|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|Medical condition in easily understood language
|Diseases [C] - Digestive System Diseases [C06]
|E.1.2 Medical condition or disease under investigation
|System Organ Class
|10017947 - Gastrointestinal disorders
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|Sub-study 1: Randomized, double-blind, placebo-controlled maintenance
To evaluate efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active ulcerative colitis (UC) responded to IV risankizumab induction treatment in Study M16-067
Sub-study 2: Randomized, exploratory maintenance
To evaluate efficacy and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring vs clinical assessment for dose escalation) as maintenance therapy in subjects with moderately to severely active UC responded to induction treatment in Study M16-067
Sub-study 3: Open-label long term extension
To evaluate long-term safety of risankizumab in subjects completed Sub-study 1 or 2 or subjects responded to induction treatment in study M16-067 with no final endoscopy due to COVID-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab.
|Secondary objectives of the trial
|Trial contains a sub-study
|Principal inclusion criteria
|Entry and completion of Study M16-067. Completion includes the final endoscopy of Study M16-067. If the final endoscopy for Study M16-067 is missing during the COVID-19 pandemic due to local regulation prohibiting endoscopy, subjects may be allowed to enroll in Sub-study 3 should they meet clinical response per Partial Adapted Mayo Score.
Achieved clinical response at the last visit of Study M16-067.
|Principal exclusion criteria
|Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Study M16-067 that in the Investigator's judgment makes the subject unsuitable for this study.
|E.5 End points
|Primary end point(s)
|Sub-study 1 or 2 : Proportion of subjects with clinical remission per Adapted Mayo score at Week 52.
Sub-study 3: Evaluation of long-term safety
|Timepoint(s) of evaluation of this end point
|Secondary end point(s)
|1.Proportion of subjects with endoscopic improvement at Week 52.
2.Proportion of subjects achieving clinical remission per Full Mayo score at Week 52 in subjects with a Full Mayo score of 6 to 12 at Baseline (of induction)
3.Proportion of subjects who discontinued corticosteroid use at Week 52 in subjects taking steroids at Baseline (of induction).
4.Proportion of subjects with clinical remission per Adapted Mayo score at Week 52 in subjects with clinical remission at Week 0.
5.Proportion of subjects who discontinued corticosteroid use, remained corticosteroid free for 90 days and achieved clinical remission at Week 52 in subjects taking steroids at Baseline (of induction).
6.Proportion of subjects with clinical response per Adapted Mayo score at Week 52.
7.Proportion of subjects achieving histologic-endoscopic mucosal improvement at Week 52.
8.Proportion of subjects with endoscopic remission at Week 52.
9.Proportion of subjects with endoscopic improvement at Week 52 in subjects with endoscopic improvement at Week 0.
10.Proportion of subjects with UC-related hospitalizations through Week 52.
11.Proportion of subjects with histologic remission at Week 52.
12.Proportion of subjects who reported no abdominal pain at Week 52
13.Proportion of subjects who reported no bowel urgency at Week 52
14.Proportion of subjects with mucosal healing at Week 52.
15.Change from Baseline (of induction) to Week 52 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.
16.Proportion of subjects with UC-related surgeries through Week 52.
17.Change from Baseline (of induction) to Week 52 in FACIT-Fatigue.
18.Proportion of subjects with clinical response per Adapted Mayo score at Week 52 in subjects with pancolitis at Baseline.
19.Proportion of subjects who reported no nocturnal bowel movements at Week 52.
20.Proportion of subjects who reported no tenesmus at Week 52.
21.Change from Baseline (of induction) to Week 52 in number of fecal incontinence episodes per week
22.Change from Baseline (of induction) to Week 52 in number of days over a week with sleep interrupted due to UC symptoms.
23.Change from Week 0 to Week 52 in Short Form-36 (SF-36)
|Timepoint(s) of evaluation of this end point
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
|Number of treatment arms in the trial
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|Number of sites anticipated in the EEA
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
|If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
|Korea, Republic of
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days
|In all countries concerned by the trial years
|In all countries concerned by the trial months
|In all countries concerned by the trial days