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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: Placebo; Drug: Sarilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01061723

2009-016068-35 (EudraCT Number)

DRI11073

Details and patient eligibility

About

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

Full 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.

Enrollment: 301 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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301 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (for sarilumab) weekly (qw) for 12 weeks.

Treatment:

Drug: Placebo

Sarilumab 100 mg q2w

Experimental group

Description:

Sarilumab 100 mg Subcutaneous (SC) injection alternating with placebo every other week (q2w) for 12 weeks.

Treatment:

Drug: Sarilumab

Drug: Placebo

Sarilumab 150 mg q2w

Experimental group

Description:

Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.

Treatment:

Drug: Sarilumab

Drug: Placebo

Sarilumab 100 mg qw

Experimental group

Description:

Sarilumab 100 mg SC injection qw for 12 weeks.

Treatment:

Drug: Sarilumab

Sarilumab 200 mg q2w

Experimental group

Description:

Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.

Treatment:

Drug: Sarilumab

Drug: Placebo

Sarilumab 150 mg qw

Experimental group

Description:

Sarilumab 150 mg SC injection qw for 12 weeks.

Treatment:

Drug: Sarilumab