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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
Date last updated
27/11/2023

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
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
Secondary ID [1] 0 0
2019-000904-14
Secondary ID [2] 0 0
M19-164
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque 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 - 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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
Timepoint [1] 0 0
At Week 16
Secondary outcome [1] 0 0
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
Timepoint [1] 0 0
At Week 16
Secondary outcome [2] 0 0
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
Timepoint [2] 0 0
At Week 16
Secondary outcome [3] 0 0
Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0
Timepoint [3] 0 0
At Week 16
Secondary outcome [4] 0 0
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
Timepoint [4] 0 0
At Week 52
Secondary outcome [5] 0 0
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
Timepoint [5] 0 0
At Week 52
Secondary outcome [6] 0 0
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
Timepoint [6] 0 0
At Week 52
Secondary outcome [7] 0 0
Proportion of Participants Achieving a PSS 0
Timepoint [7] 0 0
At Week 52
Secondary outcome [8] 0 0
Time to Achieve sPGA 0/1
Timepoint [8] 0 0
Up to Week 52
Secondary outcome [9] 0 0
Time to Achieve sPGA 0
Timepoint [9] 0 0
Up to Week 52

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
12/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/11/2022
Sample size
Target
Accrual to date
Final
244
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St George Dermatology & Skin Cancer Centre /ID# 213888 - Kogarah
Recruitment hospital [2] 0 0
Veracity Clinical Research /ID# 213889 - Woolloongabba
Recruitment hospital [3] 0 0
Skin Health Institute Inc /ID# 213886 - Carlton
Recruitment hospital [4] 0 0
Fremantle Dermatology /ID# 213887 - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Germany
State/province [15] 0 0
Bayern
Country [16] 0 0
Germany
State/province [16] 0 0
Hessen
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Bochum
Country [19] 0 0
Germany
State/province [19] 0 0
Luebeck
Country [20] 0 0
Germany
State/province [20] 0 0
Mahlow
Country [21] 0 0
Germany
State/province [21] 0 0
Memmingen
Country [22] 0 0
Germany
State/province [22] 0 0
Munich
Country [23] 0 0
Israel
State/province [23] 0 0
Tel-Aviv
Country [24] 0 0
Israel
State/province [24] 0 0
Afula
Country [25] 0 0
Israel
State/province [25] 0 0
Petakh Tikva
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Italy
State/province [27] 0 0
Bologna
Country [28] 0 0
Italy
State/province [28] 0 0
Cagliari
Country [29] 0 0
Italy
State/province [29] 0 0
Milan
Country [30] 0 0
Italy
State/province [30] 0 0
Modena
Country [31] 0 0
Italy
State/province [31] 0 0
Napoli
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Cadiz
Country [35] 0 0
Spain
State/province [35] 0 0
Valencia
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taichung
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei City
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taoyuan City
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Fife
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Dudley
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Leeds
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Newcastle Upon Tyne
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Salford

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04102007
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04102007