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Cicatricial AlopeciaPhase 2NCT05549934

Ritlecitinib for Cicatricial Alopecia

A Phase 2 study testing PF-06651600 in people with Cicatricial Alopecia, run by Emma Guttman at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Alopecia could be subdivided into two main groups of diseases: non-scarring alopecia, such as male pattern baldness, or alopecia areata (AA), in which hair follicles are preserved, yet quiescent, and scarring alopecia, also known as cicatricial alopecia (CA), in which hair follicles are irreversibly destroyed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cicatricial Alopecia
What is being tested?
PF-06651600
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
15 Dec 2022to 20 Mar 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects of any gender, age 18 years or older, at the time of informed consent at Screening
  • Subjects who are willing and able to adhere to the study visit schedule and comply with protocol requirements.
  • Subject self-reports a history of at least 6 months of CA (LPP/FFA or CCCA). Diagnosis will be made clinically (according to the LPPAI37, FFASI36 and/or CHLG38).
  • Subject has a negative Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening or within the last 12 months.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • Is not a woman of childbearing potential (WOCBP) OR;
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  • Is a WOCBP (all female participants, regardless of whether or not they have experienced/reported menarche, are considered WOCBP unless they are permanently sterile or confirmed infertile). A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of <1%, during the intervention period and for at least 28 days after the last dose of study intervention.
  • And if a WOCBP, must have a negative highly sensitive serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline performed before the first dose of study intervention.
  • Subject is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.

Who cannot join

  • Subject's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia.
  • Subject has a history of CA for ≥ 7 years since their disease onset, severe fibrosing disease, or very rapid hair loss at screening (de novo patients only).
  • Subject has a history of moderate to severe keloids on the scalp, as determined by clinical examination at screening.
  • Other scalp disease that may impact assessment (e.g., scalp psoriasis, dermatitis, etc.).
  • Subject is pregnant or breastfeeding.
  • Participation in other studies involving investigational drug(s) within 4 weeks or within 5 half-lives (if known), whichever is longer, prior to study entry and/or during study participation (de novo patients only).
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  • Active systemic diseases that may cause hair loss (e.g., systemic lupus erythematosus, thyroiditis, systemic sclerosis, etc.).
  • Any Psychiatric condition in the opinion of the investigator precludes participation in the study.
  • Subjects with a Columbia Suicide Severity Rating Scale (C-SSRS) score of "yes" on questions 4 and/or 5 at Visit 2 (Baseline).
  • Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (particularly thyroid disease which can be associated with hair loss), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator, the subject is inappropriate for entry into this study, or unwilling/unable to comply with STUDY PROCEDURES.
  • History of thromboembolic events including DVT and PE or history of inherited coagulopathies.
  • Any present malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  • History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
  • History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
  • History of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 0.
  • Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 0 or superficial skin infection within 1 week prior to Day 0.
  • Significant trauma or major surgery within 1 month of signing informed consent.
  • Considered in imminent need for surgery or with elective surgery scheduled to occur during the study.
  • Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening for subjects determined by the investigators to be at high-risk for this disease.
  • ANY of the following abnormalities in the clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary:
  • Absolute neutrophil count of <1.2 x 109/L (<1200/mm3);
  • Hemoglobin <11.0 g/dL or hematocrit <33%;
  • Platelet count of <150 x 109/L (<150,000/mm3);
  • Absolute lymphocyte count of <0.80 x 109 /L (<800/mm3);
  • Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/ml/min/1.73m2 based on CKD-Epi 2021 (creatine equation);
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >2 times the ULN;
  • Total bilirubin greater than or equal to 1.5 times the ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is less than or equal to ULN.
  • Have an active history of alcohol or substance abuse within 1 year prior to Day 0.
  • Donation of blood in excess of 500 mL within 8 weeks prior to Day 0.
  • Subject has received a live attenuated vaccine ≤ 6 weeks prior to study screening.
  • Subject has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints, at determined by the PI.
  • History of adverse systemic or allergic reactions to components of study drug.
  • Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, within 8 weeks prior to baseline visit.
  • Use of other non-biologic systemic agent for CA, including, 5α-reductase inhibitors, hydroxychloroquine, or retinoids, within 4 weeks prior to baseline visit.
  • Use of an intralesional corticosteroids or oral JAK inhibitor (tofacitinib, ruxolitinib, or any JAK1/TYK2 product) within 4 weeks prior to the baseline visit (de novo patients only).
  • Subject has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus or cyclosporine within 1 week before the baseline visit.
  • Subject has been previously treated with biological drugs in the last 12 weeks for other indications.
  • Subjects previously tested with a positive or indeterminable PPD or QFT result, including subjects that completed standard tuberculosis therapy.
  • Screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment, e.g. acute myocardial infarction, serious tachy or brady arrhythmias or that are indicative of serious underlying heart disease (e.g. cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff-Parkinson-White syndrome and other clinically relevant abnormalities which may affect participant safety or interpretation of study results. A history of additional risk factors for Torsades de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of long QT syndrome).
  • If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated 2 more times and the average of 3 QTc or QRS values should be used to determine the participants' eligibility. Participants with average screening value QTcF > 450 ms should be excluded.
  • The use of prohibited and permitted CYP3A substrates are provided in Appendix 2.1 and 2.2, respectively and medications that prolong the QT/QTcF interval in Appendix 3.
  • Have hearing loss with progression over the previous 5 years, or sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating, or progressive.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: A Pilot Study to Assess Safety and Biomarker Responses of Ritlecitinib (JAK3/TEC Inhibitor) in Cicatricial Alopecia

