Completed

FUTURE 2A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis

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What is being tested

Secukinumab (AIN457)

+ Placebo

Drug
Who is being recruted

Arthritis+10

+ Bone Diseases

+ Joint Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 14, 2013

Actual date on which the first participant was enrolled.

At baseline (BSL), subjects whose eligibility was confirmed were randomized to one of the following four treatment groups. * 75 mg secukinumab * 150 mg secukinumab * 300 mg secukinumab * Placebo At Week 16, all subjects were classified as responders (≥ 20% improvement from BSL in both tender and swollen joint counts) or non-responders. Subjects who were randomized to a secukinumab treatment group at baseline were targeted to remain on the same dose for the entire trial. Subjects who were randomized to placebo at baseline were re-randomized at Week 16 as follows: Placebo non-responders received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 16. Placebo responders continued to receive placebo at Week 16 and Week 20 and received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 24. This was a double-blind, double-dummy, randomized treatment trial until week 52 analysis was completed and open label afterwards. An amendment to the study protocol (after all patients were in the trial for 2-3 years) introduced changes whereby patients previously treated with secukinumab 75 mg s.c. could change to receive 150 mg s.c. or 300 mg s.c., and patients previously treated with secukinumab 150 mg s.c. could change to receive 300 mg s.c., as deemed appropriate by the investigators.

Official TitleA Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis
NCT01752634
Principal SponsorNovartis Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

397 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesPsoriasisSkin DiseasesSpinal DiseasesSpondylitisArthritis, PsoriaticSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousSpondylarthritisSpondylarthropathies

Criteria

6 inclusion criteria required to participate
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

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10 exclusion criteria prevent from participating
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:

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Placebo at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. Non-responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 16. Responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 24.

Group II

Experimental
Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.

Group III

Experimental
Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4

Group IV

Experimental
Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 76 locations

Suspended

Novartis Investigative Site

Peoria, United StatesOpen Novartis Investigative Site in Google Maps
Suspended

Novartis Investigative Site

Aventura, United States
Suspended

Novartis Investigative Site

Palm Harbor, United States
Suspended

Novartis Investigative Site

Sarasota, United States
Completed76 Study Centers