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

Phase 2

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: TAK-279; Drug: Placebo

• Registration Number: NCT06254950
• Lead Sponsor: Takeda

Brief 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.

Detailed Description

Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period.

An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -

1. TAK-279 Dose 1

2. TAK-279 Dose 2

3. Placebo

The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations
|
Related News

Study Timeline

• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-12
• Study Start: 2024-03-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-09-30
• Study Completion: 2027-08-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days.
2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one conventional, biologic or advance therapy for UC.
4. Participants must meet the contraception recommendations.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-279 Dose 1	TAK-279	TAK-279, capsules, orally at Dose 1 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.
TAK-279 Dose 2	TAK-279	TAK-279, capsules, orally at Dose 2 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.
Placebo	TAK-279	TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally either Dose 1 or Dose 2 up to Week 52 based on the response.
Placebo	Placebo	TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally either Dose 1 or Dose 2 up to Week 52 based on the response.

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12	Baseline and Week 12	The FACIT-Fatigue is a reliable and valid instrument for measuring fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue.
Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)	Baseline, Week 12	Clinical response defined as reduction from baseline in mMS of ≥2 points and ≥30% from baseline and a decrease from baseline in the RB subscore of ≥1 point or an absolute RB subscore of ≤1 point at Week 12.
Percentage of Participants Achieving Symptomatic Remission at Week 12	Week 12	Symptomatic remission is defined as a RB subscore of 0 and SF subscore of ≤1.
Percentage of Participants Achieving Endoscopic Improvement at Week 12	Week 12	Endoscopic improvement defined as a modified Mayo ES of ≤1 (score of 1 modified to exclude friability).
Percentage of Participants Achieving Endoscopic Remission at Week 12	Week 12	Endoscopic remission defined as a modified Mayo ES of 0.
Percentage of Participants With no Bowel Urgency at Week 12	Week 12	Bowel urgency measured by the bowel urgency electronic diary (eDiary) item at Week 12.
Percentage of Participants With no Abdominal Pain at Week 12	Week 12	Abdominal pain measured by abdominal pain eDiary item at Week 12.
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score ≥170 at Week 12	Week 12	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.
Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12	Baseline and Week 12	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.

Trial Locations

Locations (132)

GastroIntestinal BioSciences; 🇺🇸 Los Angeles, California, United States

United Medical Doctors; 🇺🇸 Murrieta, California, United States

UCI Health; 🇺🇸 Orange, California, United States

West Central Gastroenterology, LLP, d/b/a/ Gastro Florida; 🇺🇸 Clearwater, Florida, United States

Auzmer Research; 🇺🇸 Lakeland, Florida, United States

GI PROS, Inc.; 🇺🇸 Naples, Florida, United States

USF Health Morsani Center for Advanced Healthcare; 🇺🇸 Tampa, Florida, United States

Emory University Hospital, The Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Atlanta Center For Gastroenterology, P.C.; 🇺🇸 Decatur, Georgia, United States

Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University Of Louisville; 🇺🇸 Louisville, Kentucky, United States

Woodholme Gastroenterology Associates; 🇺🇸 Glen Burnie, Maryland, United States

BVL Clinical Research; 🇺🇸 Liberty, Missouri, United States

Las Vegas Medical Research; 🇺🇸 Las Vegas, Nevada, United States

Rochester Clinical Research; 🇺🇸 New York, New York, United States

DiGiovanna Institute for Medical Education and Research; 🇺🇸 North Massapequa, New York, United States

Hightower Clinical - SSM Health; 🇺🇸 Oklahoma City, Oklahoma, United States

Gastroenterology Associates, PA; 🇺🇸 Greenville, South Carolina, United States

Novel Research, LLC; 🇺🇸 Bellaire, Texas, United States

Tyler Research Institute, LLC; 🇺🇸 Tyler, Texas, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Nepean Clinical School; 🇦🇺 Kingswood, New South Wales, Australia

Concord Repatriation General Hospital; 🇦🇺 Sydney, New South Wales, Australia

Western Health/Footscray Hospital; 🇦🇺 Melbourne, Victoria, 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, Belgium

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium

Heritage Medical Research Clinic - University Of Calgary; 🇨🇦 Calgary, Alberta, Canada

Fraser Clinical Trials; 🇨🇦 New Westminster, British Columbia, Canada

London Health Sciences Centre - University Hospital; 🇨🇦 London, Ontario, Canada

London Health Sciences Centre - Victoria Hospital; 🇨🇦 London, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada

The Research Institute of the McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada

Hepato-Gastroenterologie HK, s.r.o.; 🇨🇿 Hradec Kralove, Czechia

Fakultni Nemocnice Ostrava (FNO); 🇨🇿 Ostrava-Poruba, Czechia

Axon Clinical s.r.o.; 🇨🇿 Praha 5, Czechia

Odense Universitetshospital (OUH) (Odense University Hospital); 🇩🇰 Odense, Syddanmark, Denmark

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Sydvestjysk Region/Esbjerg Hospital; 🇩🇰 Esbjerg, Denmark

Hillerod Hospital, Hilleroed Sygehus; 🇩🇰 Hillerod, Denmark

Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling; 🇩🇰 Hvidovre, Denmark

Region Sjaelland Sygehus Nord, Koge Sygehus; 🇩🇰 Koge, Denmark

Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau; 🇫🇷 Chambray-les-Tours, France

CHU De Clermont Ferrand - Hopital Estaing; 🇫🇷 Clermont-Ferrand, France

Hopital l'Archet 2; 🇫🇷 Nice Cedex 3, France

Hopital Nord Chu Saint-Etienne; 🇫🇷 Saint Etienne, France

Centre Hospitalier Regional Universitaire de Nancy Hopital Brabois; 🇫🇷 Vandoeuvre les Nancy, France

Agaplesion Markus Krankenhaus; 🇩🇪 Frankfurt Am Main, Germany

Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.); 🇩🇪 Hamburg, Germany

Medizinische Hochschule Hannover, Hannover Medical School; 🇩🇪 Hannover, Germany

Praxis fur Gastroenterologie; 🇩🇪 Heidelberg, Germany

Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel; 🇩🇪 Kiel, Germany

St. Marien- und St. Annastiftskrankenhaus; 🇩🇪 Ludwigshafen, Germany

Universitaetsklinikum Mannheim GmbH; 🇩🇪 Mannheim, Germany

Universitaetsklinikum Tuebingen; 🇩🇪 Tuebingen, Germany

University Hospital Of Ulm, Universitatsklinikum Ulm; 🇩🇪 Ulm, Germany

University General Hospital of Patras; 🇬🇷 Patras, Achaia, Greece

Evaggelismos Hospital (Evangelismos Hospital)-University of Athens; 🇬🇷 Athens, Attiki, Greece

University Hospital of Heraklion; 🇬🇷 Heraklion, Crete, Greece

Sotiria General Hospital of Athens; 🇬🇷 Athens, Greece

G.N.A. Gennimatas; 🇬🇷 Athens, Greece

Clinexpert; 🇭🇺 Budapest, Hungary

Semmelweis Egyetem; 🇭🇺 Budapest, Hungary

Pannonia Maganorvosi Centrum Kft.; 🇭🇺 Budapest, Hungary

Javorszky Odon Korhaz; 🇭🇺 Vac, Hungary

IRCCS A.O.U. Policlinico S. Orsola - Malpighi; 🇮🇹 Bologna, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital; 🇮🇹 Milan, Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello; 🇮🇹 Palermo, Italy

Azienda Ospedaliera San Camillo Forlanini; 🇮🇹 Rome, Italy

IRCCS Istituto clinico humanitas - Humanitas Mirasole spa; 🇮🇹 Rozzano, Italy

AO Ordine Mauriziano di Torino; 🇮🇹 Torino, Italy

Toho University Sakura Medical Center; 🇯🇵 Sakura, Chiba, Japan

Sapporo Medical University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Kansai Medical University Hospital; 🇯🇵 Hirakata, Osaka, Japan

