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Clinical Trials List

Protocol NumberM16-066
NCT Number(ClinicalTrials.gov Identfier)NCT03398135

2018-01-01 - 2027-12-31

Phase III

Recruiting5

Terminated1

ICD-10K51

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

  • Trial Applicant

    AbbVie

  • Sponsor

    Abbvie

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Ming-Chih Hou Digestive System Department
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator 林敬斌 Digestive System Department
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHUNG-HSIN CHANG Digestive System Department
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Wei Chou Digestive System Department
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jung Kuo Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Ulcerative Colitis

Objectives

Sub-study 1: Randomized, double-blind, placebo-controlled maintenance To evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active ulcerative colitis (UC) who responded to IV risankizumab induction treatment in Study M16-067. Sub-study 2: Randomized, exploratory maintenance To evaluate the 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 who 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 who completed Sub-study 1 or 2 or subjects who responded to induction treatment in Study M16-067 with no final endoscopy due to the COVID-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab.

Test Drug

Risankizumab

Active Ingredient

risankizumab

Dosage Form

IV / SC

Dosage

1800 mg, 1200 mg, 600 mg, 360 mg, 180 mg

Endpoints

Sub-Study 1 (Risankizumab vs Placebo)
Primary Endpoint: Proportion of subjects with clinical remission per Adapted Mayo score at Week 52.

Sub-Study 3 Efficacy Variables
Primary Endpoint: evaluation of long-term safety

Inclution Criteria

1. 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 Substudy 3 should they meet clinical response.
2. Achieved clinical response, defined as decrease in Adapted Mayo Score ≥ 2 points and ≥ 30% from
Baseline, PLUS a decrease in RBS ≥ 1 or an absolute RBS ≤ 1 at the last visit of Study M16-067.
For subjects with missing final endoscopy for Study M16-067 due to COVID-19 pandemic, clinical
response is defined as a decrease in Partial Adapted Mayo Score ≥ 1 point and ≥ 30% from
Baseline, PLUS a decrease in RBS ≥ 1 or an absolute RBS ≤ 1 at the last visit of Study M16-067.
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 M16-066 if high grade colonic dysplasia or colon cancer is
discovered at the endoscopy performed at the final visit of Study M16-067.
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 Study M16-067 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 M16-067.
4. Subject is not in compliance with prior and concomitant medication requirements throughout
Study M16-067.
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

  • Taiwan

    12 participants

  • Global

    760 participants

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