A Study to evaluate the efficacy and safety of MEDI-546 compared toplacebo in subjects with Systemic Lupus Erythematosus

• Conditions: Systemic Lupus Erythematosus; MedDRA version: 17.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-004296-36-HU
• Lead Sponsor: MedImmune, LLC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-29
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening
Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
Weight greater than or equal to 40 kg
Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
No evidence of cervical malignancy on Pap smear within 2 years of randomization
Female subjects must be willing to avoid pregnancy
Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Active severe SLE-driven renal disease or unstable renal disease prior to screening
Active severe or unstable neuropsychiatric SLE
Clinically significant active infection including ongoing and chronic infections
History of human immunodeficiency virus (HIV)
Confirmed Positive tests for hepatitis B or positive test for hepatitis C
History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
Live or attenuated vaccine within 4 weeks prior to screening
Subjects with significant hematologic abnormalities

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified