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

NCT02294227 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457F23362014-003849-10
• Study Type: interventional
• Target: 341
• Locations: 13 countries
• Sites: 64

Brief Summary

The purpose of this study was 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 PsA despite current or previous NSAID or DMARD therapy

Conditions

Arthritis, Psoriatic

Keywords

AIN457; psoriatic arthritis; chronic inflammatory disease; loading regimen; secukinumab; self-injection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With American College of Rheumatology 20 (ACR20) Response

  The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.

  16 weeks

Secondary Outcomes (5)

• Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16

  week 16

• Psoriatic Area and Severity Index 75 (PASI75)

  16 weeks

• Short Form Health Survey Physical Component Score (SF-36-PCS)

  16 weeks

• Number of Participants With American College of Rheumatology 50 (ACR50)

  16 weeks

• Number of Participants With American College of Rheumatology 20 (ACR20) Response

  4 weeks

Study Arms (3)

Secukinumab 150 mg

EXPERIMENTAL

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. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator

Biological: Secukinumab

Secukinumab 150 mg No load

EXPERIMENTAL

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. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator

Biological: Secukinumab

Placebo

PLACEBO COMPARATOR

Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator

Other: Placebo

Interventions

Secukinumab BIOLOGICAL

Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.

Secukinumab 150 mg; Secukinumab 150 mg No load

Placebo OTHER

Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.

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 (64)

Novartis Investigative Site

Mesa, Arizona, 85202, United States

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Novartis Investigative Site

Upland, California, 91786, United States

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Novartis Investigative Site

Denver, Colorado, 80230, United States

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Novartis Investigative Site

Palm Harbor, Florida, 34684, United States

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Novartis Investigative Site

Sarasota, Florida, 34239, United States

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Novartis Investigative Site

Peoria, Illinois, 61602, United States

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Novartis Investigative Site

Shreveport, Louisiana, 71101, United States

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Novartis Investigative Site

Saint Clair Shores, Michigan, 48081, United States

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Novartis Investigative Site

St Louis, Missouri, 63117, United States

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Novartis Investigative Site

Lincoln, Nebraska, 68516, United States

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Novartis Investigative Site

Albany, New York, 12206, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

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Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

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Novartis Investigative Site

Charleston, South Carolina, 29460, United States

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Novartis Investigative Site

Greenville, South Carolina, 29601, United States

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Novartis Investigative Site

Mesquite, Texas, 75150, United States

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Novartis Investigative Site

Burlington, Vermont, 05401, United States

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Novartis Investigative Site

Seattle, Washington, 98104, United States

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Novartis Investigative Site

Seattle, Washington, 98122, United States

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Novartis Investigative Site

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

Aalst, 9300, Belgium

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Novartis Investigative Site

Brussels, 1070, Belgium

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Novartis Investigative Site

Brussels, 1200, Belgium

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Novartis Investigative Site

Yvoir, 5530, Belgium

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Novartis Investigative Site

Plovdiv, 4000, Bulgaria

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Novartis Investigative Site

Sofia, 1431, Bulgaria

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Novartis Investigative Site

Victoria, British Columbia, V8V 3M9, Canada

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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

Bruntál, Czech Republic, 792 01, Czechia

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Novartis Investigative Site

Hlučín, Czech Republic, 748 01, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 128 50, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 140 00, Czechia

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Novartis Investigative Site

Uherské Hradiště, Czech Republic, 686 01, Czechia

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Novartis Investigative Site

Le Mans, 72037, France

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Novartis Investigative Site

Montpellier, 34195, France

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Frankfurt am Main, 60528, Germany

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Novartis Investigative Site

Göttingen, 37075, Germany

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Novartis Investigative Site

Hamburg, 20095, Germany

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Novartis Investigative Site

Hamburg, 22415, Germany

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Novartis Investigative Site

Herne, 44649, Germany

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Novartis Investigative Site

Magdeburg, 39110, Germany

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Novartis Investigative Site

Nienburg, 31582, Germany

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Novartis Investigative Site

Rozzano, MI, 20089, Italy

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Novartis Investigative Site

Verona, VR, 37126, Italy

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Novartis Investigative Site

Bologna, 40138, Italy

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Novartis Investigative Site

Bialystok, 15-461, Poland

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Novartis Investigative Site

Dopiewo, 62 069, Poland

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Novartis Investigative Site

Elblag, 82-300, Poland

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Novartis Investigative Site

Lodz, 90-265, Poland

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Novartis Investigative Site

Poznan, 60-218, Poland

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Novartis Investigative Site

Poznan, 61 113, Poland

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Novartis Investigative Site

Petrozavodsk, 185019, Russia

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Novartis Investigative Site

Saint Petersburg, 190068, 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

Yekaterinburg, 620035, Russia

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Novartis Investigative Site

Stockholm, SE-17176, Sweden

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Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

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Related Publications (3)

• 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

• Kivitz AJ, Nash P, Tahir H, Everding A, Mann H, Kaszuba A, Pellet P, Widmer A, Pricop L, Abrams K. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatol Ther. 2019 Sep;6(3):393-407. doi: 10.1007/s40744-019-0163-5. Epub 2019 Jun 21.

  PMID: 31228101 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

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: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

+1 (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 17, 2014
• First Posted: November 19, 2014
• Study Start: May 29, 2015
• Primary Completion: February 16, 2016
• Study Completion: December 19, 2017
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Locations

IT (3); BU (2); CA (4); FR (2); DE (8); RU (5); AU (4); BE (4); CZ (5); PL (6); US (19); GB (1); SE (1)