Overview

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis

Status:
Recruiting
Trial end date:
2027-03-31
Target enrollment:
0
Participant gender:
All
Summary
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics of obinutuzumab in adolescent participants aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborator:
Genentech, Inc.
Treatments:
Acetaminophen
Diphenhydramine
Methylprednisolone
Mycophenolic Acid
Obinutuzumab
Prednisone
Promethazine
Criteria
Inclusion Criteria:

- 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