Clinical Trials List
2017-12-21 - 2020-04-01
Phase III
Recruiting5
ICD-10K50.90
Crohn's disease, unspecified, without complications
ICD-10K50
Crohn's disease [regional enteritis]
ICD-9555.0
Regional enteritis, small intestine
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 Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Tsung-Yu Tsai Digestive System Department
- Chun-Lung Feng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 康瑞文 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王煥昇 Division of Colorectal Surgery
- 姜正愷 Division of Colorectal Surgery
- 張世慶 Division of Colorectal Surgery
- Hung-Hsin Lin Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- 謝銘鈞 Division of Hematology & Oncology
- 翁昭旼 Digestive System Department
- YEN-HSUAN NI Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Co-Primary Endpoint: Proportion of subjects with clinical remission at Week 52 and proportion of
subjects with endoscopic response at Week 52.
Ranked Secondary Endpoints:
1. Proportion of subjects with clinical remission (Crohn's disease activity index [CDAI] < 150) at
Week 52 in subjects with baseline (of the induction study) CDAI of 220 to 450.
2. Proportion of subjects who discontinued corticosteroid use and achieved clinical remission at
Week 52 in subjects taking steroids 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 patients with sustained clinical remission at both Weeks 0 and Week 52.
5. Proportion of subjects with enhanced clinical response at Week 52.
6. Proportion of subjects with clinical remission and endoscopic response at Week 52.
7. Proportion of subjects with endoscopic healing at Week 52.
8. Change from Week 0 in Crohn's Symptom Severity (CSS) at Week 52.
9. Proportion of subjects with resolution of EIMs at Week 52 in subjects with EIMs at baseline (of
induction).
10. Proportion of subjects with deep remission at Week 52.
11. Proportion of subjects with hospitalizations through Week 52.
12. Proportion of subjects with draining fistulas at Week 52 in subjects with draining fistulas at baseline
(of induction).
13. Change from baseline FACIT-Fatigue at Week 52.
14. Change from baseline Short Form-36 at Week 52.
15. Proportion of subjects with CD-related surgeries through Week 52.
Inclution Criteria
1. Entry and completion of Study M16-006 or Study M15-991. Completion includes the final
endoscopy of Study M16-006 or Study M15-991.
2. Achieved clinical response, defined as ≥ 30% decrease in average daily SF and/or ≥ 30% decrease in
average daily AP score, and both not worse than Baseline of the induction study, at the last visit of
Study M16-006 or Study M15-991.
3. If female, subject must meet the criteria as stated in Section 5.2.4 of this protocol Contraception
Recommendations.
4. Subject must be able and willing to give written informed consent and to comply with the
requirements of this study protocol, including self-administration or care-giver administration of SC
injections. In Japan, if the subject is < 20 years old, a subject's parent or legal guardian must be
willing to give written informed consent.
Exclusion Criteria
1. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Subjects should not be enrolled in Study M16-000 if high grade colonic dysplasia or colon cancer is
discovered at the endoscopy performed at the final visit of Study M16-006 or Study M15-991.
2. 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 Studies M16-006 or M15-991 that in the
Investigator's judgment makes the subject unsuitable for this study.
3. Confirmed positive urine pregnancy test at the Final Visit of Study M16-006 or Study M15-991.
4. Subject is not in compliance with prior and concomitant medication requirements throughout
Studies M16-006 or M15-991.
5. Subject with any active or chronic recurring infections based on the Investigator's assessment makes
the subject an unsuitable candidate for the study.
6. Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms
suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
912 participants
