Health Condition 1: null- Systemic Lupus Erythematosus Health Condition 2: M329- Systemic lupus erythematosus, unspecified
Conditions
Interventions
Intervention1: Drug Sifalimumab
Sifalimumab
Sifalimumab: Treatment Arm 1 (n equall as 136) IV Sifalimumab for 48 weeks,
Treatment Arm 2 (n equall as 136) IV Sifalimumab for 48 weeks,
Treatment Arm 3
Sponsors
MedImmune
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, one of which must be: a) Significantly positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at central lab; OR b) Elevated anti-dsDNA or Sm antibody at screening as determined by central lab Disease history of SLE less or equal 24 weeks at screening Weight less than 40 kg Currently receiving stable dose of oral prednisone 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 Females with an intact cervix must have no evidence of cervical malignancy documented on a Pap smear with 6 months of baseline Females must be willing to avoid pregnancy throughout the study including the 180 day follow-up safety period Negative TB test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization
Exclusion criteria
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 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 Herpes Zoster within 3 months of screening, History of cancer other than basal cancer or cervical cancer treated with apparent success less or equal 1 year prior to randomization, Receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer) prior to screening, Live or attenuated vaccine within 4 weeks prior to screening, Subjects with substance abuse, Subjects with significant laboratory abnormalities in the hepatic, renal or hematologic systems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint for this study is the proportion of subjects achieving a response in an SLE responder index SRI (4) in subjects with chronic, moderately-to-severely active SLETimepoint: At Day 365 (Week 52) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include comparison between sifalimumab and placebo groups on the proportion of subjects able to reduce oral corticosteroids doses in subjects on more or equal 10 mg Prednisone equivalent at baseline, to improve active inflammatory cutaneous lesions as measured by the CLASI, to reduction in fatigue as measured by the Facit-Fatigue Scale Timepoint: At Day 365 (Week 52) | — |
Countries
Argentina, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, India, Italy, Mexico, Netherlands, Peru, Philippines, Poland, Romania, South Africa, Spain, Thailand, United States of America
Contacts
Public ContactMs Ranju Sharma
Medical & Regulatory Affairs
Outcome results
None listed