Recruiting
Phase 2

Obinutuzumab

Sponsor:

Hoffmann-La Roche

Code:

NCT05039619

Conditions

Lupus Nephritis

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Obinutuzumab

Placebo

Mycophenolate Mofetil

Acetaminophen/paracetamol

Diphenhydramine hydrochloride (HCl)

Study Details

Brief summary:

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.

Conditions

Lupus Nephritis

Study ID

NCT05039619

Start date

May 12, 2022

Status verified date

Sep, 2026

Completion date

Jun 14, 2030

Anticipated

Primary completion date

Jun 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants who are age 12 to <18 years at the time of randomization
  • Participants who are age 5 to <12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)
  • International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening
  • Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
  • Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria
  • Significant proteinuria defined by a UPCR above > 0.5 based on a first-morning void (FMV) collection at screening
  • During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.

Exclusion Criteria:

  • Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
  • Sclerosis in >50% of glomeruli on renal biopsy
  • Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions
  • Presence of rapidly progressive glomerulonephritis
  • Pure Class V LN
  • Intolerance or contraindication to study therapies
  • Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization
  • History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders
  • History of serious recurrent or chronic infection
  • History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years
  • Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation
  • Currently active alcohol or drug abuse or history of alcohol or drug abuse

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blinded Obinutuzumab

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).

placebo comparator: Placebo

Placebo participants will receive obinutuzumab matched placebo on Day 1, Day 14, Week 24, Week 26 and Week 52.

experimental: Open-Label Obinutuzumab

Younger participants aged 5 to <12 will receive obinutuzumab 1000 mg IV infusions on Days 1, 14, Week 24, Week 26 and Week 52.

Interventions

Obinutuzumab

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.

Placebo

Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.

Mycophenolate Mofetil

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.

Acetaminophen/paracetamol

Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.

Diphenhydramine hydrochloride (HCl)

Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.

Methylprednisolone

Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.

Prednisone

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.

Primary outcome measure

  • Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP) [ Time Frame: Week 76 ]
  • Percentage of Participants with Adverse Events (PP) [ Time Frame: Baseline to Week 76 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)global.rochegenentechtrials@roche.com

Locations

Loma Linda University health

Recruiting

Loma Linda, California, United States, 92354

UCSF Benioff Childrens Hospital

Recruiting

San Francisco, California, United States, 94158

Children's Hospital Colorado, Anchutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Emory Children's Center

Recruiting

Atlanta, Georgia, United States, 30322

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Louisiana State University

Recruiting

Shreveport, Louisiana, United States, 71103

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Cohen Children's Medical Center of New York

Recruiting

Queens, New York, United States, 11042

Cincinnati Childrens Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Hospital Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.