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Corticosteroid
Mycophenolate Mofetil/Mycophenolic Acid for Lupus Nephritis
Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), weeks 4, 12, 24, 36, 52
Awards & highlights
Study Summary
This trial will compare the effectiveness and safety of a combination of drugs including obinutuzumab with mycophenolate mofetil/mycophenolic acid, to a placebo combined with mycophenolate mofetil/mycophenolic acid, in people with proliferative lupus nephritis.
Eligible Conditions
- Lupus Nephritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1), weeks 4, 12, 24, 36, 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), weeks 4, 12, 24, 36, 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52
Secondary outcome measures
Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab
Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52
Change From Baseline in C4 Levels at Week 52
+18 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ObinutuzumabExperimental Treatment4 Interventions
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
Group II: PlaceboPlacebo Group4 Interventions
Participants will receive placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil/Mycophenolic Acid
2015
Completed Phase 2
~130
Obinutuzumab
2015
Completed Phase 3
~3250
Methylprednisolone
2015
Completed Phase 4
~2280
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,266 Total Patients Enrolled
5 Trials studying Lupus Nephritis
730 Patients Enrolled for Lupus Nephritis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,910 Total Patients Enrolled
6 Trials studying Lupus Nephritis
1,111 Patients Enrolled for Lupus Nephritis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious medical condition that could cause dangerous bleeding or organ problems, and may need treatments like plasmapheresis or blood transfusions.You have certain eye, brain, or nervous system conditions that are not well controlled, including seizures, confusion, inflammation of the spinal cord, stroke, difficulty with balance, or ongoing memory problems caused by lupus.You have received cyclophosphamide or calcineurin inhibitors in the past 3 months before the study.You have previously had a bad reaction to MMF or MPA medication.You have received a specific type of treatment that targets B-cells, other than anti-CD20, within the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Obinutuzumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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