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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03675308




Registration number
NCT03675308
Ethics application status
Date submitted
12/09/2018
Date registered
15/09/2018
Date last updated
17/12/2018

Titles & IDs
Public title
A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
Scientific title
A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
Secondary ID [1] 0 0
2017-002465-22
Secondary ID [2] 0 0
M16-011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - placebo for rizankizumab
Other interventions - risankizumab

Placebo Comparator: Placebo - Participants randomized to receive double-blind placebo for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).

Experimental: Risankizumab - Participants randomized to receive double-blind risankizumab for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).


Other interventions: placebo for rizankizumab
Placebo for risankizumab administered by subcutaneous (SC) injection

Other interventions: risankizumab
Risankizumab administered by subcutaneous (SC) injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving at least 20% Improvement in American College of Rheumatology (ACR20) at Week 24 - ACR20 is defined as at least 20% improvement in swollen joint count, tender joint count, and at least 3 out of the following 5 variables: 1) Patient's Assessment of psoriatic arthritis (PsA) Pain Intensity visual analog scale (VAS), 2) Patient's Global Assessment of Disease VAS, 3) Physician's Global Assessment of Disease Activity VAS, 4) Patient's Assessment of Disability on Health Assessment Questionnaire Disability Index (HAQ-DI), and 5) Serum high-sensitivity C-reactive protein (serum hs-CRP).
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Change from Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) - The HAQ-DI is a self-reported questionnaire of how the patient's illness affects their ability to function in their daily life over the past week.
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percentage of Participants With = 90% Reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 24 in Participants With = 3% Body Surface Area (BSA) Involving Psoriasis at Baseline - PASI90 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.
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Change from Baseline to Week 24 in modified Total Sharp Score (PsA-mTSS) at Week 24 - The modified PsA-mTSS method is used to evaluate radiographic evidence of damage.
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 - The percentage of participants who achieve MDA.
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Change from Baseline to Week 24 in Fingernail Psoriasis - Fingernail psoriasis will be evaluated using either the Physician Global Assessment - Fingernails (PGA-F) or the modified Nail Psoriasis Severity Index (mNAPSI), depending on location.
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Change from Baseline to Week 24 in Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline - The LEI will be used to assess the presence or absence of enthesitis.
Timepoint [6] 0 0
Baseline, Week 24
Secondary outcome [7] 0 0
Change from Baseline to Week 24 in Leeds Dactylitis Index (LDI) in Participants With Dactylitis at Baseline - The LDI will be used to assess the presence or absence of dactylitis.
Timepoint [7] 0 0
Baseline, Week 24
Secondary outcome [8] 0 0
Change from Baseline to Week 24 in the 36-Item Short Form Health Questionnaire (SF-36) Physical Component Summary (PCS) Score - The SF-36 is a 36-item, general health, self-administered questionnaire.
Timepoint [8] 0 0
Baseline, Week 24
Secondary outcome [9] 0 0
Change from Baseline to Week 24 in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaire Score - The FACIT-Fatigue is a 13-item questionnaire that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases.
Timepoint [9] 0 0
Baseline, Week 24

Eligibility
Key inclusion criteria
- Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening
Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening
Visit.

- Subject has active disease at Baseline

- Diagnosis of active plaque psoriasis.

- Subject has demonstrated an inadequate response or intolerance to conventional
synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject is considered by investigator, for any reason, to be an unsuitable candidate
for the study.

- Subject has a known hypersensitivity to risankizumab.

- Subject has previous treatment with biologic agent.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
22/02/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/10/2024
Actual
Sample size
Target
880
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital /ID# 207592 - Garran
Recruitment hospital [2] 0 0
Rheumatology Research Unit /ID# 207200 - Maroochydore
Recruitment hospital [3] 0 0
Griffith University /ID# 207505 - Southport
Recruitment hospital [4] 0 0
Emeritus Research /ID# 207202 - Camberwell
Recruitment hospital [5] 0 0
Monash Health /ID# 208034 - Clayton
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment outside Australia
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United States of America
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Arizona
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California
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Argentina
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Buenos Aires
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Argentina
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Rosario, Santa FE
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Argentina
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San Miguel de Tucuman
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Argentina
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Santa Fe
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Brazil
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Parana
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Grad Zagreb
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Tallinn
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Tel-Aviv
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Haifa
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Kfar Saba
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Cluj
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Martin
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Pieštany
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Gauteng
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Sweden
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Orebro
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Sweden
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Solna
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Sweden
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Uppsala
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Sweden
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Vasteras
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Taiwan
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Taipei
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Taiwan
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Dalin Township
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Taiwan
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Taichung City
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Taiwan
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Taoyuan City
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Ukraine
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Kyivska Oblast
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Ukraine
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Vinnytska Oblast
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Ukraine
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Volynska Oblast
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Ukraine
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Cherkasy
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Ukraine
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Chernihiv
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Kharkiv
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Ukraine
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Khmelnitskyi
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Ukraine
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Kryvyi Rih
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Ukraine
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Poltava
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United Kingdom
State/province [110] 0 0
Torquay

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the safety and efficacy of risankizumab versus
placebo in subjects with moderately to severely active psoriatic arthritis (PsA).
Trial website
https://clinicaltrials.gov/show/NCT03675308
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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable