A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: GDC-0853; Placebo
Intervention description: Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.; Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard
      of care therapy in participants with moderate to severe active systemic lupus erythematosus
      (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fulfillment of SLE classification criteria according to either American College of
             Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC)
             criteria at any time prior to or at screening

          -  At least one serologic marker of SLE at screening as follows: positive antinuclear
             antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive
             anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody

          -  At both screening and Day 1, moderate to severe active SLE, defined as meeting all of
             the following unless indicated otherwise: Systemic Lupus Erythematosus Disease
             Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K
             score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0
             (out of 3), and currently receiving at least one standard oral treatment for SLE

          -  If on oral corticosteroids (OCS), the dose must be </= 40 mg/day prednisone (or
             equivalent)

          -  Stable doses of anti-malarial or immunosuppressive therapies

          -  Participants must be willing to avoid pregnancy

        Exclusion Criteria:

          -  Proteinuria > 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR)
             in a first morning void urine sample

          -  Active proliferative lupus nephritis (as assessed by the investigator) or histological
             evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in
             the 6 months prior to screening (or during the screening period)

          -  History of having required hemodialysis or high dose corticosteroids (>100 mg/d)
             prednisone or equivalent) for the management of lupus renal disease within 90 days of
             Day 1

          -  Neuropsychiatric or central nervous system lupus manifestations

          -  Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter
             per minute (mL/min) or on chronic renal replacement therapy

          -  History of receiving a solid organ transplant

          -  Evidence of active, latent, or inadequately treated infection with Mycobacterium
             tuberculosis (TB)

          -  Significant and uncontrolled medical disease within the 12 weeks prior to screening in
             any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine,
             metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the
             investigator's or Sponsor's opinion, would preclude study participation

          -  History of cancer, including hematological malignancy and solid tumors, within 10
             years of screening

          -  Need for systemic anticoagulation with warfarin, other oral or injectable
             anticoagulants, or anti-platelet agents

          -  Evidence of chronic and/or active hepatitis B or C