NCT01061723

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

A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

The duration of participation in this study for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks safety follow-up period.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Sarilumab	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-02-03
• Last updated: 2017-08-08
• Results posted: 2017-08-08

Locations

80 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Lithuania, Netherlands, Poland, Spain, Turkey (Türkiye)