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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/NCT03478787
Registration number
NCT03478787
Ethics application status
Date submitted
23/03/2018
Date registered
27/03/2018
Date last updated
13/07/2021
Titles & IDs
Public title
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
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Scientific title
A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
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Secondary ID [1]
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2017-004932-12
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Secondary ID [2]
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M16-766
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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:
Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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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 - risankizumab
Treatment: Drugs - secukinumab
Experimental: Risankizumab - Participants randomized to risankizumab receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Active Comparator: Secukinumab - Participants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
Treatment: Drugs: risankizumab
Subcutaneous (SC) injection
Treatment: Drugs: secukinumab
Subcutaneous (SC) injection
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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 a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
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Assessment method [1]
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The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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Percentage of Participants With a PASI 90 at Week 52
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Assessment method [2]
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The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
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Timepoint [2]
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Week 52
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Secondary outcome [1]
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Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52
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Assessment method [1]
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
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Assessment method [2]
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The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all 3; Almost clear (1) = mean > 0, < 1.5; Mild (2) = mean = 1.5, < 2.5; Moderate (3) = mean = 2.5, < 3.5; and Severe (4) = mean = 3.5.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
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Assessment method [3]
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The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
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Timepoint [3]
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Week 52
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Eligibility
Key inclusion criteria
- Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least
6 months before the Baseline Visit
- Subject has stable moderate to severe chronic plaque psoriasis with or without
psoriatic arthritis
- Subject must be a candidate for systemic therapy as assessed by the investigator;
- Subject must be an acceptable candidate to receive secukinumab according to the local
label for this compound.
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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
- History of erythrodermic psoriasis, generalized or localized pustular psoriasis,
medication-induced or medication-exacerbated psoriasis, or new onset guttate
psoriasis; or active skin disease other than psoriasis that could interfere with the
assessment of psoriasis;
- Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or
active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein
derivative (PPD) test result may participate in the study if further work up
(according to local practice/guidelines) establishes conclusively that the subject has
no evidence of active tuberculosis. If presence of latent tuberculosis is established,
then treatment must have been initiated and maintained according to local country
guidelines.
- Active systemic infection during the last 2 weeks prior to Baseline Visit (exception:
common cold)
- History of any documented active or suspected malignancy or history of any malignancy
within the last 5 years except for successfully treated non-melanoma skin cancer
(NMSC) or localized carcinoma in situ of the cervix
- Previous exposure to risankizumab
- Previous exposure to secukinumab
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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 assessing the outcomes
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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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Type of endpoint/s
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Statistical methods / analysis
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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
8/05/2018
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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
8/07/2020
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Sample size
Target
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Accrual to date
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Final
327
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Arizona
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California
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Connecticut
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Florida
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Maryland
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Seine-Maritime
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France
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Nice
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France
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Paris
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France
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Reims
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Valencia
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Granada
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Madrid
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United Kingdom
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The main objective of this study is to evaluate the efficacy and safety of risankizumab
compared with secukinumab for the treatment of adult subjects with moderate to severe plaque
psoriasis who are candidates for systemic therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03478787
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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AbbVie Inc.
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Address
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03478787
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