A study to compare different doses of fenebrutinib with a “placebo” – in patients with lupus

Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

  • Autoimmune Disorder
  • Systemic Lupus Erythematosus
Please note that the recruitment status of the trial at your site may differ.
Trial Status:

Completed

This trial runs in
Countries
  • Argentina
  • Brazil
  • Bulgaria
  • Chile
  • Colombia
  • Germany
  • Mexico
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom
  • United States
Trial Identifier:

NCT02908100 2016-001039-11 GA30044

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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).

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT02908100,GA30044,2016-001039-11 Trial Identifier
      All Gender
      ≥ 18 Years & ≤ 75 Years Age
      No Healthy Volunteers

      Researchers wanted to find out what effect, good or bad, fenebrutinib caused in comparison to a placebo, in patients with systemic lupus erythematosus (lupus). A computer randomly decided which patients joined one of two fenebrutinib dose groups and which patients joined the placebo group. This was a double-blind study where patients and researchers did not know which of the 3 groups each patient belonged to.  

      Trial 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).

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT02908100,GA30044,2016-001039-11 Trial Identifier
      GDC-0853 (high dose), GDC-0853 (low dose), Placebo Treatments
      Systemic Lupus Erythematosus Condition
      Official Title

      A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      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

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