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Janus Kinase (JAK) Inhibitor

Baricitinib for Frontal Fibrosing Alopecia

Phase 4

Waitlist Available

Led By Boni Elewski, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have classic presentation with frontal loss of scalp hair

Have active Frontal Fibrosing Alopecia (FFA) diagnosed on or prior to screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 12,24, and 36

Awards & highlights

Study Summary

This trial aims to test if Baricitinib is safe and effective in treating frontal fibrosing alopecia (FFA).

Who is the study for?

This trial is for individuals with frontal fibrosing alopecia (FFA), a type of hair loss affecting the front of the scalp. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of FFA.Check my eligibility

What is being tested?

The study is testing Baricitinib, a medication taken as a 4 mg oral tablet, to see if it's safe and effective in treating FFA. The main goal is to determine whether this drug can help manage symptoms or halt progression of hair loss in affected individuals.See study design

What are the potential side effects?

While specific side effects for Baricitinib in this trial context aren't listed, common ones from similar trials include headache, upper respiratory infections, nausea, and potential increase in liver enzymes. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am experiencing hair loss at the front of my scalp.

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I have been diagnosed with active Frontal Fibrosing Alopecia before my screening visit.

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I have lost my eyebrows.

Select...

I am a woman who has not had a period for at least 12 months due to menopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 12,24, and 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 12,24, and 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 12,24, and 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

30% Change in Lichen Planopilaris Activity (LPPAI) Scores

Secondary outcome measures

Change in inflammation on histology as seen on scalp biopsy

Improvement in Eyebrow Assessment

Improvement in Physician Global Assessment (PGA)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: BaricitinibExperimental Treatment1 Intervention

All patients will be treated with the active product, Baricitinib. Each patient will take 4mg of Baricitinib daily for 36 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Baricitinib 4 MG Oral Tablet

2020

Completed Phase 4

~110

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,618 Previous Clinical Trials

3,201,545 Total Patients Enrolled

University of Alabama at BirminghamLead Sponsor

1,589 Previous Clinical Trials

2,280,339 Total Patients Enrolled

Boni Elewski, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

4 Previous Clinical Trials

508 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific criteria must individuals meet in order to be considered eligible for participation in this clinical research study?

"Individuals aged between 18 and 90 years old diagnosed with frontal fibrosing alopecia are eligible to participate in this study, which aims to enroll approximately 15 participants."

Answered by AI

Are new participants currently being recruited for this ongoing medical study?

"As per the details on clinicaltrials.gov, this specific research study is currently not in the process of seeking new participants. Despite being listed initially on 2/20/2024 and last edited on 1/31/2024, it is no longer enrolling individuals. Nonetheless, there are numerous other studies - a total of 93 at present - actively looking for eligible candidates to participate."

Answered by AI

Is there an age restriction for potential participants in this medical study, specifically excluding individuals over the age of 75?

"To be eligible for this research study, individuals between the ages of 18 and 90 are welcome to apply. There are a total of 16 studies tailored for those under 18 years old and another set of 66 studies designed for participants over the age of 65."

Answered by AI