A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN

INTERVENTION: Product Name: not applicable Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: not applicable Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: not applicable Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Ankylosing Spondylitis ; MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis PRIMARY OUTCOME: Main Objective: The primary objective of the study is to evaluate the efficacy by (ASAS20) (Assessment in Ankylosing Spondylitis Working Group responses criteria) of SAR153191 in patients with AS (Ankylosing Spondylitis) Primary end point(s): The primary efficacy endpoint will be the percentage of patients who achieve the assessment in AS International Working Group Criteria for improvement (ASAS20) at Week 12 Secondary Objective: The secondary objectives are:; assessment of higher level of response ASAS40; partial remission; disease activity; range of motion; changes in MRI score; the safety and tolerability of SAR153191 in patients with AS; to document PK profile of SAR153191 in patients with AS INCLUSION CRITERIA: I 01. Patients with active AS based on the Modified New York criteria for ankylosing spondylitis. I 02. Patients must had an adequate trial of at least 2 different NSAIDs taking for at least 2 weeks in each case and on a stable dose for =2 weeks or be intolerant to NSAIDs. I 03. Active disease must be present for =3 months and be present at screening and at baseline as defined: ‐ Bath AS Disease Activity Index (BASDAI) score of =4 (NRS 0‐10); ‐ Total back pain score =4 (NRS 0‐10). I 04. Patients treated with corticosteroid must be on a stable dose for >2 weeks prior to baseline. I 05. Patients treated with DMARDs: hydroxychloroquine, sulfasalazine and MTX must be on a stable dose =12 weeks. I 06. Patients must give informed consent prior to any procedure related to the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range