Alopecia could be subdivided into two main groups of diseases: non-scarring alopecia, such as male pattern baldness, or alopecia areata (AA), in which hair follicles are preserved, yet quiescent, and scarring alopecia, also known as cicatricial alopecia (CA), in which hair follicles are irreversibly destroyed. CA leads to scarred areas, most commonly on the scalp, that cannot re-grow hair. Despite being a long-term condition, that often has significant impact on patients' well-being, available effective treatments for these diseases are lacking. In addition, the molecular abnormalities causing CA are largely unknown. The research team will be administering a new investigational drug (a JAK3/TEC inhibitor), ritlecitinib, which has shown statistically significant improvement in scalp hair loss for AA patients in a proof of concept and phase 2b/3 studies (B7981015 AA study). This is an open-label clinical trial. CA patients will be asked to provide small samples of skin and blood throughout the treatment period, to find out how they respond to the drug, and to attempt to better understand these diseases.

Being tested
PF-06651600
Keywords
frontal fibrosing alopecia, FFA, lichen planopilaris, LPP, central centrifugal, scarring alopecia, CCCA
Medical subject headings
Alopecia, Lichen Planus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06651600Drug

    Also called Ritlecitinib

    tablets containing active drug (a combined JAK3/TEC inhibitor)

Study groups in NCT05549934
Study groupRoleWhat they receive
PF-06651600 (Ritlecitinib)Experimental200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
Receives: Drug: PF-06651600

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Ct Values of mRNA Levels of CCL5 Gene

    Log-fold Changes in mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 24. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene

    Measured: Baseline to Week 24

  2. Number of Treatment-Emergent Adverse Events

    The adverse event will be described and categorized as Treatment-emergent, Serious, abnormal in vital signals, and abnormalities in laboratory parameters.

    Measured: Week 48

Secondary outcomes (3)

  1. Percent Change in the Frontal Fibrosis Alopecia Severity Index (FFASI)

    The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline from a total score of 0-84, with higher score indicating more severity. Percent change in FFASI at Week 24 and Week 48 as compared to baseline.

    Measured: Baseline, Week 24, and Week 48

  2. Percent Change in the Lichen Planopilaris Activity Index (LPPAI)

    The Lichen Planopilaris Activity Index is a numeric composite index that aggregates symptoms and signs of pruritus, pain, burning, scalp erythema , perifollicular erythema, perifollicular scale , pull test and spreading. Symptoms and signs are measured in a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). Full range from 0-10, higher score indicates more severity. Percent change in the LPPAI at Week 24 and Week 48 as compared to baseline.

    Measured: Baseline, Week 24 and Week 48

  3. Percentage Change From Baseline in Change in Central Hair Loss Grade (CHLG)

    Percent change in Central Hair Loss Grade (CHLG) is an ordinal photographic outcome derived from a validated central scalp alopecia photographic scale to capture the pattern and severity of central hair loss. The scale uses standardized photographs and grades severity from 0 to 5, with 0 representing no hair loss, grades 1 and 2 representing early hair loss, and grades 3 to 5 representing probable CCCA with increasing severity.

    Measured: Baseline, Week 24 and Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2022
  2. Study start15 Dec 2022
  3. Primary completion20 Mar 2025
  4. Study completion20 Mar 2025

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05549934
Sponsor's protocol ID
GCO 22-1234
Status last verified
Jul 2026
First submitted
19 Sep 2022
Last updated
15 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Not shared

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06651600 in people with Cicatricial Alopecia, run by Emma Guttman at 1 site 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 9 inclusion and 42 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Ct Values of mRNA Levels of CCL5 Gene (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05549934.

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 15 Jul 2026.

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