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

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 - M16-066

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54535

Enrollment

Registered

2018-05-02

Start date

2019-05-28

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

form of inflammatory Bowel Disease (IBD) Ulcerative Colitis

Interventions

Subjects receive once every eight weeks SC risankizumab or SC placebo. They receive this medication until the end of the study or till premature discontinuation. For subjects requiring rescue therap

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 COVID-19 pandemic, or due to the geo-political conflict in Ukraine and surrounding impacted regions, 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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
1.Proportion of subjects with endoscopic improvement at Week 52. 2. Proportion of subjects achieving histologic-endoscopic mucosal improvement at Week 52. 3. Proportion of subjects with endoscopic remission at Week 52. 4. Proportion of subjects achieving clinical remission per Adapted Mayo score at Week 52 with no corticosteroid use for 90 days. 5. Proportion of subjects with clinical remission per Adapted Mayo score at Week 52 in subjects with clinical remission at Week 0. 6. Proportion of subjects who reported no bowel urgency at Week 52 7. Proportion of subjects who reported no abdominal pain at Week 52 8. Proportion of subjects achieving histologic-endoscopic mucosal 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 clinical response per Adapted Mayo score at Week 52 11. Change from Baseline (of induction) to Week 52 in FACIT-Fatigue. 12. Change from Baseline (of induction) to Week 52 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score. 13. Proportion of subjects who reported no nocturnal bowel movements at Week 52. 14. Proportion of subjects who reported no tenesmus at Week 52. 15. Change from Baseline (of induction) to Week 52 in number of fecal incontinence episodes per Week. 16. Change from Baseline (of induction) to Week 52 in number of days over a week with sleep interrupted due to UC symptoms. 17. Proportion of subjects with exposure adjusted occurrence of UC-related hospitalizations through Week 52.	—

Measure

Time frame

1.Proportion of subjects with endoscopic improvement at Week 52. 2. Proportion of subjects achieving histologic-endoscopic mucosal improvement at Week 52. 3. Proportion of subjects with endoscopic remission at Week 52. 4. Proportion of subjects achieving clinical remission per Adapted Mayo score at Week 52 with no corticosteroid use for 90 days. 5. Proportion of subjects with clinical remission per Adapted Mayo score at Week 52 in subjects with clinical remission at Week 0. 6. Proportion of subjects who reported no bowel urgency at Week 52 7. Proportion of subjects who reported no abdominal pain at Week 52 8. Proportion of subjects achieving histologic-endoscopic mucosal 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 clinical response per Adapted Mayo score at Week 52 11. Change from Baseline (of induction) to Week 52 in FACIT-Fatigue. 12. Change from Baseline (of induction) to Week 52 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score. 13. Proportion of subjects who reported no nocturnal bowel movements at Week 52. 14. Proportion of subjects who reported no tenesmus at Week 52. 15. Change from Baseline (of induction) to Week 52 in number of fecal incontinence episodes per Week. 16. Change from Baseline (of induction) to Week 52 in number of days over a week with sleep interrupted due to UC symptoms. 17. Proportion of subjects with exposure adjusted occurrence of UC-related hospitalizations through Week 52.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)