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

Phase 3Active Not RecruitingNCT04963296

Hoffmann-La Roche303 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

303

Conditions

Systemic Lupus Erythematosus

Interventions

ObinutuzumabDRUG

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

PlaceboDRUG

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

Acetaminophen/ParacetamolDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (64)

Outcomes

Primary Outcomes

Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52

SRI(4) requires reduction from baseline of \>=4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), no new systems or organs affected, as defined by \>=1 new British Isles Lupus Assessment Group (BILAG) A or \>=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of \>=0.30 points on a 3-point Physician's Global Assessment Visual Analogue Scale (PGA-VAS).

Time frame: Week 52

Secondary Outcomes

Percentage of Participants who Achieve SRI(6) at Week 52

SRI(6) requires reduction from baseline of \>=6 points in the SLEDAI-2K, no new systems or organs affected, as defined by \>=1 new BILAG A or \>=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of \>=0.30 points on a 3-point PGA-VAS.

Time frame: Week 52

Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control

No treatment with prednisone \>=7.5 mg/day (or equivalent) and no receipt of intravenous, intramuscular, or intra-articular corticosteroids.

Time frame: From Week 40 to Week 52

Time to First BILAG Flare over 52 Weeks

Flare is defined as the occurrence of \>=1 new BILAG A or \>=2 new BILAG B manifestations from the previous visit

Time frame: From baseline to Week 52

Percentage of Participants who Achieve a Sustained SRI(4) Response

Achievement of SRI(4) at all study visits from Week 40 through Week 52.

Time frame: From Week 40 to Week 52

Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52

Data from ClinicalTrials.gov

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