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
- Diseases
- Crohn's disease, Ulcerative colitis
- 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
Sites (97)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Not yet recruiting |
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Not yet recruiting |
| University Multiprofile Hospital For Active Treatment Kaspela EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment Hadji Dimitar OOD Coordinator of this site? Confirm its status | Sliven | Bulgaria | Recruiting |
| Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Acibadem City Clinic Tokuda University Hospital EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| University Hospital Queen Govanna Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Chongqing General Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangdong | China | Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| SurGal Clinic s.r.o. Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Recruiting |
| Vojenska Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Zidenice | Czechia | Recruiting |
| Nemocnice České Budějovice, a.s. Coordinator of this site? Confirm its status | České Budějovice | Czechia | Recruiting |
| Hepato-Gastroenterologie HK, s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Gastromedic s.r.o Coordinator of this site? Confirm its status | Pardubice | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Endohope klinika s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Axon Clinical s.r.o. Coordinator of this site? Confirm its status | Prague 5 | Czechia | