Loading clinical trials...

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus

NCT04963296•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
•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

Locations (64)

Pinnacle Research Group

Anniston, Alabama, United States

Unity Health - White County Medical Center- Rheumatology

Searcy, Arkansas, United States

Providence Medical Foundation

Fullerton, California, United States

Arthritis & Rheumatism

Aventura, Florida, United States

Great Lakes Center of Rheumatology

Lansing, Michigan, United States

Clinical Research Institute of Michigan, LLC

Troy, Michigan, United States

Northwell Health Division of Rheumatology

Great Neck, New York, United States

Columbia University Medical Center

New York, New York, United States

Joint & Muscle Research Institute

Charlotte, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Key Dates

Start Date

October 26, 2021

Primary Completion Date

September 15, 2025

Completion Date

March 14, 2028

Last Updated

January 7, 2026

Enrollment

303

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

Obinutuzumab

DRUG

Placebo

DRUG

Acetaminophen/Paracetamol

DRUG

Diphenhydramine hydrochloride

DRUG

Methylprednisolone

DRUG

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

View study

RECRUITINGPHASE1

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

NCT07371468

Systemic Lupus Erythematosus

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus

Alnuctamab for Refractory SLE (LATTE Study)

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases