A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized Double-Blind Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Cutaneous Lupus Erythematosus
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information
    2. Participant must be = 18 years of age at the time of signing the consent
    3. All women of childbearing potential must practice effective contraception during the study treatment period and for 126 days after their last dose of study treatment.
      • In addition, participants should not donate eggs during the study treatment period and for at least 126 days after their last dose of study treatment.
      - Postmenopausal status must be confirmed as follows:
      • Women = 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause
      • Women > 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause, or at least 5 continuous years of natural (spontaneous) amenorrhea without an alternative medical cause
    4. Must have a histologically confirmed (in the past or at Screening) diagnosis of CLE with or without systemic manifestations. For participants without historical biopsy data, a skin biopsy must be performed from an active CLE lesion at Screening to confirm CLE diagnosis prior to randomization
    5. Must have an active CLE lesion despite an adequate trial of antimalarial treatment. One of the 2 conditions should be met:
      • antimalarial agents used for at least 12 weeks (either continuous or cumulative) prior to Screening
      • OR
      • previously documented discontinuation of antimalarial agents due to poor tolerability and/or side effects, and/or lack of therapeutic effect for at least 12 weeks of treatment (and not continuous is acceptable)

You may not be eligible for this study if the following are true:

    1. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered. A washout period will be required prior to randomization.
      Participation in observational registries will be allowed.

    2. Medical History and Current Health Status
    3. History or positive test result at Screening for HIV
    4. Current hepatitis C infection. Participants with positive HCV antibody and undetectable HCV RNA are eligible to participate in the study
      NOTE: Eligible participants with risk for HCV exposure can be tested every 6 months during the study at the discretion of the Investigator
    5. Current hepatitis B virus infection. Participants with the following immune profiles according to United States Centers for Disease Control and Prevention are eligible to participate in the study:
      • Immunity to hepatitis B from previous natural infection
      • Previous vaccination
    6. History of chronic, recurrent (3 or more of the same type of infection in a 52-week period), or recent serious infection (e.g., pneumonia, septicemia) including viral infections, or requiring anti-infective treatment within the 12 weeks prior to Screening
    7. History of severe herpes infection, such as herpetic encephalitis, ophthalmic herpes, or disseminated herpes.
    8. Signs of herpes or varicella zoster viral infection (specifically chicken pox, shingles, or herpes zoster) within 12 weeks prior to Screening
    9. Previous positive SARS-CoV-2 test (within 14 days prior to Screening)
    10. History of or current diagnosis of active TB or untreated LTBI
    11. NOTE: Participants with current household contacts with active TB will be excluded, unless the participant is being treated and there is evidence that household contacts are being treated.
    12. Presence of uncontrolled class III or IV congestive heart failure
    13. History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies with the exception of basal cell carcinomas of the skin, squamous cell carcinomas of the skin, and carcinoma in situ of the cervix that have been completely excised and considered cured for > 2 years prior to Screening. For cervical neoplasia, based on the classification used locally, participants with CIN grades 2 or 3; or low-grade squamous intraepithelial lesion or high-grade squamous intraepithelial lesion; as well as participants with a medical history of positive results for high-risk types of human papilloma virus will be excluded.
    14. Any active skin conditions other than CLE that may interfere with the study assessments of CLE such as but not limited to psoriasis, non-LE alopecia areata, non-LE skin lupus manifestation (e.g., cutaneous vascular disease, periungual telangiectasia, sclerodactyly, rheumatoid nodules, erythema multiform, leg ulcers) or drug-induced lupus.
    15. History or current diagnosis of any other systemic autoimmune disease other than secondary Sjögren’s syndrome, such as but not limited to rheumatoid arthritis, psoriatic arthritis, dermatomyositis, systemic sclerosis (scleroderma), clinically significant nonSLE related vasculitis syndrome
    16. Active severe lupus nephritis
    17. Active neuropsychiatric SLE including, but not limited to, the following: seizure, new or worsening impaired level of consciousness, psychosis, delirium or confusional state, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, or mononeuritis multiplex
    18. History of suicide attempt or suicidal ideation within 1 year prior to Screening.
    19. History of substance abuse (except for cannabinoid) within 6 months prior to Screening

