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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03398135
Ethics application status
Date submitted
8/01/2018
Date registered
12/01/2018
Date last updated
18/06/2024

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
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
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

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.

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 (OL) Clinical Assessment Risankizumab - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Experimental: Substudy 2: OL Therapeutic Drug Monitoring Risankizumab - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

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

Experimental: OL Continuous Treatment Extension - Dose 1 - Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.

Experimental: OL Continuous Treatment Extension - Dose 2 - Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 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
Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Percentage of Participants with Adverse Events (AE)
Timepoint [2] 0 0
Up to Week 300
Secondary outcome [1] 0 0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Timepoint [11] 0 0
Week 0 to Week 52
Secondary outcome [12] 0 0
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [12] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [13] 0 0
Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Sub-Study 1: Percentage of Participants Achieving No Tenesmus
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week
Timepoint [15] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [16] 0 0
Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms
Timepoint [16] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [17] 0 0
Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization
Timepoint [17] 0 0
Through Week 52

Eligibility
Key inclusion criteria
- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants 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 M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Participant is not in compliance with prior and concomitant medication requirements throughout Studies 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/09/2028
Actual
Sample size
Target
Accrual to date
Final
1242
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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HaDarom
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Israel
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Haifa
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Israel
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Rome
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Aichi
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Chiba
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Fukuoka
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Gunma
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Romania
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Cluj
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Timisoara
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Moskovskaya Oblast
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Permskiy Kray
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Russian Federation
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Sankt-Peterburg
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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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Novosibirsk
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Russian Federation
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Pushkin
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St. Petersburg
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Russian Federation
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Tooting

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 participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies and a Continuous Treatment Extension (CTE): 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 participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.
Trial website
https://clinicaltrials.gov/study/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries