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

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Systemic Lupus Erythematosus

Interventions: Obinutuzumab, Placebo, Acetaminophen/Paracetamol, Diphenhydramine hydrochloride, Methylprednisolone

Countries: United States, Argentina, Brazil, Czechia, France, Italy, Mexico, New Zealand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (64)

Anniston, Alabama, United States
Searcy, Arkansas, United States
Fullerton, California, United States
Aventura, Florida, United States
Lansing, Michigan, United States
Troy, Michigan, United States
Great Neck, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Middleburg Heights, Ohio, United States
Colleyville, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Buenos Aires, Argentina
Buenos Aires, Argentina
San Miguel, Argentina
Salvador, Estado de Bahia, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Juiz de Fora, Minas Gerais, Brazil
Curtiba, Paraná, Brazil
Ribeirão Preto, São Paulo, Brazil
São Bernardo do Campo, São Paulo, Brazil
Prague, Czechia
Paris, France
Rome, Lazio, Italy
Milan, Lombardy, Italy
Pisa, Tuscany, Italy
Cona (Ferrara), Veneto, Italy
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