Evaluating Obinutuzumab for Lupus Nephritis in Adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Loma Linda University health
  Loma Linda, California, United States Recruiting
• UCSF Benioff Childrens Hospital
  San Francisco, California, United States Recruiting
• Children's Hospital Colorado, Anchutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Emory Children's Center
  Atlanta, Georgia, United States Recruiting
• Indiana University Health University Hospital
  Indianapolis, Indiana, United States Recruiting
• Louisiana State University
  Shreveport, Louisiana, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below.
• Email: global.rochegenentechtrials@roche.com
• Phone: 888-662-6728 (U.S. and Canada)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• LUPKYNIS in combination with belimumab, obinutuzumab, or anifrolumab for lupus nephritis

  This trial tests whether adding LUPKYNIS to other biologics (belimumab, obinutuzumab, or anifrolumab) plus a mycophenolic acid analog and a steroid can rapidly improve kidney health in adults with biopsy-proven lupus nephritis.

  Recruiting at 27 sites Phase 4 Aurinia Pharmaceuticals Inc. · La Mesa, California and 26 other locations · NCT07611214

• Comparing treatments for lupus nephritis without added oral steroids

  This study is testing whether a treatment for lupus nephritis using obinutuzumab and mycophenolate mofetil without steroids can work just as well as a treatment that includes steroids.

  Recruiting Phase 3 Assistance Publique - Hôpitaux de Paris · Paris · NCT04702256

• TranspoCART19 CAR-T therapy in adults with refractory lupus nephritis

  This trial tests whether a patient’s own CD19 CAR-T cells can be safely given and potentially help adults with lupus nephritis that isn’t responding to standard treatments.

  Recruiting Phase 1/2 Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Badalona, Barcelona and 7 other locations · NCT07799116

• Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis

  This trial tests whether adding voclosporin to standard lupus nephritis treatment (MMF and prednisolone) early on improves kidney inflammation compared to standard therapy alone.

  Recruiting Phase 4 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam · NCT07760480

• Obinutuzumab beta with low-dose steroids in new-onset ANCA-associated glomerulonephritis

  This study tests whether adding Obinutuzumab beta to a rapid-tapering glucocorticoid plan can help people with new-onset ANCA-associated glomerulonephritis see if they achieve remission.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing · NCT07746180

• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

  This trial tests whether a combo of orelabrutinib, obinutuzumab, and a short course of venetoclax is safe and effective for adults with newly diagnosed mantle cell lymphoma.

  Recruiting at 2 sites Phase 2 The First Affiliated Hospital with Nanjing Medical University · Changzhou, Jiangsu and 1 other locations · NCT07719556

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.