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NCT05039619RecruitingPhase 2

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

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)

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
1 Sept 2021
Start date
12 May 2022
Primary completion date
15 Jun 2028
Lead sponsor
Hoffmann-La Roche
Diseases
Lupus (SLE)
NCT number
NCT05039619
EU CT number
2023-505825-15-00
EudraCT number
2021-000097-29

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 12 May 2022 to the primary completion date, 15 Jun 2028
  • 42 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation

Other illness

  • Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
  • Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions
  • 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
  • Currently active alcohol or drug abuse or history of alcohol or drug abuse

Other

  • Sclerosis in \>50% of glomeruli on renal biopsy
  • Presence of rapidly progressive glomerulonephritis
  • Pure Class V LN

Who the study is looking for

  • 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.

Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Pesquisa Sao Lucas
Coordinator of this site? Confirm its status
CampinasBrazilRecruiting
Hospital Universitário Onofre Lopes - UFRN
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PetrópolisBrazilRecruiting
Instituto de Ensino da Saude e Gestao - IESG
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SalvadoBrazilRecruiting
Ser Servicos Especializados Em Reumatologia
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SalvadorBrazilRecruiting
Universidade Federal de Sao Paulo - UNIFES
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São PauloBrazilActive, not recruiting
Hospital das Clinicas FMUSP
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São PauloBrazilRecruiting
Hospital Sainte-Justine
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MontrealCanadaRecruiting
The Hospital for Sick Children
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TorontoCanadaRecruiting
Hospital Sant Joan De Deu Barcelona
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Esplugues de LlobregatSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Royal Hospital for Children
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GlasgowUnited KingdomWithdrawn
Alder Hey Childrens Hospital
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LiverpoolUnited KingdomRecruiting
Great Ormond Street Hospital for Children
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LondonUnited KingdomRecruiting
IRCCS Istituto Giannina Gaslini
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GenoaItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Ospedale Pediatrico Bambino Gesù
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RomeItalyRecruiting
CREA Hospital Mexico Americano
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GuadalajaraMexicoRecruiting
Clinstile, S.A. de C.V.
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Mexico CityMexicoRecruiting
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoRecruiting
Instituto de Ginecología y Reproducción
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LimaPeruActive, not recruiting
Clinica El Golf
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San IsidroPeruActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Saint-Petersburg State
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St-peterburgRussiaWithdrawn
Emory Children's Center
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AtlantaUnited StatesRecruiting
Children's Hospital Colorado, Anchutz Medical Campus
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AuroraUnited StatesRecruiting
Cincinnati Childrens Hospital
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CincinnatiUnited StatesRecruiting
Texas Arthritis Center
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El PasoUnited StatesWithdrawn
Hackensack University Medical Center
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HackensackUnited StatesRecruiting
Indiana University Health University Hospital
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IndianapolisUnited StatesRecruiting
Loma Linda University Health
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Loma LindaUnited StatesRecruiting
Chldren?s Hospital of Philadelphia
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PhiladelphiaUnited StatesWithdrawn
Cohen Children's Medical Center of New York
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QueensUnited StatesRecruiting
UCSF Benioff Childrens Hospital
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San FranciscoUnited StatesRecruiting
Louisiana State University
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ShreveportUnited StatesRecruiting
Red Cross War Memorial Children?s Hospital
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Cape TownSouth AfricaWithdrawn
Groote Schuur Hospital
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Cape TownSouth AfricaWithdrawn
Panaroma Medical Center
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PanoramaSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.