Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis (FUTURE 2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01752634
First received: October 23, 2012
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Secukinumab (AIN457)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response) criteria [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of PFS secukinumab at Week 24 is superior to placebo in subjects with active PsA based on the proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response


Secondary Outcome Measures:
  • Proportion of subjects achieving a PASI75 response in the subgroup of subjects who have ≥3% skin involvement with psoriasis [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that The efficacy of secukinumab at Week 24 is superior to placebo based on the proportion of subjects achieving a PASI75 response in the subgroup of subjects who have ≥3% skin involvement with psoriasis

  • Proportion of subjects achieving a PASI90 response in the subgroup of subjects who have ≥3% skin involvement with psoriasis [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab at Week 24 is superior to placebo based on the proportion of subjects achieving a PASI90 response in the subgroup of subjects who have ≥3% skin involvement with psoriasis

  • Change from baseline in DAS28-CRP [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the improvement (change) from baseline on secukinumab is superior to placebo for the DAS28-CRP at Week 24

  • Change from baseline in SF36-PCS [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the improvement (change) from baseline on secukinumab is superior to placebo for the SF36-PCS at Week 24

  • Change from baseline in HAQ-DI [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the improvement (change) from baseline on secukinumab is superior to placebo for the HAQ-DI at Week 24

  • Proportion of subjects achieving ACR50 response criteria [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of PFS secukinumab at Week 24 is superior to placebo in subjects with active PsA based on the proportion of subjects achieving an American College of Rheumatology 50 (ACR50) response

  • Proportion of subjects with dactylitis in the subset of subjects who have dactylitis at baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab pooled regimen at Week 24 is superior to placebo based on the proportion of subjects with dactylitis in the subset of subjects who have dactylitis at baseline

  • Proportion of subjects with enthesitis in the subset of subjects who have enthesitis at baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab pooled regimen at Week 24 is superior to placebo based on the proportion of subjects with enthesitis in the subset of subjects who have enthesitis at baseline


Estimated Enrollment: 400
Study Start Date: April 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secukinumab (AIN457) 150 mg s.c.
Group 2 - Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
Drug: Secukinumab (AIN457)
Secukinumab (AIN457)
Experimental: Secukinumab (AIN457) 75 mg s.c.
Group 1- Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
Drug: Secukinumab (AIN457)
Secukinumab (AIN457)
Placebo Comparator: Placebo s.c.
Group 4 - Placebo at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4
Drug: Placebo
Placebo PFS for s.c. administration.
Experimental: Secukinumab (AIN457) 300 mg s.c.
Group 3 - Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4
Drug: Secukinumab (AIN457)
Secukinumab (AIN457)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752634

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111 ext +41613241111

  Show 119 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01752634     History of Changes
Other Study ID Numbers: CAIN457F2312, 2012-004439-22
Study First Received: October 23, 2012
Last Updated: June 10, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Thailand: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Therapeutic Goods Administration (TGA)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency (Anvisa)
Canada: Health Canada (Biologics and Genetic Therapies Directorate)
Czech Republic: State institute for drug control (SUKL)
Germany: Federal Institute for Vaccines and Biomedicines (PEI)
Philippines: Department of Health
Poland: Minister of Health
Russia: Ministry of Public Health and Social Development of the Russian Federation

Keywords provided by Novartis:
Psoriatic arthritis, PsA, ACR, CASPAR, PASDAS

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014