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

• Status: Recruiting
• Trial end date: 2027-11-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Acetaminophen; Diphenhydramine; Methylprednisolone; Obinutuzumab; Promethazine

Criteria

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, C4, and/or CH50 as determined by the central laboratory at screening

• High disease activity at screening, based on; BILAG-2004 (level A disease in >=1 organ system and/or Level 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

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