A Phase 2 interventional study of Obinutuzumab and Placebo in Lupus Nephritis, sponsored by Hoffmann-La Roche. Recruiting at 44 sites in 12 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \<12 with LN.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's planned enrollment of 40 is below the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1, Day 14, Week 24, Week 26 and Week 52. Participants with a body weight of 45 kg or more will receive the 1000 mg dose. Participants with a body weight below 45 kg will receive a weight adjusted dose of 20 mg/kilogram (kg).
Drug: Obinutuzumab · Drug: Mycophenolate Mofetil · Drug: Acetaminophen/paracetamol · Drug: Diphenhydramine hydrochloride (HCl) · Drug: Methylprednisolone · Drug: Prednisone
Placebo participants will receive obinutuzumab matched placebo on Day 1, Day 14, Week 24, Week 26 and Week 52.
Drug: Placebo · Drug: Mycophenolate Mofetil · Drug: Acetaminophen/paracetamol · Drug: Diphenhydramine hydrochloride (HCl) · Drug: Methylprednisolone · Drug: Prednisone
Younger participants aged 5 to \<12 will receive obinutuzumab 1000 mg IV infusions on Days 1, 14, Week 24, Week 26 and Week 52.
Drug: Obinutuzumab · Drug: Mycophenolate Mofetil · Drug: Acetaminophen/paracetamol · Drug: Diphenhydramine hydrochloride (HCl) · Drug: Methylprednisolone · Drug: Prednisone
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.
Also known as: Gazyva
Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.
Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m\^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards.
Drug page: Acetaminophen
Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.
Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.
Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.
Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg/day followed by a guided taper to 5mg/day or less by Week 24.
Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP)
CRR is defined as achievement of all of the following: * Urinary protein-to-creatinine ratio (UPCR) \<0.5 g/g * Estimated Glomerular Filtration Rate (eGFR) \>=85% of baseline * No occurrence of intercurrent events
Time frame: Week 76
Percentage of Participants with Adverse Events (PP)
Time frame: Baseline to Week 76
Percentage of Participants Achieving a CRR (AP)
Time frame: Weeks 24 and 52
Percentage of Participants who Achieve CRR with Successful Prednisone Taper (AP)
Time frame: Week 76
Percentage of Participants who Achieve a PRR (AP)
Time frame: Week 76
Percentage of Participants Achieving an Overall Response (CRR or PRR) (AP)
PRR is defined as: achievement of all of the following: * \>=50% reduction in urinary protein-to-creatinine ratio (UPCR) from baseline * UPCR \< 1 g/g (or \< 3 g/g if the baseline UPCR was \>=3 g/g) * eGFR \>=85% of baseline * No occurrence of intercurrent events
Time frame: Weeks 24, 52, and 76
Change in UPCR (AP)
Time frame: Baseline to Week 76
Change in eGFR (AP)
Time frame: Baseline to Week 76
Time to Onset of CRR over the Course of 76 weeks (AP)
Time frame: Up to Week 76
Percentage of Participants who Experience Treatment Failure (AP)
Time frame: Week 12 to Week 76
Change in anti-dsDNA titers (AP)
Time frame: Baseline to Week 76
Change in C3 Complement Levels (AP)
Time frame: Baseline to Week 76
Change in C4 Complement Levels (AP)
Time frame: Baseline to Week 76
Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 (AP)
Time frame: Baseline to Week 76
Serum Concentrations of Obinutuzumab (AP)
Time frame: Baseline to Week 76
Percentage of Participants Achieving B-cell Depletion (AP)
Time frame: Baseline, Weeks 4, 24, 52 and 76
Change in Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale (PedsQL)-Fatigue Total Score (AP)
Time frame: Baseline to Week 76
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (AP)
Time frame: Baseline to Week 76
Change from Baseline in Child Health Questionnaire-Parent Form 28 (CHQ-PF28) Domain Scores (AP)
Time frame: Baseline to Week 76
Percentage of Participants with Anti-drug Antibodies (ADA) (AP)
Time frame: Weeks 0, 24, 52 and 76
Relationship Between ADA Status and Percentage of Participants Achieving a CRR (AP)
Time frame: Weeks 24, 52 and 76
Percentage of Participants Achieving a CRR (PP)
Time frame: Week 76
Percentage of Participants Achieving an Overall Response (PP)
PRR is defined as achievement of all of the following: * \>=50% reduction in UPCR from baseline * UPCR \< 1 g/g (or \< 3 g/g if the baseline UPCR was \>=3 g/g) * eGFR \>=85% of baseline * No occurrence of intercurrent events
Time frame: Week 76
Percentage of Participants who Achieve CRR with Successful Prednisone Taper (PP)
Time frame: Week 76
Change in eGFR (PP)
Time frame: Baseline to Week 76
Percentage of Participants Achieving B-cell Depletion (PP)
Time frame: Baseline, Weeks 4, 24, 52 and 76
Percentage of Participants with ADAs (PP)
Time frame: Weeks 0, 24, 52 and 76
Change in anti-dsDNA titers (PP)
Time frame: Baseline to Week 76
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Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Obinutuzumab