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Clinical Trials in Poland / NCT04963296
Active, not recruiting Phase 3

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

NCT04963296 · tracked via the Priya Life Science Poland tracker
Phase
Phase 3
Started
2021-10-26
Last updated
2026-05-14

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

Obinutuzumab →PlaceboAcetaminophen/Paracetamol →Diphenhydramine hydrochloride →Methylprednisolone →

Obinutuzumab: Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.

Placebo: Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.

Acetaminophen/Paracetamol: Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

Diphenhydramine hydrochloride: Diphenhydramine 50 mg will be administered as premedication prior to infusions.

Methylprednisolone: Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (64)

FacilityCityRegionStatus
Pinnacle Research Group Anniston Alabama
Unity Health - White County Medical Center- Rheumatology Searcy Arkansas
Providence Medical Foundation Fullerton California
Arthritis & Rheumatism Aventura Florida
Great Lakes Center of Rheumatology Lansing Michigan
Clinical Research Institute of Michigan, LLC Troy Michigan
Northwell Health Division of Rheumatology Great Neck New York
Columbia University Medical Center New York New York
Joint & Muscle Research Institute Charlotte North Carolina
The Ohio State University Wexner Medical Center Columbus Ohio
Paramount Medical Research & Consulting, LLC Middleburg Heights Ohio
Precision Comprehensive Clinical Research Solutions Colleyville Texas
Texas Arthritis Center El Paso Texas
Prolato Clinical Research Center Houston Texas
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
Hospital das Clinicas - UFMG Belo Horizonte Minas Gerais
Santa Casa de Misericordia Belo Horizonte Minas Gerais
Centro Mineiro de Pesquisa - CMIP Juiz de Fora Minas Gerais
Centro de Estudos em Terapias Inovadoras ? CETI Curtiba Paraná
Hospital das Clinicas - FMUSP Ribeirao Preto Ribeirão Preto São Paulo
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X* São Bernardo do Campo São Paulo
Revmatologicky Ustav Prague Czechia
Ch Pitie Salpetriere Paris France
Policlinico Universitario Agostino Gemelli Rome Lazio
IRCCS S. Raffaele Milan Lombardy
A.O. Universitaria Pisana Pisa Tuscany
Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna Cona (Ferrara) Veneto
Uni Di Padova Padova Veneto
Centro de Investigacion Alberto Bazzoni S.A. de C.V. Torreón Coahuila
Unidad de Reumatologia Rehabilitacion Integral Mexicali Estado de Baja California
Centro de Investigación y Tratamiento Reumatológico S.C. Mexico City Mexico CITY (federal District)
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI) Culiacán Sinaloa
Middlemore Hospital Auckland New Zealand
Wellington Hospital Wellington New Zealand
Hogar Clínica San Juan de Dios Arequipa Peru
Clínica San Juan Bautista CSJB Lima Peru

+ 24 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04963296 on ClinicalTrials.gov ↗ ← All trials in Poland