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

NCT04963296 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2026-05-14

No results posted yet for this 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.

Conditions

Interventions

DRUG

Obinutuzumab

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

DRUG

Placebo

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

DRUG

Acetaminophen/Paracetamol

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

DRUG

Diphenhydramine hydrochloride

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

DRUG

Methylprednisolone

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2025-09-15
Completion
2028-03-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Czechia
  • France
  • Italy
  • Mexico
  • New Zealand
  • Peru
  • Poland
  • Russia
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04963296 on ClinicalTrials.gov