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

NCT ID: NCT02159053

Last Updated: 2019-04-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-18

Study Completion Date

2018-01-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Spondylitis, Ankylosing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Secukinumab 150 mg s.c. with loading

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

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

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

Secukinumab 150 mg s.c. without loading

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

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

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

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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Secukinumab

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

Intervention Type BIOLOGICAL

Secukinumab

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Secukinumab (AIN457) 150 mg s.c. Secukinumab (AIN457) 150 mg s.c.

Eligibility Criteria

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Inclusion Criteria

Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs.

Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.

Other protocol-defined inclusion/exclusion criteria do apply.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Anniston, Alabama, United States

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Upland, California, United States

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Aventura, Florida, United States

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Peoria, Illinois, United States

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Shreveport, Louisiana, United States

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Lincoln, Nebraska, United States

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Voorhees Township, New Jersey, United States

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Oklahoma City, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Columbia, South Carolina, United States

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Mesquite, Texas, United States

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Seattle, Washington, United States

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Kogarah, New South Wales, Australia

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Maroochydore, Queensland, Australia

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Hobart, Tasmania, Australia

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Malvern East, Victoria, Australia

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Graz, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Targovishte, , Bulgaria

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Winnipeg, Manitoba, Canada

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Pointe-Claire, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Ostrava, Czech Republic, Czechia

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Prague, Czech Republic, Czechia

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Prague, Czech Republic, Czechia

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Uherské Hradiště, Czech Republic, Czechia

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Frederiksberg, , Denmark

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Odense, , Denmark

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Hyvinkää, , Finland

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Jyväskylä, , Finland

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Göttingen, Lower Saxony, Germany

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Bad Doberan, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Chemnitz, , Germany

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Erlangen, , Germany

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Germering, , Germany

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Hamburg, , Germany

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Herne, , Germany

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Leipzig, , Germany

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Magdeburg, , Germany

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München, , Germany

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Würzburg, , Germany

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Athens, , Greece

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Athens, , Greece

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Pátrai, , Greece

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Genova, GE, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Torino, TO, Italy

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Verona, VR, Italy

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Amsterdam, , Netherlands

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Heerlen, , Netherlands

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Leiden, , Netherlands

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Rotterdam, , Netherlands

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Kongsvinger, , Norway

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Bialystok, , Poland

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Elblag, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Barnaul, , Russia

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Barnaul, , Russia

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Kemerovo, , Russia

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S.-Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Piešťany, SVK, Slovakia

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Partizánske, , Slovakia

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Sabinov, , Slovakia

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Stará Ľubovňa, , Slovakia

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Topoľčany, , Slovakia

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Córdoba, Andalusia, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Santander, Cantabria, Spain

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A Coruña, Galicia, Spain

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Santiago de Compostela, Galicia, Spain

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Barakaldo, Vizcaya, Spain

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Madrid, , Spain

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Fribourg, , Switzerland

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Sankt Gallen, , Switzerland

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Leytonstone, London, United Kingdom

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Doncaster, , United Kingdom

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Wolverhampton, , United Kingdom

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Countries

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United States Australia Austria Bulgaria Canada Czechia Denmark Finland Germany Greece Italy Netherlands Norway Poland Russia Slovakia Spain Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35305260 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34773130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34618347 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33722947 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31203228 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30121827 (View on PubMed)

Related Links

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http://www.novartisclinicaltrials.com

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.

Other Identifiers

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2013-005575-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457F2320

Identifier Type: -

Identifier Source: org_study_id

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