Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus; Active Cutaneous Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Intervention: BIIB059 (litifilimab); Placebo
Intervention description: Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus

Summary:

      The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in
      reducing disease activity in participants with systemic lupus erythematosus (SLE) with active
      cutaneous manifestations and joint involvement (Part A), and in participants with active
      cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic
      CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations
      (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in
      reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of
      BIIB059 (Parts A and B).
    

Eligibility criteria:

        Key Inclusion Criteria:

        Part A:

          1. Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the
             1997 revised American College of Rheumatology (ACR) classification criteria for SLE
             along with active skin manifestations and joint involvement.

          2. At least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen
             joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints
             and/or wrist.

          3. Demonstrate at least one sign of active lupus skin disease, including acute cutaneous
             lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or
             chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus
             (DLE)), with skin activity defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at
             the time of Screening and randomization.

        Part B:

        1. Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index
        Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has
        been histologically confirmed (in the past or at Screening), with or without SLE
        manifestations.

        Key Exclusion Criteria:

          1. Active lupus nephritis or moderate-to-severe or chronic kidney disease.

          2. Any active skin conditions other than CLE that may interfere with the study (e.g.,
             psoriasis, non-LE skin lupus, drug-induced lupus).

          3. History of chronic, recurrent (3 or more of the same type of infection in a 12-month
             period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as
             determined by the Investigator and requiring anti-infective treatment within 12 weeks
             prior to Screening.

          4. Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were
             initiated less than 12 weeks prior to Randomization.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply