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Clinical Trials List

Protocol NumberM16-067
NCT Number(ClinicalTrials.gov Identfier)NCT03398148
Completed

2018-01-01 - 2023-05-12

Phase II/III

Recruiting6

ICD-10K51

Ulcerative colitis

ICD-9556.9

Ulcerative colitis, unspecified

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie Biopharmaceuticals GmbH Taiwan Branch

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/16

Investigators and Locations

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
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator 林敬斌 Division of General Internal Medicine
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
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Ulcerative Colitis (UC)

Objectives

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Test Drug

Risankizumab

Active Ingredient

risankizumab/安慰劑

Dosage Form

N/A

Dosage

N/A

Endpoints

Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.

For Sub-Study 1, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1.

Week 12
Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.

For Sub-Study 2, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1. Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopic activity will confer an endoscopic subscore of 2.

Week 12

Inclution Criteria

Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

Exclusion Criteria

Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
Participant receiving prohibited medications and treatment.
Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
Participant with currently known complications of UC (e.g., megacolon).
No known active Coronavirus Disease - 2019 (COVID-19) infection.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    720 participants

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