Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Sarilumab; Placebo
Intervention description: Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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
    

Eligibility 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.