Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Taiwan / NCT06254950
Active, not recruiting Phase 2

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

NCT06254950 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Takeda
Phase
Phase 2
Started
2024-03-29
Last updated
2026-08-17

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

TAK-279 →Placebo

TAK-279: TAK-279 capsules.

Placebo: TAK-279 placebo-matching capsules.

Study summary

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems.

The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks).

During the study, participants will visit their study clinic several times.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days. In South Korea, the age requirement for adult participants is ≥19 years of age. 2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES. 3. Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC. 4. Participants must meet the contraception recommendations. Exclusion Criteria: 1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD). 2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study. 3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma. 4. Participants who have failed 3 or more classes of advanced therapies.

Primary outcome measure(s)

  • Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS) — Week 12
    The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component subscore ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined an mMS of ≤2 with SF subscore ≤ 1, RB subscore = 0, and ES ≤ 1 (score of 1 modified to exclude friability).

Trial sites (141)

FacilityCityRegionStatus
GastroIntestinal BioSciences Los Angeles California
United Medical Doctors Murrieta California
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida Clearwater Florida
Auzmer Research Lakeland Florida
GI PROS, Inc. Naples Florida
USF Health Morsani Center for Advanced Healthcare Tampa Florida
Emory University Hospital, The Emory Clinic Atlanta Georgia
Atlanta Center For Gastroenterology, P.C. Decatur Georgia
University Of Louisville Louisville Kentucky
Woodholme Gastroenterology Associates Glen Burnie Maryland
Las Vegas Medical Research Las Vegas Nevada
University Gastroenterology Providence Rhode Island
Gastroenterology Associates, PA Greenville South Carolina
Novel Research, LLC Bellaire Texas
Tyler Research Institute, LLC Tyler Texas
University of Washington Medical Center Seattle Washington
Concord Repatriation General Hospital Sydney New South Wales
Mater Cancer Care Centre-Mater Health Services South Brisbane Queensland
Flinders Medical Centre Bedford Park South Australia
The Queen Elizabeth Hospital Woodville South Australia
The Alfred Hospital Melbourne Victoria
Western Health/Footscray Hospital Melbourne Victoria
Sir Charles Gairdner Hospital Lung Institute Of Western Australia Nedlands Western Australia
Royal Perth Hospital Perth Western Australia
Harry Perkins Medical Research Institute Fiona Stanley Hospital Murdoch Australia
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel Brussels Anderlecht / Region Capitale de Bruxelles/ Brussel
Universitair Ziekenhuis Leuven Leuven Belgium
UMBAL Kaspela Plovdiv Bulgaria
Pecs University Clinical Center Mohacs Hospital Sofia Bulgaria
Acibadem City clinic Tokuda hospital Sofia Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOOD Sofia Bulgaria
University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna) Sofia Bulgaria
University Hospital City Clinic Cancer Center Sofia Bulgaria
Heritage Medical Research Clinic - University Of Calgary Calgary Alberta
Fraser Clinical Trials New Westminster British Columbia
London Health Sciences Centre - University Hospital London Ontario
London Health Sciences Centre - Victoria Hospital London Ontario
Centre Hospitalier de l'Universite de Montreal Montreal Quebec
The Research Institute of the McGill University Health Center Montreal Quebec
Chongqing General Hospital Chongqing Chongqing Sheng

+ 101 more sites — see the full list on the official registry below.

More Takeda trials in Taiwan

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions Recruiting
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions Recruiting
TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations Active, not recruiting
A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer Active, not recruiting
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia Active, not recruiting

Other trials for the same condition

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis Recruiting
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis. Active, not recruiting
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis Recruiting
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06254950 on ClinicalTrials.gov ↗ ← All trials in Taiwan