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Phase 2 N=11 Treatment

A Study of Deucravacitinib to Treat LPP and FFA

Lichen Planopilaris

Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Jun 2025
Primary outcome: Primary: Complete and Partial Response to Deucravacitinib Measured by Lichen Planopilaris Activity Index (LPPAI) Score — 9 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Deucravacitinib (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Complete and Partial Response to Deucravacitinib Measured by Lichen Planopilaris Activity Index (LPPAI) Score
9
SECONDARY
Response to Deucravacitinib Measured by Physician Global Assessment (PGA) Score
8 0.008 sig
SECONDARY
Change in the Dermatology-LQI Score
0.0 0.629
SECONDARY
Change in Pruritus Visual Analogue Scale (VAS)
-1.6; -2.7
SECONDARY
Change in Pruritus Verbal Rating Scale (VRS)
-0.9; -0.9
SECONDARY
Change in Numerical Rating Scale (NRS) for Itch
-1.9 0.175
SECONDARY
Change in Skindex-16
-21.0 0.014 sig

Summary

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

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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 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 th
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06091956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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