Crohn's DiseasePhase 2NCT06233461
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
A Phase 2 study testing TAK-279 in people with Crohn's Disease, run by Takeda at 201 sites in 25 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- 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
- 268 participants
- Where
- 201 sitesin 25 countries
- Study dates
- 5 Mar 2024to 23 Jul 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 CD 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 CD assessed by SES-CD and CDAI.
- 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.
Who cannot join
- Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
- Have complications of CD that might require surgery during the study.
- Participants with a current ostomy.
- Participants who have failed 3 or more classes of advanced therapies.
Trial locations and contacts
201 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
201 sites in 25 countries
United States30 sites, 26 recruiting
- Recruiting
Emory University Hospital, The Emory Clinic
Atlanta, Georgia, 30322
Site Contact, heba.iskandar@emoryhealthcare.org
Heba Iskandar
- Recruiting
Novel Research, LLC
Bellaire, Texas, 77401
Site Contact, 281-491-9779, sana@novelresearch.net
Moazzam Sana
- Recruiting
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, Florida, 33762
Site Contact, 727-347-0005, lmweiss@gastrofl.com
Lawrence Michael Weiss
- Completed
TDDC - Baylor University Medical Center Gaston Ave
Dallas, Texas, 75246
- Recruiting
Atlanta Center For Gastroenterology, P.C.
Decatur, Georgia, 30033
Site Contact, 404-512-3280, dbrausher@acgaec.com
David Rausher
- Completed
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
Fort Worth, Texas, 76104
- Recruiting
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, 21061
Site Contact, 410-863-4899, konwueme@woodholmegi.com
Kenolisa Onwueme
- Recruiting
Gastroenterology Associates, PA
Greenville, South Carolina, 29615
Site Contact, 910-488-3857, mbarnesmd@gastroassociates.com
Matthew Barnes
- Recruiting
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Site Contact, 319-384-6336, steven-polyak@uiowa.edu
Steven Polyak
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Site Contact, skapur@kumc.edu
Saurabh Kapur
- Recruiting
One of a Kind Clinical research Center TX LLC
Kingwood, Texas, 77339
Site Contact, 346-847-9375, sguha@hrgastro.com
Sushovan Guha
- Recruiting
Auzmer Research
Lakeland, Florida, 33813
Site Contact, 208-346-8900, jligeon@auzmer.com
John Ligeon
- Recruiting
Las Vegas Medical Research
Las Vegas, Nevada, 89128
Site Contact, 702-750-0000, cstone@nevadagastro.com
Christian Stone
- Recruiting
BVL Clinical Research
Liberty, Missouri, 64068
Site Contact, 816-222-4241, info@BVLresearch.com
Christopher Bartalos
- Recruiting
University Of Louisville
Louisville, Kentucky, 40202
Site Contact, 502-852-6991, gerald.dryden@louisville.edu
Gerald Dryden
- Completed
TDDC dba Alliance Research
Mansfield, Texas, 76063
- Recruiting
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Site Contact, 440-205-1225, kfriedenberg@thectnx.com
Keith Friedenberg
- Recruiting
Wellness Clinical Research
Miami Lakes, Florida, 33016
Site Contact, 786-483-7856, lucky@wellnessclinicalresearch.com
Lucky Flores
- Recruiting
United Medical Doctors
Murrieta, California, 92563
Site Contact, 951-566-5229, drhongpi@unitedmd.com
John Hong
- Recruiting
GI PROS, Inc.
Naples, Florida, 34102
Site Contact, 239-649-1336, rphillips212@comcast.net
Raymond Phillips
- Recruiting
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, 10029
Site Contact, 917-538-2158, adam.steinlauf@mssm.edu
Adam Steinlauf
- Completed
Hightower Clinical - SSM Health
Oklahoma City, Oklahoma, 73102
- Recruiting
UCI Health
Orange, California, 92868
Site Contact, 714-456-5694, rfearn@hs.uci.edu
Robert Fearn
- Not yet recruiting
AdventHealth (Florida Hospital) Medical Group
Orlando, Florida, 32804
Site Contact, 843-876-8282, jennifer.semineriodiehl.md@adventhealth.com
Jennifer Seminerio-Diehl
- Recruiting
University Gastroenterology Providence
Providence, Rhode Island, 02904
Site Contact, lisa.mueller@gialliance.com
Lisa Mueller
- Not yet recruiting
Rochester Clinical Research, Inc
Rochester, New York, 14609
Site Contact, 585-329-9644, jgoldstein@rcrclinical.com
Jonathan Goldstein
- Recruiting
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
Site Contact, 210-581-2812, js_bull@yahoo.com
Jeff Bullock
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Site Contact, 206-543-3500, leesd@uw.edu
Scott Lee
- Recruiting
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612
Site Contact, msrosari@usf.edu
Michelle Rosario
- Recruiting
Tyler Research Institute, LLC
Tyler, Texas, 75701
Site Contact, 903-630-6211, aaron.duvall@iterativehealth.com
George Duvall
Poland19 sites, 18 recruiting
- Recruiting
Manermed Sp. z o.o - CM Medis
Bydgoszcz, 85229
Site Contact, 523655105, mariaklopocka@cm-medis.pl
Maria Klopocka
- Recruiting
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153
Site Contact, 426786480, ewuncia@poczta.onet.pl
Ewa Malecka-Wojciesko
- Recruiting
Centrum Medyczne Med-Gastr
Lodz, 91-034
Site Contact, 502357277, amamos@wp.pl
Arkadiusz Mamos
- Recruiting
AmiCare Sp. z o.o. Sp. k.
