A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
NCT ID: NCT04963296
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
303 participants
INTERVENTIONAL
2021-10-26
2028-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Obinutuzumab
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.
Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine hydrochloride
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Placebo
Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.
Placebo
Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.
Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine hydrochloride
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Interventions
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Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
Placebo
Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.
Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine hydrochloride
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Anti-nuclear antibody (ANA) \>=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
* Low C3 or low C4 or low CH50 complement as determined by the central laboratory at screening
* High disease activity at screening, based on; BILAG-2004 (Category A disease in \>=1 organ system and/or Category B disease in \>=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score \>=8) and Physician's Global Assessment (PGA) (score \>=1.0 on a 0 to 3 visual analogue scale \[VAS\])
* High disease activity on Day 1, based on; SLEDAI-2K (score \>=8) and PGA (score \>=1.0 on a 0 to 3 VAS)
* Current receipt of \>=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants
* The Medical Monitor may be consulted if there are any questions related to eligibility criteria
Exclusion Criteria
* Presence of significant lupus-associated renal disease and/or renal impairment
* Receipt of an excluded therapy, including any anti-CD20, anti-CD19 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
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Unity Health - White County Medical Center- Rheumatology
Searcy, Arkansas, United States
Providence Medical Foundation
Fullerton, California, United States
Arthritis & Rheumatism
Aventura, Florida, United States
Great Lakes Center of Rheumatology
Lansing, Michigan, United States
Clinical Research Institute of Michigan, LLC
Troy, Michigan, United States
Northwell Health Division of Rheumatology
Great Neck, New York, United States
Columbia University Medical Center
New York, New York, United States
Joint & Muscle Research Institute
Charlotte, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States
Texas Arthritis Center
El Paso, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Organizacion Medica de Investigacion
Buenos Aires, , Argentina
DOM Centro de Reumatología
Buenos Aires, , Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel, , Argentina
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia, Brazil
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Misericordia
Belo Horizonte, Minas Gerais, Brazil
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, Brazil
Centro de Estudos em Terapias Inovadoras ? CETI
Curtiba, Paraná, Brazil
Hospital das Clinicas - FMUSP Ribeirao Preto
Ribeirão Preto, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
São Bernardo do Campo, São Paulo, Brazil
Revmatologicky Ustav
Prague, , Czechia
Ch Pitie Salpetriere
Paris, , France
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
IRCCS S. Raffaele
Milan, Lombardy, Italy
A.O. Universitaria Pisana
Pisa, Tuscany, Italy
Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna
Cona (Ferrara), Veneto, Italy
Uni Di Padova
Padua, Veneto, Italy
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
Torreón, Coahuila, Mexico
Unidad de Reumatologia Rehabilitacion Integral
Mexicali, Estado de Baja California, Mexico
Centro de Investigación y Tratamiento Reumatológico S.C.
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
Culiacán, Sinaloa, Mexico
Middlemore Hospital
Auckland, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Hogar Clínica San Juan de Dios
Arequipa, , Peru
Clínica San Juan Bautista CSJB
Lima, , Peru
Instituto de Ginecología y Reproducción
Lima, , Peru
Clinica El Golf
San Isidro, , Peru
Clinica San Antonio;Investigaciones Trujillo S.A.C.
Trujillo, , Peru
Szpital Uniwersytecki
Bydgoszcz, , Poland
Medyczne Centrum Hetmanska
Poznan, , Poland
Prywatna Praktyka Lekarska
Poznan, , Poland
Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM
Poznan, , Poland
MICS Centrum Medyczne Warszawa
Warsaw, , Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, , Poland
REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna
Wroc?aw, , Poland
Republican clinical hospital named after G.G. Kuvatov
Ufa, Bashkortostan Republic, Russia
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
Moscow, Moscow Oblast, Russia
FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health
Saint Petersburg, Sankt-Peterburg, Russia
Panorama Medical Center
Cape Town, , South Africa
Winelands Medical Research
Cape Town, , South Africa
Emmed Research
Pretoria, , South Africa
Dr Asokan Naidoo
Umhlanga, , South Africa
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Addenbrooke'S Hospital
Cambridge, , United Kingdom
Chapel Allerton Hospital
Leeds, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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Other Identifiers
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2020-005760-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504774-38-00
Identifier Type: OTHER
Identifier Source: secondary_id
CA42750
Identifier Type: -
Identifier Source: org_study_id
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