Overview

This trial is active, not recruiting.

Condition psoriatic arthritis
Treatments secukinumab (ain457), placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date April 2013
End date January 2019
Trial size 398 participants
Trial identifier NCT01752634, 2012-004439-22, CAIN457F2312

Summary

This study is to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data will be collected during the post Week 52 period of the study.

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)
Primary purpose treatment
Arm
(Experimental)
Group 2 - Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
secukinumab (ain457)
Secukinumab (AIN457)
(Experimental)
Group 1- Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
secukinumab (ain457)
Secukinumab (AIN457)
(Placebo Comparator)
Group 4 - Placebo at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4
placebo
Placebo PFS for s.c. administration.
(Experimental)
Group 3 - Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4
secukinumab (ain457)
Secukinumab (AIN457)

Primary Outcomes

Measure
Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response criteria
time frame: Week 24

Secondary Outcomes

Measure
Proportion of subjects achieving a PASI75 response in the subgroup of subjects who have ≥3% skin involvement with psoriasis
time frame: Week 24
Proportion of subjects achieving a PASI90 response in the subgroup of subjects who have ≥3% skin involvement with psoriasis
time frame: Week 24
Change from baseline in DAS28-CRP
time frame: Week 24
Change from baseline in SF36-PCS
time frame: Week 24
Change from baseline in HAQ-DI
time frame: Week 24
Proportion of subjects achieving ACR50 response criteria
time frame: Week 24
Proportion of subjects with dactylitis in the subset of subjects who have dactylitis at baseline
time frame: Week 24
Proportion of subjects with enthesitis in the subset of subjects who have enthesitis at baseline
time frame: Week 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:Patients eligible for inclusion in this study have 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 24 - 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. Exclusion Criteria: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, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks - Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα, investigational or approved - Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)

Additional Information

Official title A 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Novartis.