Lodz, Łódź Voivodeship, 91-495
Site Contact, 426394944, r.drozda@amicare.pl
Rafal Drozda
- Recruiting
Medrise sp. z o.o
Lublin, 20-582
Site Contact, 795404502, wit.danilkiewicz@medrise.pl
Wit Danilkiewicz
- Recruiting
Solumed Centrum Medyczne
Poznan, 60-529
Site Contact, 48668864584, magdalena.andrzejewska@solumed.pl
Magdalena Andrzejewska
- Recruiting
Centrum Medyczne Medyk Sp. z o.o. Sp. K.
Rzeszów, 35-326
Site Contact, 178652000, r.filip.medyk@gmail.com
Rafal Filip
- Recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35302
Site Contact, 604481752, korczowski@op.pl
Bartosz Korczowski
- Not yet recruiting
Endoskopia Sp. z o.o.
Sopot, 81-756
Site Contact, 501011879, badanie.kliniczne@wp.pl
Marek Horynski
- Recruiting
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434
Site Contact, 914332919, gawdis@twojaprzychodnia.com
Beata Gawdis-Wojnarska
- Recruiting
Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
Torun, Kujawsko-pomo, 87-100
Site Contact, 566119968, adamkopon@interia.pl
Adam Kopon
- Recruiting
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
Tychy, 43-100
Site Contact, 322178866, romanczyk@htcentrum.pl
Tomasz Romanczyk
- Recruiting
Panstwowy Instytut Medyczny MSWiA
Warsaw, Masovian Voivodeship, 02-507
Site Contact, 46695666611, grazyna.rydzewska@pimmswia.gov.pl
Grazyna Rydzewska-Wyszkowska
- Recruiting
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
Site Contact, 500111648, j.kierkus@med-net.pl
Jaroslaw Kierkus
- Completed
PlanetMed Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, 52-210
- Recruiting
Centrum Medyczne Melita Medical
Wroclaw, Lower Silesian Voivodeship, 53-611
Site Contact, 661302302, j.leszczyszyn@melitamedical.pl
Jaroslaw Leszczyszyn
- Recruiting
Centrum Badan Klinicznych
Wroclaw, 51-162
Site Contact, 713267900, napora.piotr@cbk.wroc.pl
Piotr Napora
- Recruiting
Centrum Medyczne Oporow
Wroclaw, 52-416
Site Contact, radoslaw.kempinski@cmoporow.com
Radoslaw Kempinski
- Recruiting
ETG Zamosc
Zamość, 22400
Site Contact, 722222288, k.wojcik@etg-network.com
Katarzyna Wojcik
China16 sites, 16 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Site Contact, wxh05271@126.com
Xuehong Wang
- Recruiting
The Second People's Hospital of Changzhou
Changzhou, Jiangsu
Site Contact, 13813016290@126.com
Wenjia Liu
- Recruiting
Chongqing General Hospital
Chongqing, Chongqing Sheng, 400013
Site Contact, 2368755000, 542162214@qq.com
Hong Guo
- Recruiting
Sun Yat-sen University (SYSU) - The First Affiliated Hospital
Guangzhou, Guangdong, 510080
Site Contact, Chenbaili05@163.com
Baili Chen
- Recruiting
Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
Guangzhou, 510655
Site Contact, 2038254000, helen_gao818@163.com
Xiang Helen Gao
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Site Contact, 13757118653, 1254499542@qq.com
Yan Chen
- Recruiting
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
Hangzhou, 310016
Site Contact, 57186006642, caoq@srrsh.com
Qian Cao
- Recruiting
Huizhou First Hospital
Huizhou, Guangdong, 516001
Site Contact, zhongxuanfang@yeah.net
Xuanfang Zhong
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Site Contact, lanzhong_13gcp@163.com
Lan Zhong
- Recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Site Contact, caozj_renji@163.com
Zhi-jun Cao
- Recruiting
Shanghai Pudong New District Zhoupu Hospital
Shanghai, 201318
Site Contact, 2163200874, zhihuaran@vip.163.com
Zhihua Ran
- Recruiting
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
Shenyang, Liaoning, 110022
Site Contact, zhengchangqing88@163.com
Changqing Zheng
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Site Contact, louisetangwensz@163.com
Wen Tang
- Recruiting
Wuhan University - Renmin Hospital (Hubei General Hospital)
Wuhan, Hubei, 430060
Site Contact, 18627068700, anping_05@163.com
Ping An
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361000
Site Contact, 18759212670, trudy1@163.com
Yanyun Fan
- Recruiting
The First Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang, 310006
Site Contact, yhfansjr@163.com
Yihong Fan
Japan13 sites, 13 recruiting
- Recruiting
Tsujinaka Hospital Kashiwanoha
Chiba, 277-0871
Site Contact, ken.takeuchi@gpro.com
Ken Takeuchi
- Recruiting
Fukuoka University Hospital
Fukuoka, 814-0180
Site Contact, 81929211011, ibdnanakuma@fukuoka-u.ac.jp
Fumihito Hirai
- Recruiting
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Site Contact, +81 534352111, sugimken@hama-med.ac.jp
Ken Sugimoto
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, 5731191
Site Contact, naganuma.mak@kmu.ac.jp
Makoto Naganuma
- Recruiting
The Jikei University Hospital
Minato, Tokyo, 105-8471
Site Contact, m.saruta@jikei.ac.jp
Masayuki Saruta
- Recruiting
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
Site Contact, 422475511, thisamatsu@ks.kyorin-u.ac.jp
Tadakazu Hisamatsu
- Recruiting
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, 020-8505
Site Contact, +81-19-613-6111, tmatsumo@iwate-med.ac.jp
Takayuki Matsumoto
- Recruiting
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501
Site Contact, sh-shinzaki@hyo-med.ac.jp
Shinichiro Shinzaki
- Recruiting
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Site Contact, yoshi_yokoyamaa@yahoo.co.jp
Yoshihiro Yokoyama
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Site Contact, ykakuta@tohoku.ac.jp
Yoichi Kakuta
- Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka, 569-8686
Site Contact, kazuki.kakimoto@ompu.ac.jp
Kazuki Kakimoto
- Recruiting
Institute of Science Tokyo Hospital
Tokyo, 113-8519
Site Contact, 338136111, rokamoto.gast@tmd.ac.jp
Ryuichi Okamoto
- Recruiting
Toyama University Hospital
Toyama, 930-0194
Site Contact, 666453811, kenjiw@med.u-toyama.ac.jp
Kenji Watanabe
Czechia12 sites, 12 recruiting
- Recruiting
SurGal Clinic SRO
Brno, 602 00
Site Contact, +420724101038, ulbrych.jan@surgalclinic.cz
Jan Ulbrych
- Recruiting
Vojenska Nemocnice Brno
Brno, 615 00
Site Contact, + 420 973 44 55 20, dstepek@vnbrno.cz
David Stepek
- Recruiting
University Hospital Brno
Brno, 625 00
Site Contact, +420532233500, konecny.stefan@fnbrno.cz
Stefan Konecny
- Recruiting
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 370 01
Site Contact, +420 777 563 349, mbortlik@seznam.cz
Martin Bortlik
- Recruiting
Nemocnice Horovice (NH Hospital a.s.)
Hořovice, Central Bohemia, 268 31
Site Contact, 602158805, sercl@seznam.cz
Zuzana Serclova
- Recruiting
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012
Site Contact, 495218475, tomas.vanasek@hepato-gastro.com
Tomas Vanasek
- Recruiting
EndoArt
Ostrava, 71000
Site Contact, mudr.koskova@seznam.cz
Radka Koskova
- Recruiting
Fakultni Nemocnice Ostrava (FNO)
Ostrava-Poruba, 708 52
Site Contact, +420 597 375 202, pavel.svoboda@fno.cz
Pavel Svoboda
- Recruiting
Gastromedic s.r.o
Pardubice, 530 03
Site Contact, + 420 466 649 009, vaclav.leksa@seznam.cz
Vaclav Leksa
- Recruiting
Axon Clinical s.r.o.
