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Purpose

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease - Urine protein to creatinine ratio greater than or equal to (>/=) 1 on a 24-hour collection - Other inclusion criteria may apply

Exclusion Criteria

  • Pregnancy or breastfeeding - Severe renal impairment or the need for dialysis or renal transplantation - Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening - Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation - Known active infection of any kind or recent major episode of infection - Intolerance or contraindication to study therapies - Other exclusion criteria may apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Obinutuzumab 		Participants will be randomized into 2 groups. Group 1 will receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Group 2 receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, and 52 plus MMF and oral prednisone. Group 2 participants will receive a placebo infusion at their Week 50 visit. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.
  • Drug: Obinutuzumab
    Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
    Other names:
    • Gazyva, GA101, RO5072759
  • Drug: MMF
    MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
  • Drug: Prednisone
    Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
  • Drug: Methylprednisolone
    Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
  • Drug: Acetaminophen
    Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
  • Drug: Diphenhydramine
    Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Placebo Comparator
Placebo 		Placebo participants will receive obinutuzumab matched placebo at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.
  • Drug: Obinutuzumab
    Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
    Other names:
    • Gazyva, GA101, RO5072759
  • Drug: MMF
    MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
  • Drug: Prednisone
    Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
  • Drug: Placebo
    Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.
  • Drug: Methylprednisolone
    Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
  • Drug: Acetaminophen
    Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
  • Drug: Diphenhydramine
    Diphenhydramine 50 mg will be administered as premedication prior to infusions.

More Details

Status
Active, not recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.