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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03398135




Registration number
NCT03398135
Ethics application status
Date submitted
8/01/2018
Date registered
8/01/2018
Date last updated
28/01/2019

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065
Secondary ID [1] 0 0
2016-004676-22
Secondary ID [2] 0 0
M16-066
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
Treatment: Drugs - placebo for risankizumab

Experimental: Substudy 2: Open-label Risankizumab Dose 1 - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Experimental: Substudy 1: Double-blind Risankizumab Dose 2 - Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.

Experimental: Substudy 2: Open-label Risankizumab Dose 2 - Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.

Experimental: Substudy 3: Open-label Extension Risankizumab - Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.

Placebo Comparator: Substudy 1: Double-blind Placebo - Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.

Experimental: Substudy 1: Double-blind Risankizumab Dose 1 - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.


Treatment: Drugs: risankizumab
subcutaneous (SC) injection

Treatment: Drugs: placebo for 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 52 - Clinical remission per adapted Mayo Score.
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0 - Clinical remission per adapted Mayo Score.
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction) - Participants who discontinued corticosteroid use.
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction). - Clinical remission per adapted Mayo Score.
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Percentage of participants with endoscopic remission at Week 52 - Endoscopic remission per endoscopy subscore.
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52 - The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.
Timepoint [5] 0 0
Week 0, Week 52
Secondary outcome [6] 0 0
Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52 - Participants who underwent surgery related to UC.
Timepoint [6] 0 0
52 weeks
Secondary outcome [7] 0 0
Percentage of participants with hospitalization through Week 52 - Participants with an event that results in admission to the hospital.
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52 - The SF-36 is an indicator of overall health status.
Timepoint [8] 0 0
Week 0, Week 52
Secondary outcome [9] 0 0
Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52 - The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Timepoint [9] 0 0
Week 0, Week 52
Secondary outcome [10] 0 0
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52 - 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 [10] 0 0
Week 0, Week 52
Secondary outcome [11] 0 0
Percentage of participants with endoscopic improvement at Week 52 - Endoscopic improvement per endoscopy subscore.
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction) - Clinical remission per full Mayo Score.
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0 - Endoscopic improvement per endoscopy subscore.
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Percentage of participants with clinical response per adapted Mayo score at Week 52 - Clinical response per adapted Mayo score.
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Percentage of participants with histologic remission at Week 52 - Histologic remission per Geboes Score.
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Percentage of participants with mucosal healing at Week 52 - Mucosal healing defined as endoscopic and histologic remission.
Timepoint [16] 0 0
Week 52

Eligibility
Key inclusion criteria
- Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical
response
Minimum age
16 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who have a known hypersensitivity to risankizumab or the excipients of any of
the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse
event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes
the subject unsuitable for this study

- Subject is considered by the Investigator, for any reason, to be an unsuitable
candidate for the study

- Subject is not in compliance with prior and concomitant medication requirements
throughout Studies M16-065 and M16-067

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 assessing the outcomes
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
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
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Quilmes
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Grad Zagreb
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Cairo
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Thueringen
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Baranya
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HaDarom
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Tel-Aviv
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Lazio
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Italy
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Italy
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Verona
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Italy
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Ancona
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Italy
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Genoa
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Italy
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Milan
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Italy
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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
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Mie
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Japan
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Miyagi
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Japan
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Nagasaki
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Japan
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Saitama
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Japan
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Shiga
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Japan
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Tokyo
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Japan
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Yamagata
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Japan
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Isehara
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Japan
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Kashihara
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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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Daegu Gwang Yeogsi
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Busan
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Korea, Republic of
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Latvia
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Riga
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Lithuania
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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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Selangor
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Kelantan
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Mexico
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Mexico
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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
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Canterbury
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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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Lodzkie
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Malopolskie
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Mazowieckie
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Slaskie
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Poland
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Zachodniopomorskie
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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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Portugal
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Coimbra
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Portugal
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Guimaraes
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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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Viseu
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Puerto Rico
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San Juan
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Romania
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Bucharest
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Romania
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Timisoara
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Russian Federation
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Kabardino-Balkarskaya Respublika
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Russian Federation
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Kaliningradskaya Oblast
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Russian Federation
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Kemerovskaya Oblast
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Russian Federation
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Moskovskaya Oblast
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Russian Federation
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Tyumenskaya Oblast
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Russian Federation
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Dzerzhinskiy
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Russian Federation
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Moscow
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Russian Federation
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Pushkin
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Ulyanovsk
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Serbia
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Beograd
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Serbia
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Sumadijski Okrug
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Serbia
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Vojvodina
Country [197] 0 0
Singapore
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Singapore
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Slovakia
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Banska Bystrica
Country [199] 0 0
Slovakia
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Nitra
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Slovakia
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Presov
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Slovenia
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Ljubljana
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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Western Cape
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South Africa
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Cape Town
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Spain
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Pontevedra
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Gijon
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Spain
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Southampton

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 evaluate safety and efficacy of risankizumab in subjects with
ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in
a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind,
placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory
maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who
completed Substudy 1 or 2.
Trial website
https://clinicaltrials.gov/show/NCT03398135
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