A Study to Evaluate the Effectiveness and Safety of Obinutuzumab in Patients With Lupus

RECRUITING

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This parallel-group, double-blind, placebo-controlled study will assess the efficacy and safety of obinutuzumab versus placebo in patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

Conditions:

Systemic Lupus Erythematosus

Study Start (Actual) 2021-10-26

Primary Completion (Estimated) 2025-11-30

Study Completion (Estimated) 2027-11-30

Enrollment (Estimated) 300

Study Type INTERVENTIONAL

Phase PHASE3

Locations:

📍 Anniston, Alabama, United States

📍 Birmingham, Alabama, United States

📍 Searcy, Arkansas, United States

📍 Fullerton, California, United States

📍 Upland, California, United States

📍 Aurora, Colorado, United States

📍 Aventura, Florida, United States

📍 Miami, Florida, United States

📍 Orlando, Florida, United States

📍 Tampa, Florida, United States

📍 Atlanta, Georgia, United States

📍 Hagerstown, Maryland, United States

📍 Lansing, Michigan, United States

📍 Troy, Michigan, United States

📍 Brooklyn, New York, United States

📍 Great Neck, New York, United States

📍 New York, New York, United States

📍 Charlotte, North Carolina, United States

📍 Cincinnati, Ohio, United States

📍 Columbus, Ohio, United States

📍 Middleburg Heights, Ohio, United States

📍 Amarillo, Texas, United States

📍 Colleyville, Texas, United States

📍 El Paso, Texas, United States

📍 Houston, Texas, United States

📍 Ciudad Autónoma de Buenos Aires, Argentina

📍 San Miguel, Argentina

📍 San Nicolás, Argentina

📍 Salvador, BA, Brazil

📍 Belo Horizonte, MG, Brazil

📍 Juiz de Fora, MG, Brazil

📍 Curtiba, PR, Brazil

📍 Porto Alegre, RS, Brazil

📍 Ribeirao Preto, SP, Brazil

📍 Sao Bernardo Do Campo, SP, Brazil

📍 Prague, Czechia

📍 Brest, France

📍 Le Kremlin Bicetre, France

📍 Nice, France

📍 Paris, France

📍 Rennes, France

📍 Strasbourg, France

📍 Cona (FE), Emilia-Romagna, Italy

📍 Roma, Lazio, Italy

📍 Brescia, Lombardia, Italy

📍 Milano, Lombardia, Italy

📍 Pisa, Toscana, Italy

📍 Padova, Veneto, Italy

📍 Mexicali, BAJA California, Mexico

📍 Torreon, Coahuila, Mexico

📍 Mexico, DF, Mexico CITY (federal District), Mexico

📍 Monterrey, Nuevo LEON, Mexico

📍 Culiacán Rosales, Sinaloa, Mexico

📍 Auckland, New Zealand

📍 Wellington, New Zealand

📍 Arequipa, Peru

📍 Lima, Peru

📍 San Isidro, Peru

📍 Trujillo, Peru

📍 Bydgoszcz, Poland

📍 Poznan, Poland

📍 Warszawa, Poland

📍 Wroc?aw, Poland

📍 UFA, Baskortostan, Russian Federation

📍 Yaroslavl, Jaroslavl, Russian Federation

📍 Moscow, Moskovskaja Oblast, Russian Federation

📍 Ryazan, Rjazan, Russian Federation

📍 Sankt-Petersburg, Sankt Petersburg, Russian Federation

📍 Yekaterinburg, Sankt Petersburg, Russian Federation

📍 Kazan, Tatarstan, Russian Federation

📍 Yaroslavl, Volgograd, Russian Federation

📍 Smolensk, Russian Federation

📍 Cape Town, South Africa

📍 Chatsworth, South Africa

📍 Polokwane, South Africa

📍 Port Elizabeth, South Africa

📍 Pretoria, South Africa

📍 Somerset West, South Africa

📍 Umhlanga, South Africa

📍 Santiago de Compostela, LA Coruña, Spain

📍 Vigo, Pontevedra, Spain

📍 Bilbao, Vizcaya, Spain

📍 Barcelona, Spain

📍 Madrid, Spain

📍 Cambridge, United Kingdom

📍 Derby, United Kingdom

📍 Leeds, United Kingdom

📍 Liverpool, United Kingdom

📍 London, United Kingdom

📍 Manchester, United Kingdom

📍 Preston, United Kingdom

More locations available...

Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2021-07-07
First Submitted that Met QC Criteria2021-07-07
First Posted2021-07-15

Study Record Updates

Last Update Submitted that Met QC Criteria2024-07-11
Last Update Posted2024-07-12
Last Verified2024-07