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Evaluating Obinutuzumab for Lupus Nephritis in Adolescents

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to < 12)

Phase 2 Interventional Hoffmann-La Roche · NCT05039619

This study is testing if a medication called obinutuzumab can help teenagers with lupus nephritis feel better and improve their kidney health.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment40 (estimated)
Ages5 Years to 17 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsobinutuzumab
Locations42 sites (Loma Linda, California and 41 other locations)
Trial IDNCT05039619 on ClinicalTrials.gov

What this trial studies

This phase II, randomized, double-blind, placebo-controlled study aims to assess the safety, efficacy, and pharmacokinetics of obinutuzumab in adolescents aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis. Additionally, it will evaluate the open-label safety and pharmacokinetics of obinutuzumab in younger pediatric participants aged 5 to less than 12 once recruitment for this cohort is open. The study involves administering obinutuzumab, placebo, and other supportive medications to determine their effects on the condition.

Who should consider this trial

Good fit: Ideal candidates include adolescents aged 12 to less than 18 with active Class III or IV lupus nephritis, as well as younger children aged 5 to less than 12 once recruitment opens.

Not a fit: Patients with isolated Class V lupus nephritis or those not meeting the specific inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for adolescents suffering from lupus nephritis.

How similar studies have performed: Other studies have shown promise in treating lupus nephritis with similar biologic therapies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Loma Linda, California and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus Nephritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.