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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT05039619

Registry updated: 2026-10-06
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Description

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.

Interventions

  • Obinutuzumab (Drug)
    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 (Drug)
    Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.
  • Mycophenolate Mofetil (Drug)
    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 (Drug)
    Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.
  • Diphenhydramine hydrochloride (HCl) (Drug)
    Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.
  • Methylprednisolone (Drug)
    Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.
  • Prednisone (Drug)
    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.

Eligibility 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

Conditions

Lupus Nephritis

Locations

  • Loma Linda University health — Loma Linda, California, United States
  • UCSF Benioff Childrens Hospital — San Francisco, California, United States
  • Children's Hospital Colorado, Anchutz Medical Campus — Aurora, Colorado, United States
  • Emory Children's Center — Atlanta, Georgia, United States
  • Indiana University Health University Hospital — Indianapolis, Indiana, United States
  • Louisiana State University — Shreveport, Louisiana, United States
  • Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Cohen Children's Medical Center of New York — Queens, New York, United States
  • Cincinnati Childrens Hospital — Cincinnati, Ohio, United States
  • Chldren?s Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
  • Texas Arthritis Center — El Paso, Texas, United States
  • Ser Servicos Especializados Em Reumatologia — Salvador, Estado de Bahia, Brazil
  • Instituto de Ensino da Saude e Gestao - IESG — Salvado, Estado de Bahia, Brazil
  • Hospital Universitário Onofre Lopes - UFRN — Petrópolis, Rio Grande do Norte, Brazil
  • Centro de Pesquisa São Lucas — Campinas, São Paulo, Brazil
  • Hospital das Clinicas - FMUSP — São Paulo, São Paulo, Brazil
  • Universidade Federal de Sao Paulo - UNIFES — São Paulo, Brazil
  • The Hospital for Sick Children — Toronto, Ontario, Canada
  • Hospital Sainte-Justine — Montreal, Quebec, Canada
  • CH de Bicêtre — Le Kremlin-Bicêtre, France
  • Hôpital Robert Debré — Paris, France
  • Hop Necker Enfants Malades — Paris, France
  • CHU de Toulouse - Hôpital des Enfants — Toulouse, France
  • Ospedale Pediatrico Bambino Gesu — Rome, Lazio, Italy
  • IRCCS G. Gaslini — Genoa, Liguria, Italy
  • Clinica Pediatrica II De Marchi — Milan, Lombardy, Italy
  • CREA Hospital Mexico Americano — Guadalajara, Jalisco, Mexico
  • Clinstile S.A de C.V. — Mexico City, Mexico CITY (federal District), Mexico
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez — Monterrey, Nuevo León, Mexico
  • Instituto de Ginecología y Reproducción — Lima, Peru
  • Clinica El Golf — San Isidro, Peru
  • Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
  • Szpital Specjalistyczny dla Dzieci i Doroslych — Torun, Poland
  • Saint-Petersburg State — St-peterburg, Sankt-Peterburg, Russia
  • Red Cross War Memorial Children?s Hospital — Cape Town, South Africa
  • Groote Schuur Hospital — Cape Town, South Africa
  • Panaroma Medical Center — Panorama, South Africa
  • Hospital Sant Joan De Deu — Esplugas de Llobregat, Barcelona, Spain
  • Hospital Ramon y Cajal — Madrid, Spain
  • Hospital de La Paz — Madrid, Spain
  • Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica — Valencia, Spain
  • Royal Hospital For Children — Glasgow, United Kingdom
  • Alder Hey Childrens Hospital — Liverpool, United Kingdom
  • Great Ormond Street Hospital for Children — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record