24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

NCT01989468 | Completed Phase 3 Results

• 2 other identifiers: CAIN457F23182013-004002-25
• Study Type: interventional
• Target: 414
• Locations: 13 countries
• Sites: 77

Brief Summary

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis; AIN457; PsA; ACR; CASPAR; PASDAS; secukinumab; autoinjector

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24

  A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]

  Week 24

Secondary Outcomes (9)

• Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24

  Week 24

• Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24

  Week 24

• Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24

  Week 24

• Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24

  Week 24

• Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24

  Week 24

Study Arms (3)

Secukinumab (AIN457) 150 mg s.c.

EXPERIMENTAL

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

Biological: Secukinumab

Secukinumab (AIN457) 300 mg s.c.

EXPERIMENTAL

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

Biological: Secukinumab

Placebo

PLACEBO COMPARATOR

Matching Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.

Biological: Placebo

Interventions

Secukinumab BIOLOGICAL

Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)

Also known as: Secukinumab 150 mg, Secukinumab 300 mg

Secukinumab (AIN457) 150 mg s.c.; Secukinumab (AIN457) 300 mg s.c.

Placebo BIOLOGICAL

Secukinumab placebo provided in 1 mL autoinjector

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
• Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
• Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
• Inadequate control of symptoms with NSAID.

You may not qualify if:

• Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
• Subjects taking high potency opioid analgesics.
• Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
• Ongoing use of prohibited psoriasis treatments / medications.
• Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
• Previous treatment with any cell-depleting therapies.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (77)

Novartis Investigative Site

Aventura, Florida, 33180, United States

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Novartis Investigative Site

Palm Harbor, Florida, 34684, United States

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Sarasota, Florida, 34239, United States

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Indianapolis, Indiana, 46256, United States

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Bowling Green, Kentucky, 42101, United States

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St Louis, Missouri, 63117, United States

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Novartis Investigative Site

Freehold, New Jersey, 07728, United States

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Albany, New York, 12206, United States

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Duncansville, Pennsylvania, 16635, United States

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Austin, Texas, 78731, United States

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Mesquite, Texas, 75150, United States

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Wenatchee, Washington, 98801, United States

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Kogarah, New South Wales, 2217, Australia

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Novartis Investigative Site

Maroochydore, Queensland, 4558, Australia

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Novartis Investigative Site

Hobart, Tasmania, 7000, Australia

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Novartis Investigative Site

Malvern East, Victoria, 3145, Australia

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Novartis Investigative Site

Sofia, 1413, 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

Veliko Tarnovo, 5000, Bulgaria

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Novartis Investigative Site

Victoria, British Columbia, V8V 3M9, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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Novartis Investigative Site

Toronto, Ontario, M9W 4L6, Canada

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Novartis Investigative Site

Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Novartis Investigative Site

Bruntál, Czech Republic, 792 01, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 128 50, Czechia

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Novartis Investigative Site

Uherské Hradiště, Czech Republic, 686 01, Czechia

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Novartis Investigative Site

Aachen, 52064, Germany

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Novartis Investigative Site

Berlin, 10117, 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

Gommern, 39245, Germany

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Novartis Investigative Site

Hamburg, 20095, Germany

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Novartis Investigative Site

Hamburg, 22081, Germany

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Novartis Investigative Site

Hamburg, 22415, Germany

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Novartis Investigative Site

Hanover, 30625, Germany

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Novartis Investigative Site

Hildesheim, 31134, Germany

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Novartis Investigative Site

Magdeburg, 39110, Germany

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Novartis Investigative Site

Zerbst, 39261, Germany

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Novartis Investigative Site

Bologna, BO, 40138, Italy

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Novartis Investigative Site

Catania, CT, 95100, Italy

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Novartis Investigative Site

Genova, GE, 16132, Italy

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Novartis Investigative Site

Rozzano, MI, 20089, Italy

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Novartis Investigative Site

Reggio Emilia, RE, 42123, Italy

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Novartis Investigative Site

Torino, TO, 10128, Italy

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Novartis Investigative Site

Verona, VR, 37126, 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

Rotterdam, 3079 DZ, Netherlands

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Novartis Investigative Site

Caguas, 00725, Puerto Rico

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Novartis Investigative Site

Ponce, 00716, Puerto Rico

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Novartis Investigative Site

Chelyabinsk, 454076, Russia

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Novartis Investigative Site

Moscow, 115522, Russia

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Novartis Investigative Site

Rostov-on-Don, 344022, Russia

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Novartis Investigative Site

Saratov, 410053, Russia

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Novartis Investigative Site

Sestroretsk, 197706, Russia

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Novartis Investigative Site

Yaroslavl, 150003, Russia

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Novartis Investigative Site

Yekaterinburg, 620028, Russia

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Novartis Investigative Site

Seville, Andalusia, 41009, Spain

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Novartis Investigative Site

Santander, Cantabria, 39008, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

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Novartis Investigative Site

A Coruña, Galicia, 15006, 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

London, England, E11 1NR, United Kingdom

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Novartis Investigative Site

Salford, Manchester, M6 8HD, United Kingdom

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Novartis Investigative Site

Cannock, Staffordshire, WS11 2XY, United Kingdom

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Novartis Investigative Site

Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom

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Novartis Investigative Site

Barnsley, S75 2EP, United Kingdom

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Novartis Investigative Site

Eastbourne, BN21 2UD, United Kingdom

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Novartis Investigative Site

Harrogate, HG2 7SX, United Kingdom

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Novartis Investigative Site

Hull, HU3 2JZ, United Kingdom

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Novartis Investigative Site

London, NW3 2QG, United Kingdom

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Novartis Investigative Site

London, SE1 9RT, United Kingdom

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Novartis Investigative Site

Manchester, M23 9LT, United Kingdom

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Novartis Investigative Site

Torquay, TQ2 7AA, United Kingdom

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Novartis Investigative Site

Tyne and Wear, NE29 8NH, United Kingdom

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Related Publications (5)

• Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.

  PMID: 38446397 DERIVED

• Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.

  PMID: 34795065 DERIVED

• Coates LC, Wallman JK, McGonagle D, Schett GA, McInnes IB, Mease PJ, Rasouliyan L, Quebe-Fehling E, Asquith DL, Fasth AER, Pricop L, Gaillez C. Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies. Arthritis Res Ther. 2019 Dec 4;21(1):266. doi: 10.1186/s13075-019-2055-z.

  PMID: 31801620 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

• Nash P, Mease PJ, McInnes IB, Rahman P, Ritchlin CT, Blanco R, Dokoupilova E, Andersson M, Kajekar R, Mpofu S, Pricop L; FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018 Mar 15;20(1):47. doi: 10.1186/s13075-018-1551-x.

  PMID: 29544534 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

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: November 7, 2013
• First Posted: November 21, 2013
• Study Start: April 10, 2014
• Primary Completion: May 27, 2015
• Study Completion: March 28, 2018
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-04

Locations

CA (4); DE (12); NL (3); PR (2); BU (4); RU (7); IT (7); AU (4); ES (4); CH (2); GB (13); CZ (3); US (12)