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

NCT01061723 | Completed Phase 2 Results DMC

• 2 other identifiers: DRI110732009-016068-35
• Study Type: interventional
• Target: 301
• Locations: 13 countries
• Sites: 76

Brief 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

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12

  Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index \[BASFI\]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain.

  Baseline to Week 12 (Last Observation Carried Forward [LOCF])

Secondary Outcomes (11)

• Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12

  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

  Baseline to Week 12 (LOCF)

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12

  Baseline, Week 12 (LOCF)

• Change From Baseline in BASDAI Score at Week 12

  Baseline, Week 12 (LOCF)

• Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12

  Baseline, Week 12 (LOCF)

Study Arms (6)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Sarilumab 100 mg q2w

EXPERIMENTAL

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

Drug: Sarilumab; Drug: Placebo

Sarilumab 150 mg q2w

EXPERIMENTAL

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

Drug: Sarilumab; Drug: Placebo

Sarilumab 100 mg qw

EXPERIMENTAL

Sarilumab 100 mg SC injection qw for 12 weeks.

Drug: Sarilumab

Sarilumab 200 mg q2w

EXPERIMENTAL

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

Drug: Sarilumab; Drug: Placebo

Sarilumab 150 mg qw

EXPERIMENTAL

Sarilumab 150 mg SC injection qw for 12 weeks.

Drug: Sarilumab

Interventions

Sarilumab DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Also known as: SAR153191, REGN88

Sarilumab 100 mg q2w; Sarilumab 100 mg qw; Sarilumab 150 mg q2w; Sarilumab 150 mg qw; Sarilumab 200 mg q2w

Placebo DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Placebo; Sarilumab 100 mg q2w; Sarilumab 150 mg q2w; Sarilumab 200 mg q2w

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (80)

