A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)

NCT06240351 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: IRB-3000095252026154
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).

Conditions

Frontal Fibrosing Alopecia

Outcome Measures

Primary Outcomes (1)

• 30% Change in Lichen Planopilaris Activity (LPPAI) Scores

  Percentage of patients achieving 30% change in LPPAI scores. LPPAI is a numeric scale that includes key signs and symptoms of FFA and allows for statistical comparison of disease activity. It captures patient reported symptoms (pruritus, pain, burning), clinical signs (erythema, perifollicular erythema, and scale), and other disease activity features (anagen pull and spreading). The total score distributes 30% weight to symptoms, 30% to signs, 25% to anagen pull, and 15% to spreading. The scale then ranges from 0-10 where 0 is no disease and 10 is worst disease.

  From baseline to week 12, 24, and 36

Secondary Outcomes (5)

• Improvement in Physician Global Assessment (PGA)

  From baseline to week 12, 24, and 36

• Change in inflammation on histology as seen on scalp biopsy

  From baseline to week 12,24, and 36

• Improvement in trichoscopic grading of peripheral cast by way of Tosti Scale

  From baseline to week 12,24, and 36

• Improvement in Eyebrow Assessment

  From baseline to week 12,24, and 36

• Improvement in Visual Analog Scale (VAS)

  From baseline to week 12,24, and 36

Study Arms (1)

Baricitinib

EXPERIMENTAL

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

Drug: Baricitinib 4 MG Oral Tablet

Interventions

Baricitinib 4 MG Oral Tablet DRUG

Baricitinib is a Janus kinase (JAK) inhibitor

Also known as: Olumiant

Baricitinib

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: This condition mostly impacts post-menopausal women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female at least 18 years of age, and able to provide informed consent
• Females who are post-menopausal defined, as not have menses for at least 12 months without an alternative medical cause and elevated follicle stimulating hormone in the postmenopausal range as measured during screening
• Have active FFA that has been diagnosed on or prior to screening visit.
• Have LPPAI score equal to or greater than 5 at screening.
• Have evidence of eyebrow loss at baseline
• Have evidence of hairline recession at baseline
• Have classic presentation with frontal loss of scalp hair
• Negative screening for tuberculosis (Quantiferon Gold, T-spot) within 3 months prior to screening or at the screening visit.
• Agree not to have a live vaccination during the study the exception is herpes zoster vaccine

You may not qualify if:

• Systemic treatments for FFA within 4 weeks of the baseline visit or 5 half lives whichever one is longer. (ex: finasteride, pioglitazone, hydroxychloroquine, or immunosuppressant medications, such as mycophenolate mofetil).
• Dutasteride within the last 6 months
• Have a LPPAI score less than 5 at screening
• Immunocompromised and with risk factors concerning to investigator for study participation
• Previous treatment with an oral JAK inhibitor
• Any condition in the opinion of the investigator which would interfere with the study assessments or procedure
• Subject is pregnant or breast feeding
• Surgical intervention including face lifts and micro-blading on the treatment areas
• Any intervention (facelifts micro blading) that could affect the treatment areas (i.e. scalp and eyebrows)
• Laser or phototherapy intervention on the treatment areas
• Have evidence of active TB or latent TB

Sponsors & Collaborators

• Eli Lilly and Company: collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Interventions

baricitinib

Study Officials

• Boni Elewski, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 5, 2024
• Study Start: April 22, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)