Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis

NCT04209205 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CAIN457P12302
• Study Type: interventional
• Target: 381
• Locations: 15 countries
• Sites: 80

Brief Summary

The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy.

Conditions

Psoriatic Arthritis

Keywords

Active Psoriatic Arthritis; Intravenous secukinumab; PsA

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With American College of Rheumatology 50 (ACR50) Response Comparison Between Treatment Groups Using Non-responder Imputation at Week 16 (Full Analysis Set)

  Percentage of participants with active psoriatic arthritis (PsA) who achieved an American College of Rheumatology 50 (ACR50) response The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)

  Baseline up to Week 16

Secondary Outcomes (10)

• Percentage of Participants With American College of Rheumatology 20 (ACR20) Response Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set)

  Baseline up to Week 16

• Percentage of Participants With Minimal Disease Activity (MDA 5/7) Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set)

  Baseline up to Week 16

• Percentage of Participants With Psoriasis Area and Severity Index 90 (PASi90) Score for Patients With a >= 3% Body Surface Area Psoriasis at Baseline Using On-responder Imputation at Week 16 (Full Analysis Set)

  Baseline up to Week 16

• Psoriatic Arthritis Disease Activity Score (PASDAS) Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)

  Baseline up to Week 16

• Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set)

  Baseline up to Week 16

Study Arms (2)

AIN457 6 mg/kg - 3 mg/kg i.v.

EXPERIMENTAL

AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).

Drug: AIN457 6 mg/kg i.v.; Drug: AIN457 3 mg/kg

Placebo

PLACEBO COMPARATOR

Matching placebo from baseline to Week 16 and switch to AIN457 3mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).

Drug: Placebo

Interventions

AIN457 6 mg/kg i.v. DRUG

AIN457 6 mg/kg delivered by i.v. infusion

Also known as: secukinumab

AIN457 6 mg/kg - 3 mg/kg i.v.

Placebo DRUG

Matching placebo to AIN457 i.v. infusion

Placebo

AIN457 3 mg/kg DRUG

AIN457 3 mg/kg delivered by i.v. infusion

Also known as: secukinumab

AIN457 6 mg/kg - 3 mg/kg i.v.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Patients eligible for inclusion in this study had to fulfill all of the following criteria: * Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each) * Rheumatoid factor and anti-CCP antibodies negative at screening * Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or documented history of plaque psoriasis * Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs * Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 16 * Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52. Patients fulfilling any of the following criteria are not eligible for inclusion in this study: * Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician * Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) * Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor * Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. The following wash-out periods need to be observed: * Oral or topical retinoids- 4 weeks * Photochemotherapy (e.g. PUVA)- 4 weeks * Phototherapy (UVA or UVB)- 2 weeks * Topical skin treatments (except in face, eyes, scalp and genital area during screening, only corticosteroids with mild to moderate potency)- 2 weeks * Any intramuscular or intravenous corticosteroid treatment within 4 weeks before randomization. * Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before randomization. * Subjects who have previously been treated with more than 3 different TNF inhibitors (investigational or approved). * Subjects who have ever received biologic immunomodulating agents, investigational or approved except for those targeting TNFα. * Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (80)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

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Novartis Investigative Site

Fountain Valley, California, 92708, United States

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Novartis Investigative Site

Fullerton, California, 92835, United States

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Novartis Investigative Site

La Mesa, California, 91942, United States

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Novartis Investigative Site

Santa Monica, California, 90404, United States

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Novartis Investigative Site

Upland, California, 91786, United States

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Novartis Investigative Site

Van Nuys, California, 91405, United States

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Novartis Investigative Site

West Hills, California, 91307, United States

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Novartis Investigative Site

Denver, Colorado, 80230, United States

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Novartis Investigative Site

Clearwater, Florida, 33765, United States

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Novartis Investigative Site

Miami, Florida, 33032, United States

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Novartis Investigative Site

Ocoee, Florida, 34761, United States

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Novartis Investigative Site

Plantation, Florida, 33324, United States

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Novartis Investigative Site

Tampa, Florida, 33624, United States

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Novartis Investigative Site

Winter Park, Florida, 32789, United States

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Novartis Investigative Site

Marietta, Georgia, 30060, United States

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Novartis Investigative Site

Indianapolis, Indiana, 46256, United States

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Novartis Investigative Site

Bowling Green, Kentucky, 42101, 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

Voorhees Township, New Jersey, 08043, United States

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Novartis Investigative Site

Rochester, New York, 14642, United States

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Novartis Investigative Site

Greensboro, North Carolina, 27408, United States

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Novartis Investigative Site

Middleburg Heights, Ohio, 44130, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

