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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04102007
Registration number
NCT04102007
Ethics application status
Date submitted
23/09/2019
Date registered
25/09/2019
Titles & IDs
Public title
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
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Scientific title
A Phase 3b, Multicenter, Interventional, Open-label Study of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Have a Suboptimal Response to Secukinumab or Ixekizumab and Are Switched to Risankizumab
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Secondary ID [1]
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2019-000904-14
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Secondary ID [2]
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M19-164
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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:
Plaque 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
Other: Risankizumab - Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab
Treatment: Drugs: Risankizumab
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
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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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Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
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Assessment method [1]
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The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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Timepoint [1]
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At Week 16
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Secondary outcome [1]
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Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
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Assessment method [1]
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The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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Timepoint [1]
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At Week 16
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Secondary outcome [2]
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Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
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Assessment method [2]
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The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
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Timepoint [2]
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At Week 16
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Secondary outcome [3]
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Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0
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Assessment method [3]
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The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are:
pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
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Timepoint [3]
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At Week 16
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Secondary outcome [4]
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Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
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Assessment method [4]
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The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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Timepoint [4]
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At Week 52
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Secondary outcome [5]
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Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
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Assessment method [5]
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The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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Timepoint [5]
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At Week 52
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Secondary outcome [6]
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Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
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Assessment method [6]
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The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
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Timepoint [6]
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At Week 52
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Secondary outcome [7]
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Proportion of Participants Achieving a PSS 0
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Assessment method [7]
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The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are:
pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
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Timepoint [7]
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At Week 52
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Secondary outcome [8]
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Time to Achieve sPGA 0/1
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Assessment method [8]
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The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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Timepoint [8]
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Up to Week 52
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Secondary outcome [9]
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Time to Achieve sPGA 0
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Assessment method [9]
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The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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Timepoint [9]
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Up to Week 52
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Eligibility
Key inclusion criteria
* Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0).
* Participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of Screening and Baseline visits.
* Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global Assessment (sPGA) 2/3
* Participant must be eligible for continued biologic therapy as assessed by the investigator.
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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, psoriatic arthritis.
* Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis.
* 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.
* History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator.
* Participant with exposure to risankizumab or any IL-23 inhibitors.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
12/11/2019
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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
7/11/2022
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Sample size
Target
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Accrual to date
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Final
244
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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St George Dermatology & Skin Cancer Centre /ID# 213888 - Kogarah
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Recruitment hospital [2]
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Veracity Clinical Research /ID# 213889 - Woolloongabba
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Recruitment hospital [3]
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Skin Health Institute Inc /ID# 213886 - Carlton
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Recruitment hospital [4]
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Fremantle Dermatology /ID# 213887 - Fremantle
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3053 - Carlton
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Recruitment postcode(s) [4]
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6160 - Fremantle
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Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Connecticut
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Florida
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Texas
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Luebeck
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Germany
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Mahlow
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Germany
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Memmingen
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Tel-Aviv
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Israel
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Afula
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Israel
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Petakh Tikva
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Italy
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Milano
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Italy
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Bologna
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Milan
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Italy
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Modena
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Napoli
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Barcelona
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Madrid
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Cadiz
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Valencia
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Taichung
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Taiwan
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Taoyuan City
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Fife
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Dudley
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Leeds
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Newcastle Upon Tyne
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.
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Trial website
https://clinicaltrials.gov/study/NCT04102007
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/07/NCT04102007/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/07/NCT04102007/SAP_002.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04102007