The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03478787




Registration number
NCT03478787
Ethics application status
Date submitted
23/03/2018
Date registered
23/03/2018
Date last updated
31/10/2018

Titles & IDs
Public title
Risankizumab Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis
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
Secondary ID [1] 0 0
M16-766
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Treatment: Drugs - secukinumab

Experimental: Risankizumab - Risankizumab administered by subcutaneous (SC) injection.

Active Comparator: Secukinumab - Secukinumab administered by subcutaneous (SC) injection.


Treatment: Drugs: risankizumab
Subcutaneous (SC) injection.

Treatment: Drugs: secukinumab
Subcutaneous (SC) injection.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 52 - PASI 90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Percentage of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 - PASI 90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52 - PASI 100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 52 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52 - PASI 75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [3] 0 0
Week 52

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.
Minimum age
18 Years
Maximum age
No limit
Gender
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; 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 /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

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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Woden Dermatology /ID# 204496 - Phillip
Recruitment hospital [2] 0 0
St George Dermatology & Skin Cancer Centre /ID# 204498 - Kogarah
Recruitment hospital [3] 0 0
Veracity Clinical Research /ID# 204497 - Woolloongabba
Recruitment hospital [4] 0 0
North Eastern Health Specialis /ID# 204494 - Hectorville
Recruitment hospital [5] 0 0
Skin and Cancer Foundation /ID# 204495 - Carlton
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5073 - Hectorville
Recruitment postcode(s) [5] 0 0
3053 - Carlton
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
New Brunswick
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
France
State/province [25] 0 0
Seine-Maritime
Country [26] 0 0
France
State/province [26] 0 0
Nice
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Reims
Country [29] 0 0
France
State/province [29] 0 0
Toulouse
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt
Country [31] 0 0
Germany
State/province [31] 0 0
Munich
Country [32] 0 0
Italy
State/province [32] 0 0
Lazio
Country [33] 0 0
Italy
State/province [33] 0 0
Lombardia
Country [34] 0 0
Italy
State/province [34] 0 0
Ancona
Country [35] 0 0
Italy
State/province [35] 0 0
Bologna
Country [36] 0 0
Italy
State/province [36] 0 0
Rome
Country [37] 0 0
Netherlands
State/province [37] 0 0
Gelderland
Country [38] 0 0
Netherlands
State/province [38] 0 0
Noord-Brabant
Country [39] 0 0
Netherlands
State/province [39] 0 0
Amsterdam
Country [40] 0 0
Netherlands
State/province [40] 0 0
Rotterdam
Country [41] 0 0
Poland
State/province [41] 0 0
Lodzkie
Country [42] 0 0
Poland
State/province [42] 0 0
Malopolskie
Country [43] 0 0
Poland
State/province [43] 0 0
Mazowieckie
Country [44] 0 0
Poland
State/province [44] 0 0
Podkarpackie
Country [45] 0 0
Poland
State/province [45] 0 0
Podlaskie
Country [46] 0 0
Spain
State/province [46] 0 0
Alicante
Country [47] 0 0
Spain
State/province [47] 0 0
Granada
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Manises
Country [50] 0 0
Spain
State/province [50] 0 0
Valencia
Country [51] 0 0
United Kingdom
State/province [51] 0 0
London, City Of
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Leeds
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Salford

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03478787
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

No data has been provided for results reporting
Summary results
Other publications