NCT04221477Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 271 (actual)
- First submitted
- 7 Jan 2020
- Start date
- 10 Aug 2020
- Primary completion date
- 15 Aug 2024
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Lupus (SLE)
- NCT number
- NCT04221477
- EU CT number
- 2023-503628-22-00
- EudraCT number
- 2019-004034-42
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 271
- From 10 Aug 2020 to the primary completion date, 15 Aug 2024
- 70 sites in 15 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
- Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
- Intolerance or contraindication to study therapies
Other illness
- Severe renal impairment or the need for dialysis or renal transplantation
- Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude participant participation
- Known active infection of any kind or recent major episode of infection
Other
- Pregnancy or breastfeeding
- Other exclusion criteria may apply
Who the study is looking for
- Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
- Urine protein to creatinine ratio greater than or equal to (\>/=) 1 on a 24-hour collection
- Other inclusion criteria may apply
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (70)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Organización Médica de Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| DOM Centro de Reumatología Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Sanatorio Allende Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Instituto Pro-Renal Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital das Clinicas - FMUSP Ribeirao Preto Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| Ser Servicos Especializados Em Reumatologia Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Centro Multidisciplinar de Estudos Clínicos - CEMEC*X* Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| Hospital das Clinicas FMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Clinica De La Costa Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| Hospital Universitario San Ignacio Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Hospital Pablo Tobón Uribe Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Staedtisches Klinikum Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Rabin MC- Belinson campus Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sourasky Medical Centre Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| University Hospital Consorziale Policlinico Coordinator of this site? Confirm its status | Bari | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Active, not recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Centro de Investigación y Tratamiento Reumatológico S.C Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital Universitario Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Instituto Peruano del Hueso y la Articulación Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Instituto del Cerebro y la Columna Vertebral SAC Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Clínica San Juan Bautista CSJB Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Instituto de Ginecología y Reproducción Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Hospital Nacional Cayetano Heredia Coordinator of this site? Confirm its status | San Martín de Porres | Peru | Unknown status |
| Medyczne Centrum Hetmańska Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Rheuma Medicus Zaklad Opieki Zdrowotnej Coordinator of this site? Confirm its status | Warszawa | Poland | Active, not recruiting |
| Szpital Kliniczny Dzieciatka Jezus Coordinator of this site? Confirm its status | Warszawa | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| ?Kazan (Privolzhsky) Federal University? Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Univ Colorado Health Sci Ctr Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Wallace Rheumatic Study Center Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| University of Alabama at Birmingham Medical Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Kaiser Permanente-Fontana Coordinator of this site? Confirm its status | Fontana | United States | Unknown status |
| Georgia Nephrology Coordinator of this site? Confirm its status | Lawrenceville | United States | Unknown status |
| North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| Southwest Rheumatology Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Yale Medical Group Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Langone Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oklahoma Medical Research Foundation Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| AD-CARE, University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Utah Health Science center Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Kaiser Permanente San Francisco Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Stanford University Medical Center Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Groote Schuur Hospital and University of Cape Town Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.