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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03398148




Registration number
NCT03398148
Ethics application status
Date submitted
8/01/2018
Date registered
12/01/2018
Date last updated
21/06/2019

Titles & IDs
Public title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
Secondary ID [1] 0 0
2016-004677-40
Secondary ID [2] 0 0
M16-067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - risankizumab IV
Treatment: Drugs - placebo for risankizumab
Treatment: Drugs - risankizumab SC

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 2 - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.

Experimental: Substudy 2, Induction 1: Open-label Risankizumab Dose 2 - Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a) - Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 3 - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.

Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 1 - Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.

Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 2 - Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a) - Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b) - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Experimental: Substudy 2, Induction 1: Double-blind Risankizumab Dose 1 - Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.

Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 3 - Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.

Placebo Comparator: Substudy 1, Induction 1: Double-blind Placebo - Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 2 - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 3 - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.

Placebo Comparator: Substudy 2, Induction 1: Double-blind Placebo - Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b) - Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.

Experimental: Substudy 1, Induction 1: Open-label Risankizumab Dose 3 - Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.


Treatment: Drugs: risankizumab IV
risankizumab intravenous (IV) infusion

Treatment: Drugs: placebo for risankizumab
placebo for risankizumab

Treatment: Drugs: risankizumab SC
risankizumab 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 clinical remission per adapted Mayo Score at Week 12 - Clinical remission per adapted Mayo Score.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline - Clinical remission per full Mayo Score.
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12 - The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12 - The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12 - The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Percentage of participants achieving clinical response per adapted Mayo Score at week 12 - Clinical response per adapted Mayo Score.
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of participants with endoscopic remission at Week 12 - Endoscopic remission per endoscopy subscore.
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4 - Clinical response per partial adapted Mayo Score (without endoscopy).
Timepoint [7] 0 0
Week 4
Secondary outcome [8] 0 0
Percentage of participants with mucosal healing at Week 12 - Mucosal healing defined as endoscopic and histologic remission.
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12 - The SF-36 is an indicator of overall health status.
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Percentage of participants with hospitalization through Week 12 - Participants with an event that results in admission to the hospital.
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12 - Participants who underwent surgery related to UC.
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Percentage of participants with endoscopic improvement at Week 12 - Endoscopic improvement per endoscopy subscore.
Timepoint [12] 0 0
Week 12

Eligibility
Key inclusion criteria
- Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally
permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage
5 for development at the Baseline Visit

- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to
Baseline.

- Active UC as assessed by adapted Mayo Score

- Demonstrated intolerance or inadequate response to one or more biologic therapies

- Females must be postmenopausal for more than 2 years or surgically sterile or
practicing specific forms of birth control.
Minimum age
16 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel
disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.

- Subject receiving prohibited medications and treatment.

- Extent of inflammatory disease limited to the rectum as assessed by screening
endoscopy.

- Subject with currently known complications of UC (e.g., megacolon).

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 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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United States of America
State/province [3] 0 0
Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Nebraska
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Nevada
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New York
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North Carolina
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Tennessee
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Utah
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Virginia
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Washington
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American Samoa
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Coronado
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Argentina
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Santa Fe
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Argentina
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Buenos Aires
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Argentina
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Quilmes
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Argentina
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San Miguel de Tucuman
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Austria
State/province [32] 0 0
Niederoesterreich
Country [33] 0 0
Austria
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Wien
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Austria
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Graz
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Austria
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Salzburg
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Belgium
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Bruxelles-Capitale
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Belgium
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Liege
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Belgium
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Oost-Vlaanderen
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Belgium
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Bonheiden
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Jette, Brussels
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Parana
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Rio Grande Do Sul
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Rio de Janeiro
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Sliven
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Sofia
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Nova Scotia
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Ontario
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Quebec
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Araucania
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Region Metropolitana De Santiago
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Concepción
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Chile
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China
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Jilin
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Zhejiang
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Wuhan
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Grad Zagreb
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Hovedstaden
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Hvidovre
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Alexandria
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Egypt
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Cairo
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Menoufiya
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Alpes-Maritimes
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France
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Gironde
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France
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Ile-de-France
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France
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Loire
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France
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Amiens Cedex 1
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Germany
State/province [93] 0 0
Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Schleswig-Holstein
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Germany
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Thueringen
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Germany
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Berlin
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Germany
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Braunschweig
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Hannover
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Germany
State/province [104] 0 0
Heidelberg
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Germany
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Kassel
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Germany
State/province [106] 0 0
Landshut
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Germany
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Lueneburg
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Germany
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Minden
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Germany
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Munich
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Germany
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Regensburg
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Germany
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Tuebingen
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Greece
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Attiki
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Pireaus
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Greece
State/province [116] 0 0
Thessaloniki
Country [117] 0 0
Israel
State/province [117] 0 0
HaDarom
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Israel
State/province [118] 0 0
Tel-Aviv
Country [119] 0 0
Israel
State/province [119] 0 0
Yerushalayim
Country [120] 0 0
Israel
State/province [120] 0 0
Haifa
Country [121] 0 0
Israel
State/province [121] 0 0
Jerusalem
Country [122] 0 0
Israel
State/province [122] 0 0
Ramat Gan
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Italy
State/province [123] 0 0
Calabria
Country [124] 0 0
Italy
State/province [124] 0 0
Emilia-Romagna
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Italy
State/province [125] 0 0
Lazio
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Italy
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Lombardia
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Italy
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Milano
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Italy
State/province [128] 0 0
Sicilia
Country [129] 0 0
Italy
State/province [129] 0 0
Verona
Country [130] 0 0
Italy
State/province [130] 0 0
Genoa
Country [131] 0 0
Italy
State/province [131] 0 0
Milan
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Italy
State/province [132] 0 0
Rome
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Gunma
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Japan
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Hiroshima
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Japan
State/province [139] 0 0
Hokkaido
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Japan
State/province [140] 0 0
Hyogo
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Japan
State/province [141] 0 0
Ishikawa
Country [142] 0 0
Japan
State/province [142] 0 0
Kanagawa
Country [143] 0 0
Japan
State/province [143] 0 0
Mie
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Japan
State/province [144] 0 0
Miyagi
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Japan
State/province [145] 0 0
Nagasaki
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Japan
State/province [146] 0 0
Saitama
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Japan
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Shiga
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Japan
State/province [148] 0 0
Tokyo
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Japan
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Yamagata
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Japan
State/province [150] 0 0
Isehara
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Japan
State/province [151] 0 0
Kagoshima
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Japan
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Kashihara
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Japan
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Minato-ku
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Japan
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Nishinomiya-shi
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Japan
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Sagamihara-shi
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Japan
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Saga
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Japan
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Shimizu-sho
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Japan
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Toyoake
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Japan
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Wakayama
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Japan
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Yokkaichi-shi
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Japan
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Yokohama-shi
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Korea, Republic of
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Busan Gwang Yeogsi
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Korea, Republic of
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Korea, Republic of
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Busan
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Korea, Republic of
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Guri-si
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Riga
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Malaysia
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Selangor
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Mexico
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Morelos
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Mexico
State/province [174] 0 0
Merida Yucatan
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Mexico
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Mexico
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Netherlands
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Noord-Holland
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Netherlands
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Tilburg
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New Zealand
State/province [178] 0 0
Canterbury
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New Zealand
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Waikato
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New Zealand
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Lower Hutt
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New Zealand
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Wellington
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Poland
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Dolnoslaskie
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Poland
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Malopolskie
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Poland
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Mazowieckie
Country [185] 0 0
Poland
State/province [185] 0 0
Slaskie
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Poland
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Warminsko-mazurskie
Country [187] 0 0
Poland
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Bydgoszcz
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Portugal
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Faro
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Portugal
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Lisboa
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Portugal
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Setubal
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Coimbra
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Portugal
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Guimaraes
Country [193] 0 0
Portugal
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Porto
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Portugal
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Santa Maria Da Feira
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Portugal
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of
risankizumab as induction treatment in subjects with moderately to severely active ulcerative
colitis (UC), and to identify the appropriate induction dose of risankizumab for further
evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared
to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Trial website
https://clinicaltrials.gov/show/NCT03398148
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03398148