A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT04963296

Run by

Hoffmann-La Roche

People needed

303

Starts

2021-10-26

Expected to finish

2028-03-13

Last updated by the study team

2026-05-14

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Pinnacle Research Group — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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