Overview

This trial is active, not recruiting.

Condition arthritis, psoriatic
Treatments secukinumab, placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date May 2015
End date December 2017
Trial size 341 participants
Trial identifier NCT02294227, 2014-003849-10, CAIN457F2336

Summary

The purpose of this study is 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 AS despite current or previous NSAID, non-biologic DMARD or biologic anti-TNFα therapy

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(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, Secukinumab dose may be escalated to 300 mg as judged appropriate by the investigator
secukinumab
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
(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, Secukinumab dose may be escalated to 300 mg as judged appropriate by the investigator
secukinumab
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
(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 will be switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, Secukinumab dose may be escalated to 300 mg as judged appropriate by the investigator
placebo
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Primary Outcomes

Measure
Assessment of American College of Rheumatology 20 (ACR20)
time frame: 16 weeks

Secondary Outcomes

Measure
Disease Activity Score for 28 joints (DAS28-CRP) utilizing hsCRP
time frame: 16 weeks
Psoriatic Area and Severity Index 75 (PASI75)
time frame: 16 weeks
Short Form Health Survey Physical Component Score (SF-36-PCS)
time frame: 16 weeks
American College of Rheumatology 50 (ACR50)
time frame: 16 weeks
Assessment of American College of Rheumatology 20 (ACR20)
time frame: 4 weeks
Overall safety and tolerability as measured by number of adverse events and serious adverse events
time frame: 112 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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. - Other protocol-defined inclusion criteria do apply. Exclusion Criteria: - 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. - Other protocol-defined exclusion criteria do apply.

Additional Information

Official title A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Novartis.