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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02074982
Registration number
NCT02074982
Ethics application status
Date submitted
27/02/2014
Date registered
3/03/2014
Date last updated
21/07/2017
Titles & IDs
Public title
Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
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Scientific title
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 (CLEAR)
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Secondary ID [1]
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2013-003434-32
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Secondary ID [2]
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CAIN457A2317
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Type Psoriasis
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Condition category
Condition code
Skin
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0
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Dermatological conditions
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Skin
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0
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AIN457 300 mg
Treatment: Drugs - ustekinumab 45/90 mg
Treatment: Drugs - placebo secukinumab
Experimental: AIN457 300 mg - patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
Active Comparator: Ustekinumab - patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
Treatment: Drugs: AIN457 300 mg
Treatment: Drugs: ustekinumab 45/90 mg
Treatment: Drugs: placebo secukinumab
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
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Assessment method [1]
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Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
PASI 90 responders were defined as participants achieving = 90% improvement at Week 16
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4
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Assessment method [1]
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Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving = 75% improvement at Week 4
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Timepoint [1]
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Week 4
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Secondary outcome [2]
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Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52
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Assessment method [2]
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Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
PASI 90 responders were defined as participants achieving = 90% improvement at Week 52
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Timepoint [2]
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Week 52
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Eligibility
Key inclusion criteria
- patients with moderate to severe plaque type psoriasis for at least 6 months before
randomization
- patients eligible for systemic therapy with inadequately controlled psoriasis
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- forms of sporiasis other than plaque type psoriasis
- previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting
(IL)-17A or IL-17RA
Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/06/2016
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Sample size
Target
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Accrual to date
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Final
676
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Phillip
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Novartis Investigative Site - East Melbourne
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2606 - Phillip
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2010 - Sydney
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4102 - Woolloongabba
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3002 - East Melbourne
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Funding & Sponsors
Primary sponsor type
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
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Summary
Brief summary
This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have
plaque-type psoriasis
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02074982
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02074982
Download to PDF