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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01061723
• Date of registration: 02/02/2010
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis ALIGN
• Scientific title: A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)
• Date of first enrolment: February 2010
• Target sample size: 301
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01061723
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Czechia, France, Germany, Hungary, Lithuania, Netherlands, Poland, Spain, Turkey, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Sarilumab

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12 [Time Frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF])]

Secondary Outcome(s)

Change From Baseline in Chest Expansion at Week 12 [Time Frame: Baseline, Week 12 (LOCF)]

Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12 [Time Frame: Baseline to Week 12 (LOCF)]

Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12 [Time Frame: Baseline to Week 12 (LOCF)]

Change From Baseline in ASAS Individual Components at Week 12 [Time Frame: Baseline, Week 12 (LOCF)]

Change From Baseline in BASDAI Score at Week 12 [Time Frame: Baseline, Week 12 (LOCF)]

Change From Baseline in Swollen Joint Index at Week 12 [Time Frame: Baseline, Week 12 (LOCF)]

Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12 [Time Frame: Baseline to Week 12 (LOCF)]

Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12 [Time Frame: Baseline, Week 12 (LOCF)]

Change From Baseline in Hs-CRP at Week 12 [Time Frame: Baseline, Week 12 (LOCF)]

Change From Baseline in Magnetic Resonance Imaging (MRI) Score of the Spine Assessed by the Berlin Modification of the AS Spine MRI-active (ASspiMRI-a) Score at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 [Time Frame: Baseline, Week 12 (LOCF)]

Secondary ID(s)

2009-016068-35

DRI11073

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 08/08/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01061723