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

300 patients around the world

Available in Argentina, Mexico, United States, Brazil, Peru, Spain

Hoffmann-La Roche

5Research sites

300Patients around the world

This study is for people with

Lupus

Systemic lupus erythematosus

To 75 Years

All Gender

: 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

: 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

Centro de Investigaciones Médicas Tucumán

Recruiting

Lavalle 506, T4000 San Miguel de Tucumán, Tucumán, Argentina

Hospital Das Clínicas Da Universidade Federal de Minas Gerais - UFMG

Recruiting

Av. Prof. Alfredo Balena, 110 2 floor - Room 216 - Santa Efigênia, Belo Horizonte - MG, 30130-100

Hospital de Clínicas de Porto Alegre - HCPA/UFRGS

Recruiting

Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Recruiting

Campus Universitário S/N, Bloco G Subsolo II, Monte Alegre, Ribeirão Preto, Sao Paulo

CEMEC - Centro Multidisciplinar de Estudos Clínicos

Recruiting

R. Silva Jardim, 187 - 63 - Centro, São Bernardo do Campo - SP, 09715-090, Brazil

StudyALLEGORY

SponsorHoffmann-La Roche

Study typeInterventional

Conditions

Systemic lupus erythematosus

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT04963296