16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

NCT02008916 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457F23142013-001090-24
• Study Type: interventional
• Target: 226
• Locations: 10 countries
• Sites: 57

Brief Summary

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

Conditions

Spondylitis, Ankylosing

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response

  ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo.

  16 weeks

Secondary Outcomes (8)

• ASAS 40 Response

  16 weeks

• Serum hsCRP

  Baseline and 16 weeks

• ASAS 5/6 Response

  16 weeks

• Bath Ankylosing Spondylitis Disease Activity Index / BASDAI

  Baseline and 16 weeks

• Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)

  Week 8 and Week 12

Study Arms (3)

Secukinumab 10 mg/kg i.v. / 300 mg s.c.

EXPERIMENTAL

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Drug: Secukinumab

Secukinumab 10 mg/kg i.v. / 150 mg s.c.

EXPERIMENTAL

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Drug: Secukinumab

Placebo i.v. and s.c.

PLACEBO COMPARATOR

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Drug: Placebo secukinumab

Interventions

Secukinumab DRUG

AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).

Also known as: AIN457

Secukinumab 10 mg/kg i.v. / 150 mg s.c.; Secukinumab 10 mg/kg i.v. / 300 mg s.c.

Placebo secukinumab DRUG

Placebo to AIN457 (Secukinumab)

Placebo i.v. and s.c.

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 (57)

Novartis Investigative Site

Mobile, Alabama, 36604, United States

Location

Novartis Investigative Site

Mesa, Arizona, 85202, United States

Location

Novartis Investigative Site

Peoria, Arizona, 85381, United States

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Novartis Investigative Site

Upland, California, 91786, United States

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Novartis Investigative Site

Palm Harbor, Florida, 34684, United States

Location

Novartis Investigative Site

Pembroke Pines, Florida, 33026, United States

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Novartis Investigative Site

Passaic, New Jersey, 07055, United States

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Novartis Investigative Site

Albany, New York, 12206, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

Location

Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29460, United States

Location

Novartis Investigative Site

Jackson, Tennessee, 38305, United States

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Novartis Investigative Site

Austin, Texas, 78731, United States

Location

Novartis Investigative Site

Mesquite, Texas, 75150, United States

Location

Novartis Investigative Site

Aalst, 9300, Belgium

Location

Novartis Investigative Site

Brussels, 1070, Belgium

Location

Novartis Investigative Site

Uherské Hradiště, Czech Republic, 686 01, Czechia

Location

Novartis Investigative Site

Prague, 128 50, Czechia

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Novartis Investigative Site

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

Cottbus, 03042, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Erlangen, 91056, Germany

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Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Hamburg, 22081, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

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Novartis Investigative Site

Herne, 44649, Germany

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Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Magdeburg, 39110, Germany

Location

Novartis Investigative Site

München, 81541, Germany

Location

Novartis Investigative Site

Zerbst, 39261, Germany

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Novartis Investigative Site

Athens, GR, 115 27, Greece

Location

Novartis Investigative Site

Thessaloniki, GR, 564 29, Greece

Location

Novartis Investigative Site

Athens, 115 21, Greece

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Novartis Investigative Site

Athens, 115 27, Greece

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Novartis Investigative Site

Heraklion, 700 13, Greece

Location

Novartis Investigative Site

Torreón, Coahuila, 27000, Mexico

Location

Novartis Investigative Site

Mexicali, Estado de Baja California, 21100, Mexico

Location

Novartis Investigative Site

Culiacan, State of Mexico, 80000, Mexico

Location

Novartis Investigative Site

Almada, 2801 951, Portugal

Location

Novartis Investigative Site

Lisbon, 1050-034, Portugal

Location

Novartis Investigative Site

Lisbon, 1349-019, Portugal

Location

Novartis Investigative Site

Lisbon, 1649-035, Portugal

Location

Novartis Investigative Site

Kazan', 420097, Russia

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Saint Petersburg, 190068, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197022, Russia

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Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Santander, Cantabria, 39008, Spain

Location

Novartis Investigative Site

A Coruña, Galicia, 15006, Spain

Location

Novartis Investigative Site

El Palmar, Murcia, 30120, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Novartis Investigative Site

London, England, E11 1NR, United Kingdom

Location

Novartis Investigative Site

Norwich, NR4 7UY, United Kingdom

Location

Novartis Investigative Site

Torquay, TQ2 7AA, United Kingdom

Location

Related Publications (7)

• 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 AA, Miceli-Richard C, Baraliakos X, Marzo-Ortega H, Gladman DD, Blanco R, Das Gupta A, Martin R, Safi J Jr, Porter B, Shete A, Rosenbaum JT. Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies. ACR Open Rheumatol. 2020 May;2(5):294-299. doi: 10.1002/acr2.11139. Epub 2020 Apr 30.

  PMID: 32352653 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

• Pavelka K, Kivitz A, Dokoupilova E, Blanco R, Maradiaga M, Tahir H, Pricop L, Andersson M, Readie A, Porter B. Efficacy, safety, and tolerability of secukinumab in patients with active ankylosing spondylitis: a randomized, double-blind phase 3 study, MEASURE 3. Arthritis Res Ther. 2017 Dec 22;19(1):285. doi: 10.1186/s13075-017-1490-y.

  PMID: 29273067 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

Novartis.email@novartis.com

862-778-8300

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: December 8, 2013
• First Posted: December 11, 2013
• Study Start: January 14, 2014
• Primary Completion: February 23, 2015
• Study Completion: December 11, 2017
• Last Updated: January 8, 2019
• Results First Posted: December 12, 2018

Record last verified: 2018-12

Locations

PT (4); GB (3); US (14); BE (2); RU (4); ME (3); DE (14); ES (6); CZ (2); GR (5)