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Immunosuppressant
Baricitinib 2 MG [Olumiant] for Mucous Membrane Pemphigoid
Phase 2
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is testing whether the drug baricitinib can improve symptoms in people with ocular mucous membrane pemphigoid, a rare autoimmune disorder that can lead to vision loss.
Eligible Conditions
- Mucous Membrane Pemphigoid
- Cicatrizing Conjunctivitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment Response
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BaricitinibExperimental Treatment1 Intervention
4mg daily
Group II: AntiproliferativeActive Control3 Interventions
methotrexate, azathioprine, or mycophenolate
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,707 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,615 Previous Clinical Trials
3,201,056 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are using certain medications, like eye drops for glaucoma.You have a skin condition called Stevens-Johnsons Syndrome.You have Rosacea.You have eczema or atopic dermatitis.You have been diagnosed with a medical condition called Ocular Mucous Membrane Pemphigoid.You have an eye condition that is currently active.You have a skin condition called Lichen Planus.You have a serious medical condition that could put you at risk or make it difficult to understand the study results. This includes conditions related to your heart, lungs, liver, stomach, hormones, blood, brain, and mental health.You have received a live vaccine within the past 12 weeks or are expected to receive one during the study.Your health condition makes it too risky for you to take part in the study.Your disease is advancing very quickly and participating in the study could be dangerous for you.You currently have a serious infection or had one within the past four weeks that could be risky for you to participate in the trial.The type of patient and their medical condition.You have a condition called Graft vs Host Disease.You must be 18 years or older.You have been diagnosed with Ocular Mucous Membrane Pemphigoid.You have had a heart attack, stroke, or heart failure within the last 12 weeks.You have a history of cancer within the last 5 years or you have symptoms that suggest you may have a type of cancer that affects the immune system.You have a history of using illegal drugs or abusing alcohol within the past two years. You are currently using or plan to use illegal drugs during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Baricitinib
- Group 2: Antiproliferative
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any additional volunteers being enrolled into this clinical investigation?
"Per the information provided on clinicaltrials.gov, this trial is engaging with prospective patients and has been since February 21st 2022; the last update to its profile was made on the same day."
Answered by AI
Has Baricitinib 2 MG [Olumiant] obtained regulatory clearance from the FDA?
"Although there is limited data indicating the efficacy of Baricitinib 2 MG [Olumiant], our team has assigned a score of 2 based on existing evidence that supports its safety."
Answered by AI
How many participants are being recruited for this research endeavor?
"Affirmative. Clinicaltrials.gov confirms that recruitment for this clinical trial is active and currently underway, having been initially posted on the 21st of February 2022 with a subsequent update made to details on the same day. The study requires 20 participants from only one medical centre."
Answered by AI
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