Investigational Site Number 840006

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 840033

Anaheim, California, 92801, United States

Location

Investigational Site Number 840027

Los Angeles, California, 90048, United States

Location

Investigational Site Number 840007

San Diego, California, 92108, United States

Location

Investigational Site Number 840013

San Francisco, California, 94143, United States

Location

Investigational Site Number 840017

Upland, California, 91786, United States

Location

Investigational Site Number 840009

Boca Raton, Florida, 33486, United States

Location

Investigational Site Number 840001

Naples, Florida, 34102, United States

Location

Investigational Site Number 840032

Orlando, Florida, 32806, United States

Location

Investigational Site Number 840015

Boise, Idaho, 83702, United States

Location

Investigational Site Number 840021

Rock Island, Illinois, 61201, United States

Location

Investigational Site Number 840018

Kansas City, Kansas, 66160-7321, United States

Location

Investigational Site Number 840003

Wheaton, Maryland, 20902, United States

Location

Investigational Site Number 840029

Worcester, Massachusetts, 01655, United States

Location

Investigational Site Number 840008

Lansing, Michigan, 48823, United States

Location

Investigational Site Number 840002

St Louis, Missouri, 63141, United States

Location

Investigational Site Number 840028

Freehold, New Jersey, 07728, United States

Location

Investigational Site Number 840016

Albany, New York, 12206, United States

Location

Investigational Site Number 840036

Syracuse, New York, 13210, United States

Location

Investigational Site Number 840010

Toledo, Ohio, 43606, United States

Location

Investigational Site Number 840005

Oklahoma City, Oklahoma, 73109, United States

Location

Investigational Site Number 840023

Bethlehem, Pennsylvania, 18015, United States

Location

Investigational Site Number 840014

Duncansville, Pennsylvania, 16635, United States

Location

Investigational Site Number 840004

Dallas, Texas, 75231, United States

Location

Investigational Site Number 840030

Houston, Texas, 77034, United States

Location

Investigational Site Number 840034

Chesapeake, Virginia, 23320, United States

Location

Investigational Site Number 036003

Hobart, 7001, Australia

Location

Investigational Site Number 036001

Malvern East, 3145, Australia

Location

Investigational Site Number 036004

Shenton Park, 6008, Australia

Location

Investigational Site Number 036002

Woolloongabba, 4102, Australia

Location

Investigational Site Number 040001

Graz, 8036, Austria

Location

Investigational Site Number 040002

Vienna, 1100, Austria

Location

Investigational Site Number 056003

Brussels, 1020, Belgium

Location

Investigational Site Number 056005

Genk, 3600, Belgium

Location

Investigational Site Number 056001

Ghent, 9000, Belgium

Location

Investigational Site Number 056002

Leuven, 3000, Belgium

Location

Investigational Site Number 056004

Liège, 4000, Belgium

Location

Investigational Site Number 124007

London, N6A 4V2, Canada

Location

Investigational Site Number 124004

Montreal, H2L 1S6, Canada

Location

Investigational Site Number 124008

Newmarket, L3Y 3R7, Canada

Location

Investigational Site Number 124003

Pointe-Claire, H9R 3Z2, Canada

Location

Investigational Site Number 124001

Québec, G1V 4R4, Canada

Location

Investigational Site Number 124006

Saskatoon, S7K 0H6, Canada

Location

Investigational Site Number 124005

Toronto, M5T 2S8, Canada

Location

Investigational Site Number 124009

Trois-Rivières, G8Z 1Y2, Canada

Location

Investigational Site Number 124002

Vancouver, V5Z 1L7, Canada

Location

Investigational Site Number 124010

Vancouver, V5Z 3Y1, Canada

Location

Investigational Site Number 203003

Brno, 63800, Czechia

Location

Investigational Site Number 203005

Hlučín, 74801, Czechia

Location

Investigational Site Number 203002

Hradec Králové, 50005, Czechia

Location

Investigational Site Number 203001

Prague, 12850, Czechia

Location

Investigational Site Number 203004

Uherské Hradiště, 68601, Czechia

Location

Investigational Site Number 250001

Besançon, 25030, France

Location

Investigational Site Number 250005

Bordeaux, 33076, France

Location

Investigational Site Number 250002

Créteil, 94010, France

Location

Investigational Site Number 250003

Paris, 75014, France

Location

Investigational Site Number 276002

Berlin, 12200, Germany

Location

Investigational Site Number 276004

Erlangen, 91054, Germany

Location

Investigational Site Number 276003

Frankfurt am Main, 60590, Germany

Location

Investigational Site Number 276005

Hamburg, 22081, Germany

Location

Investigational Site Number 276001

Herne, 44652, Germany

Location

Investigational Site Number 348001

Budapest, 1023, Hungary

Location

Investigational Site Number 348003

Debrecen, 4032, Hungary

Location

Investigational Site Number 348005

Sátoraljaújhely, 3980, Hungary

Location

Investigational Site Number 348004

Veszprém, 8200, Hungary

Location

Investigational Site Number 440001

Kaunas, LT-50009, Lithuania

Location

Investigational Site Number 440002

Vilnius, LT-08661, Lithuania

Location

Investigational Site Number 528001

Amsterdam, 1105 AZ, Netherlands

Location

Investigational Site Number 528002

Nijmegen, 6525 GA, Netherlands

Location

Investigational Site Number 616002

Bialystok, 15-354, Poland

Location

Investigational Site Number 616001

Krakow, 30-510, Poland

Location

Investigational Site Number 616004

Lublin, 20-607, Poland

Location

Investigational Site Number 616005

Torun, 87-100, Poland

Location

Investigational Site Number 616003

Warsaw, 02-637, Poland

Location

Investigational Site Number 724004

A Coruña, 15006, Spain

Location

Investigational Site Number 724005

Barcelona, 08907, Spain

Location

Investigational Site Number 724002

Madrid, 28007, Spain

Location

Investigational Site Number 724001

Seville, 41008, Spain

Location

Investigational Site Number 792002

Ankara, 06100, Turkey (Türkiye)

Location

Investigational Site Number 792001

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

• Sieper J, Braun J, Kay J, Badalamenti S, Radin AR, Jiao L, Fiore S, Momtahen T, Yancopoulos GD, Stahl N, Inman RD. Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN). Ann Rheum Dis. 2015 Jun;74(6):1051-7. doi: 10.1136/annrheumdis-2013-204963. Epub 2014 Feb 18.

  PMID: 24550171 RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

sarilumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 8, 2017
• Results First Posted: August 8, 2017

Record last verified: 2017-07

Locations

US (26); ES (4); BE (5); CA (10); CZ (5); LI (2); DE (5); NL (2); PL (5); AU (2); FR (4); TU (2); HU (4)