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A Study to Evaluate the Safety and Efficacy of Obinutuzumab, an Antibody Targeting Certain Types of Immune Cells, in Participants With Lupus Nephritis (LN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02550652
First received: September 14, 2015
Last updated: October 3, 2016
Last verified: October 2016
  Purpose
This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate (MMF) with placebo plus MMF in Class III and IV patients with proliferative Lupus Nephritis (LN).

Condition Intervention Phase
Lupus Nephritis
Drug: Mycophenolate Mofetil
Drug: Obinutuzumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Subjects With ISN/RPS 2003 Class III or IV Lupus Nephritis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants who Achieve Complete Renal Response (CRR) [ Time Frame: Week 52 ]

Secondary Outcome Measures:
  • Percentage of Participants who Achieve a Modified CRR (mCRR1) [ Time Frame: Week 52 ]
  • Percentage of Participants who Achieve a Second mCRR (mCRR2) [ Time Frame: Week 52 ]
  • Change in Patient's Global Assessment From Baseline to Week 52 [ Time Frame: Baseline to Week 52 ]
  • Peripheral Blood CD19-positive B-cell Count [ Time Frame: Up to approximately 24 months ]
  • Percentage of Participants who Achieve Overall Response [ Time Frame: Week 52 ]
  • Time to First Overall Response Over the Course of 52 weeks [ Time Frame: Baseline (Day 1) to Week 52 ]
  • Percentage of Participants who Achieve Partial Renal Response (PRR) [ Time Frame: Week 52 ]
  • Percentage of Participants who Achieve CRR [ Time Frame: Week 24 ]
  • Time to CRR Over the Course of 52 Weeks [ Time Frame: Baseline (Day 1) to Week 52 ]
  • Percent Change From Baseline in Biomarkers of LN Disease Activity [ Time Frame: Baseline to 104 Week ]

Estimated Enrollment: 120
Study Start Date: November 2015
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obinutuzumab
Participants will receive obinutuzumab 1000 milligram (mg) intravenous (IV) infusion on Day 1, 15, 168, and 182 along with MMF at a starting dose of 500 mg/day administered orally in 2 or 3 divided doses. MMF dose will be up titrated based on tolerability to a maximum dose of 2.5 gram/day (g/day).
Drug: Mycophenolate Mofetil Drug: Obinutuzumab
Participants will receive obinutuzumab 1000 milligram (mg) intravenous (IV) infusion on Day 1, 15, 168, and 182 along with MMF at a starting dose of 500 mg/day administered orally in 2 or 3 divided doses. MMF dose will be up titrated based on tolerability to a maximum dose of 2.5 gram/day (g/day).
Other Name: GA101;RO5072759
Placebo Comparator: Placebo
Participants will receive placebo matched to obinutuzumab IV infusion on Day 1, 15, 168, and 182 along with MMF at a starting dose of 500 mg/day administered orally in 2 or 3 divided doses. MMF dose will be up titrated based on tolerability to a maximum dose of 2.5 g/day.
Drug: Mycophenolate Mofetil Drug: Placebo
Participants will receive placebo matched to obinutuzumab IV infusion on Day 1, 15, 168, and 182 along with MMF at a starting dose of 500 mg/day administered orally in 2 or 3 divided doses. MMF dose will be up titrated based on tolerability to a maximum dose of 2.5 g/day.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of systemic lupus erythematosus (SLE), according to current American College of Rheumatology criteria
  • Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior to screening. Patients may co-exhibit Class V disease in addition to either Class III or Class IV disease.
  • Patients must demonstrate active urinary sediment as evidenced by >=10 red blood cells/high power field or the presence of red cell casts.
  • Proteinuria (urine protein to creatinine ratio) >1.0
  • For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 18 months after the last dose of study drug
  • For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period

Exclusion Criteria:

  • Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE
  • Presence of rapidly progressive glomerulonephritis
  • Severe renal impairment as defined by estimated glomerular filtration rate (GFR) <30 milliliter per minute or the need for dialysis or renal transplant
  • Greater than 50% of glomeruli with sclerosis on renal biopsy
  • Treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to randomization
  • Unstable disease with thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion
  • Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude patient participation
  • Concomitant chronic conditions, excluding SLE, (e.g., asthma, Crohn's disease) that required oral or systemic steroid use in the 52 weeks prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02550652

Contacts
Contact: Reference Study ID Number: WA29748 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 61 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02550652     History of Changes
Other Study ID Numbers: WA29748  2015-002022-39 
Study First Received: September 14, 2015
Last Updated: October 3, 2016

Additional relevant MeSH terms:
Lupus Nephritis
Lupus Erythematosus, Systemic
Obinutuzumab
Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 20, 2017