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Lichen PlanopilarisPhase 2NCT06091956

A Study of Deucravacitinib to Treat LPP and FFA

A Phase 2 study testing Deucravacitinib in people with Lichen Planopilaris, run by Mayo Clinic at 2 sites 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

The purpose of this clinical research study is to learn more about the use of Deucravacitinib in the treatment of Lichen Planopilaris. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lichen Planopilaris
What is being tested?
Deucravacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
7 Nov 2023to 24 Dec 2024
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 must be able to understand and comply with the requirements of the study and communicate with the investigator. Subjects must give written, signed, and dated informed consent before any study related activity is performed. When appropriate, a legal representative will sign the informed consent according to local laws and regulation.
  • Subjects must have biopsy proven LPP/FFA and active disease.

Who cannot join

  • On excluded therapies, not on a stable dose of a therapy, or incompletely washed out for a therapy.
  • Known hypersensitivity or other adverse reaction to Deucravacitinib (BMS-986165).
  • Variants of LPP/FFA deemed by the investigators to be inappropriate for Deucravacitinib (BMS-986165).
  • Pregnant or nursing (lactating) women (pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test).
  • Women of childbearing potential [Post-menopausal or not of child-bearing potential is defined by 1 year of natural (spontaneous) amenorrhea or surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. Oophorectomy alone must be confirmed by follow up hormone level assessment to be considered not of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception which includes:
  • Total abstinence (Periodic abstinence and withdrawal are not acceptable methods of contraception); Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. Oophorectomy alone requires follow up hormone level assessment for fertility; Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject; Barrier methods of contraception: condom or occlusive cap; Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have complete efficacy (failure < 1%). (The dose of the contraceptive should be stable for 3 months).
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  • Active inflammatory diseases of the scalp and forms of hair loss other than LPP/FFA that might confound the evaluation of the benefit of Deucravacitinib (BMS-986165).
  • Tattooing of the scalp that, in the opinion of the investigator, may interfere with accurate assessment of clinical response to Deucravacitinib (BMS-986165).
  • Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the investigator, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
  • Moderate-to-severe renal impairment including patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m^2.
  • Active systemic infections during the 2 weeks prior to randomization (common cold viruses excluded) or any infection that reoccurs on a regular basis.
  • Current severe progressive or uncontrolled disease which the investigator renders the subject unsuitable for the trial or puts the subject at increased risk.
  • Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator would pose an unacceptable risk to the patient.
  • Have experienced any of the following within 12 weeks of screening: VTE (DVT/pulmonary embolism [PE]), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
  • Have a history of recurrent (≥ 2) VTE (DVT/PE).
  • Have a history of lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for < 5 years prior to randomization.
  • Have had symptomatic herpes zoster infection within 12 weeks prior to randomization.
  • Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement).
  • ALT or AST > 2 x upper limits of normal (ULN); alkaline phosphatase (ALP) ≥ 2 x ULN; total bilirubin ≥ 1.5 x ULN; hemoglobin < 10 g/dL (100.0 g/L); total white blood cell count < 3000 cells/μL (< 3.00 x 10^3/μL or < 3.00 billion/L); neutropenia (absolute neutrophil count [ANC] < 1500 cells/µL) (< 1.50 x 10^3/lµL or < 1.50 billion/L); lymphopenia (lymphocyte count < 1000 cells/μL) (< 1.00 x 10^3/μL or < 1.00 billion/L); thrombocytopenia (platelets < 100,000 cells/μL) (< 100 x 10^3/μL or < 100 billion/L)
  • Have a positive test for hepatitis B virus (HBV) defined as: positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA). Note: Patients who are HBcAb-positive and HBV DNA-negative may be enrolled in the study but will require additional HBV DNA monitoring during the study.
  • Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive): Note: Patients who have documented anti-HCV treatment for a past HCV infection AND are HCV RNA-negative may be enrolled in the study.
  • Have evidence of HIV infection and/or positive HIV antibodies.
  • Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
  • Have evidence of active TB or latent TB
  • Have evidence of active TB, defined in this study as the following: positive purified protein derivative (PPD) test (≥ 5 mm induration between approximately 2 and 3 days after application, regardless of vaccination history), medical history, clinical features, and abnormal chest x-ray at screening; QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. Patients are excluded from the study if the test is not negative and there is clinical evidence of active TB; Exception: patients with a history of active TB who have documented evidence of appropriate treatment, have no history of re-exposure since their treatment was completed, have no clinical features of active TB, and have a screening chest x-ray with no evidence of active TB may be enrolled if other entry criteria met. Such patients would not be required to undergo the protocol-specific TB testing for PPD, QuantiFERON®-TB Gold test, or T-SPOT®.TB test but must have a chest x-ray at screening (i.e., chest imaging performed within the past 6 months will not be accepted).
  • Have evidence of untreated/inadequately or inappropriately treated latent TB, defined in this study as the following: positive PPD test, no clinical features consistent with active TB, and a chest x-ray with no evidence of active TB at screening; or if the PPD test is positive and the patient has no medical history or chest x-ray findings consistent with active TB, the patient may have a QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with local TB guidelines). If the test results are not negative, the patient will be considered to have latent TB (for purposes of this study); or QuantiFERON®-TB Gold test or T- SPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. If the test results are positive, the patient will be considered to have latent TB. If the test is not negative, the test may be repeated once within approximately 2 weeks of the initial value. If the repeat test results are again not negative, the patient will be considered to have latent TB (for purposes of this study).
  • Have been exposed to a live vaccine within 12 weeks of randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination).
  • Have donated more than a single unit of blood within 4 weeks prior to screening or intend to donate blood during the course of the study.
  • Have a history of intravenous drug abuse, other illicit drug abuse, or chronic alcohol abuse within the 2 years prior to screening or are concurrently using, or expected to use during the study, illicit drugs (including marijuana).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Deucravacitinib (BMS-986165) in the Treatment of Lichen Planopilaris