Kitasato University Kitasato Institute Hospital; 🇯🇵 Minato-ku, Tokyo, Japan

The jikei University Hospital; 🇯🇵 Minato, Tokyo, Japan

Kyorin University Hospital; 🇯🇵 Mitaka-City, Tokyo, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka, Japan

Saga University Hospital; 🇯🇵 Saga, Japan

Yonsei University Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center (AMC); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

St. Elisabeth Ziekenhuis; 🇳🇱 Tilburg, Netherlands

Akershus University Hospital; 🇳🇴 Lorenskog, Akershus, Norway

Vestre Viken HF - Baerum Sykehus; 🇳🇴 Drammen, Gjettum, Norway

Oslo Univeristy Hospital Ulleval Hospital; 🇳🇴 Oslo, Norway

Centrum Medyczne Melita Medical; 🇵🇱 Wroclaw, Dolnolskie, Poland

PlanetMed Sp. z o.o.; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie; 🇵🇱 Torun, Kujawsko-pomo, Poland

AmiCare Sp. z o.o. Sp. k.; 🇵🇱 Lodz, Lodzkie, Poland

Panstwowy Instytut Medyczny MSWiA; 🇵🇱 Warszawa, Mazowieckie, Poland

Centrum Medyczne Pratia Gdynia; 🇵🇱 Gdynia, Pomorskie, Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne; 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi; 🇵🇱 Lodz, Poland

Centrum Medyczne Med-Gastr; 🇵🇱 Lodz, Poland

Medrise sp. z o.o; 🇵🇱 Lublin, Poland

Centrum Medyczne MedykSp. z o.o. Sp. K.; 🇵🇱 Rzeszow, Poland

Korczowski Bartosz, Gabinet Lekarski; 🇵🇱 Rzeszow, Poland

H-T. Centrum Medyczne Sp. z o.o. Sp.k.; 🇵🇱 Tychy, Poland

Wojskowy Instytut Medyczny; 🇵🇱 Warsaw, Poland

WIP Warsaw IBD Point Profesor Kierkus; 🇵🇱 Warsaw, Poland

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy; 🇵🇱 Wroclaw, Poland

ETG Zamosc; 🇵🇱 Zamosc, Poland

Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis; 🇷🇴 Timisoara, Jud Timis, Romania

Clinical Hospital Colentina-Spitalul Clinic Colentina; 🇷🇴 Bucharest, Romania

Clinica Medicum; 🇷🇴 Bucharest, Romania

Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu Sisesti; 🇷🇴 Bucuresti, Romania

Fakultna nemocnica F. D. Roosevelta; 🇸🇰 Banska Bystrica, Slovakia

Cliniq s. r. o.; 🇸🇰 Bratislava, Slovakia

Endomed; 🇸🇰 Kosice, Slovakia

Fakultna Nemocnica s poliklinikou Nove Zamky; 🇸🇰 Nove Zamky, Slovakia

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Spain

Hospital Juan Ramon Jimenez; 🇪🇸 Huelva, Spain

Hospital General Universitario Gregorio Maranon (HGUGM); 🇪🇸 Madrid, Spain

University Hospital Basel; 🇨🇭 Basel, Switzerland

Changhua Christian Hospital (CCH); 🇨🇳 Changhua City, Changhua County, Taiwan

National Taiwan University Hospital (NTUH); 🇨🇳 Taipei City, Zhongzheng District, Taiwan

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung City, Taiwan

Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan

Clinical Research Centre - Barts Health NHS Trust; 🇬🇧 London, E1 2at, United Kingdom

St George's University Hospitals NHS Foundation Trust; 🇬🇧 London, Greater London, United Kingdom

South Eastern Health and Social Care Trust - The Ulster Hospital; 🇬🇧 Belfast, United Kingdom

Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom

St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom