Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 August 2016 |
Main ID: |
EUCTR2013-003434-32-ES |
Date of registration:
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13/12/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A long-term study of the efficacy and safety of secukinumab compared with ustekinumab in adult subjects with moderate to severe plaque psoriasis
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Scientific title:
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A 52-week, multicenter, randomized, double-blind study of subcutaneous secukinumab to demonstrate efficacy as assessed by Psoriasis Area and Severity Index at 16 weeks of treatment compared to ustekinumab and to assess long-term safety, tolerability and efficacy in subjects with moderate to severe plaque psoriasis - Efficacy of secukinumab compared to ustekinumab in patients with plaque-type psoriasis |
Date of first enrolment:
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17/01/2014 |
Target sample size:
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640 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003434-32 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Bulgaria
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Canada
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Denmark
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Estonia
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France
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Germany
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Greece
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Guatemala
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Hungary
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Israel
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Italy
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Korea, Republic of
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Netherlands
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Norway
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Portugal
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Slovakia
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Spain
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Switzerland
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Departamento Medico (ICRO)
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Address:
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Gran Via Corts Catalanes, 764
08013
Barcelona
Spain |
Telephone:
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+34900353036 |
Email:
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eecc.novartis@novartis.com |
Affiliation:
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Novartis Farmacéutica, S.A. |
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Name:
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Departamento Medico (ICRO)
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Address:
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Gran Via Corts Catalanes, 764
08013
Barcelona
Spain |
Telephone:
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+34900353036 |
Email:
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eecc.novartis@novartis.com |
Affiliation:
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Novartis Farmacéutica, S.A. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with moderate to severe plaque type psoriasis for at least 6 months before randomization 2. Patients eligible for systemic therapy with inadequately controlled psoriasis 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 576 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria: 1. Forms of psoriasis other than plaque type psoriasis 2. Previous exposure secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA
Other protocol-defined inclusion/exclusion criteria may apply.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
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Plaque psoriasis MedDRA version: 16.1
Level: LLT
Classification code 10050576
Term: Psoriasis vulgaris
System Organ Class: 100000004858
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Intervention(s)
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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 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
Trade Name: Stelara Product Name: ustekinumab Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Other descriptive name: USTEKINUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 16
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Secondary Objective: To demonstrate the superiority of secukinumab versus ustekinumab as to the speed of onset To demonstrate the superiority of secukinumab versus ustekinumab based on the proportion of PASI 90 responders
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Primary end point(s): Proportion of PASI 90 responders
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Main Objective: To demonstrate the superiority of secukinumab compared to ustekinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: week 4 week 52
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Secondary end point(s): Speed of onset PASI 90 Response status
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Secondary ID(s)
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CAIN457A2317
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2013-003434-32-NL
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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