Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Phase 2 Completed 301 enrolled Sanofi Regeneron Pharmaceuticals · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Primary objective: \- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: * to demonstrate that Sarilumab was effective on: * assessment of higher level of response \[ASAS 40% response criteria (ASAS40)\] * partial remission * disease activity * range of motion * Magnetic Resonance Imaging (MRI) of the spine * to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS

Timeline

Start: 2010-02
Primary completion: 2011-06
Completion: 2011-06

Outcome

Missed primary endpoint

paper At week 12, there was no statistically significant difference in ASAS20 response rate between placebo (ASAS20 = 24.0%) and any sarilumab dose group. PMID 24550171 ↗

Publications

Results Sieper J, Braun J, Kay J, Badalamenti S, Radin AR, Jiao L, Fiore S, Momtahen T, Yancopoulos GD, Stahl N, Inman RD. Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN). Ann Rheum Dis. 2015 Jun;74(6):1051-7. doi: 10.1136/annrheumdis-2013-204963. Epub 2014 Feb 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sarilumab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Sarilumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Sarilumab	Monoclonal antibody	200 mg	Subcutaneous