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Ulcerative ColitisPhase 2NCT06254950

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

A Phase 2 study testing TAK-279 in people with Ulcerative Colitis, run by Takeda at 141 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
TAK-279
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
213 participants
Where
141 sitesin 22 countries
Study dates
29 Mar 2024to 4 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
  • 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.
  • Participants must meet the contraception recommendations.

Who cannot join

  • 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).
  • Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
  • Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
  • Participants who have failed 3 or more classes of advanced therapies.

Trial locations and contacts

141 sites in 22 countries.

141 sites in 22 countries

United States16 sites

  • Emory University Hospital, The Emory Clinic

    Atlanta, Georgia, 30322

  • Novel Research, LLC

    Bellaire, Texas, 77401

  • West Central Gastroenterology, LLP, d/b/a/ Gastro Florida

    Clearwater, Florida, 33762

  • Atlanta Center For Gastroenterology, P.C.

    Decatur, Georgia, 30033

  • Woodholme Gastroenterology Associates

    Glen Burnie, Maryland, 21061

  • Gastroenterology Associates, PA

    Greenville, South Carolina, 29607

  • Auzmer Research

    Lakeland, Florida, 33813

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • GastroIntestinal BioSciences

    Los Angeles, California, 90067

  • University Of Louisville

    Louisville, Kentucky, 40202

  • United Medical Doctors

    Murrieta, California, 92563

  • GI PROS, Inc.

    Naples, Florida, 34102

  • University Gastroenterology

    Providence, Rhode Island, 02904

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • USF Health Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

Other trials in United States

Poland12 sites

  • Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, 90-153

  • Medrise sp. z o.o

    Lublin, 20-582

  • Centrum Medyczne MedykSp. z o.o. Sp. K.

    Rzeszów, 35-326

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35302

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie

    Torun, Kujawsko-pomo, 87-100

  • H-T. Centrum Medyczne Sp. z o.o. Sp.k.

    Tychy, 43-100

  • Panstwowy Instytut Medyczny MSWiA

    Warsaw, Masovian Voivodeship, 02-507

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501

  • Centrum Medyczne Melita Medical

    Wroclaw, Dolnolskie, 50-449

  • PlanetMed Sp. z o.o.

    Wroclaw, Lower Silesian Voivodeship, 52-210

Other trials in Poland

Czechia11 sites

  • SurGal Clinic SRO

    Brno, 602 00

  • Vojenska Nemocnice Brno

    Brno, 636 00

  • University Hospital Brno

    Brno, 639 00

  • NH Hospital

    Hořovice, Central Bohemia, 268 31

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 50012

  • EndoArt

    Ostrava, 71000

  • Fakultni Nemocnice Ostrava (FNO)

    Ostrava-Poruba, 708 00

  • Gastromedic s.r.o

    Pardubice, 530 03

  • Endohope Clinic

    Prague, 10100

  • Axon Clinical s.r.o.

    Prague, 15000

  • Masaryk Hospital

    Ústí nad Labem, 40113

Other trials in Czechia

China10 sites

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • The Second People's Hospital of Changzhou

    Changzhou, Jiangsu, 200001

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing General Hospital

    Chongqing, Chongqing Sheng, 401147

  • Wuhan University - Renmin Hospital (Hubei General Hospital)

    Chongqing, Hubei, 430060

  • Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)

    Guangzhou, Guangdong, 3011

  • Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)

    Hangzhou, 310016

  • Renji hospital shanghai jiao tong university school of medicine

    Shanghai, Shanghai Municipality

  • Shanghai Pudong New District Zhoupu Hospital

    Shanghai, 201318

  • China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus

    Shenyang, Liaoning, 110022

Other trials in China

Australia9 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Western Health/Footscray Hospital

    Melbourne, Victoria, 3011

  • Harry Perkins Medical Research Institute Fiona Stanley Hospital

    Murdoch, 6150

  • Sir Charles Gairdner Hospital Lung Institute Of Western Australia

    Nedlands, Western Australia, 6009

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Mater Cancer Care Centre-Mater Health Services

    South Brisbane, Queensland, 4101

  • Concord Repatriation General Hospital

    Sydney, New South Wales, 2139

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Japan8 sites

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Kansai Medical University Hospital

    Hirakata, Osaka, 5731191

  • The jikei University Hospital

    Minato, Tokyo, 105-8471

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

  • Saga University Hospital

    Saga, 849-0937

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-8741

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

Other trials in Japan

Germany7 sites

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431

  • Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)

    Hamburg, 20251

  • Praxis fur Gastroenterologie

    Heidelberg, 69115

  • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel

    Kiel, 24105

  • St. Marien- und St. Annastiftskrankenhaus

    Ludwigshafen, 67065

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • University Hospital Of Ulm, Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Bulgaria6 sites

  • UMBAL Kaspela

    Plovdiv, 4001

  • Pecs University Clinical Center Mohacs Hospital

    Sofia, 1000

  • Acibadem City clinic Tokuda hospital

    Sofia, 1407

  • Diagnostic-Consultative Center Aleksandrovska EOOD

    Sofia, 1431

  • University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)

    Sofia, 1527

  • University Hospital City Clinic Cancer Center

    Sofia, 1784

Other trials in Bulgaria

Canada6 sites

  • Heritage Medical Research Clinic - University Of Calgary

    Calgary, Alberta, T2N 4Z6

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario, N6A 5W9

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 0A9

  • The Research Institute of the McGill University Health Center

    Montreal, Quebec, H3G 1A4

  • Fraser Clinical Trials

    New Westminster, British Columbia, V3L 3W4

Other trials in Canada

Denmark6 sites

  • Aalborg Hospital

    Aalborg, 9100

  • Sydvestjysk Region/Esbjerg Hospital

    Esbjerg, 6700

  • Hillerod Hospital, Hilleroed Sygehus

    Hillerød, 3400

  • Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling

    Hvidovre, 2650

  • Region Sjaelland Sygehus Nord, Koge Sygehus

    Køge, 4600

  • Odense Universitetshospital (OUH) (Odense University Hospital)

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Romania6 sites

  • Monza-Ares Srl

    Bucharest, Sector 2, 021967

  • Clinical Hospital Colentina-Spitalul Clinic Colentina

    Bucharest, 0 50159

  • Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu Sisesti

    Bucharest, 13823

  • Delta Health Care

    Bucharest, 14142

  • Spital Clinic Dr I Cantacuzino

    Bucharest, 20475

  • Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis

    Timișoara, Jud Timis, 300002

Other trials in Romania

Greece5 sites

  • Evaggelismos Hospital (Evangelismos Hospital)-University of Athens

    Athens, Attica, 106 76

  • Sotiria General Hospital of Athens

    Athens, 11527

  • G.N.A. Gennimatas

    Athens, 15669

  • University Hospital of Heraklion

    Heraklion, Crete, 71110

  • University General Hospital of Patras

    Pátrai, Achaia, 26504

Other trials in Greece

Hungary5 sites

  • Clinexpert

    Budapest, 1033

  • Semmelweis Egyetem

    Budapest, 1082

  • Pannonia Maganorvosi Centrum Kft.

    Budapest, 1136

  • Mohacsi Korhaz

    Mohács, 7700

  • Javorszky Odon Korhaz

    Vác, 2600

Other trials in Hungary

Italy5 sites

  • IRCCS A.O.U. Policlinico S. Orsola - Malpighi

    Bologna, 40138

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital

    Milan, 20132

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

    Palermo, 90146

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, 152

  • IRCCS Istituto clinico humanitas - Humanitas Mirasole spa

    Rozzano, 20089

Other trials in Italy

Slovakia5 sites

  • Fakultna nemocnica F. D. Roosevelta

    Banská Bystrica, 97401

  • Cliniq s. r. o.

    Bratislava, 811 09

  • Endomed

    Košice, 4013

  • Fakultna Nemocnica s poliklinikou Nove Zamky

    Nové Zámky, 94034

  • Accout Center, s.r.o.- Gastroenterologicka ambulancia

    Šahy, 936 01

Other trials in Slovakia

South Korea5 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722

  • Asan Medical Center (AMC)

    Seoul, 5505

  • Samsung Medical Center

    Seoul, 6351

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

France4 sites

  • CHU De Clermont Ferrand - Hopital Estaing

    Clermont-Ferrand, 63000

  • Hopital l'Archet 2

    Nice, 6202

  • Hopital Nord Chu Saint-Etienne

    Saint-Etienne, 42055

  • Centre Hospitalier Regional Universitaire de Nancy Hopital Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Israel4 sites

  • Assuta Ashdod University Hospital

    Ashdod, 7747629

  • Soroka Mc

    Beersheba, 84101

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital

    Ramat Gan, 5265601

Other trials in Israel

United Kingdom4 sites

  • South Eastern Health and Social Care Trust - The Ulster Hospital

    Belfast, BT16 1RH

  • Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Clinical Research Centre - Barts Health NHS Trust

    London, E1 2at, E1 2AT

  • St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust

    London, SE1 7EH

Other trials in United Kingdom

Taiwan3 sites

  • Changhua Christian Hospital (CCH)

    Changhua, Changhua County, 50006

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital (NTUH)

    Taipei, Zhongzheng District, 100

Other trials in Taiwan

Belgium2 sites

  • Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel

    Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, 1070

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

Other trials in Belgium

Norway2 sites

  • Akershus University Hospital

    Lorenskog, Akershus, 1478

  • Oslo Univeristy Hospital Ulleval Hospital

    Oslo, 450

Other trials in Norway

About this study

Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis

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.

Read the 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.

Being tested
TAK-279, Placebo
Keywords
Drug Therapy, Latitude UC, Latitude Research Program
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-279Drug

    Also called Zasocitinib

    TAK-279 capsules.

  • PlaceboDrug

    TAK-279 placebo-matching capsules.

Study groups in NCT06254950
Study groupRoleWhat they receive
TAK-279 Dose 1ExperimentalTAK-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.
Receives: Drug: TAK-279
TAK-279 Dose 2ExperimentalTAK-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.
Receives: Drug: TAK-279
PlaceboPlacebo comparatorTAK-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.
Receives: Drug: TAK-279; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS)

    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).

    Measured: Week 12

Secondary outcomes (9)

  1. Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)

    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.

    Measured: Baseline, Week 12

  2. Percentage of Participants Achieving Symptomatic Remission at Week 12

    Symptomatic remission is defined as a RB subscore of 0 and SF subscore of ≤1.

    Measured: Week 12

  3. Percentage of Participants Achieving Endoscopic Improvement at Week 12

    Endoscopic improvement defined as a modified Mayo ES of ≤1 (score of 1 modified to exclude friability).

    Measured: Week 12

  4. Percentage of Participants Achieving Endoscopic Remission at Week 12

    Endoscopic remission defined as a modified Mayo ES of 0.

    Measured: Week 12

  5. Percentage of Participants With no Bowel Urgency at Week 12

    Bowel urgency measured by the bowel urgency electronic diary (eDiary) item at Week 12.

    Measured: Week 12

  6. Percentage of Participants With no Abdominal Pain at Week 12

    Abdominal pain measured by abdominal pain eDiary item at Week 12.

    Measured: Week 12

  7. Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score ≥170 at 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.

    Measured: Week 12

  8. Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at 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.

    Measured: Baseline and Week 12

  9. Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at 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.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start29 Mar 2024
  3. Primary completion14 Jul 2026
  4. Study completion4 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06254950
Sponsor's protocol ID
TAK-279-UC-2001
Other IDs
2023-506769-67-00, jRCT2031240228, 2023
Status last verified
Aug 2026
First submitted
2 Feb 2024
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-279 in people with Ulcerative Colitis, run by Takeda at 141 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States, Poland, Czechia, China, Australia and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06254950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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