A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

Key facts

Study ID

NCT02550652

Run by

Hoffmann-La Roche

People needed

126

Starts

2015-11-13

Expected to finish

2023-08-02

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Systemic Lupus Erythematosus (SLE), according to current American College of Rheumatology (ACR) criteria
• Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior to or during screening. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
• Proteinuria (urine protein to creatinine ratio) greater than (>) 1.0
• For women who are not postmenopausal (greater than or equal to [>/=] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
• For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period

You may not qualify if…

• Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE
• Presence of rapidly progressive glomerulonephritis
• Severe renal impairment as defined by estimated Glomerular Filtration Rate (GFR) <30 milliliters per minute (mL/min) or the need for dialysis or renal transplant
• Greater than 50% of glomeruli with sclerosis on renal biopsy
• Treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to randomization
• Unstable disease with thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
• History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion
• Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude participant participation
• Concomitant chronic conditions, excluding SLE, (e.g., asthma, Crohn's disease) that required oral or systemic steroid use in the 52 weeks prior to screening
• Previous treatment with an anti-cluster of differentiation (CD20)-targeted therapy within 12 months
• Previous treatment with a biologic B-cell-targeted therapy (other than anti-CD20) within 6 months of randomization
• Known intolerance to MMF or MPA

Where it is running

• Univ of California, San Diego — La Jolla, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Emory Uni ; Division of Rheumatology — Atlanta, Georgia, United States
• Suny Downstate Medical Center; Rheumatology — Brooklyn, New York, United States
• North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology — Great Neck, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Ohio State University; Division of Nephrology — Columbus, Ohio, United States
• Cemic; Haematology — Buenos Aires, Argentina
• CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica — San Juan, Argentina
• Organizacion Medica de Investigacion — San Nicolás, Argentina
• Ser Servicos Especializados Em Reumatologia — Salvador, Estado de Bahia, Brazil
• Hospital das Clinicas - UFMG — Belo Horizonte, Minas Gerais, Brazil
• Centro Mineiro de Pesquisa - CMIP — Juiz de Fora, Minas Gerais, Brazil
• Instituto Scribner. — Curitiba, Paraná, Brazil
• LMK Serviços Médicos S/S — Porto Alegre, Rio Grande do Sul, Brazil
• Universidade Federal de Sao Paulo - UNIFES — São Paulo, São Paulo, Brazil
• Clinica De La Costa — Barranquilla, Colombia
• Hospital Universitario San Ignacio — Bogotá, Colombia
• Riesgo De Fractura; Rheumatology — Bogotá, Colombia
• Hospital Pablo Tobon Uribe — Medellín, Colombia
• Hospital Clinica Catolica — Guadalupe, Costa Rica
• HOPITAL HENRI MONDOR; SERVICE DE Nephrologie — Créteil, France
• Hopital Claude Huriez; Internal Medicine — Lille, France
• Hopital europeen Marseille; Service de medecine interne — Marseille, France
• Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii — Paris, France

Full record on ClinicalTrials.gov

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