A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
Phase 3 – large-scale trial before approval
Conditions:
Systemic Lupus Erythematosus
Sponsor: Hoffmann-La Roche
trial.available_in:
БГ
Overview
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.
Who can participate
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
14
Argentina (1)
Organizacion Medica de Investigacion
Buenos Aires
Brazil (1)
Ser Servicos Especializados Em Reumatologia
Salvador , Estado de Bahia
Czech Republic (1)
Revmatologicky Ustav
Prague
France (1)
Ch Pitie Salpetriere
Paris
Italy (1)
Policlinico Universitario Agostino Gemelli
Rome , Lazio
Mexico (1)
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
Torreón , Coahuila
New Zealand (1)
Middlemore Hospital
Auckland
Peru (1)
Hogar Clínica San Juan de Dios
Arequipa
Poland (1)
Szpital Uniwersytecki
Bydgoszcz
Russia (1)
Republican clinical hospital named after G.G. Kuvatov