Central Centrifugal Cicatricial AlopeciaPhase 2NCT07843732
Baricitinib for Central Centrifugal Cicatricial Alopecia in Adults of African Descent
A Phase 2 study testing Baricitinib in people with Central Centrifugal Cicatricial Alopecia, run by Raven Clinical Research at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Central Centrifugal Cicatricial Alopecia
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Oct 2024to 28 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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.
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- 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.
- Unable or unwilling to comply with study procedures for the duration of the study.
- Investigator site personnel directly affiliated with this study, or their immediate family.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Site 04
Burlington, Wisconsin, 53105
Site 03
Fairfax, Virginia, 22033
Site 02
Marriottsville, Maryland, 21104
Site 01
McLean, Virginia, 22102
About this study
Official title: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Adult Patients of African Descent With Biopsy-proven Central Centrifugal Cicatricial Alopecia (CCCA)
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.
Read the detailed description
Single-arm, open-label, Phase 2 study conducted in three periods: a screening period of approximately 4 weeks, a 52-week treatment period from Day 1 through Day 365, and a post-treatment follow-up period of approximately 4 weeks. Participants attended a screening visit, eight in-office visits and five safety follow-up telephone contacts. Investigational product was dispensed at Visits 2, 4, 6, 8 and 10 and collected at each subsequent visit for accountability. Efficacy was assessed by direct clinical examination supported by standardized clinical photography. Safety assessments included vital signs, physical assessment, laboratory analysis, the Columbia-Suicide Severity Rating Scale and adverse event collection at every contact. Twenty-seven participants received at least one dose and 17 completed the Day 365 visit.
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Being tested
- Baricitinib
- Keywords
- CCCA, scarring alopecia, cicatricial alopecia, JAK inhibitor, baricitinib, skin of color
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called Olumiant, LY3009104
Oral tablet, 2 mg twice daily for a total daily dose of 4 mg, administered for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib 4 mg daily | Experimental | Participants received baricitinib 2 mg orally twice daily, for a total daily dose of 4 mg, for 52 weeks. Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Month 12
Secondary outcomes (5)
Investigator Re-Assessment Score
The Investigator Re-Assessment is a single-item observer-rated scale of scalp hair loss relative to baseline, scored from -3 to 3, where -3 is severely worse, 0 is stable with no change and 3 is greatly improved. One score is recorded per participant per timepoint and is reported in units on a scale. Higher scores indicate greater improvement.
Measured: Months 1, 3, 6, 9 and 12
Change from Baseline in Investigator Global Assessment Score at Months 1, 3, 6 and 9
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. Change from baseline is the score at each timepoint minus the baseline score, reported in units on a scale. A negative value indicates improvement.
Measured: Baseline and Months 1, 3, 6 and 9
Change from Baseline in Psychological Quality of Life Total Score
Participant-completed questionnaire of five items on the effect of central centrifugal cicatricial alopecia on hair styling, daily activities, work and personal relationships. Each item is scored 0 not at all to 3 very much, and the five items are summed to a total score of 0 to 15, reported in units on a scale. Change from baseline is the score at each timepoint minus the baseline score. A negative value indicates improvement.
Measured: Baseline and Months 1, 3, 6, 9 and 12
Change from Baseline in Patient Subjective Measurements Total Score
Participant-rated scalp symptom questionnaire of five items: itching, burning or stinging, tenderness, soreness and sharp pain. Each item is rated 0 not at all to 10 most severe imaginable, and the five items are summed to a total score of 0 to 50, reported in units on a scale. Change from baseline is the score at each timepoint minus the baseline score. A negative value indicates improvement.
Measured: Baseline and Months 1, 3, 6, 9 and 12
Number of Participants With at Least One Dermatoscopic Feature of Central Centrifugal Cicatricial Alopecia Present
Participants are counted once at each timepoint if any of the following is present on dermatoscopic examination: peripilar grey or white halo, perifollicular scaling, honeycomb pattern, erythema, increased interfollicular distance, broken hairs, pinpoint white dots, or interfollicular hyperpigmented patches. Reported as number of participants.
Measured: Months 1, 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start22 Oct 2024
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Centrifugal Cicatricial AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raven Clinical Research
- Sponsor type
- Research network
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Chesahna Kindred, MD, MBA, FAAD, Principal investigator, Raven Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843732
- Sponsor's protocol ID
- I4V-US-X009
- Other IDs
- 12129
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Adult Patients of African Descent With Biopsy-proven Central Centrifugal Cicatricial Alopecia (CCCA)
- ClinicalTrials.gov ID
- NCT07843732
- Acronym / sponsor ID
- I4V-US-X009
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Keywords
- CCCA, scarring alopecia, cicatricial alopecia, JAK inhibitor, baricitinib, skin of color
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Raven Clinical ResearchResearch network
- Collaborators
- Eli Lilly and Company
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Single-arm, open-label, Phase 2 study conducted in three periods: a screening period of approximately 4 weeks, a 52-week treatment period from Day 1 through Day 365, and a post-treatment follow-up period of approximately 4 weeks. Participants attended a screening visit, eight in-office visits and five safety follow-up telephone contacts. Investigational product was dispensed at Visits 2, 4, 6, 8 and 10 and collected at each subsequent visit for accountability. Efficacy was assessed by direct clinical examination supported by standardized clinical photography. Safety assessments included vital signs, physical assessment, laboratory analysis, the Columbia-Suicide Severity Rating Scale and adverse event collection at every contact. Twenty-seven participants received at least one dose and 17 completed the Day 365 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baricitinib 4 mg daily | Experimental | Drug: BaricitinibParticipants received baricitinib 2 mg orally twice daily, for a total daily dose of 4 mg, for 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: Olumiant, LY3009104Oral tablet, 2 mg twice daily for a total daily dose of 4 mg, administered for 52 weeks. | Drug | Baricitinib 4 mg daily |
Primary outcome
Change from Baseline in Investigator Global Assessment Score at Month 12
Time frame: Baseline and 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.
5 secondary outcomes
Investigator Re-Assessment Score
Time frame: Months 1, 3, 6, 9 and 12
Change from Baseline in Investigator Global Assessment Score at Months 1, 3, 6 and 9
Time frame: Baseline and Months 1, 3, 6 and 9
Change from Baseline in Psychological Quality of Life Total Score
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Change from Baseline in Patient Subjective Measurements Total Score
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Number of Participants With at Least One Dermatoscopic Feature of Central Centrifugal Cicatricial Alopecia Present
Time frame: Months 1, 3, 6, 9 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chesahna Kindred, MD, MBA, FAAD principal investigator
Raven Clinical Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib in people with Central Centrifugal Cicatricial Alopecia, run by Raven Clinical Research at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Investigator Global Assessment Score at Month 12 (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.