Date: 2011-07-12
Type of information: Results
phase: 2b
Announcement: results
Company: Sanofi (France) Regeneron Pharmaceutical (USA)
Product: sarilumab
Action
mechanism: This fully-human antibody targets the interleukin-6 receptor (IL-6R).
Disease: ankylosing spondylitis
Therapeutic area: Autoimmune diseases
Country:
Trial
details: The 300-patient ALIGN trial is a randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of sarilumab in patients with AS who had an inadequate response to NSAIDs. The primary outcome measure of the trial was the percentage of patients who achieved a 20% improvement in AS International Working Group Criteria for improvement (ASAS20) at 12 weeks. The secondary endpoints included ASAS40 response, partial remission, and changes in disease activity, safety and tolerability. In the ALIGN trial, the same dose regimens were tested as in part A of the MOBILITY trial. (NCT01061723 and NCT01061736)
Latest
news: Sanofi and Regeneron Pharmaceuticals have announced results from Phase 2b trials in ankylosing spondylitis with sarilumab (REGN88/ SAR153191), a novel, high-affinity, subcutaneously administered, fully-human antibody targeting the interleukin-6 receptor (IL-6R). In the Phase 2b ALIGN trial in ankylosing spondylitis (AS), sarilumab did not demonstrate significant and clinically meaningful improvements in signs and symptoms of active AS compared to placebo in patients who had inadequate response to NSAIDs. Sarilumab was generally well tolerated. The most common adverse events reported more frequently in active treatment arms included infections and neutropenia. Full data of both Phase 2b trials will be submitted for presentation at an upcoming scientific conference.
