| Eligibility |
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 < 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).
- 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).
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