant\]: Two tabs daily	Antiproliferative n=1 participants at risk methotrexate, azathioprine, or mycophenolate Methotrexate: Target dose: 20mg weekly Azathioprine: Target dose: 2mg/kg daily Mycophenolate: Target Dose: 1g twice daily
Respiratory, thoracic and mediastinal disorders Anaphylaxis	0.00% 0/1 • Averse events were recorded for 2 weeks for the participant in the standard of care arm and 8 months for the participant on the baricitinib arm.	100.0% 1/1 • Number of events 1 • Averse events were recorded for 2 weeks for the participant in the standard of care arm and 8 months for the participant on the baricitinib arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignancy	100.0% 1/1 • Number of events 1 • Averse events were recorded for 2 weeks for the participant in the standard of care arm and 8 months for the participant on the baricitinib arm.	0.00% 0/1 • Averse events were recorded for 2 weeks for the participant in the standard of care arm and 8 months for the participant on the baricitinib arm.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Paley, Director of the Ocular Rheumatology Clinic

Washington University School of Medicine

Phone: 314-273-7556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Baricitinib n=1 Participants 4mg daily Baricitinib 2 MG \[Olumiant\]: Two tabs daily	Antiproliferative n=1 Participants methotrexate, azathioprine, or mycophenolate Methotrexate: Target dose: 20mg weekly Azathioprine: Target dose: 2mg/kg daily Mycophenolate: Target Dose: 1g twice daily	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants