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

NCT ID: NCT04209205

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-29
• Study Completion Date: 2022-05-17

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.

Detailed Description

This multicenter study used a randomized, double-blind, placebo-controlled, parallel-group design. A screening (SCR) period running up to 10 weeks before randomization was used to assess subject eligibility followed by a treatment period of 52 weeks.

At baseline, 381 patients with active psoriatic arthritis were randomized to one of the two treatment groups in a 1:1 randomization:

Group 1: Approximately 190 patients with active psoriatic arthritis; These patients received secukinumab 6 mg/kg i.v. at BSL, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4.

Group 2: Approximately 190 patients with active psoriatic arthritis; These patients received i.v. placebo at BSL and at Weeks 4, 8, and 12, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 16.

Study consisted of 4 periods: a screening period (up to 10 weeks), treatment period 1 (total duration of 16 weeks) and treatment period 2 (total duration of 36 weeks) followed by a safety follow up period of 8 weeks after the end of treatment visit (i.e., Week 52).

Primary endpoint analysis will be performed with Week 16 data (last patient completing Treatment period 1 (Week 16). Long-term efficacy and safety assessments will be performed up to Week 52.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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).

Group Type: EXPERIMENTAL

AIN457 6 mg/kg i.v.

Intervention Type: DRUG

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

AIN457 3 mg/kg

Intervention Type: DRUG

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

Placebo

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to AIN457 i.v. infusion

Interventions

AIN457 6 mg/kg i.v.

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

Intervention Type: DRUG

Placebo

Matching placebo to AIN457 i.v. infusion

Intervention Type: DRUG

AIN457 3 mg/kg

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

Intervention Type: DRUG

Other Intervention Names

secukinumab; secukinumab

Eligibility Criteria

Inclusion 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Fountain Valley, California, United States

Novartis Investigative Site

Fullerton, California, United States

Novartis Investigative Site

La Mesa, California, United States

Novartis Investigative Site

Santa Monica, California, United States

Novartis Investigative Site

Upland, California, United States

Novartis Investigative Site

Van Nuys, California, United States

Novartis Investigative Site

West Hills, California, United States

Novartis Investigative Site

Denver, Colorado, United States

Novartis Investigative Site

Clearwater, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Ocoee, Florida, United States

Novartis Investigative Site

Plantation, Florida, United States

Novartis Investigative Site

Tampa, Florida, United States

Novartis Investigative Site

Winter Park, Florida, United States

Novartis Investigative Site

Marietta, Georgia, United States

Novartis Investigative Site

Indianapolis, Indiana, United States

Novartis Investigative Site

Bowling Green, Kentucky, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Lincoln, Nebraska, United States

Novartis Investigative Site

Voorhees Township, New Jersey, United States

Novartis Investigative Site

Rochester, New York, United States

Novartis Investigative Site

Greensboro, North Carolina, United States

Novartis Investigative Site

Middleburg Heights, Ohio, United States

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Novartis Investigative Site

Tulsa, Oklahoma, United States

Novartis Investigative Site

Duncansville, Pennsylvania, United States

Novartis Investigative Site

Jackson, Tennessee, United States

Novartis Investigative Site

Austin, Texas, United States

Novartis Investigative Site

Mesquite, Texas, United States

Novartis Investigative Site

Newport News, Virginia, United States

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Burgas, , Bulgaria

Novartis Investigative Site

Plovdiv, , Bulgaria

Novartis Investigative Site

Plovdiv, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Novartis Investigative Site

Bogotá, , Colombia

Novartis Investigative Site

Cundinamarca, , Colombia

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Uherské Hradiště, , Czechia

Novartis Investigative Site

Athens, , Greece

Novartis Investigative Site

Thessaloniki, , Greece

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Surat, Gujarat, India

Novartis Investigative Site

Bangalore, Karnataka, India

Novartis Investigative Site

Nashik, Maharashtra, India

Novartis Investigative Site

New Delhi, , India

Novartis Investigative Site

Seremban, Negeri Sembilan, Malaysia

Novartis Investigative Site

Kuching, Sarawak, Malaysia

Novartis Investigative Site

Selangor Darul Ehsan, , Malaysia

Novartis Investigative Site

Lipa City, Batangas, Philippines

Novartis Investigative Site

Dasmariñas, Cavite, Philippines

Novartis Investigative Site

Manila, , Philippines

Novartis Investigative Site

Quezon City, , Philippines

Novartis Investigative Site

Krakow, Lesser Poland Voivodeship, Poland

Novartis Investigative Site

Karwiany, , Poland

Novartis Investigative Site

Krakow, , Poland

Novartis Investigative Site

Sochaczew, , Poland

Novartis Investigative Site

Warsaw, , Poland

Novartis Investigative Site

Kemerovo, , Russia

Novartis Investigative Site

Nizhny Novgorod, , Russia

Novartis Investigative Site

Rostov-on-Don, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Yaroslavl, , Russia

Novartis Investigative Site

Yekaterinburg, , Russia

Novartis Investigative Site

Panorama, Western Cape, South Africa

Novartis Investigative Site

Stellenbosch, , South Africa

Novartis Investigative Site

Bangkoknoi, Bangkok, Thailand

Novartis Investigative Site

Songkhla, Hat Yai, Thailand

Novartis Investigative Site

Khon Kaen, THA, Thailand

Novartis Investigative Site

Bangkok, , Thailand

Novartis Investigative Site

Bursa, Gorukle, Turkey (Türkiye)

Countries

United States; Brazil; Bulgaria; Colombia; Czechia; Greece; Guatemala; India; Malaysia; Philippines; Poland; Russia; South Africa; Thailand; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1500

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

Other Identifiers

CAIN457P12302

Identifier Type: -

Identifier Source: org_study_id