Prague, 15000
Site Contact, 776 767 590, jmatous@gmail.com
Jan Matous
- Recruiting
Endohope Clinic
Prague, 15000
Site Contact, bajer@endohope.cz
Lukas Bajer
- Recruiting
Masaryk Hospital
Ústí nad Labem, 40113
Site Contact, 477112430, jiri.stehlik@kzcr.eu
Jiri Stehlik
Australia9 sites, 9 recruiting
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Site Contact, 882044964, reme.mountifield@sa.gov.au
Reme Mountifield
- Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Site Contact, 297676111, rupert.leong@health.nsw.gov.au
Rupert Leong
- Recruiting
Northern Hospital Epping
Epping, 3076
Site Contact, +61384052290, Robert.Little@nh.org.au
Robert Little
- Recruiting
Western Health/Footscray Hospital
Footscray, Victoria, 3011
Site Contact, ian.kronborg@wh.org.au
Ian Kronborg
- Recruiting
Harry Perkins Medical Research Institute Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Site Contact, lena.thin@health.wa.gov.au
Lena Thin
- Recruiting
Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer Centre
Nedlands, 6009
Site Contact, nabil.siddique@health.wa.gov.au
Nabil Siddique
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Site Contact, kannan.venugopal@health.wa.gov.au
Kannan Venugopal
- Recruiting
Mater Cancer Care Centre-Mater Health Services
South Brisbane, Queensland, 4101
Site Contact, 731638196, jakob.begun@mater.uq.edu.au
Jakob Begun
- Recruiting
The Queen Elizabeth Hospital
Woodville, South Australia, 5011
Site Contact, 882225827, Robert.Bryant@sa.gov.au
Robert Bryant
Brazil9 sites, 9 recruiting
- Not yet recruiting
Universidade Estadual Paulista Julio De Mesquita Filho (Unesp) - Faculdade de Medicina de Botucatu
Botucatu, São Paulo, 18618-970
Site Contact, 1438801171, ligiasassaki@gmail.com
Ligia Yukie Sassaki
- Recruiting
L2 IP - Instituto de Pesquisas Clinicas LTDA
Brasília, Federal District, 70200-730
Site Contact, +55(61)34454300, contato@l2ip.com.br
Luciana Teixeira de Campos
- Recruiting
UniversidadeEstadualde Campinas - UNICAMP
Campinas, São Paulo, 13083-887
Site Contact, 551935218554, crisknvc@unicamp.br
Cristiane Kibune Nagasako Vieira da Cruz
- Not yet recruiting
Centro de Estudos Clnicos do Interior Paulista (CECIP)
Jaú, São Paulo, 17201-130
Site Contact, +55 14 3622-0500 / 98116-9078, cecipjau@gmail.com
Bruna Meyer de Mattos Correa
- Recruiting
Galileo Medical Research
Juiz de Fora, Minas Gerais, 36033-318
Site Contact, 3232369250, julio.chebli@ufjf.br
Julio Maria Fonseca Chebli
- Not yet recruiting
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903
Site Contact, luharlacher@yahoo.com.br
Luciana Harlacher
- Recruiting
Ribeiralo Preto Medical School, University of Salo Paulo
Ribeirão Preto, São Paulo, 14048-900
Site Contact, 1636022956, rogeriosparra@gmail.com
Rogerio Parra
- Recruiting
Irmandade da Santa Casa da Misericordia de Santos
Santos, São Paulo, 11075-900
Site Contact, 1332195353, gastrocor@gastrocor.med.br
Jose Eduardo Vasconcelos Fernandes
- Recruiting
Solare Trials
São Paulo, 01307-002
Site Contact, 55 11 98369-9227, marjorieargollo@hotmail.com
Marjorie Costa Argollo
Canada9 sites, 8 recruiting
- Recruiting
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, T2N 4Z6
Site Contact, (403) 592-5013, christopher.ma@ucalgary.ca
Christopher Ma
- Recruiting
Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Site Contact, 9024736861, jennifer.jones@nshealth.ca
Jennifer Jones
- Active, not recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
- Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
Site Contact, 5196676878, terry.ponich@lhsc.on.ca
Terry Ponich
- Recruiting
London Digestive Disease Institute
London, Ontario, N6K 1M6
Site Contact, vjairath@lddi.ca
Vipul Jairath
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
Site Contact, 5142953671, robert.battat.med@ssss.gouv.qc.ca
Robert Battat
- Recruiting
The Research Institute of the McGill University Health Center
Montreal, Quebec, H3G 1A4
Site Contact, (514) 934-8309, talat.bessissow@mcgill.ca
Talat Bessissow
- Recruiting
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4
