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

NCT ID: NCT06240351

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2027-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baricitinib

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

Group Type: EXPERIMENTAL

Baricitinib 4 MG Oral Tablet

Intervention Type: DRUG

Baricitinib is a Janus kinase (JAK) inhibitor

Interventions

Baricitinib 4 MG Oral Tablet

Baricitinib is a Janus kinase (JAK) inhibitor

Intervention Type: DRUG

Other Intervention Names

Olumiant

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Boni Elewski

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boni Elewski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ralee' Bunt, MSPH

Role: CONTACT

erikabunt@uabmc.edu

205-502-9960

Melissa Kitts

Role: CONTACT

mkitts@uabmc.edu

205-502-9960

Facility Contacts

Ralee Bunt, MSPH

Role: primary

erikabunt@uabmc.edu

205-502-9960

Other Identifiers

2026154

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300009525

Identifier Type: -

Identifier Source: org_study_id