16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis

NCT02159053 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457F23202013-005575-41
• Study Type: interventional
• Target: 350
• Locations: 18 countries
• Sites: 87

Brief Summary

The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.

Conditions

Spondylitis, Ankylosing

Keywords

AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, secukinumab, self-injection

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks

  ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20 percent (%) and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include: 1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)

  16 Weeks

Secondary Outcomes (9)

• Percentage of Participants Responded for ASAS 40 Response at 16 Weeks

  16 Weeks

• Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks

  Baseline, 16 Weeks

• Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks

  16 Weeks

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks

  Baseline, 16 Weeks

• Change From Baseline in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)

  Baseline, 16 Weeks

Study Arms (3)

Secukinumab 150 mg s.c. with loading

EXPERIMENTAL

Secukinumab 150 mg at Baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.

Biological: Secukinumab

Secukinumab 150 mg s.c. without loading

EXPERIMENTAL

Secukinumab 150 mg at Baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2, and 3.

Biological: Secukinumab

Placebo

PLACEBO COMPARATOR

Placebo at Baseline, Weeks 1, 2, 3, 4, 8, and 12, followed by dosing with Secukinumab 150 mg every four weeks starting at Week 16.

Biological: Placebo

Interventions

Secukinumab BIOLOGICAL

Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Also known as: Secukinumab (AIN457) 150 mg s.c.

Secukinumab 150 mg s.c. with loading

Placebo BIOLOGICAL

Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Placebo

Eligibility Criteria

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (90)

Novartis Investigative Site

Anniston, Alabama, 36207-5710, United States

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Novartis Investigative Site

Upland, California, 91786, United States

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Aventura, Florida, 33180, United States

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Peoria, Illinois, 61602, United States

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Shreveport, Louisiana, 71101, United States

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Lincoln, Nebraska, 68516, United States

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Voorhees Township, New Jersey, 08043, United States

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Oklahoma City, Oklahoma, 73103, United States

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Duncansville, Pennsylvania, 16635, United States

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Columbia, South Carolina, 29204, United States

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Mesquite, Texas, 75150, United States

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Seattle, Washington, 98101, United States

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Kogarah, New South Wales, 2217, Australia

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Maroochydore, Queensland, 4558, Australia

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Hobart, Tasmania, 7000, Australia

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Malvern East, Victoria, 3145, Australia

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Graz, 8036, Austria

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Vienna, 1100, Austria

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Vienna, A-1060, Austria

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Novartis Investigative Site

Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Novartis Investigative Site

Sofia, 1431, Bulgaria

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Novartis Investigative Site

Sofia, 1505, Bulgaria

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Novartis Investigative Site

Targovishte, 7700, Bulgaria

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Novartis Investigative Site

Winnipeg, Manitoba, R3A 1M1, Canada

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Novartis Investigative Site

Pointe-Claire, Quebec, H9R 3J1, Canada

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Novartis Investigative Site

Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Novartis Investigative Site

Ostrava, Czech Republic, 772 00, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 128 50, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 148 00, Czechia

