A Study of Deucravacitinib to Treat LPP and FFA

NCT06091956 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 23-001929
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lichen Planopilaris

Outcome Measures

Primary Outcomes (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.

  24 weeks

Secondary Outcomes (6)

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

  Baseline, 24 weeks

• Change in the Dermatology-LQI Score

  Baseline, 24 weeks

• Change in Pruritus Visual Analogue Scale (VAS)

  Baseline, 24 weeks

• Change in Pruritus Verbal Rating Scale (VRS)

  Baseline, 24 weeks

• Change in Numerical Rating Scale (NRS) for Itch

  Baseline, 24 weeks

Study Arms (1)

Deucravacitinib Treatment for Lichen Planopilaris

EXPERIMENTAL

Subjects diagnosed with Lichen Planopilaris (LP) will receive Deucravacitinib for 24 weeks.

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

6 milligram (mg) orally administrated, twice daily

Also known as: BMS-986165

Deucravacitinib Treatment for Lichen Planopilaris

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Mayo Clinic: lead
• Bristol-Myers Squibb: collaborator

Study Sites (2)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lichen Planus

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Aaron Mangold, M.D.
• Organization: Mayo Clinic

Mangold.Aaron@mayo.edu

480-301-6169

Study Officials

• Aaron Mangold, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: November 7, 2023
• Primary Completion: May 21, 2024
• Study Completion: December 24, 2024
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)