Site Contact, dr.mindylam.office@gmail.com
Mindy Lam
- Recruiting
University of Toronto - Mount Sinai Hospital - The Lunenfeld-Tanenbaum Research Institute
Toronto, Ontario, M5G 1X5
Site Contact, +1 4165865121, hillary.steinhart@sinaihealth.ca
Allan Hillary Steinhart
Germany7 sites, 7 recruiting
- Recruiting
Universitaetsklinik Frankfurt
Frankfurt, 60590
Site Contact, 069 63 01 54 41, blumenstein@em.uni-frankfurt.de
Irina Blumenstein
- Recruiting
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431
Site Contact, 6995332201, axel.dignass@agaplesion.de
Axel Dignass
- Recruiting
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, 24105
Site Contact, 43150022202, Stefan.Schreiber@uksh.de
Stefan Schreiber
- Recruiting
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, 67067
Site Contact, 4081914626, tanja.kuehbacher@st-marienkrankenhaus.de
Tanja Kuehbacher
- Recruiting
Universitaetsklinikum Mannheim GmbH
Mannheim, 68167
Site Contact, 6213834010, wolfgang.reindl@umm.de
Wolfgang Reindl
- Recruiting
Universitaetsklinikum Tuebingen
Tübingen, 72076
Site Contact, karsten.bueringer@med.uni-tuebingen.de
Karsten Bueringer
- Recruiting
University Hospital Of Ulm, Universitatsklinikum Ulm
Ulm, 89081
Site Contact, 7315000, jochen.klaus@uniklinik-ulm.de
Jochen Klaus
Romania7 sites, 7 recruiting
- Recruiting
Delta Health Care
Bucharest, 014142
Site Contact, +40745086734, cameliachioncel@yahoo.com
Camelia Chioncel
- Recruiting
Clinical Hospital Colentina-Spitalul Clinic Colentina
Bucharest, 020125
Site Contact, +40722588451, bogmateescu@gmail.com
Radu Bogdan Mateescu
- Recruiting
Spital Clinic Dr I Cantacuzino
Bucharest, 020475
Site Contact, +40729923661, bogbusuioc@gmail.com
Bogdan Busuioc
- Recruiting
Clinica Medicum
Bucharest, 021967
Site Contact, theodor.voiosu@gmail.com
Theodor-Alexandru Voiosu
- Recruiting
Institutul Clinic Fundeni
Bucharest, 022328
Site Contact, preda_monicaa@yahoo.com
Carmen Preda
- Recruiting
Centrul Medical Valahia
Ploieşti, Prahova, 100032
Site Contact, +40244521330, stancu.george@valahiamedical.ro
George Stancu
- Recruiting
Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
Timișoara, Jud Timis, 300002
Site Contact, +40748331222, goldisadi@yahoo.com
Adrian Eugen Goldis
South Korea7 sites, 7 recruiting
- Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
Site Contact, 109332333, kto0440@paik.ac.kr
Tae-Oh Kim
- Recruiting
Kosin University Gospel Hospital
Busan, 49267
Site Contact, 10 8692 0690, moonone70@hanmail.net
Won Moon
- Recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
Site Contact, 10 2755 0758, doctorlyj@naver.com
Yoo Jin Lee
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Site Contact, 222281990, geniushee@yuhs.ac
Jae Hee Cheon
- Recruiting
Asan Medical Center (AMC)
Seoul, 05505
Site Contact, shpark78@amc.seoul.kr
Sang Hyoung Park
- Recruiting
Samsung Medical Center
Seoul, 06351
Site Contact, 2 3410 3409, bowelkim@gmail.com
Young-Ho Kim
- Recruiting
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Site Contact, 33 741 0505, hyskim@yonsei.ac.kr
Hyun Soo Kim
Bulgaria6 sites, 6 recruiting
- Recruiting
UMHAT Kaspela
Plovdiv, 4001
Site Contact, +359 887559241, dessislavs@gmail.com
Desislav Stanchev
- Recruiting
Multi-Profile Hospital for Active Treatment (MHAT) Hadji Dimitar
Sliven, 8800
Site Contact, 887396768, md.pavlov@mail.bg
Dimitar Pavlov
- Recruiting
Acibadem City clinic Tokuda hospital
Sofia, 1407
Site Contact, p_karagyozov@bitex.bg
Petko Karagyozov
- Recruiting
Diagnostic-Consultative Center Aleksandrovska EOOD
Sofia, 1431
Site Contact, 9888579043, prof.petrova@mail.bg
Diana Stefanova-Petrova
- Recruiting
University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
Sofia, 1527
Site Contact, +359 886 108 077, penchev.dr@gmail.com
Plamen Penchev
- Recruiting
Acibadem City Clinic Mladost Hospital
Sofia, 1784
Site Contact, 28155205, dr_assenp@abv.bg
Asen Petrov
Denmark6 sites, 6 recruiting
- Recruiting
Sydvestjysk Region/Esbjerg Hospital
Esbjerg, 6700
Site Contact, michael.dam.jensen@rsyd.dk
Michael Dam Jensen
- Recruiting
Aalborg Hospital
Gistrup, 9260
Site Contact, 99326226, jaf@rn.dk
Jan Fallingborg
- Recruiting
Hillerod Hospital, Hilleroed Sygehus
Hillerød, 3400
Site Contact, salvatore.leotta.02@regionh.dk
Salvatore Leotta
- Recruiting
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
Hvidovre, 2650
Site Contact, johan.burisch@regionh.dk
Johan Burisch
- Recruiting
Region Sjaelland Sygehus Nord, Koge Sygehus
Køge, 4600
Site Contact, nyna@regionsjaelland.dk
Nynne Andersen
- Recruiting
Odense Universitetshospital (OUH) (Odense University Hospital)
Odense, Region Syddanmark, 5000
Site Contact, 65411286, jens.kjeldsen@rsyd.dk
Jens Kjeldsen
France6 sites, 6 recruiting
- Recruiting
Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau
Chambray-lès-Tours, 37170
Site Contact, d.moussata@chu-tours.fr
Driffa Moussata
- Recruiting
CHU De Clermont Ferrand - Hopital Estaing
Clermont-Ferrand, 63000
Site Contact, 473750504, a_buisson@chu-clermontferrand.fr
Anthony Buisson
- Recruiting
Centres Medico-Chirurgicaux Ambroise Pare-Pierre Cherest-Hartmann - Clinique Ambroise Pare
Neuilly-sur-Seine, 92200
Site Contact, 140875630, carmen.stefanescu@institutdesmici.fr
Carmen Stefanescu
- Recruiting
CHU Nice - Hopital l'Archet 2
Nice, 06202
Site Contact, nicolau.a@chu-nice.fr
Adrien Nicolau
- Recruiting
Hopital Nord Chu Saint-Etienne
Saint-Etienne, 42055
Site Contact, 477828619, xavier.roblin@chu-st-etienne.fr
Xavier Roblin
- Recruiting
Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
Vandœuvre-lès-Nancy, 54511
Site Contact, B.caron@chru-nancy.fr
Benedicte Caron
Greece6 sites, 6 recruiting
- Recruiting
Evangelismos Hospital
Athens, Attica, 106 76
Site Contact, 2132041634, nikos.viazis@gmail.com
Nikos Viazis
- Recruiting
University of Athens School of Medicine, Alexandra General Hospital
Athens, Attica, 11528
Site Contact, 6977252383, evazamb@gmail.com
Evanthia Zampeli
- Recruiting
Sotiria General Hospital of Athens
Athens, 11527
Site Contact, 2107456261, gbamias@gmail.com
Giorgos Bamias
- Recruiting
G.N.A. Gennimatas
Athens, 15669
Site Contact, gmicha78@hotmail.com
Georgios Michalopoulos
- Recruiting
University General Hospital of Heraklion
Heraklion, Crete, 71110
Site Contact, 302810392254, ikoutroubakis@gmail.com
Ioannis Koutroubakis
- Recruiting
University General Hospital of Patras
Pátrai, Achaia, 26504
Site Contact, +30 6977563564, kxthomo@hotmail.com
Konstantinos Thomopoulos
Italy6 sites, 6 recruiting
- Recruiting
IRCCS - AOU Policlinico S. Orsola - Malpighi
Bologna, 40138
Site Contact, 3386897614, fernando.rizzello@unibo.it
Fernando Rizzello
- Recruiting
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
Milan, 20132
Site Contact, +39 022643 8790, ibd.trials@hsr.it
Silvio Danese
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146
Site Contact, 916802966, ambrogiorlando@gmail.com
Ambrogio Orlando
- Recruiting
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, 00168
Site Contact, 630156265, antonio.gasbarrini@unicatt.it
Antonio Gasbarrini
- Recruiting
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152
Site Contact, 658703308, rcosintino@scamilloforlanini.rm.it
Rocco Cosintino
- Recruiting
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, 20089
Site Contact, 630159357, alessandro.armuzzi@hunimed.eu
Alessandro Armuzzi
Israel5 sites, 5 recruiting
- Recruiting
Assuta Ashdod Medical Center
Ashdod, 7747629
Site Contact, adizo@ashmc.co.il
Adi Lahat-Tzok
- Recruiting
Soroka Mc
Beersheba, 8410101
Site Contact, 36973270, doronsh@clalit.org.il
Doron Schwartz
- Recruiting
Digestive Disease Institute, Shaare Zedek Medical Center
Jerusalem, 9103102
Site Contact, +972 26555116, ariellash@szmc.org.il
Ariella Shitrit
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
Site Contact, michal.openhaim@clalit.org.il
Michal Openhaim
- Recruiting
The Chaim Sheba Medical Center
Ramat Gan, 5265601
Site Contact, asaflevartovsky.research@sheba.health.gov.il
Asaf Levartovsky
Slovakia5 sites, 5 recruiting
- Recruiting
Fakultna nemocnica F. D. Roosevelta
Banská Bystrica, 97401
Site Contact, 905838606, balaz78@gmail.com
Jozef Balaz
- Recruiting
Cliniq s. r. o.
Bratislava, 811 09
Site Contact, +421 917 752 297, hlavaty.studie@cliniq.sk
Tibor Hlavaty
- Recruiting
Endomed
Košice, 4013
Site Contact, 905271215, fedurco@endomed.sk
Miroslav Fedurco
- Recruiting
Fakultna Nemocnica s poliklinikou Nove Zamky
Nové Zámky, 94034
Site Contact, 907888900, ibdclinicaltrialsnz@gmail.com
Juraj Durina
- Recruiting
Accout Center, s.r.o.- Gastroenterologicka ambulancia
Šahy, Nitra Region, 936 01
Site Contact, +421905499894, fhorvath.studie@gmail.com
Frantisek Horvath
United Kingdom5 sites, 5 recruiting
- Recruiting
South Eastern Health and Social Care Trust - The Ulster Hospital
Belfast, BT16 1RH
Site Contact, 0289 0484511 ext 21994, paul.agnew@setrust.hscni.net
Paul Agnew
- Recruiting
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Site Contact, 01223 245151, sreedhar.subramanian2@nhs.net
Sreedhar Subramanian
- Recruiting
Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust
London, E1 2at, E1 2AT
Site Contact, gareth.parkes@nhs.net
Gareth Parkes
- Recruiting
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London, SE1 7EH
Site Contact, mark.samaan@nhs.net
Mark Samaan
- Recruiting
NIHR UCLH Clinical Research Facility - University College London Hospitals NHS Foundation Trust
London, W1T 7HA
Site Contact, 8451555000, paul.harrow1@nhs.net
Paul Harrow
Belgium4 sites, 4 recruiting
- Recruiting
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, 1070
Site Contact, 25553111, denis.franchimont@hubruxelles.be
Denis Franchimont
- Recruiting
CHU Saint-Pierre - Porte de Hal
Brussels, 1000
Site Contact, 25354109, vinciane.muls@stpierre-bru.be
Vinciane Muls
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
Site Contact, joao.sabino@uzleuven.be
Joao Pedro Guedelha Sabino
- Recruiting
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, 4000
Site Contact, catherine.reenaers@chuliege.be
Catherine Reenaers
Hungary4 sites, 4 recruiting
- Recruiting
Clinexpert
Budapest, 1033
Site Contact, 36209650290, horvat.gyula.gasztro@gmail.com
Gyula Horvat
- Recruiting
Semmelweis Egyetem
Budapest, 1082
Site Contact, 36208250460, miheller.pal@med.semmelweis-univ.hu
Pal Miheller
- Recruiting
Pannonia Maganorvosi Centrum Kft.
Budapest, 1136
Site Contact, 36303116694, schnabelrobert@hotmail.com
Robert Schnabel
- Recruiting
PTE KK, Mohacsi Korhaz
Mohács, 7700
Site Contact, +36202689900, csizi13@gmail.com
Csaba Csizmadia
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
Amsterdam, 1081
Site Contact, +31(0)20 4447016, k.b.gecse@amsterdamumc.nl
Krisztina Gecse
- Recruiting
Zuyderland Medisch Centrum - Sittard-Geleen
Geleen, Limburg, 6162 BG
Site Contact, 884597800, a.vanbodegraven@zuyderland.nl
Adriaan van Bodegraven
- Recruiting
St. Elisabeth Ziekenhuis
Tilburg, 5022 GC
Site Contact, 135391313, r.laheij@etz.nl
Robert Laheij
Taiwan3 sites, 3 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, Changhua County, 50006
Site Contact, 47238595, 91646@cch.org.tw
Hsu-Heng Yen
- Recruiting
China Medical University Hospital
Taichung, 40447
Site Contact, 975680970, codecol@yahoo.com.tw
Jen-Wei Chou
- Recruiting
National Taiwan University Hospital (NTUH)
Taipei, Zhongzheng District, 100
Site Contact, 223123456, shuchenwei@ntu.edu.tw
Shu-Chen Wei
Norway2 sites, 2 recruiting
- Recruiting
Akershus Universitetssykehus HF
Lorenskog, Akershus, 1478
Site Contact, Stephan.Andreas.Brackmann@ahus.no
Stephan Brackmann
- Recruiting
Oslo Univeristy Hospital Ulleval Hospital
Oslo, 0450
Site Contact, venkri@ous-hf.no
Vendel Kristensen
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Site Contact, janhendrik.niess@clarunis.ch
Jan Niess
- Recruiting
Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
Bern, 3012
Site Contact, juilleratp@intesto.ch
Pascal Juillerat
About this study
Official title: 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.
