Study to demonstrate the efficacy (including inhibition of structural damage), safety and tolerability up to 2 years of secukinumab in Active Psoriatic Arthritis

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2015-000050-38-GR
• Date of registration: 05/11/2015
• Prospective Registration: No
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study to demonstrate the efficacy (including inhibition of structural damage), safety and tolerability up to 2 years of secukinumab in Active Psoriatic Arthritis
• Scientific title: A Phase III, randomized, double-blind, placebo controlled multi-center study of subcutaneous secukinumab (150 mg and 300 mg) in prefilled syringe to demonstrate efficacy (including inhibition of structural damage), safety, and tolerability up to 2 years in subjects with active psoriatic arthritis (FUTURE 5) - FUTURE 5
• Date of first enrolment: 24/09/2015
• Target sample size: 990
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000050-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Austria, Brazil, Canada, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, Germany, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Philippines, Russian Federation, Serbia, Spain, Sweden, Thailand, United Kingdom, United States, Vietnam

Key inclusion & exclusion 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 BSL =3 tender joints out of 78 and =3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).
-Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
-Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a 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 who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
-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.
-Subjects on MTX must be on folic acid supplementation at randomization.
-Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
-Subjects who have been on a TNFa inhibitor must have experienced an inadequate response to previous or current treatment with a TNFa inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFa inhibitor.
-Subjects who have previously been treated with TNFa inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization.
-Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 920
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion criteria:
-Chest X-ray or chest 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 IL-17 or IL-17 receptor.
-Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
-Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
-Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa (investigational or approved).
-Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents
-Other protocol-defined exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Psoriatic Arthritis
MedDRA version: 18.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Intervention(s)

Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: W24,AIN=secukinumab
-Efficacy AIN150mg(w/ or w/o loading)or 300mg(w/ loading),compared w/pbo based on proportion of subjects achieving ACR50
-Change from BSL with AIN150mg(w/ or w/o loading)or 300mg(w/ loading) compared w/pbo for joint/bone structural damage
-Improvement on AIN150mg(w/ or w/o loading)or 300mg(w/ loading),compared w/pbo for changes in HAQ-DI relative to BSL
-Efficacy AIN pooled regimen(w/ or w/o loading,300mg w/ loading) compared w/pbo based on proportion of subjects w/ dactylitis or enthesitis in the subset of subjects who have dactylitis or enthesitis at BSL
-Efficacy AIN150mg(w/ or w/o loading),or 300mg(w/ loading) compared w/pbo based on proportion of subjects achieving PASI75
-Improvement on AIN150mg(w/ or w/o loading)or 300mg(w/ loading) compared w/pbo relative to BSL for
•changes in DAS28-CRP(hsCRP)
•SF-36-PCS
-Efficacy AIN150mg(w/ or w/o loading),or 300mg(w/ loading) compared w/pbo based on proportion of subjects achieving PASI90
-Safety/tolerability

Timepoint(s) of evaluation of this end point: 24 weeks

Main Objective: To demonstrate that the efficacy of secukinumab 150 mg s.c. (with or without loading regimen) or 300 mg s.c. with loading regimen, at Week 24 is superior to placebo based on proportion of subjects achieving American College of Rheumatology 20 (ACR20) response in subjects with active PsA.

Primary end point(s): American College of Rheumatology 20 (ACR20) response

Secondary Outcome(s)

Secondary end point(s): -American College of Rheumatology 50 (ACR50) response
-Van der Heijde modified total Sharp score
-Health assessment questionnaire disability index© (HAQ-DI©) score
-Dactylitis
-Enthesitis
-Psoriasis Area and Severity Index 75 (PASI75) response
-Disease Activity Score for 28 joints (DAS28-CRP)
-Short Form 36 Health Survey (SF36) physical component score
-Psoriasis Area and Severity Index 90 (PASI90)

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary ID(s)

CAIN457F2342

2015-000050-38-LT

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact: