A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

October 30, 2026 updated by: Takeda

A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation.

The participants will be treated with TAK-279 for 52 weeks (1 year).

During the study, participants will visit their study clinic 15 times.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279.

The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  1. TAK-279 Dose 1
  2. TAK-279 Dose 2
  3. TAK-279 Dose 3
  4. Placebo

This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Epping, Australia, 3076
        • Recruiting
        • Northern Hospital Epping
        • Principal Investigator:
          • Robert Little
        • Contact:
      • Nedlands, Australia, 6009
        • Recruiting
        • Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer Centre
        • Principal Investigator:
          • Nabil Siddique
        • Contact:
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Principal Investigator:
          • Rupert Leong
        • Contact:
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Cancer Care Centre-Mater Health Services
        • Principal Investigator:
          • Jakob Begun
        • Contact:
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
        • Principal Investigator:
          • Reme Mountifield
      • Woodville, South Australia, Australia, 5011
        • Recruiting
        • The Queen Elizabeth Hospital
        • Principal Investigator:
          • Robert Bryant
        • Contact:
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Recruiting
        • Western Health/Footscray Hospital
        • Contact:
        • Principal Investigator:
          • Ian Kronborg
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Harry Perkins Medical Research Institute Fiona Stanley Hospital
        • Principal Investigator:
          • Lena Thin
        • Contact:
      • Perth, Western Australia, Australia, 6000
  • Belgium
      • Brussels, Belgium, 1000
        • Recruiting
        • CHU Saint-Pierre - Porte de Hal
        • Principal Investigator:
          • Vinciane Muls
        • Contact:
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven
        • Principal Investigator:
          • Joao Pedro Guedelha Sabino
        • Contact:
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
        • Principal Investigator:
          • Catherine Reenaers
        • Contact:
    • Anderlecht / Region Capitale de Bruxelles/ Brussel
      • Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, Belgium, 1070
        • Recruiting
        • Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
        • Principal Investigator:
          • Denis Franchimont
        • Contact:
  • Brazil
      • São Paulo, Brazil, 01307-002
        • Recruiting
        • Solare Trials
        • Principal Investigator:
          • Marjorie Costa Argollo
        • Contact:
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Recruiting
        • L2 IP - Instituto de Pesquisas Clinicas LTDA
        • Principal Investigator:
          • Luciana Teixeira de Campos
        • Contact:
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36033-318
        • Recruiting
        • Galileo Medical Research
        • Contact:
        • Principal Investigator:
          • Julio Maria Fonseca Chebli
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Not yet recruiting
        • Hospital de Clinicas de Porto Alegre (HCPA)
        • Principal Investigator:
          • Luciana Harlacher
        • Contact:
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-970
        • Not yet recruiting
        • Universidade Estadual Paulista Julio De Mesquita Filho (Unesp) - Faculdade de Medicina de Botucatu
        • Principal Investigator:
          • Ligia Yukie Sassaki
        • Contact:
      • Campinas, São Paulo, Brazil, 13083-887
        • Recruiting
        • UniversidadeEstadualde Campinas - UNICAMP
        • Principal Investigator:
          • Cristiane Kibune Nagasako Vieira da Cruz
        • Contact:
      • Jaú, São Paulo, Brazil, 17201-130
        • Not yet recruiting
        • Centro de Estudos Clnicos do Interior Paulista (CECIP)
        • Contact:
        • Principal Investigator:
          • Bruna Meyer de Mattos Correa
      • Ribeirão Preto, São Paulo, Brazil, 14048-900
        • Recruiting
        • Ribeiralo Preto Medical School, University of Salo Paulo
        • Contact:
        • Principal Investigator:
          • Rogerio Parra
      • Santos, São Paulo, Brazil, 11075-900
        • Recruiting
        • Irmandade da Santa Casa da Misericordia de Santos
        • Principal Investigator:
          • Jose Eduardo Vasconcelos Fernandes
        • Contact:
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • Recruiting
        • UMHAT Kaspela
        • Contact:
        • Principal Investigator:
          • Desislav Stanchev
      • Sliven, Bulgaria, 8800
        • Recruiting
        • Multi-Profile Hospital for Active Treatment (MHAT) Hadji Dimitar
        • Principal Investigator:
          • Dimitar Pavlov
        • Contact:
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Diagnostic-Consultative Center Aleksandrovska EOOD
        • Principal Investigator:
          • Diana Stefanova-Petrova
        • Contact:
      • Sofia, Bulgaria, 1784
        • Recruiting
        • Acibadem City Clinic Mladost Hospital
        • Contact:
        • Principal Investigator:
          • Asen Petrov
      • Sofia, Bulgaria, 1527
        • Recruiting
        • University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
        • Contact:
        • Principal Investigator:
          • Plamen Penchev
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Acibadem City clinic Tokuda hospital
        • Contact:
        • Principal Investigator:
          • Petko Karagyozov
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • Heritage Medical Research Clinic - University Of Calgary
        • Contact:
        • Principal Investigator:
          • Christopher Ma
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre
        • Principal Investigator:
          • Jennifer Jones
        • Contact:
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre - Victoria Hospital
        • Principal Investigator:
          • Terry Ponich
        • Contact:
      • London, Ontario, Canada, N6K 1M6
        • Recruiting
        • London Digestive Disease Institute
        • Principal Investigator:
          • Vipul Jairath
        • Contact:
      • London, Ontario, Canada, N6A 5A5
        • Active, not recruiting
        • London Health Sciences Centre - University Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Recruiting
        • University of Toronto - Mount Sinai Hospital - The Lunenfeld-Tanenbaum Research Institute
        • Principal Investigator:
          • Allan Hillary Steinhart
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Recruiting
        • The Research Institute of the McGill University Health Center
        • Principal Investigator:
          • Talat Bessissow
        • Contact:
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal
        • Principal Investigator:
          • Robert Battat
        • Contact:
  • China
      • Guangzhou, China, 510655
        • Recruiting
        • Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
        • Principal Investigator:
          • Xiang Helen Gao
        • Contact:
      • Hangzhou, China, 310016
        • Recruiting
        • Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
        • Principal Investigator:
          • Qian Cao
        • Contact:
      • Shanghai, China, 201318
        • Recruiting
        • Shanghai Pudong New District Zhoupu Hospital
        • Principal Investigator:
          • Zhihua Ran
        • Contact:
      • Zhejiang, China, 310006
        • Recruiting
        • The First Affiliated Hospital of Zhejiang Chinese Medical University
        • Principal Investigator:
          • Yihong Fan
        • Contact:
    • Chongqing Sheng
      • Chongqing, Chongqing Sheng, China, 400013
        • Recruiting
        • Chongqing General Hospital
        • Principal Investigator:
          • Hong Guo
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Zhongshan Hospital Xiamen University
        • Principal Investigator:
          • Yanyun Fan
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Sun Yat-sen University (SYSU) - The First Affiliated Hospital
        • Principal Investigator:
          • Baili Chen
        • Contact:
      • Huizhou, Guangdong, China, 516001
        • Recruiting
        • Huizhou First Hospital
        • Principal Investigator:
          • Xuanfang Zhong
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Wuhan University - Renmin Hospital (Hubei General Hospital)
        • Principal Investigator:
          • Ping An
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Principal Investigator:
          • Xuehong Wang
        • Contact:
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Recruiting
        • The Second People's Hospital of Changzhou
        • Contact:
        • Principal Investigator:
          • Wenjia Liu
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Wen Tang
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Recruiting
        • China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
        • Principal Investigator:
          • Changqing Zheng
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Recruiting
        • Renji Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Zhi-jun Cao
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Principal Investigator:
          • Lan Zhong
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Yan Chen
        • Contact:
  • Czechia
      • Brno, Czechia, 625 00
        • Recruiting
        • University Hospital Brno
        • Principal Investigator:
          • Stefan Konecny
        • Contact:
      • Brno, Czechia, 602 00
        • Recruiting
        • SurGal Clinic SRO
        • Principal Investigator:
          • Jan Ulbrych
        • Contact:
      • Brno, Czechia, 615 00
        • Recruiting
        • Vojenska Nemocnice Brno
        • Principal Investigator:
          • David Stepek
        • Contact:
      • Hradec Králové, Czechia, 50012
        • Recruiting
        • Hepato-Gastroenterologie HK, s.r.o.
        • Principal Investigator:
          • Tomas Vanasek
        • Contact:
      • Ostrava, Czechia, 71000
        • Recruiting
        • EndoArt
        • Principal Investigator:
          • Radka Koskova
        • Contact:
      • Ostrava-Poruba, Czechia, 708 52
        • Recruiting
        • Fakultni Nemocnice Ostrava (FNO)
        • Principal Investigator:
          • Pavel Svoboda
        • Contact:
      • Pardubice, Czechia, 530 03
        • Recruiting
        • Gastromedic s.r.o
        • Principal Investigator:
          • Vaclav Leksa
        • Contact:
      • Prague, Czechia, 15000
        • Recruiting
        • Axon Clinical s.r.o.
        • Principal Investigator:
          • Jan Matous
        • Contact:
      • Prague, Czechia, 15000
        • Recruiting
        • Endohope Clinic
        • Principal Investigator:
          • Lukas Bajer
        • Contact:
      • Ústí nad Labem, Czechia, 40113
        • Recruiting
        • Masaryk Hospital
        • Principal Investigator:
          • Jiri Stehlik
        • Contact:
      • České Budějovice, Czechia, 370 01
        • Recruiting
        • Nemocnice Ceske Budejovice, a.s.
        • Principal Investigator:
          • Martin Bortlik
        • Contact:
    • Central Bohemia
      • Hořovice, Central Bohemia, Czechia, 268 31
        • Recruiting
        • Nemocnice Horovice (NH Hospital a.s.)
        • Principal Investigator:
          • Zuzana Serclova
        • Contact:
  • Denmark
      • Esbjerg, Denmark, 6700
        • Recruiting
        • Sydvestjysk Region/Esbjerg Hospital
        • Principal Investigator:
          • Michael Dam Jensen
        • Contact:
      • Gistrup, Denmark, 9260
        • Recruiting
        • Aalborg Hospital
        • Principal Investigator:
          • Jan Fallingborg
        • Contact:
          • Site Contact
          • Phone Number: 99326226
          • Email: jaf@rn.dk
      • Hillerød, Denmark, 3400
        • Recruiting
        • Hillerod Hospital, Hilleroed Sygehus
        • Contact:
        • Principal Investigator:
          • Salvatore Leotta
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
        • Contact:
        • Principal Investigator:
          • Johan Burisch
      • Køge, Denmark, 4600
        • Recruiting
        • Region Sjaelland Sygehus Nord, Koge Sygehus
        • Contact:
        • Principal Investigator:
          • Nynne Andersen
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital (OUH) (Odense University Hospital)
        • Contact:
        • Principal Investigator:
          • Jens Kjeldsen
  • France
      • Chambray-lès-Tours, France, 37170
        • Recruiting
        • Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau
        • Principal Investigator:
          • Driffa Moussata
        • Contact:
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU De Clermont Ferrand - Hopital Estaing
        • Principal Investigator:
          • Anthony Buisson
        • Contact:
      • Neuilly-sur-Seine, France, 92200
        • Recruiting
        • Centres Medico-Chirurgicaux Ambroise Pare-Pierre Cherest-Hartmann - Clinique Ambroise Pare
        • Contact:
        • Principal Investigator:
          • Carmen Stefanescu
      • Nice, France, 06202
        • Recruiting
        • CHU Nice - Hopital l'Archet 2
        • Principal Investigator:
          • Adrien Nicolau
        • Contact:
      • Saint-Etienne, France, 42055
        • Recruiting
        • Hopital Nord Chu Saint-Etienne
        • Principal Investigator:
          • Xavier Roblin
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54511
        • Recruiting
        • Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
        • Principal Investigator:
          • Benedicte Caron
        • Contact:
  • Germany
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitaetsklinik Frankfurt
        • Contact:
        • Principal Investigator:
          • Irina Blumenstein
      • Frankfurt am Main, Germany, 60431
        • Recruiting
        • Agaplesion Markus Krankenhaus
        • Contact:
        • Principal Investigator:
          • Axel Dignass
      • Kiel, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
        • Principal Investigator:
          • Stefan Schreiber
        • Contact:
      • Ludwigshafen, Germany, 67067
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitaetsklinikum Mannheim GmbH
        • Contact:
        • Principal Investigator:
          • Wolfgang Reindl
      • Tübingen, Germany, 72076
      • Ulm, Germany, 89081
        • Recruiting
        • University Hospital Of Ulm, Universitatsklinikum Ulm
        • Contact:
        • Principal Investigator:
          • Jochen Klaus
  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • Sotiria General Hospital of Athens
        • Principal Investigator:
          • Giorgos Bamias
        • Contact:
      • Athens, Greece, 15669
        • Recruiting
        • G.N.A. Gennimatas
        • Contact:
        • Principal Investigator:
          • Georgios Michalopoulos
    • Achaia
      • Pátrai, Achaia, Greece, 26504
        • Recruiting
        • University General Hospital of Patras
        • Contact:
        • Principal Investigator:
          • Konstantinos Thomopoulos
    • Attica
      • Athens, Attica, Greece, 106 76
        • Recruiting
        • Evangelismos Hospital
        • Contact:
        • Principal Investigator:
          • Nikos Viazis
      • Athens, Attica, Greece, 11528
        • Recruiting
        • University of Athens School of Medicine, Alexandra General Hospital
        • Contact:
        • Principal Investigator:
          • Evanthia Zampeli
    • Crete
      • Heraklion, Crete, Greece, 71110
        • Recruiting
        • University General Hospital of Heraklion
        • Principal Investigator:
          • Ioannis Koutroubakis
        • Contact:
  • Hungary
      • Budapest, Hungary, 1082
      • Budapest, Hungary, 1136
        • Recruiting
        • Pannonia Maganorvosi Centrum Kft.
        • Principal Investigator:
          • Robert Schnabel
        • Contact:
      • Budapest, Hungary, 1033
      • Mohács, Hungary, 7700
        • Recruiting
        • PTE KK, Mohacsi Korhaz
        • Principal Investigator:
          • Csaba Csizmadia
        • Contact:
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • Assuta Ashdod Medical Center
        • Principal Investigator:
          • Adi Lahat-Tzok
        • Contact:
      • Beersheba, Israel, 8410101
        • Recruiting
        • Soroka Mc
        • Principal Investigator:
          • Doron Schwartz
        • Contact:
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Digestive Disease Institute, Shaare Zedek Medical Center
        • Contact:
        • Principal Investigator:
          • Ariella Shitrit
      • Kfar Saba, Israel, 4428164
      • Ramat Gan, Israel, 5265601
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS - AOU Policlinico S. Orsola - Malpighi
        • Principal Investigator:
          • Fernando Rizzello
        • Contact:
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
        • Principal Investigator:
          • Silvio Danese
        • Contact:
      • Palermo, Italy, 90146
        • Recruiting
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
        • Contact:
        • Principal Investigator:
          • Ambrogio Orlando
      • Roma, Italy, 00168
        • Recruiting
        • A. Gemelli University Hospital, Catholic University of the Sacred Heart
        • Principal Investigator:
          • Antonio Gasbarrini
        • Contact:
      • Rome, Italy, 00152
        • Recruiting
        • Azienda Ospedaliera San Camillo Forlanini
        • Contact:
        • Principal Investigator:
          • Rocco Cosintino
      • Rozzano, Italy, 20089
        • Recruiting
        • IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
        • Principal Investigator:
          • Alessandro Armuzzi
        • Contact:
  • Japan
      • Chiba, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital Kashiwanoha
        • Principal Investigator:
          • Ken Takeuchi
        • Contact:
      • Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital
        • Principal Investigator:
          • Fumihito Hirai
        • Contact:
      • Tokyo, Japan, 113-8519
        • Recruiting
        • Institute of Science Tokyo Hospital
        • Contact:
        • Principal Investigator:
          • Ryuichi Okamoto
      • Toyama, Japan, 930-0194
        • Recruiting
        • Toyama University Hospital
        • Contact:
        • Principal Investigator:
          • Kenji Watanabe
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital
        • Principal Investigator:
          • Yoshihiro Yokoyama
        • Contact:
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Shinichiro Shinzaki
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Recruiting
        • Iwate Medical University Uchimaru Medical Center
        • Contact:
        • Principal Investigator:
          • Takayuki Matsumoto
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Principal Investigator:
          • Yoichi Kakuta
        • Contact:
    • Osaka
      • Hirakata, Osaka, Japan, 5731191
        • Recruiting
        • Kansai Medical University Hospital
        • Principal Investigator:
          • Makoto Naganuma
        • Contact:
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
        • Principal Investigator:
          • Kazuki Kakimoto
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital
        • Contact:
        • Principal Investigator:
          • Ken Sugimoto
    • Tokyo
      • Minato, Tokyo, Japan, 105-8471
        • Recruiting
        • The Jikei University Hospital
        • Principal Investigator:
          • Masayuki Saruta
        • Contact:
      • Mitaka, Tokyo, Japan, 181-8611
        • Recruiting
        • Kyorin University Hospital
        • Contact:
        • Principal Investigator:
          • Tadakazu Hisamatsu
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • Recruiting
        • Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
        • Contact:
        • Principal Investigator:
          • Krisztina Gecse
      • Tilburg, Netherlands, 5022 GC
        • Recruiting
        • St. Elisabeth Ziekenhuis
        • Principal Investigator:
          • Robert Laheij
        • Contact:
    • Limburg
      • Geleen, Limburg, Netherlands, 6162 BG
        • Recruiting
        • Zuyderland Medisch Centrum - Sittard-Geleen
        • Contact:
        • Principal Investigator:
          • Adriaan van Bodegraven
  • Norway
      • Oslo, Norway, 0450
        • Recruiting
        • Oslo Univeristy Hospital Ulleval Hospital
        • Principal Investigator:
          • Vendel Kristensen
        • Contact:
    • Akershus
      • Lorenskog, Akershus, Norway, 1478
  • Poland
      • Bydgoszcz, Poland, 85229
        • Recruiting
        • Manermed Sp. z o.o - CM Medis
        • Principal Investigator:
          • Maria Klopocka
        • Contact:
      • Lodz, Poland, 91-034
        • Recruiting
        • Centrum Medyczne Med-Gastr
        • Principal Investigator:
          • Arkadiusz Mamos
        • Contact:
      • Lodz, Poland, 90-153
        • Recruiting
        • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
        • Principal Investigator:
          • Ewa Malecka-Wojciesko
        • Contact:
      • Lublin, Poland, 20-582
        • Recruiting
        • Medrise sp. z o.o
        • Principal Investigator:
          • Wit Danilkiewicz
        • Contact:
      • Poznan, Poland, 60-529
        • Recruiting
        • Solumed Centrum Medyczne
        • Principal Investigator:
          • Magdalena Andrzejewska
        • Contact:
      • Rzeszów, Poland, 35302
        • Recruiting
        • Korczowski Bartosz, Gabinet Lekarski
        • Principal Investigator:
          • Bartosz Korczowski
        • Contact:
      • Rzeszów, Poland, 35-326
        • Recruiting
        • Centrum Medyczne Medyk Sp. z o.o. Sp. K.
        • Principal Investigator:
          • Rafal Filip
        • Contact:
      • Sopot, Poland, 81-756
        • Not yet recruiting
        • Endoskopia Sp. z o.o.
        • Principal Investigator:
          • Marek Horynski
        • Contact:
      • Tychy, Poland, 43-100
        • Recruiting
        • H-T. Centrum Medyczne Sp. z o.o. Sp.k.
        • Principal Investigator:
          • Tomasz Romanczyk
        • Contact:
      • Warsaw, Poland, 04-501
        • Recruiting
        • Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
      • Wroclaw, Poland, 52-416
      • Wroclaw, Poland, 51-162
        • Recruiting
        • Centrum Badan Klinicznych
        • Principal Investigator:
          • Piotr Napora
        • Contact:
      • Zamość, Poland, 22400
        • Recruiting
        • ETG Zamosc
        • Principal Investigator:
          • Katarzyna Wojcik
        • Contact:
    • Kujawsko-pomo
      • Torun, Kujawsko-pomo, Poland, 87-100
        • Recruiting
        • Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
        • Principal Investigator:
          • Adam Kopon
        • Contact:
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Completed
        • PlanetMed Sp. z o.o.
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-611
        • Recruiting
        • Centrum Medyczne Melita Medical
        • Principal Investigator:
          • Jaroslaw Leszczyszyn
        • Contact:
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Recruiting
        • Panstwowy Instytut Medyczny MSWiA
        • Principal Investigator:
          • Grazyna Rydzewska-Wyszkowska
        • Contact:
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
        • Principal Investigator:
          • Beata Gawdis-Wojnarska
        • Contact:
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 91-495
        • Recruiting
        • AmiCare Sp. z o.o. Sp. k.
        • Principal Investigator:
          • Rafal Drozda
        • Contact:
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Institutul Clinic Fundeni
        • Contact:
        • Principal Investigator:
          • Carmen Preda
      • Bucharest, Romania, 020475
        • Recruiting
        • Spital Clinic Dr I Cantacuzino
        • Principal Investigator:
          • Bogdan Busuioc
        • Contact:
      • Bucharest, Romania, 014142
        • Recruiting
        • Delta Health Care
        • Principal Investigator:
          • Camelia Chioncel
        • Contact:
      • Bucharest, Romania, 020125
        • Recruiting
        • Clinical Hospital Colentina-Spitalul Clinic Colentina
        • Principal Investigator:
          • Radu Bogdan Mateescu
        • Contact:
      • Bucharest, Romania, 021967
        • Recruiting
        • Clinica Medicum
        • Principal Investigator:
          • Theodor-Alexandru Voiosu
        • Contact:
    • Jud Timis
      • Timișoara, Jud Timis, Romania, 300002
        • Recruiting
        • Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
        • Principal Investigator:
          • Adrian Eugen Goldis
        • Contact:
    • Prahova
      • Ploieşti, Prahova, Romania, 100032
        • Recruiting
        • Centrul Medical Valahia
        • Principal Investigator:
          • George Stancu
        • Contact:
  • Slovakia
      • Banská Bystrica, Slovakia, 97401
        • Recruiting
        • Fakultna nemocnica F. D. Roosevelta
        • Principal Investigator:
          • Jozef Balaz
        • Contact:
      • Bratislava, Slovakia, 811 09
        • Recruiting
        • Cliniq s. r. o.
        • Principal Investigator:
          • Tibor Hlavaty
        • Contact:
      • Košice, Slovakia, 4013
        • Recruiting
        • Endomed
        • Principal Investigator:
          • Miroslav Fedurco
        • Contact:
      • Nové Zámky, Slovakia, 94034
        • Recruiting
        • Fakultna Nemocnica s poliklinikou Nove Zamky
        • Contact:
        • Principal Investigator:
          • Juraj Durina
    • Nitra Region
      • Šahy, Nitra Region, Slovakia, 936 01
        • Recruiting
        • Accout Center, s.r.o.- Gastroenterologicka ambulancia
        • Principal Investigator:
          • Frantisek Horvath
        • Contact:
  • South Korea
      • Busan, South Korea, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Principal Investigator:
          • Tae-Oh Kim
        • Contact:
      • Busan, South Korea, 49267
        • Recruiting
        • Kosin University Gospel Hospital
        • Principal Investigator:
          • Won Moon
        • Contact:
      • Daegu, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Principal Investigator:
          • Yoo Jin Lee
        • Contact:
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
        • Principal Investigator:
          • Jae Hee Cheon
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Young-Ho Kim
        • Contact:
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center (AMC)
        • Principal Investigator:
          • Sang Hyoung Park
        • Contact:
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Recruiting
        • Yonsei University Wonju Severance Christian Hospital
        • Principal Investigator:
          • Hyun Soo Kim
        • Contact:
  • Switzerland
      • Basel, Switzerland, 4031
      • Bern, Switzerland, 3012
        • Recruiting
        • Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
        • Contact:
        • Principal Investigator:
          • Pascal Juillerat
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Principal Investigator:
          • Jen-Wei Chou
        • Contact:
    • Changhua County
      • Changhua, Changhua County, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
        • Principal Investigator:
          • Hsu-Heng Yen
    • Zhongzheng District
      • Taipei, Zhongzheng District, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital (NTUH)
        • Contact:
        • Principal Investigator:
          • Shu-Chen Wei
  • United Kingdom
      • Belfast, United Kingdom, BT16 1RH
        • Recruiting
        • South Eastern Health and Social Care Trust - The Ulster Hospital
        • Principal Investigator:
          • Paul Agnew
        • Contact:
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
        • Principal Investigator:
          • Mark Samaan
        • Contact:
      • London, United Kingdom, W1T 7HA
        • Recruiting
        • NIHR UCLH Clinical Research Facility - University College London Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Paul Harrow
        • Contact:
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Sreedhar Subramanian
    • E1 2at
      • London, E1 2at, United Kingdom, E1 2AT
        • Recruiting
        • Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust
        • Principal Investigator:
          • Gareth Parkes
        • Contact:
  • United States
    • California
      • Murrieta, California, United States, 92563
        • Recruiting
        • United Medical Doctors
        • Principal Investigator:
          • John Hong
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Health
        • Contact:
        • Principal Investigator:
          • Robert Fearn
    • Florida
      • Clearwater, Florida, United States, 33762
        • Recruiting
        • West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
        • Principal Investigator:
          • Lawrence Michael Weiss
        • Contact:
      • Lakeland, Florida, United States, 33813
        • Recruiting
        • Auzmer Research
        • Principal Investigator:
          • John Ligeon
        • Contact:
      • Miami Lakes, Florida, United States, 33016
      • Naples, Florida, United States, 34102
        • Recruiting
        • GI PROS, Inc.
        • Principal Investigator:
          • Raymond Phillips
        • Contact:
      • Orlando, Florida, United States, 32804
        • Not yet recruiting
        • AdventHealth (Florida Hospital) Medical Group
        • Principal Investigator:
          • Jennifer Seminerio-Diehl
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • USF Health Morsani Center for Advanced Healthcare
        • Contact:
        • Principal Investigator:
          • Michelle Rosario
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Atlanta Center For Gastroenterology, P.C.
        • Principal Investigator:
          • David Rausher
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • The University of Iowa Hospitals & Clinics
        • Contact:
        • Principal Investigator:
          • Steven Polyak
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Saurabh Kapur
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University Of Louisville
        • Principal Investigator:
          • Gerald Dryden
        • Contact:
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Woodholme Gastroenterology Associates
        • Principal Investigator:
          • Kenolisa Onwueme
        • Contact:
    • Missouri
      • Liberty, Missouri, United States, 64068
        • Recruiting
        • BVL Clinical Research
        • Principal Investigator:
          • Christopher Bartalos
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Medical Research
        • Principal Investigator:
          • Christian Stone
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
        • Contact:
        • Principal Investigator:
          • Adam Steinlauf
      • Rochester, New York, United States, 14609
        • Not yet recruiting
        • Rochester Clinical Research, Inc
        • Principal Investigator:
          • Jonathan Goldstein
        • Contact:
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • Great Lakes Gastroenterology Research, LLC
        • Contact:
        • Principal Investigator:
          • Keith Friedenberg
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Completed
        • Hightower Clinical - SSM Health
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Recruiting
        • University Gastroenterology Providence
        • Principal Investigator:
          • Lisa Mueller
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Gastroenterology Associates, PA
        • Principal Investigator:
          • Matthew Barnes
        • Contact:
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Novel Research, LLC
        • Principal Investigator:
          • Moazzam Sana
        • Contact:
      • Dallas, Texas, United States, 75246
        • Completed
        • TDDC - Baylor University Medical Center Gaston Ave
      • Fort Worth, Texas, United States, 76104
        • Completed
        • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • One of a Kind Clinical research Center TX LLC
        • Principal Investigator:
          • Sushovan Guha
        • Contact:
      • Mansfield, Texas, United States, 76063
        • Completed
        • TDDC dba Alliance Research
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute, LLC
        • Principal Investigator:
          • Jeff Bullock
        • Contact:
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Tyler Research Institute, LLC
        • Contact:
        • Principal Investigator:
          • George Duvall
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Principal Investigator:
          • Scott Lee
        • Contact:
          • Site Contact
          • Phone Number: 206-543-3500
          • Email: leesd@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female aged 18-75 years old with diagnosis of CD 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 CD assessed by SES-CD and CDAI.
  3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.

Exclusion Criteria:

  1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
  2. Have complications of CD that might require surgery during the study.
  3. Participants with a current ostomy.
  4. Participants who have failed 3 or more classes of advanced therapies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TAK-279 Dose 1

Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally.
Drug: TAK-279

TAK-279 capsules.

Other Names:
  • Zasocitinib
Drug: Placebo

TAK-279 placebo-matching capsules.
Experimental: TAK-279 Dose 2

Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally.
Drug: TAK-279

TAK-279 capsules.

Other Names:
  • Zasocitinib
Drug: Placebo

TAK-279 placebo-matching capsules.
Experimental: TAK-279 Dose 3

Participants will be randomized to receive TAK-279 Dose 3 capsules orally.
Drug: TAK-279

TAK-279 capsules.

Other Names:
  • Zasocitinib
Experimental: Placebo

Participants will be randomized to receive TAK-279 placebo-matching capsules orally.
Drug: Placebo

TAK-279 placebo-matching capsules.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Time Frame: Week 12

Endoscopic response is defined by decrease in SES-CD >50% from baseline (or for participants with isolated ileal disease, SES-CD <=4 or at least a 2-point reduction from baseline). SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
Time Frame: Week 12

Clinical remission is defined as a CDAI score of <150 points.
Week 12
Percentage of Participants With a Clinical Response Based on the CDAI at Week 12
Time Frame: Week 12

Clinical response is defined as >=100-point decrease from Baseline in CDAI score.
Week 12
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.
Time Frame: Week 12

Endoscopic remission as per SES-CD is defined as SES-CD score <=4 or <=2 for ileal disease, no subscore >1.
Week 12
Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12
Time Frame: Week 12

Clinical remission based on PRO2 is defined as average daily liquid or very soft stool frequency (SF) score <=2.8 and not worse than baseline and average daily abdominal pain (AP) score <=1 and not worse than baseline.
Week 12
Percentage of Participants With a Clinical Response in PRO2 at Week 12
Time Frame: Week 12

Clinical response based on PRO2 is defined as >=30% decrease in average daily very soft or liquid stools and/ or >=30% decrease in average AP from baseline.
Week 12
Percentage of Participants With no Bowel Urgency at Week 12
Time Frame: Week 12

Bowel urgency is assessed using a 1-item daily patient diary that asks participants to indicate if they had an urgent bowel movement (when they felt the need to rush to the toilet to avoid an accident) in the past 24 hours. Response options, "Yes" or "No" will be coded as numeric values.
Week 12
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 at Week 12
Time Frame: Week 12

The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question will be assessed on a 7-point Likert scale. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The total score ranges from 32 to 224, with higher scores representing better quality of life.
Week 12
Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12
Time Frame: Baseline to Week 12

The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question will be assessed on a 7-point Likert scale. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The total score ranges from 32 to 224, with higher scores representing better quality of life.
Baseline to Week 12
Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12
Time Frame: Baseline to Week 12

FACIT-Fatigue questionnaire contains 13 fatigue-related questions. 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.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 23, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-279-CD-2001
  • jRCT2051240050 (Registry Identifier: jRCT)
  • 2023-506704-14-00 (Ctis: Abbreviated EU CT Number)
  • 2023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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