Baricitinib for Central Centrifugal Cicatricial Alopecia in Adults of African Descent

NCT07843732 | Completed Phase 2 FDA Drug

• 2 other identifiers: I4V-US-X00912129
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

This study evaluated the safety and efficacy of baricitinib 4 mg daily in adults of African descent with biopsy-proven central centrifugal cicatricial alopecia, a scarring alopecia for which no FDA-approved treatment exists. Participants received open-label baricitinib for 52 weeks at four sites in the United States. Scalp hair loss was assessed by the Investigator Global Assessment at baseline and by the Investigator Re-Assessment Score at each post-baseline visit, with patient-reported quality of life and scalp symptom measures collected in parallel.

Conditions

Central Centrifugal Cicatricial Alopecia

Keywords

CCCA; scarring alopecia; cicatricial alopecia; JAK inhibitor; baricitinib; skin of color

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Investigator Global Assessment Score at Month 12

  The Investigator Global Assessment is a single-item observer-rated scale of scalp hair loss scored from 0 to 4, where 0 is none and 4 is very severe. One score is recorded per participant per timepoint. Change from baseline is the Month 12 score minus the baseline score, reported in units on a scale. A negative value indicates improvement.

  Baseline and Month 12

Secondary Outcomes (5)

• Investigator Re-Assessment Score

  Months 1, 3, 6, 9 and 12

• Change from Baseline in Investigator Global Assessment Score at Months 1, 3, 6 and 9

  Baseline and Months 1, 3, 6 and 9

• Change from Baseline in Psychological Quality of Life Total Score

  Baseline and Months 1, 3, 6, 9 and 12

• Change from Baseline in Patient Subjective Measurements Total Score

  Baseline and Months 1, 3, 6, 9 and 12

• Number of Participants With at Least One Dermatoscopic Feature of Central Centrifugal Cicatricial Alopecia Present

  Months 1, 3, 6, 9 and 12

Study Arms (1)

Baricitinib 4 mg daily

EXPERIMENTAL

Participants received baricitinib 2 mg orally twice daily, for a total daily dose of 4 mg, for 52 weeks.

Drug: Baricitinib

Interventions

Baricitinib DRUG

Oral tablet, 2 mg twice daily for a total daily dose of 4 mg, administered for 52 weeks.

Also known as: Olumiant, LY3009104

Baricitinib 4 mg daily

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years of age at the time of informed consent.
• Of African descent.
• Biopsy-proven central centrifugal cicatricial alopecia with no other cause of hair loss.
• Agrees to use no other medication to treat central centrifugal cicatricial alopecia for the duration of the study.
• Women of childbearing potential must use highly effective contraception during the intervention period and for 28 days after the last dose, and must have negative pregnancy tests at screening and at baseline.
• In otherwise good general health by medical history, physical examination and laboratory testing.

You may not qualify if:

• Pregnant or breastfeeding.
• Any other form of alopecia, or any concomitant scalp or skin condition that would interfere with evaluation of study medication.
• Active systemic disease that may cause hair loss.
• Intralesional corticosteroids, oral JAK inhibitors, or any other treatment for central centrifugal cicatricial alopecia within 4 weeks of baseline.
• Systemic immunosuppressive therapy within 8 weeks of baseline, or other non-biologic systemic agents within 4 weeks of baseline.
• Participation in another interventional study within 4 weeks, or previous treatment with baricitinib.
• Active tuberculosis, inadequately treated latent tuberculosis, hepatitis B, hepatitis C, or HIV infection.
• Current or recent serious infection, or a history of recurrent eczema herpeticum.
• Screening laboratory values outside protocol-specified hematologic, hepatic or renal limits.
• Renal impairment.
• History of venous thromboembolism or high risk for venous thromboembolism.
• Myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Class III or IV heart failure within 12 weeks of screening.
• History of lymphoproliferative disease, active malignancy, or malignancy in remission for less than 5 years.
• Hypersensitivity to any component of study drug.
• Live vaccine within 12 weeks of baseline or anticipated during the study.

Sponsors & Collaborators

• Raven Clinical Research: lead
• Eli Lilly and Company: collaborator

Study Sites (4)

Site 02

Marriottsville, Maryland, 21104, United States

Location

Site 03

Fairfax, Virginia, 22033, United States

Location

Site 01

McLean, Virginia, 22102, United States

Location

Site 04

Burlington, Wisconsin, 53105, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Chesahna Kindred, MD, MBA, FAAD

  Raven Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: September 28, 2026
• Study Start: October 22, 2024
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (4)