    20. Medications
    21. Use of antimalarial agents that were initiated less than 12 weeks prior to randomization, have not been at a stable dose for at least 30 days prior to randomization, or have been taken during the 12 weeks prior to randomization at doses above the prescribed maximum listed here (hydroxychloroquine 400 mg/day, quinacrine 100 mg/day, or chloroquine 250 mg/day). If receiving an antimalarial agent at Screening, the participant must be on a stable dose from Screening to the end of treatment (Week 52).
    22. Use of high-potency topical corticosteroids for skin lesions within 1 week prior to randomization and during the study
    23. Use of topical immunosuppressants (including tacrolimus, pimecrolimus, sirolimus, high-potency intralesional corticosteroids) within 30 days prior to randomization and during the study
    24. Use of immunosuppressive or disease-modifying treatments for SLE or CLE (via an oral, IV, or SC route) that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose for at least 30 days prior to randomization, or have been taken during the last 12 weeks prior to randomization at doses above the prescribed maximum listed here (medication list includes, but is not limited to the following:
      • dapsone 150 mg/day
      • azathioprine 200 mg/day
      • 6-mercaptopurine 100 mg/day
      • mycophenolate [either as MMF 3000 mg/day or MPS 2160 mg/day]
      • methotrexate 25 mg/week
    25. Use of cyclosporine or voclosporin within 12 weeks or 5 half-lives (whichever is longer) prior to randomization and during the study.
    26. Use of cyclophosphamide or mizoribine within 24 weeks or 5 half-lives (whichever is longer) prior to randomization and during the study
    27. Use of thalidomide or lenalidomide within12 weeks prior to randomization and during the study
    28. Use of leflunomide within 24 weeks prior to randomization and during the study
    29. Use of pomalidomide within 12 weeks prior to randomization and during the study
    30. Use of IV or SC immunoglobulin or plasmapheresis within 12 weeks prior to randomization and during the study
    31. Use of minocycline within 8 weeks prior to randomization and during the study
    32. Use of intra-articular corticosteroids within 12 weeks prior to randomization and during the study
    33. Use of oral systemic corticosteroid treatment at a dose exceeding 15 mg/day of prednisone (or its equivalent), or if any dose of prednisone (or its equivalent) has not been stable for =4 weeks prior to randomization
    34. Use of IV or IM corticosteroids within 12 weeks prior to randomization and during the study
    35. Use of biologic disease-modifying agents, including but not limited to the following:
      • Abatacept, belimumab, eculizumab, sarilumab, tocilizumab, or TNF inhibitors within 16 weeks or 5 half-lives (whichever is longer) prior to randomization and during the study; OR
      • Atacicept or telitacicept within 24 weeks prior to randomization and during the study; OR
      • Vedolizumab, natalizumab within 24 weeks prior to randomization and during the study; OR
      • Ustekinumab within 24 weeks prior to randomization and during the study; OR
      • Rituximab, ocrelizumab, ofatumumab, obinutuzumab, veltuzumab, or other Bcell-directed biologic therapies within 24 weeks prior to randomization and during the study.
    36. Previous treatment with an investigational or approved agent that inhibits the IFN-1 pathway.
    37. Use of Janus kinase inhibitors, including but not limited to tofacitinib, baricitinib, or upadacitinib; use of Bruton tyrosine kinase inhibitors, including but not limited to evobrutinib or fenebrutinib; or use of tyrosine kinase inhibitors, including but not limited to deucravacitinib, within 8 weeks prior to randomization and during the study.
    38. Use of sphingosine-1-phosphate receptor modulators including but not limited to cenerimod within 16 weeks or 5 half-lives, whichever is longer, prior to randomization and during the study.
    39. Use of any investigational therapy not mentioned in the preceding criteria within 24 weeks or 5 half-lives (whichever is longer) and contact Medical Monitor prior to Screening.
    40. History of known hypersensitivity reaction to BIIB059 or any components of the formulated BIIB059 or matching placebo.
    41. Previous use of BIIB059 in clinical studies, with the exception of those participants who received placebo.
    42. Immunization with live or live-attenuated vaccines within 8 weeks prior to randomization and throughout the study, and for 24 weeks after the last dose of study treatment.
    43. Hormone replacement therapy initiated within 8 weeks prior to randomization or during the study.

    44. Other
    45. Major surgery within 12 weeks prior to Screening
    46. Plan to undergo elective procedures, or medical procedures (e.g., invasive diagnostic procedures, such as arthroscopy), major surgical procedures, or acupuncture at any time after signing the ICF until the last SFU Visit
    47. Female participants who are pregnant, currently breastfeeding, or planning to become pregnant during the study treatment period and for 126 days after the last dose of study treatment.
    48. Participation of site staff and their immediate family members.
    49. Participation of Sponsor employees or representatives of third-party organizations involved with the study.
    50. Inability to comply with study requirements.



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