Inclusion Criteria:

• Male or female, and the participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent form (ICF).
• A screening skin biopsy histology characteristic of cutaneous sarcoidosis and presentation of cutaneous sarcoidosis symptoms for ≥ 6 months where other possible etiologies (e.g. infection, non-sarcoidosis conditions associated with granuloma formation) have been reasonably excluded. Note: If results from historic biopsy are available, a skin biopsy does not have to be performed at screening unless participating in optional biopsy biomarker collection.
• A CSAMI activity score of ≥ 10 at screening and baseline (Day 1/Visit 2).
• Participants weighing > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2 at screening.
• Participants who are able and willing to understand and comply with the study requirements and capable of giving signed informed consent.

Exclusion Criteria:

• Current sarcoidosis disease presentation consistent with any of the following:
  • Solely subcutaneous sarcoidosis;
  • Solely nongranulomatous or nonspecific cutaneous sarcoidosis lesions (e.g., erythema nodosum);
  • Solely ulcerative lesions;
  •  Lofgren’s syndrome (i.e., presence of the triad of erythema nodosum, bilateral hilar lymphadenopathy on chest x-ray, and joint pain).
• Clinically significant target-organ manifestations of sarcoidosis at screening that, in the opinion of the investigator, would pose any additional safety risks or impact compliance with study procedures (including mandatory oral corticosteroid taper).
• Extracutaneous manifestations of sarcoidosis requiring escalation or initiation of a new sarcoidosis-directed therapy within the 6 months prior to baseline (Day 1/Visit 2)
• Pulmonary sarcoidosis meeting any of the following criteria:
  • Pulmonary hypertension requiring treatment; requiring supplemental oxygen or associated with resting hypoxemia; or associated with significant exercise limitation; at baseline (Day 1/Visit 2);
  • FVC percent predicted ≤ 50% at screening;
  • DLCO percent predicted ≤ 40% at screening. Note: Inclusionary FVC or DLCO assessments performed in the 12 months prior to screening do not need to be repeated, unless in the judgment of the investigator, the historic test is no longer representative of the participants’ lung function.
• History of any lymphoproliferative disorder (such as Epstein-Barr virus [EBV]-related lymphoproliferative disorder, lymphoma, leukemia).
• Cancer-associated condition, cancer, or history meeting any of the following conditions:
  • Active malignancy;
  • History of cancer within 5 years prior to baseline (Day 1/Visit 2), with the exception of the following cancers with documentation of complete resection and no evidence of recurrence for ≥ 1 year: basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma. Note: Potential participants who have an unacceptably high risk of recurrence may be rejected by the sponsor or their delegate. Additionally, the participant is required to comply with recommended follow-up testing with their treating healthcare provider of record while participating in the study.
• Severe hepatic impairment, indicated by a Child-Pugh class C designation, at screening.
• History of any of the following:
  • Thrombosis or cerebrovascular ischemic event within the last 12 months prior to baseline (Day 1/Visit 2), or history of recurrent (≥ 2) venous thrombosis or arterial thromboembolism;
  • Known hypercoagulable state (for example, protein C deficiency, protein S deficiency, Factor V Leiden mutation, etc.), which in the opinion of the investigator, places the participant at high risk for thrombosis.
• Any of the following cardiovascular risk factors:
  • A history of cardiac insufficiency defined as meeting either New York Heart Association (NYHA) Class III or Class IV criteria:
    • NYHA Class III: Marked limitation of physical activity; comfortable at rest; less than ordinary activity causes fatigue, palpitation, or dyspnea;
    • NYHA Class IV: Unable to carry on any physical activity without discomfort; symptoms of heart failure at rest; if any physical activity is undertaken, discomfort increases;
  • Current or not definitively managed clinically significant cardiac dysrhythmia;
  • Fridericia corrected QT interval (QTcF) > 450 msec for male participants or > 470 msec for female participants at screening, and confirmed by repeat ECG, if deemed necessary;
  • Unstable angina within 3 months prior to baseline (Day 1/Visit 2);
  • Myocardial infarction (MI) within 1 year prior to baseline (Day 1/Visit 2) (if an MI of indeterminate age is recorded on ECG and there is no known cardiac history, a cardiology consultation is required prior to entry);
  • Coronary artery bypass graft surgery within 1 year prior to baseline (Day 1/Visit 2).
