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NCT06764615RecruitingPhase 2

A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)

A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants With Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn's Disease

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation. This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461), TAK-279-UC-2001 (NCT06254950) and TAK-279-CD-2003 (NCT07403968). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study. The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD. The participants will be treated with TAK-279 for up to 3 years (156 weeks). During the study, participants will visit their study clinic around 15 times.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
192 (estimated)
First submitted
2 Jan 2025
Start date
28 May 2025
Primary completion date
30 Dec 2029
Lead sponsor
Takeda
NCT number
NCT06764615
EU CT number
2024-518914-18-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 192
  • From 28 May 2025 to the primary completion date, 30 Dec 2029
  • 97 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.
  • Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.

Other illness

  • Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE.

Lab values

  • Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol.

Who the study is looking for

  • The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
    • The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization prior to the initiation of any trial procedures.
  • Completion of Week 52 in the parent trials (phase 2b CD and phase 2 UC) with valid electronic (e) Diary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001).
  • Clinical or symptomatic responder at parent trial Week 52 as defined below:
    • TAK-279-CD-2001: Clinical response at Week 52 of the parent trial based on PRO2, assessed as \>=30% decrease in average daily very soft or liquid stools and/ or \>=30% decrease in average AP from parent trial baseline.
    • TAK-279-UC-2001: Symptomatic response at Week 52 of the parent trial, assessed as a reduction in partial modified Mayo score (pmMS) of \>=1 points and \>=30% from parent trial baseline; and a decrease from parent trial baseline in the rectal bleeding sub-score of \>=1 point or an absolute rectal bleeding sub-score of \<=1 point.
  • TAK-279-CD-2003: Endoscopic response at Week 12 of the parent trial, assessed as a participant achieving 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).
    • Other General Inclusion Criteria:
  • Participants must meet the contraception recommendations.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (97)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hopital Erasme
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AnderlechtBelgiumNot yet recruiting
CHU Saint-Pierre
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BrusselsBelgiumNot yet recruiting
UZ Leuven
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LeuvenBelgiumNot yet recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumNot yet recruiting
University Multiprofile Hospital For Active Treatment Kaspela EOOD
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PlovdivBulgariaRecruiting
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
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SlivenBulgariaRecruiting
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
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SofiaBulgariaRecruiting
Acibadem City Clinic Tokuda University Hospital EAD
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SofiyaBulgariaRecruiting
University Hospital Queen Govanna
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SofiyaBulgariaRecruiting
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaRecruiting
Chongqing General Hospital
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ChongqingChinaRecruiting
The First Affiliated Hospital of Sun Yat-sen University
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GuangdongChinaRecruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaRecruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
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ShanghaiChinaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
SurGal Clinic s.r.o.
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Brno-SeverCzechiaRecruiting
Vojenska Nemocnice Brno
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Brno-ZideniceCzechiaRecruiting
Nemocnice České Budějovice, a.s.
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České BudějoviceCzechiaRecruiting
Hepato-Gastroenterologie HK, s.r.o.
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Hradec KrálovéCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Gastromedic s.r.o
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PardubiceCzechiaRecruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaRecruiting
Endohope klinika s.r.o.
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PragueCzechiaRecruiting
Axon Clinical s.r.o.
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Prague 5CzechiaRecruiting
EndoArt s.r.o.
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Slezska OstravaCzechiaRecruiting
Krajska zdravotni a.s.
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Usti Nad LabemCzechiaRecruiting
Agaplesion Frankfurter Diakonie Kliniken gGmbH
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Frankfurt am MainGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyRecruiting
St. Marien und St. Annastiftskrankenhaus
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Ludwigshafen am RheinGermanyRecruiting
Heidelberg University
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MannheimGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Aalborg University Hospital
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AalborgDenmarkNot yet recruiting
Esbjerg Og Grindsted Sygehus
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EsbjergDenmarkNot yet recruiting
Hillerod Hospital
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HilleroedDenmarkNot yet recruiting
Region Hovedstaden
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HvidovreDenmarkNot yet recruiting
Region Sjaelland
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KoegeDenmarkNot yet recruiting
Odense University Hospital
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Odense CDenmarkNot yet recruiting
Centre Hospitalier Regional Universitaire De Tours
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Chambray Les ToursFranceNot yet recruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceNot yet recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceNot yet recruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceNot yet recruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceNot yet recruiting
Evaggelismos Hospital
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AthensGreeceNot yet recruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceNot yet recruiting
General Hospital of Athens "G. Gennimatas"
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AthensGreeceNot yet recruiting
Alexandra Hospital
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AthensGreeceNot yet recruiting
University General Hospital of Heraklion
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HeraklionGreeceNot yet recruiting
General University Hospital Of Patras
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PatrasGreeceNot yet recruiting
Semmelweis University
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BudapestHungaryRecruiting
Clinexpert Kft.
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Budapest IIIHungaryRecruiting
Pannonia Maganorvosi Centrum Kft.
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Budapest XIIIHungaryRecruiting
EURO-ENDO-MED Kft.
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MohácsHungaryRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyRecruiting
San Camillo Forlanini Hospital
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Inje University Haeundae Paik Hospital
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HaeundaeSouth KoreaRecruiting
Yonsei University Wonju Severance Christian Hospital
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WŏnjuSouth KoreaRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Zuyderland Medisch Centrum Stichting
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GeleenNetherlandsRecruiting
Stichting Elisabeth-TweeSteden Ziekenhuis
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TilburgNetherlandsRecruiting
Akershus University Hospital
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LoerenskogNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Manermed Sp. z o.o.
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BydgoszczPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
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LodzPolandRecruiting
Centrum Medyczne Med-Gastr Sp. z o.o.
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LodzPolandRecruiting
Amicare Sp. z o.o. S.K.
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LodzPolandRecruiting
Medrise Sp. z o.o.
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LublinPolandRecruiting
Centrum Medyczne Medyk Sp. z o.o.
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RzeszowPolandRecruiting
Korczowski Bartosz, Gabinet Lekarski
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RzeszówPolandRecruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
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SzczecinPolandRecruiting
GASTROMED Sp. z o.o.
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TorunPolandRecruiting
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
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TychyPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandRecruiting
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
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WroclawPolandRecruiting
PlanetMed Sp. z o.o.
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WroclawPolandRecruiting
Melita Medical Sp. z o.o.
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WrocławPolandRecruiting
Etg Zamosc Sp. z o.o.
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ZamośćPolandRecruiting
Institutul Clinic Fundeni
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BucharestRomaniaRecruiting
Memorial Healthcare International S R L
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BucharestRomaniaRecruiting
Monza-Ares S.R.L.
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BucharestRomaniaRecruiting
Spitalul Clinic Dr. I. Cantacuzino
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BucharestRomaniaRecruiting
Delta Health Care S.R.L
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BucharestRomaniaRecruiting
Spitalul Clinic Colentina Bucuresti
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BucharestRomaniaRecruiting
Cabinet Particular Policlinic Algomed S.R.L.
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TimisoaraRomaniaRecruiting
F D Roosevelt University General Hospital Of Banska Bystrica
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Banska BystricaSlovakiaRecruiting
Cliniq s.r.o.
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BratislavaSlovakiaRecruiting
ENDOMED, s.r.o.
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KošiceSlovakiaRecruiting
Fakultna nemocnica s poliklinikou Nove Zamky
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Nové ZámkySlovakiaRecruiting
Accout Center s.r.o.
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ŠahySlovakiaRecruiting
Woodholme Gastroenterology Associates
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Glen BurnieUnited StatesRecruiting
Tyler Research Institute, LLC
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TylerUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.