A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)
Lupus Nephritis
About this trial
This is an interventional treatment trial for Lupus Nephritis
Eligibility Criteria
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- Pregnancy or breastfeeding
- Severe renal impairment or the need for dialysis or renal transplantation
- 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
- Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
- Known active infection of any kind or recent major episode of infection
- Intolerance or contraindication to study therapies
- Other exclusion criteria may apply
Sites / Locations
- University of Alabama at Birmingham Medical Center
- Wallace Rheumatic Study Center
- Kaiser Permanente - Fontana
- Stanford University Medical Center
- Kaiser Permanente - San Francisco Medical Center
- Univ Colorado Health Sci Ctr
- Yale Medical Group; Rheumatology
- University of Miami Miller School of Medicine
- Mayo Clinic - Rochester
- North Shore University Hospital
- NYU Langone Medical Center; Seligman Center for Advanced Therapeutics
- Columbia University Medical Center
- AD-CARE, University of Rochester Medical Center
- The Ohio State University Wexner Medical Center
- Oklahoma Medical Research Foundation
- Georgia Nephrology
- University of Texas Southwestern
- Southwest Rheumatology
- University of Utah Health Science center; Internal Medicine for the University of Utah
- DOM Centro de Reumatología
- Sanatorio Allende
- Organizacion Medica de Investigacion
- Ser Servicos Especializados Em Reumatologia
- Instituto Pro-Renal
- Hospital das Clinicas - FMUSP Ribeirao Preto; Reumatologia
- Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
- Hospital das Clinicas - FMUSP
- Clinica De La Costa
- Hospital Universitario San Ignacio
- Hospital Pablo Tobon Uribe
- HOPITAL HENRI MONDOR; SERVICE DE Nephrologie
- Hopital Claude Huriez; Internal Medicine
- Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii
- Hopital Bichat Claude Bernard; Nephrologie
- Hopital Universitaire; Nephrologie Clinique Medicale B
- Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique
- Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
- Städtisches Klinik Dresden-Friedrichstadt; I. Medizinische Klinik
- Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
- Universitätsklinikum Freiburg
- Universitaetsmedizin Johannes Gutenberg; Rheumatologie
- Universitätskrankenhaus Tübingen; Innere Medizin / Hämatologie und Internistische Onkologie
- Meir Medical Center
- Rabin MC- Belinson campus
- Chaim Sheba Medical Center; Rheumatology
- Sourasky Medical Centre
- Ospedale Policlinico San Martino
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia
- Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica
- ASST Monza - Ospedale San Gerardo; Clinica Nefrologica
- Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
- Ospedale ARNAS - P.O."Civico e Benfratelli; UOC Nefrologia e Dialisi
- Azienda Ospedaliera Universitaria Careggi
- Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia
- Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
- Centro de Investigación y Tratamiento Reumatológico S.C.
- Hospital Universitario; Dr. Jose Eleuterio Gonzalez
- Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB
- Instituto del Cerebro y la Columna Vertebral SAC
- Instituto de Ginecología y Reproducción
- Hospital Nacional Cayetano Heredia; Rheumatology
- SPSK Slaskiego UM w Katowicach; Katedra i Klinika Nefrologii, Endokryn.I Chorob Przemiany Materii
- Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
- Medyczne Centrum Hetmanska; Rheumatology
- Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych
- Szpital Kliniczny Dzieciatka Jezus; Klinika Med. Transplantacyjnej, Nefrologii i Chorob Wew
- Rheuma Medicus Zaklad Opieki Zdrowotnej
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
- Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
- Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov; Rheumatology Department
- SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
- ?Kazan (Privolzhsky) Federal University?; Academic Hospital
- Groote Schuur Hospital and University of Cape Town; E13 Renal Unit & J46 Dept of Medicine
- Chris Hani Baragwanath Hospital
- Panaroma Medical Center; Clinical Trials Department
- Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna
- Hospital Clinic i Provincial; Servicio de Nefrologia
- Hospital Ramon y Cajal ; Servicio de Reumatologia
- Hospital Universitario 12 de Octubre; Servicio de Reumatologia
- Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Obinutuzumab
Placebo
Participants will be randomized into 2 groups. Group 1 will receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Group 2 receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, and 52 plus MMF and oral prednisone. Group 2 participants will receive a placebo infusion at their Week 50 visit. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.
Placebo participants will receive obinutuzumab matched placebo at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80.