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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals

Criteria

Inclusion criteria:

• Diagnosis of AS according to the New York modified criteria

• Participants must had an adequate trial of at least 2 different Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) taken for at least 2 weeks in each case and, on a stable dose for ≥2 weeks or be intolerant to NSAIDs

• Participants must had active AS for ≥3 months before screening and active disease must be present at screening and at baseline; Active AS being defined by:

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4 (Numerical Rating Scale 0-10)

• Total back pain score ≥4 (Numerical Rating Scale 0-10)

Participants treated with corticosteroid must be on a stable dose for ≥2 weeks prior to baseline

Participants treated with the Disease Modifying Anti-Rheumatic Drugs (DMARDs) hydroxychloroquine, sulfasalazine and methotrexate (MTX) must be on stable dose ≥12 weeks prior to baseline

Exclusion criteria:

• <18 years old or ≥75 years old

• Complete fusion of the spine

• Past history of non response to any anti-Tumor Necrosis Factors (TNFs) treatment or non response to any other biological treatment for AS

• Any past or current treatment with anti-TNF's or any biological agent within 3 months prior to screening

• Treatment with DMARDs except for hydroxychloroquine, sulfasalazine and MTX

• MTX >25 mg/week

• hydroxychloroquine >400 mg/day

• Sulfasalazine >3 g/day

• Treatment with oral prednisone or equivalent corticosteroids >10 mg/day within 6 weeks prior to screening

• Use of intramuscular or intra-articular corticosteroids within the last 4 weeks before screening

• Previous treatment with cyclosporine, azathioprine

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.