A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
Launched by HOFFMANN-LA ROCHE · Jul 7, 2021
Trial Information
Current as of April 25, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called obinutuzumab to see how effective and safe it is for people with systemic lupus erythematosus (SLE), a condition where the immune system mistakenly attacks healthy tissues. The trial is designed for adults aged 18 and older who have been diagnosed with SLE and are currently experiencing high levels of disease activity. Participants must have specific blood test results showing signs of the disease and must be receiving standard treatments for SLE, such as corticosteroids or antimalarial medications.
In this study, some participants will receive obinutuzumab, while others will receive a placebo (a non-active treatment) without knowing which one they get. The trial is currently active but not recruiting new participants. Those who are eligible should not be pregnant or breastfeeding, have certain severe kidney issues, or have received specific other treatments recently. If you or a family member are considering participation, it's essential to discuss with your healthcare provider to understand all the details and whether this trial is a good fit.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria \>=12 weeks prior to screening
- • 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
- • Other inclusion criteria may apply
- • The Medical Monitor may be consulted if there are any questions related to eligibility criteria
- Exclusion Criteria:
- • Pregnancy or breastfeeding
- • 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
- • Other exclusion criteria may apply
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
London, , United Kingdom
Orlando, Florida, United States
Anniston, Alabama, United States
Amarillo, Texas, United States
Cambridge, , United Kingdom
Aventura, Florida, United States
Manchester, , United Kingdom
Wellington, , New Zealand
Barcelona, , Spain
Madrid, , Spain
Anniston, Alabama, United States
Buenos Aires, , Argentina
Curtiba, Pr, Brazil
Mexicali, , Mexico
Bilbao, Vizcaya, Spain
Atlanta, Georgia, United States
Monterrey, Nuevo Leon, Mexico
Charlotte, North Carolina, United States
Porto Alegre, Rs, Brazil
Cape Town, , South Africa
Derby, , United Kingdom
Liverpool, , United Kingdom
Poznan, , Poland
Vigo, Pontevedra, Spain
Madrid, , Spain
Ufa, , Russian Federation
Culiacán Rosales, Sinaloa, Mexico
Port Elizabeth, , South Africa
Cambridge, , United Kingdom
Cincinnati, Ohio, United States
Belo Horizonte, Mg, Brazil
London, Greater London, United Kingdom
Columbus, Ohio, United States
Nice, , France
Poznan, , Poland
Charlotte, North Carolina, United States
Warszawa, , Poland
San Isidro, , Peru
Trujillo, , Peru
Hagerstown, Maryland, United States
Middleburg Heights, Ohio, United States
Roma, Lazio, Italy
Moscow, , Russian Federation
Auckland, , New Zealand
Brest, , France
Upland, California, United States
Pretoria, , South Africa
Bydgoszcz, , Poland
London, , United Kingdom
Great Neck, New York, United States
Juiz De Fora, Mg, Brazil
Bydgoszcz, , Poland
Barcelona, , Spain
Leeds, , United Kingdom
Belo Horizonte, Mg, Brazil
Sankt Petersburg, , Russian Federation
Brooklyn, New York, United States
Salvador, Ba, Brazil
Lima, , Peru
Strasbourg, , France
Le Kremlin Bicetre, , France
Warszawa, , Poland
Moscow, Moskovskaja Oblast, Russian Federation
Yekaterinburg, Sankt Petersburg, Russian Federation
Yaroslavl, Volgograd, Russian Federation
Torreon, Coahuila, Mexico
London, , United Kingdom
Ryazan, , Russian Federation
Smolensk, , Russian Federation
Monterrey, , Mexico
Colleyville, Texas, United States
Lansing, Michigan, United States
Juiz De Fora, Minas Gerais, Brazil
Polokwane, , South Africa
Fullerton, California, United States
Houston, Texas, United States
El Paso, Texas, United States
Ciudad Autónoma De Buenos Aires, , Argentina
Ribeirao Preto, Sp, Brazil
Sao Bernardo Do Campo, Sp, Brazil
Brescia, Lombardia, Italy
Mexico, Df, , Mexico
Arequipa, , Peru
Lima, , Peru
Poznan, , Poland
Cape Town, , South Africa
Chatsworth, , South Africa
Santiago De Compostela, La Coruña, Spain
San Miguel, , Argentina
Somerset West, , South Africa
Warszawa, , Poland
Birmingham, Alabama, United States
Aurora, Colorado, United States
Tampa, Florida, United States
Paris, , France
Paris, , France
Rennes, , France
Cona (Fe), Emilia Romagna, Italy
Milano, Lombardia, Italy
Pisa, Toscana, Italy
Auckland, , New Zealand
Poznan, , Poland
Wrocław, , Poland
Yaroslavl, Jaroslavl, Russian Federation
Kazan, , Russian Federation
Cape Town, , South Africa
Umhlanga, , South Africa
Preston, , United Kingdom
San Nicolás, , Argentina
Lansing, Michigan, United States
Barcelona, , Spain
Poznan, , Poland
Searcy, Arkansas, United States
New York, New York, United States
Manchester, , United Kingdom
Tampa, Florida, United States
Curtiba, Pr, Brazil
Wroc?Aw, , Poland
Sankt Petersburg, , Russian Federation
Miami, Florida, United States
Padova, Veneto, Italy
Mexico, Df, Mexico City (Federal District), Mexico
Ufa, Baskortostan, Russian Federation
Troy, Michigan, United States
Mexicali, Baja California, Mexico
Moscow, Moskovskaja Oblast, Russian Federation
Ryazan, Rjazan, Russian Federation
Sankt Petersburg, Sankt Petersburg, Russian Federation
Kazan, Tatarstan, Russian Federation
Moscow, Moskovskaja Oblast, Russian Federation
Prague, , Czechia
Nice, , France
Orlando, Florida, United States
Charlotte, North Carolina, United States
Belo Horizonte, Minas Gerais, Brazil
Salvador, Bahia, Brazil
Belo Horizonte, Minas Gerais, Brazil
Paris, , France
San Miguel, , Argentina
Lima, , Peru
Poznan, , Poland
Aventura, Florida, United States
Curtiba, Paraná, Brazil
Ribeirao Preto, São Paulo, Brazil
Sao Bernardo Do Campo, São Paulo, Brazil
Brescia, Lombardia, Italy
Milano, Lombardia, Italy
Cona (Ferrara), Veneto, Italy
Padova, Veneto, Italy
Mexicali, Baja California, Mexico
Wellington, , New Zealand
Cape Town, , South Africa
Cape Town, , South Africa
Umhlanga, , South Africa
Leeds, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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