The purpose of this clinical research study is to learn more about the use of Deucravacitinib in the treatment of Lichen Planopilaris.

Being tested
Deucravacitinib
Medical subject headings
Lichen Planus

What participants receive

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

  • DeucravacitinibDrug

    Also called BMS-986165

    6 milligram (mg) orally administrated, twice daily

Study groups in NCT06091956
Study groupRoleWhat they receive
Deucravacitinib Treatment for Lichen PlanopilarisExperimentalSubjects diagnosed with Lichen Planopilaris (LP) will receive Deucravacitinib for 24 weeks.
Receives: Drug: Deucravacitinib

What is being measured

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

  1. Complete and Partial Response to Deucravacitinib Measured by Lichen Planopilaris Activity Index (LPPAI) Score

    Number of subjects to have complete or partial response to Deucravacitinib treatment as measured by Lichen Planopilaris Activity Index (LPPAI) score: complete response = LPPAI reduction greater than 85% from baseline score and partial response = LPPAI reduction between 25-85% from baseline score. LPPAI scores range from 0 (no disease) to 10 (most severe) with higher scores indicating worsening disease.

    Measured: 24 weeks

Secondary outcomes (6)

  1. Response to Deucravacitinib Measured by Physician Global Assessment (PGA) Score

    Number of subjects to have an overall response to treatment (Deucravacitinib) as assessed by the physician using PGA. PGA scores range from 0 to 6 with scores between 0-3 indicating a response to treatment.

    Measured: Baseline, 24 weeks

  2. Change in the Dermatology-LQI Score

    Measured by the Dermatology Life Quality Index (DLQI) questionnaire that asks participants to measure their Lichen Planopilaris (LLP) or Frontal Fibrosing Alopecia (FFA) has affected their life over the last month. 10-item questionnaire using a scale of 0 (not at all) to 3 (very much). Maximum score is 30 and minimum score is 0, with higher scores indicating worsening quality of life.

    Measured: Baseline, 24 weeks

  3. Change in Pruritus Visual Analogue Scale (VAS)

    Subjects are asked on average and at its worst to rate their itch level over the past day by placing a vertical mark on the line with one end indicating no itch and the other end indicating worst imaginable itch. That point will be measured from the "No itch" end, and the number of centimeters (cm) will be reported as the pain score. VAS score interpretation: VAS 0 cm = No itch; VAS <3 cm = Mild itch; VAS ≥3 cm <7 cm = Moderate itch; VAS ≥7 cm <9 cm = Severe itch, VAS ≥9 cm <10 cm = Very severe itch.

    Measured: Baseline, 24 weeks

  4. Change in Pruritus Verbal Rating Scale (VRS)

    Subjects are asked on average and at its worst to rate their itch in the last 24 hours using a scale of 0= none, 1-mild, 2=moderate, 3= severe. Scores range from 0-3, with higher scores indicating worsening itch.

    Measured: Baseline, 24 weeks

  5. Change in Numerical Rating Scale (NRS) for Itch

    Itch is measured using numerical rating scale 0-10; 0= no itch, 1-4 = mild itch, 4-7 = moderate itch, 7-9 = severe itch, 10= very severe itch

    Measured: Baseline, 24 weeks

  6. Change in Skindex-16

    Measured by the Skindex-16 scoring system focused on itch and its impact upon quality of life. 16-item questionnaire using a scale of 0=never bothered to 6=always bothered, total score 0 to 96 with higher score indicated worse quality of life.

    Measured: Baseline, 24 weeks

Timeline

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

  1. First posted23 Oct 2023
  2. Study start7 Nov 2023
  3. Primary completion21 May 2024
  4. Study completion24 Dec 2024

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06091956
Sponsor's protocol ID
23-001929
Status last verified
Jun 2025
First submitted
16 Oct 2023
Last updated
8 Jun 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Deucravacitinib in people with Lichen Planopilaris, run by Mayo Clinic at 2 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 2 inclusion and 29 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 8 Jun 2025). 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?

Complete and Partial Response to Deucravacitinib Measured by Lichen Planopilaris Activity Index (LPPAI) Score (time frame: 24 weeks). 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 NCT06091956.

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 8 Jun 2025.

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