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Novartis Investigative Site

Tulsa, Oklahoma, 74136, United States

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Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

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Novartis Investigative Site

Jackson, Tennessee, 38305, United States

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Novartis Investigative Site

Austin, Texas, 78731, United States

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Novartis Investigative Site

Mesquite, Texas, 75150, United States

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Novartis Investigative Site

Newport News, Virginia, 23608, United States

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Novartis Investigative Site

Salvador, Estado de Bahia, 40150 150, Brazil

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Novartis Investigative Site

São Paulo, São Paulo, 04266 010, Brazil

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Novartis Investigative Site

Burgas, 8000, Bulgaria

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Novartis Investigative Site

Plovdiv, 4000, Bulgaria

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Novartis Investigative Site

Plovdiv, 4002, Bulgaria

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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

Barranquilla, Atlántico, 080002, Colombia

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Novartis Investigative Site

Bucaramanga, Santander Department, 0001, Colombia

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Novartis Investigative Site

Bogotá, 110221, Colombia

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Novartis Investigative Site

Cundinamarca, 111121, Colombia

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Novartis Investigative Site

Prague, 128 50, Czechia

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Novartis Investigative Site

Prague, 140 59, Czechia

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Novartis Investigative Site

Prague, 150 06, Czechia

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Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

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Novartis Investigative Site

Athens, 12462, Greece

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Novartis Investigative Site

Thessaloniki, 54622, Greece

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Novartis Investigative Site

Guatemala City, 01001, Guatemala

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Novartis Investigative Site

Guatemala City, 01010, Guatemala

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Novartis Investigative Site

Surat, Gujarat, 395009, India

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Novartis Investigative Site

Bangalore, Karnataka, 560 079, India

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Novartis Investigative Site

Nashik, Maharashtra, 422 101, India

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Novartis Investigative Site

New Delhi, 110029, India

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Novartis Investigative Site

Seremban, Negeri Sembilan, 70300, Malaysia

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Novartis Investigative Site

Kuching, Sarawak, 93586, Malaysia

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Novartis Investigative Site

Selangor Darul Ehsan, 68100, Malaysia

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Novartis Investigative Site

Lipa City, Batangas, 4217, Philippines

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Novartis Investigative Site

Dasmariñas, Cavite, 4114, Philippines

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Novartis Investigative Site

Manila, 1008, Philippines

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Novartis Investigative Site

Quezon City, 1102, Philippines

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Novartis Investigative Site

Krakow, Lesser Poland Voivodeship, 30-510, Poland

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Novartis Investigative Site

Karwiany, 52-200, Poland

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Novartis Investigative Site

Krakow, 30 002, Poland

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Novartis Investigative Site

Sochaczew, 96-500, Poland

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Novartis Investigative Site

Warsaw, 02-962, Poland

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Novartis Investigative Site

Kemerovo, 650029, Russia

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Novartis Investigative Site

Nizhny Novgorod, 603018, Russia

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Novartis Investigative Site

Rostov-on-Don, 344022, Russia

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Novartis Investigative Site

Saint Petersburg, 190068, Russia

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Novartis Investigative Site

Saint Petersburg, 197022, Russia

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Novartis Investigative Site

Yaroslavl, 150003, Russia

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Novartis Investigative Site

Yekaterinburg, 620109, Russia

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Novartis Investigative Site

Panorama, Western Cape, 7500, South Africa

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Novartis Investigative Site

Stellenbosch, 7600, South Africa

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Novartis Investigative Site

Bangkoknoi, Bangkok, 10700, Thailand

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Novartis Investigative Site

Songkhla, Hat Yai, 90110, Thailand

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Novartis Investigative Site

Khon Kaen, THA, 40002, Thailand

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Novartis Investigative Site

Bangkok, 10400, Thailand

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Novartis Investigative Site

Bursa, Gorukle, 16059, Turkey (Türkiye)

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

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

+ 1 862 778 8300

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
• Masking Details: This was a double-blind, randomized treatment trial. Subjects, investigator staff, persons performing the assessments remained blinded to the identity of the treatment from the time of randomization until Week 60 database lock, using the following methods: 1. Randomization data were kept strictly confidential until the time of unblinding and were not accessible by anyone else involved in the study with the exception of the bioanalyst. 2. The identity of the treatments were concealed by the use of study treatments in the form of i.v. injection, filled with secukinumab or placebo that were identical in appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: December 24, 2019
• Study Start: January 29, 2020
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: May 16, 2025
• Results First Posted: April 26, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

GU (2); CZ (4); TH (4); PH (4); GR (2); CO (4); PL (5); ZA (2); IN (4); RU (7); TU (1); BR (2); US (31); BU (5); MY (3)