• Recipient of a solid organ transplant who is currently receiving systemic immunosuppressive therapy.
• Any condition possibly affecting oral drug absorption (e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass). Note: Procedures that simply divide the stomach into separate chambers (e.g., gastric banding, gastric sleeve) are not exclusionary.
• Any other acute or chronic medical condition, psychiatric condition, laboratory abnormality, or disease activity measures that, in the judgment of the investigator or sponsor, may increase the risk associated with study participation or IMP administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study.
• Current therapy consisting of > 25 mg/day of prednisone or equivalent for commonly-used corticosteroid equivalents) or a change in corticosteroid dose in the 4 weeks prior to baseline [Day 1/Visit 2].
• Current or planned treatment with prohibited concomitant medications, including biologic therapy (e.g., TNF inhibitors) and investigational agents during the study. Prior treatment is permitted provided the specified discontinuation period is met prior to baseline (Day 1/Visit 2), including:
  • Use of topical JAK inhibitors or topical calcineurin inhibitors within 8 weeks prior to baseline (Day 1/Visit 2);
  • Intralesional corticosteroids administered within 4 weeks prior to baseline (Day 1/Visit 2).
• If receiving immunomodulatory, antimalarial, or tetracycline antibiotic therapy
• Prior exposure to brepocitinib or participation in a brepocitinib clinical trial.
• History of hypersensitivity to any constituents of the IMP formulation or other JAK inhibitors.
• Has been exposed to a live vaccine within 6 weeks prior to baseline (Day 1/Visit 2) or is expected to need/receive a live vaccine during the course of the study. Participants must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 52 weeks prior to baseline (Day 1/Visit 2). Note: Although not mandated by the protocol, vaccines recommended by local guidelines should be considered. Administration of inactivated or RNA-based (non-live) vaccines is permitted prior to or during the study; however, it should not be administered in the 2 weeks prior to any scheduled study visit.
• Active bacterial (with the exception of uncomplicated urinary tract infection), viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, or allergic aspergillosis on chest x-ray), with the exception of infections that only require topical therapy, that would substantially increase the risk to the participant if they participate in the study.
• History of recurrent bacterial (with the exception of uncomplicated urinary tract infection), viral, fungal (with the exception of infections that only required topical antifungal therapy), mycobacterial, or other infections (including but not limited to pyelonephritis, TB and atypical mycobacterial disease on chest x-ray) that would substantially increase the risk to the participant if they participate in the study.
• Have required management of acute or chronic infections as follows:
  • Currently on suppressive therapy for any chronic infection (e.g., pneumocystis, cytomegalovirus [CMV], and atypical mycobacteria) that, in the opinion of the investigator and sponsor, would place the participant at risk for reactivation and/or infection. Note: Participants receiving stable suppressive therapy for herpes simplex virus may be enrolled with the expectation that this treatment will continue for the duration of the study.
  • Hospitalization for infection within 60 days prior to baseline (Day 1/Visit 2).
  • Use of intravenous (IV) or intramuscular (IM) antibacterials, antivirals, antifungals, or anti-parasitic agents within 60 days prior to baseline (Day 1/Visit 2).
  • Use of oral antibiotics to treat an active infection within 14 days prior to baseline (Day 1/Visit 2).
• History of disseminated herpes zoster, history of disseminated herpes simplex, or recurrent (≥ 2 episodes within last 5 years prior to baseline, Day 1/Visit 2) localized, single unilateral dermatomal herpes zoster.
