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Janus Kinase (JAK) Inhibitor

Baricitinib for Alopecia

Phase 4
Recruiting
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
Must not have
Any intervention (facelifts, micro-blading) that could affect the treatment areas (i.e., scalp and eyebrows)
Surgical intervention including face lifts and micro-blading on the treatment areas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12,24, and 36
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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.
Select...
I have been diagnosed with active Frontal Fibrosing Alopecia before my screening visit.
Select...
I have lost my eyebrows.
Select...
I am a woman who has not had a period for at least 12 months due to menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had procedures like facelifts or micro-blading that could affect my scalp or eyebrows.
Select...
I have not had cosmetic procedures like face lifts or micro-blading on the treatment areas.
Select...
I have been treated with a JAK inhibitor before.
Select...
I have been diagnosed with active or latent tuberculosis.
Select...
I have not had laser or light therapy on the areas to be treated.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
30% Change in Lichen Planopilaris Activity (LPPAI) Scores
Secondary study objectives
Change in inflammation on histology as seen on scalp biopsy
Improvement in Eyebrow Assessment
Improvement in Physician Global Assessment (PGA)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,675 Previous Clinical Trials
3,463,968 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,369 Total Patients Enrolled
Boni Elewski, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
5 Previous Clinical Trials
520 Total Patients Enrolled
~6 spots leftby Apr 2025
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