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
Sites (42)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Hospital Universitário Onofre Lopes - UFRN Coordinator of this site? Confirm its status | Petrópolis | Brazil | Recruiting |
| Instituto de Ensino da Saude e Gestao - IESG Coordinator of this site? Confirm its status | Salvado | Brazil | Recruiting |
| Ser Servicos Especializados Em Reumatologia Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Universidade Federal de Sao Paulo - UNIFES Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| Hospital das Clinicas FMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hospital Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Royal Hospital for Children Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Withdrawn |
| Alder Hey Childrens Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| Great Ormond Street Hospital for Children Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| CREA Hospital Mexico Americano Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Clinstile, S.A. de C.V. Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
| Hospital Universitario Dr. Jose Eleuterio González Coordinator of this site? Confirm its status | Monterrey | Mexico | Recruiting |
| Instituto de Ginecología y Reproducción Coordinator of this site? Confirm its status | Lima | Peru | Active, not recruiting |
| Clinica El Golf Coordinator of this site? Confirm its status | San Isidro | Peru | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Saint-Petersburg State Coordinator of this site? Confirm its status | St-peterburg | Russia | Withdrawn |
| Emory Children's Center Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Children's Hospital Colorado, Anchutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Cincinnati Childrens Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Texas Arthritis Center Coordinator of this site? Confirm its status | El Paso | United States | Withdrawn |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Indiana University Health University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Loma Linda University Health Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
| Chldren?s Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Withdrawn |
| Cohen Children's Medical Center of New York Coordinator of this site? Confirm its status | Queens | United States | Recruiting |
| UCSF Benioff Childrens Hospital Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Louisiana State University Coordinator of this site? Confirm its status | Shreveport | United States | Recruiting |
| Red Cross War Memorial Children?s Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Withdrawn |
| Groote Schuur Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Withdrawn |
| Panaroma Medical Center Coordinator of this site? Confirm its status | Panorama | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.