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

STUDY OVERVIEW

This study sponsored by Hoffman La-Roche aims to assess the effectiveness and safety of obinutuzumab compared to a placebo in individuals with active, autoantibody-positive systemic lupus erythematosus (SLE) undergoing standard-of-care therapy through a parallel-group, double-blind, and placebo-controlled design.

STUDY GOALS

The study goal is to evaluate the efficacy and safety of obinutuzumab compared to placebo in individuals with active, autoantibody-positive systemic lupus erythematosus (SLE) receiving standard-of-care therapy.

LOCATION

El Paso, Texas: Texas Arthritis Center

INCLUSION CRITERIA

  • Diagnosed with SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria at least 12 weeks before screening

  • ANA level of 1:80 or higher, or elevated levels of anti-dsDNA and/or anti-Sm antibodies as determined by the central laboratory at screening

  • Low levels of C3, C4, or CH50 complement as determined by the central laboratory at screening

  • High disease activity at screening and on Day 1 based on specified criteria

  • Currently receiving at least one standard therapy for SLE at stable doses

  • Other criteria may apply

exclusion criteria

  • Pregnancy or breastfeeding

  • Significant lupus-associated renal disease or renal impairment

  • Recent use of excluded therapies such as anti-CD20, anti-CD19 therapy, cyclophosphamide, tacrolimus, ciclosporin, or voclosporin

  • Presence of significant or uncontrolled medical disease

  • Known active infection or recent major episode of infection

  • Intolerance or contraindication to study therapies

  • Other criteria may apply

For more information, visit ClinicalTrials.gov.