SLE - Efficacy and Safety of Sifalimumab
Research type
Research Study
Full title
A Phase 2b dose ranging study to evaluate the efficacy and safety of sifalimumab in sdult subjects with systemic lupus erythematosus
IRAS ID
36197
Contact name
David D'Cruz
Eudract number
2010-024069-30
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2b, multnational, multi centre, randomised, dose-ranging study to evaluate the efficacy and safety of sifalimumab in adults with Systemic Lupus Erythematosus (SLE). The aim of the study is to evaluate the efficacy of sifalimumab compared to placebo in subjects with chronic, moderately-to-severely active SLE with an inadequate response to standard of care (SOC) SLE at Day 365. Subjects will be in this study for approximately 65 weeks (4 weeks for screening, 48 weeks for treatment, 13 weeks for follow-up). A series of clinical assessments will be performed through-out the study including, but not exclusive to; SLEDAI-2K, BILAG-2004 (including index labs), Proteomics, Anti-sifalimumab antibodies, Pre-dose sifalimumab concentration and assessment of Cushingoid features. Subjects will be randomized to receive a fixed Intravenous dose of sifalimumab of either 200, 600, or 1200 mg or placebo. Sifalimumab or placebo will be administered as a fixed dose every 2 weeks for the first 3 doses and then every 4 weeks thereafter for 11 doses, for a total of 14 doses. Subjects will be maintained on a stable course of permitted SOC SLE throughout the study, except for incidences of toxicity or specified instances of increased disease activity or disease improvement. Subjects may receive up to 3 permitted burst and tapers of oral corticosteriods or intramuscular corticosteroids at or before Day 127 and will not be treated as non-responders. Subjects who receive burst and taper of oral corticosteriods or intramuscular corticosteroids after Day 127 will be treated as non-responders for the primary endpoint. Randomisation will be stratified by: geographic region, SLEDAI 2000 score at screening and by the results of a diagnostic test for type I IFN signature in whole blood at screening. Overall, approximately 544 patients will be recruited globally. Approximately 20 patients will be recruited from approximately 10 UK sites.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
11/NW/0200
Date of REC Opinion
21 Apr 2011
REC opinion
Favourable Opinion