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Novartis Investigative Site

Uherské Hradiště, Czech Republic, 686 01, Czechia

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Novartis Investigative Site

Frederiksberg, 2000, Denmark

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Novartis Investigative Site

Odense, 5000 C, Denmark

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Novartis Investigative Site

Hyvinkää, 05800, Finland

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Novartis Investigative Site

Jyväskylä, FIN-40620, Finland

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Novartis Investigative Site

Göttingen, Lower Saxony, 37075, Germany

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Bad Doberan, 18209, Germany

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Novartis Investigative Site

Berlin, 12203, Germany

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Novartis Investigative Site

Berlin, 13125, Germany

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Novartis Investigative Site

Chemnitz, 09130, Germany

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Novartis Investigative Site

Erlangen, 91056, Germany

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Novartis Investigative Site

Germering, 82110, Germany

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Novartis Investigative Site

Hamburg, 20095, Germany

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Novartis Investigative Site

Herne, 44649, Germany

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Leipzig, 04103, Germany

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Novartis Investigative Site

Magdeburg, 39110, Germany

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Novartis Investigative Site

München, 81541, Germany

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Novartis Investigative Site

Würzburg, 97080, Germany

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Novartis Investigative Site

Athens, 12462, Greece

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Novartis Investigative Site

Athens, 16673, Greece

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Novartis Investigative Site

Pátrai, 26504, Greece

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Novartis Investigative Site

Genova, GE, 16132, Italy

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Novartis Investigative Site

Milan, MI, 20100, Italy

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Torino, TO, 10126, Italy

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Novartis Investigative Site

Verona, VR, 37134, Italy

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Novartis Investigative Site

Amsterdam, 1105 AZ, Netherlands

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Novartis Investigative Site

Heerlen, 6419 PC, Netherlands

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Novartis Investigative Site

Leiden, 2333 ZA, Netherlands

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Novartis Investigative Site

Rotterdam, 3079 DZ, Netherlands

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Novartis Investigative Site

Kongsvinger, 2212, Norway

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Novartis Investigative Site

Bialystok, 15-351, Poland

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Novartis Investigative Site

Elblag, 82-300, Poland

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Novartis Investigative Site

Poznan, 60-218, Poland

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Novartis Investigative Site

Poznan, 60-702, Poland

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Novartis Investigative Site

Poznan, 61 113, Poland

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Novartis Investigative Site

Warsaw, 04 141, Poland

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Novartis Investigative Site

Barnaul, 656024, Russia

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Novartis Investigative Site

Barnaul, 656050, Russia

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Novartis Investigative Site

Kemerovo, 650000, Russia

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Novartis Investigative Site

S.-Petersburg, 192242, Russia

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Novartis Investigative Site

Saint Petersburg, 197022, Russia

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Novartis Investigative Site

Saint Petersburg, 197341, Russia

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Novartis Investigative Site

Piešťany, SVK, 921 12, Slovakia

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Novartis Investigative Site

Partizánske, 95801, Slovakia

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Novartis Investigative Site

Sabinov, 08301, Slovakia

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Novartis Investigative Site

Stará Ľubovňa, 06401, Slovakia

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Novartis Investigative Site

Topoľčany, 95501, Slovakia

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Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

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Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Novartis Investigative Site

Santander, Cantabria, 39008, Spain

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Novartis Investigative Site

A Coruña, Galicia, 15006, Spain

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Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

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Novartis Investigative Site

Barakaldo, Vizcaya, 48903, Spain

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Novartis Investigative Site

Madrid, 28222, Spain

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Novartis Investigative Site

Fribourg, 1708, Switzerland

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Novartis Investigative Site

Sankt Gallen, CH 9007, Switzerland

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Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

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Novartis Investigative Site

Doncaster, DN2 5LT, United Kingdom

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Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (6)

• Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

  PMID: 35305260 DERIVED

• Dougados M, Kiltz U, Kivitz A, Pavelka K, Rohrer S, McCreddin S, Quebe-Fehling E, Porter B, Talloczy Z. Nonsteroidal anti-inflammatory drug-sparing effect of secukinumab in patients with radiographic axial spondyloarthritis: 4-year results from the MEASURE 2, 3 and 4 phase III trials. Rheumatol Int. 2022 Feb;42(2):205-213. doi: 10.1007/s00296-021-05044-6. Epub 2021 Nov 13.

  PMID: 34773130 DERIVED

• van der Horst-Bruinsma I, Miceli-Richard C, Braun J, Marzo-Ortega H, Pavelka K, Kivitz AJ, Deodhar A, Bao W, Porter B, Pournara E. A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis. Rheumatol Ther. 2021 Dec;8(4):1775-1787. doi: 10.1007/s40744-021-00380-2. Epub 2021 Oct 7.

  PMID: 34618347 DERIVED

• Schett G, Baraliakos X, Van den Bosch F, Deodhar A, Ostergaard M, Gupta AD, Mpofu S, Fox T, Winseck A, Porter B, Shete A, Gensler LS. Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies. J Rheumatol. 2021 Aug;48(8):1251-1258. doi: 10.3899/jrheum.201111. Epub 2021 Mar 15.

  PMID: 33722947 DERIVED

• Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.

  PMID: 31203228 DERIVED

• Kivitz AJ, Wagner U, Dokoupilova E, Supronik J, Martin R, Talloczy Z, Richards HB, Porter B. Efficacy and Safety of Secukinumab 150 mg with and Without Loading Regimen in Ankylosing Spondylitis: 104-week Results from MEASURE 4 Study. Rheumatol Ther. 2018 Dec;5(2):447-462. doi: 10.1007/s40744-018-0123-5. Epub 2018 Aug 18.

  PMID: 30121827 DERIVED

Related Links

• Introduction to clinical trials conducted by Novartis and to results of completed studies, with the aim of increasing the transparency of Novartis clinical research and making publicly available objective scientific information in a standardised format.

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

8627788300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: June 9, 2014
• Study Start: May 18, 2015
• Primary Completion: February 23, 2016
• Study Completion: January 2, 2018
• Last Updated: April 10, 2019
• Results First Posted: April 10, 2019

Record last verified: 2018-11

Locations

BU (5); DE (13); GR (3); AU (4); CZ (4); US (12); CA (3); NO (1); RU (6); DK (2); NL (4); SL (5); IT (5); PL (6); FI (2); CH (2); GB (3); ES (7)