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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02074982




Registration number
NCT02074982
Ethics application status
Date submitted
27/02/2014
Date registered
3/03/2014

Titles & IDs
Public title
Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
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)
Secondary ID [1] 0 0
2013-003434-32
Secondary ID [2] 0 0
CAIN457A2317
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Type Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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: placebo secukinumab
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52
Timepoint [2] 0 0
Week 52

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2016
Sample size
Target
Accrual to date
Final
676
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Phillip
Recruitment hospital [2] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [3] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [4] 0 0
Novartis Investigative Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Kentucky
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Missouri
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New York
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Oregon
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South Carolina
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Texas
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Virginia
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Washington
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Vienna
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Austria
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Wien
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Belgium
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Gent
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Belgium
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Liege
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Belgium
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Namur
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Varna
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Ontario
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Arhus C
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Tallinn
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Estonia
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Tartu
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France
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Augsburg
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Bielefeld
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Bochum
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Dresden
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Frankfurt
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Lubeck
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Muenster
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Israel
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Kosice
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Asturias
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Spain
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Barcelona
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Spain
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Catalunya
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Spain
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Comunidad Valenciana
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Spain
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Las Palmas de G.C
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Spain
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Madrid
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Spain
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Pais Vasco
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Switzerland
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Lausanne
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Taiwan
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Lin-Kou
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Taiwan
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Taipei
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Turkey
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Balcova / Izmir
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Turkey
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Bursa
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United Kingdom
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Manchester
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Perthshire
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Surrey
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West Yorkshire
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Coventry
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Harrogate
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Hull
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United Kingdom
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Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02074982