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Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

NCT01261793•UCB Pharma

View on ClinicalTrials.gov

Summary

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Positive antinuclear antibodies (ANA) at Screening (Visit 1)
•Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
•Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
•Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
•On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion Criteria

•Subjects who are breastfeeding, pregnant, or plan to become pregnant
•Subjects with active, severe SLE disease activity which involves the renal system
•Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
•Subjects with the evidence of an immunosuppressive state
•Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
•History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
•Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
•Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
•Subjects with substance abuse or dependence or other relevant concurrent medical condition
•Subjects with history of thromboembolic events within 1 year of screening Visit.
+4 more criteria

Locations (133)

539

Birmingham, Alabama, United States

557

Little Rock, Arkansas, United States

515

Hemet, California, United States

544

Huntington Beach, California, United States

550

La Jolla, California, United States

548

Los Angeles, California, United States

589

San Diego, California, United States

531

San Leandro, California, United States

558

Torrance, California, United States

594

Westlake Village, California, United States

Key Dates

Start Date

December 1, 2010

Primary Completion Date

May 1, 2015

Completion Date

June 1, 2015

Last Updated

December 4, 2020

Enrollment

791

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

Placebo

DRUG

Epratuzumab

DRUG

Epratuzumab

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)

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RECRUITINGPHASE1

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

NCT07371468

Systemic Lupus Erythematosus

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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: December 4, 2020Data 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

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)

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)

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