• Infection with Mycobacterium tuberculosis as defined by any of the following with a TB test performed at screening or within 12 weeks prior to screening:
  • A positive interferon gamma release assay (IGRA), noting the following:
    • If the results of the IGRA are indeterminate, the test may be repeated once, and if a negative result is obtained, enrollment may proceed. A positive test on repeat is exclusionary.
    • Participants with repeat indeterminate IGRA results should have a different IGRA performed (e.g., T spot) and may be enrolled after consultation with an infectious disease and/or pulmonary specialist and sponsor agreement.
    • Participants who have previously completed an adequate course of therapy (in the opinion of an infectious disease and/or pulmonary specialist provided within the 6 months prior to screening) for latent TB infection may be enrolled regardless of screening IGRA results provided that 1) there are no current signs or symptoms of active TB and 2) the treatment is well documented in the participant’s medical records.
    •  Participants who are diagnosed with latent TB and require treatment should initiate the treatment during the Screening Period. Participants in this case will be eligible for the study only if the participant is seen by an infectious disease and/or pulmonary specialist and confirmed to have no findings of active TB and if the consultant agrees that the participant’s latent TB can be adequately treated with isoniazid (INH) plus vitamin B6. The participant must agree to complete the course of INH and vitamin B6 during the study. Additional management of latent TB should follow local guidelines or recommendations. Note: A historical NEGATIVE IGRA result from a test that was performed within the 12 weeks prior to screening can be used to establish eligibility, and repeat testing is not required.
  • Chest x-ray taken at screening with changes suggestive of active TB infection. Note: A chest x-ray or CT (or PET-CT) scan previously performed and documented within 6 months prior to screening does not require repeat
• Confirmed positive screening result for hepatitis B (hepatitis B surface antigen [HBsAg] positive; HbsAg negative, hepatitis B core antibody [HBcAb] positive, and hepatitis B surface antibody [HBsAb] negative; or HBV deoxyribonucleic acid [DNA] positive on reflex testing), hepatitis C (hepatitis C virus antibody [HCVAb] positive and hepatitis C virus [HCV] RNA positive on reflex testing), or human immunodeficiency virus [HIV] infection. Note: HbsAg negative, HBcAb positive, HBsAb positive participants will be eligible if HBV DNA is negative on reflex testing.
• Impaired kidney function, defined as serum creatinine-based eGFR < 30 mL/min/1.73 m2 at screening (and confirmed by repeat test, if deemed necessary), or renal disease associated with clinically meaningful proteinuria or interstitial nephritis.
• Any of the following abnormalities in clinical laboratory tests at screening and confirmed by repeat test, if deemed necessary:
  • Hemoglobin < 10 g/dL (100 g/L);
  • Platelet count < 100 x 109 /L (< 100,000/mm3 );
  • Absolute neutrophil count (ANC) < 1.5 x 109 /L (< 1500/mm3 );
  • Absolute lymphocyte count (ALC) < 0.75 x 109 /L (< 750/mm3 );
  • AST or ALT values > 3 × upper limit of normal (ULN);
  • Total bilirubin > 1.5 × 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 < ULN;
  • CK > 3 x ULN.
• Have had significant trauma, invasive surgery, or blood transfusion within 8 weeks prior to baseline (Day 1/Visit 2) or scheduled to occur during the study, unless approved by the medical monitor.
• History of alcohol or drug abuse, in the investigator’s opinion, unless in full remission for greater than 12 months prior to baseline (Day 1/Visit 2).
• Women who are breastfeeding, pregnant, or planning to become pregnant, or WOCBP who are unwilling to apply a highly effective birth control method for the time periods specified in Contraception Guidance for WOCBP in Appendix 3 during the study, and up to 28 days after the last dose of IMP. Note: Postmenopausal women must be amenorrheic for ≥ 1 year prior to screening AND require confirmation of elevated follicle-stimulating hormone (FSH) levels in the postmenopausal range in order to be considered as not having childbearing potential.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Priovant Therapeutics, Inc. or affiliate employees, including their family members, directly involved in the conduct of the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/04/2024. Questions regarding updates should be directed to the study team contact.