Clinical Trials List
2018-01-01 - 2030-12-31
Phase III
Recruiting5
Study ended1
ICD-10K51
Ulcerative colitis
ICD-9556.9
Ulcerative colitis, unspecified
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
-
Trial Applicant
AbbVie
-
Sponsor
AbbVie
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/10/13
Investigators and Locations
Co-Principal Investigator
- HAN-MO CHIU Digestive System Department
- 陳介章 Digestive System Department
- 曾屏輝 Digestive System Department
- YEN-HSUAN NI Division of Pediatrics
- 吳嘉峰 Division of Pediatrics
- 陳彥年 Division of General Internal Medicine
- 凃佳宏 Digestive System Department
- Huey-Ling Chen Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 盧俊良 Digestive System Department
- Jiing-Chyuan Luo Digestive System Department
- 王彥博 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳家昌 Digestive System Department
- 趙德馨 Digestive System Department
- FAN -FENG CHIANG Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Lung Feng Digestive System Department
- Tsung-Yu Tsai Digestive System Department
- 張安迪 Digestive System Department
- 吳宜樺 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Puo-Hsien Le Digestive System Department
- 許振銘 Digestive System Department
- Cheng-Tang Chiu Digestive System Department
- Ming-Wei Lai Division of Pediatrics
- Wen-Sy Tsai Division of Colorectal Surgery
- 陳繹中 Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Sub-trial 1: Percentage of participants achieving a clinical response based on the adjusted Mayo score at week 52.
Sub-trial 3: Percentage of participants experiencing adverse events [up to 300 weeks]. An adverse event (AE) is defined as any medically adverse event occurring in participants taking the medication or in clinical study participants, and is not necessarily causally related to the treatment.
Secondary endpoints:
1. Sub-trial 1: Percentage of participants achieving improvement in endoscopic findings at week 52.
2. Sub-trial 1: Percentage of participants with a baseline Mayo score of 6 to 12 who achieve clinical remission (based on the baseline Mayo score) at week 52.
3. Sub-trial 1: Percentage of participants who used steroids at the baseline (induction trial) and discontinued corticosteroid use by week 52.
4. Sub-trial 1: Percentage of participants with a clinical remission at week 0 who achieve clinical remission (based on the adjusted Mayo score) at week 52.
5. Sub-trial 1: The proportion of subjects who were using corticosteroids at the base period (induction trial) and achieved clinical remission by week 52 after discontinuing corticosteroid use and maintaining a 90-day corticosteroid-free period.
6. Sub-trial 1: The proportion of subjects achieving clinical response based on the revised Mayo score by week 52.
7. Sub-trial 1: The proportion of subjects achieving histological-endoscopic improvement by week 52.
8. Sub-trial 1: The proportion of subjects achieving endoscopic remission by week 52.
9. Sub-trial 1: The proportion of subjects who showed endoscopic improvement at week 0 and achieved endoscopic improvement by week 52.
10. The proportion of subjects hospitalized for UC-related reasons by week 52.
11. Sub-trial 1: The proportion of subjects achieving histological remission by week 52.
12. Sub-trial 1: The proportion of subjects who did not report abdominal pain by week 52.
13. Sub-trial 1: Percentage of participants who did not report irritable bowel syndrome at week 52.
14. Sub-trial 1: Percentage of participants who achieved mucosal healing at week 52.
15. Sub-trial 1: Change in total Inflammatory Bowel Disease Questionnaire (IBDQ) score from base period (induction trial) to week 52.
16. Sub-trial 1: Percentage of participants who underwent UC-related surgery by week 52.
17. Sub-trial 1: Change in FACIT-fatigue from base period (induction trial) to week 52.
18. Sub-trial 1: Percentage of participants who did not report nocturnal defecation at week 52.
19. Sub-trial 1: Percentage of participants who did not report tenesmus at week 52.
20. Sub-trial 1: Change in weekly frequency of fecal incontinence episodes from base period (induction trial) to week 52.
21. Sub-trial 1: Changes in the number of days of sleep interruption due to UC symptoms within one week from the base period (induction test) to week 52.
22. Sub-trial 1: Changes in Short Form-36 (SF-36) scores from week 0 to week 52.
Inclution Criteria
- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
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.
The Estimated Number of Participants
-
Taiwan
20 participants
-
Global
942 participants