Read the 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):
- TAK-279 Dose 1
- TAK-279 Dose 2
- TAK-279 Dose 3
- 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.
- Conditions
- Crohn's Disease
- Being tested
- TAK-279, Placebo
- Keywords
- Drug Therapy, Latitude CD, Latitude Research Program
- Medical subject headings
- Crohn Disease
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 group | Role | What they receive |
|---|---|---|
| TAK-279 Dose 1 | Experimental | Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally. Receives: Drug: TAK-279; Drug: Placebo |
| TAK-279 Dose 2 | Experimental | Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally. Receives: Drug: TAK-279; Drug: Placebo |
| TAK-279 Dose 3 | Experimental | Participants will be randomized to receive TAK-279 Dose 3 capsules orally. Receives: Drug: TAK-279 |
| Placebo | Experimental | Participants will be randomized to receive TAK-279 placebo-matching capsules orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at 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).
Measured: Week 12
Secondary outcomes (9)
Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
Clinical remission is defined as a CDAI score of <150 points.
Measured: Week 12
Percentage of Participants With a Clinical Response Based on the CDAI at Week 12
Clinical response is defined as >=100-point decrease from Baseline in CDAI score.
Measured: Week 12
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.
Endoscopic remission as per SES-CD is defined as SES-CD score <=4 or <=2 for ileal disease, no subscore >1.
Measured: Week 12
Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at 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.
Measured: Week 12
Percentage of Participants With a Clinical Response in PRO2 at 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.
Measured: Week 12
Percentage of Participants With no Bowel Urgency at 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.
Measured: Week 12
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, 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.
Measured: Week 12
Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at 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.
Measured: Baseline to Week 12
Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start5 Mar 2024
- Primary completion17 Feb 2027 (estimated)
- Study completion23 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233461
- Sponsor's protocol ID
- TAK-279-CD-2001
- Other IDs
- 2023-506704-14-00, jRCT2051240050, 2023
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2024
- Last updated
- 2 Nov 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06233461
- Acronym / sponsor ID
- TAK-279-CD-2001
- Conditions
- Crohn's Disease
- Keywords
- Drug Therapy, Latitude CD, Latitude Research Program
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 17 Feb 2027 (estimated)
- Study completion
- 23 Jul 2027 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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):
- TAK-279 Dose 1
- TAK-279 Dose 2
- TAK-279 Dose 3
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TAK-279 Dose 1 | Experimental | Drug: TAK-279, Drug: PlaceboParticipants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally. |
| TAK-279 Dose 2 | Experimental | Drug: TAK-279, Drug: PlaceboParticipants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally. |
| TAK-279 Dose 3 | Experimental | Drug: TAK-279Participants will be randomized to receive TAK-279 Dose 3 capsules orally. |
| Placebo | Experimental | Drug: PlaceboParticipants will be randomized to receive TAK-279 placebo-matching capsules orally. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
- 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.
Key exclusion criteria (4 listed)
- Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
- Have complications of CD that might require surgery during the study.
- Participants with a current ostomy.
- Participants who have failed 3 or more classes of advanced therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-279Also: ZasocitinibTAK-279 capsules. | Drug | TAK-279 Dose 1, TAK-279 Dose 2, TAK-279 Dose 3 |
| PlaceboTAK-279 placebo-matching capsules. | Drug | Placebo, TAK-279 Dose 1, TAK-279 Dose 2 |
Primary outcome
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).
9 secondary outcomes
Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
Time frame: Week 12
Percentage of Participants With a Clinical Response Based on the CDAI at Week 12
Time frame: Week 12
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.
Time frame: Week 12
Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12
Time frame: Week 12
Percentage of Participants With a Clinical Response in PRO2 at Week 12
Time frame: Week 12
Percentage of Participants With no Bowel Urgency at Week 12
Time frame: Week 12
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 at Week 12
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- To obtain more information about this study, click this linkLink provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
201 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-279 in people with Crohn's Disease, run by Takeda at 201 sites in 25 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 3 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 201 sites in United States, Poland, China, Japan, Czechia and 20 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. 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?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.