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

  • STATUS
    Recruiting
  • End date
    Mar 13, 2027
  • participants needed
    30
  • sponsor
    Hoffmann-La Roche
Updated on 10 July 2022
prednisone
diphenhydramine
proteinuria
mycophenolate
mammogram
nephritis

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).

Details
Condition Lupus Nephritis
Treatment mycophenolate mofetil, prednisone, Placebo, Methylprednisolone, Obinutuzumab, Acetaminophen/Paracetamol, Diphenhydramine hydrochloride (HCl)
Clinical Study IdentifierNCT05039619
SponsorHoffmann-La Roche
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

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
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