Language: BG BG
← Back to results
Active (not recruiting) Phase 3 NCT04963296

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
Ufa , Bashkortostan Republic
South Africa (1)
Panorama Medical Center
Cape Town
Spain (1)
Hospital Universitario Vall d'Hebron
Barcelona
United Kingdom (1)
Addenbrooke'S Hospital
Cambridge
United States (1)
Pinnacle Research Group
Anniston , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
26.10.2021
Completion date
14.03.2028
Registry ID
NCT04963296
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.