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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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27 May 2013 |
Main ID: |
EUCTR2011-002510-36-PL |
Date of registration:
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31/01/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Assessment of the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab
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Scientific title:
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A randomized, double-blind, double dummy, multicenter study to assess the safety, tolerability and long-term efficacy of intravenous (10 mg/kg) and subcutaneous (300 mg) secukinumab in subjects with moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab - Efficacy and safety of i.v and s.c secukinumab in moderate to severe chronic plaque-type psoriasis |
Date of first enrolment:
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28/03/2012 |
Target sample size:
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140 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002510-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: double dummy
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Austria
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Bulgaria
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Canada
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Czech Republic
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India
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Japan
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Poland
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Switzerland
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Taiwan
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion criteria: -Written Informed Consent must be obtained before any assessment is performed,
-Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
-Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
A partial response is defined as having achieved = PASI 50 but < 75 response.
Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 132 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria: -Pregnant women or lactating women
-Forms of psoriasis other than chronic plaque –type
-Ongoing use of prohibited psoriasis treatments
-Ongoing use of other non-psoriasis prohibited treatments
-Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
-Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
-UV therapy or excessive exposure to sunlight
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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Moderate to severe chronic plaque-type psoriasis MedDRA version: 14.1
Level: LLT
Classification code 10050576
Term: Psoriasis vulgaris
System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
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Intervention(s)
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Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Secukinumab Current Sponsor code: AIN457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: at week 8
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Secondary Objective: - Efficacy of a higher dose of s. c. secukinumab than administered in CAIN457A2304 in achieving PASI 75 or IGA 0 or 1 response - Efficacy of secukinumab treatment regimens in subjects with respect to PASI 50/75/90/100 response and IGA 0 or 1 response - Efficacy of treatment regimens with secukinumab with respect to PASI score and IGA mod 2011 score - Safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, ECGs and adverse events monitoring - Effects of treatment regimens with secukinumab with respect to the dermatology life quality index (DLQI) 0 or 1 achievement.
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Main Objective: Efficacy of intravenous administration of secukinumab compared with subcutaneous administration of secukinumab with respect to both PASI 75 and IGA 0 or 1 response
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Primary end point(s): PASI 75 and IGA 0 or 1 response
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Secondary Outcome(s)
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Secondary end point(s): Efficacy of a higher dose of s. c. secukinumab than administered in CAIN457A2304 in achieving PASI 75 or IGA 0 or 1 response
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Timepoint(s) of evaluation of this end point: over time up to week 40
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Secondary ID(s)
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2011-002510-36-CZ
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CAIN457A2307
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Source(s) of Monetary Support
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Novartis Pharma AG
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Results
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Results available:
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