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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Frontal Fibrosing Alopecia
• Intervention / Treatment: Drug: Baricitinib 4 MG Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ralee' Bunt, MSPH; Phone Number: 205-502-9960; Email: erikabunt@uabmc.edu
• Study Contact Backup: Name: Melissa Kitts; Phone Number: 205-502-9960; Email: mkitts@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
      • Contact: Ralee Bunt, MSPH; Phone Number: 205-502-9960; Email: erikabunt@uabmc.edu
      • Principal Investigator: Boni Elewski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baricitinib; 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; Baricitinib is a Janus kinase (JAK) inhibitor; Other Names: Olumiant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Physician Global Assessment (PGA)	Effectiveness of Baricitinib on improvement in Patient Global Assessment.This assessment is a scale from 0 to 4. 0 means clear skin while 4 means severe disease.	From baseline to week 12, 24, and 36
Change in inflammation on histology as seen on scalp biopsy	Effectiveness of Baricitinib on change of inflammation results on histology exam as seen on scalp biopsy. Degree of lymphocytic infiltrate will be assessed on biopsy and compared to cast thickness on trichoscopy (which correlates with severity of inflammatory changes on pathology).	From baseline to week 12,24, and 36
Improvement in trichoscopic grading of peripheral cast by way of Tosti Scale	Effectiveness of Baricitinib on the improvement in trichoscopic grading of peripheral casts (scales). Degree of lymphocytic infiltrate will be assessed on biopsy and compared to cast thickness on trichoscopy by the Tosti Scale. This is a 3 grade measure with Grade 1 being minimum scaling while Grade 3 is maximum scaling.	From baseline to week 12,24, and 36
Improvement in Eyebrow Assessment	Effectiveness of Baricitinib on the improvement of the eyebrow assessment. This is a survey for patients to answer. Answers range from 0 to 3. Answers of 0 mean "I have full eyebrows on each side" while answers of 3 mean " I have no or barely any eyebrow hairs.	From baseline to week 12,24, and 36
Improvement in Visual Analog Scale (VAS)	Effectiveness of Baricitinib on the improvement of the Visual Analog Scale. This is a 10-point visual scale to rate whether the patient's FFA seems to be worse or resolved.	From baseline to week 12,24, and 36

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Boni Elewski, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: IRB-300009525

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes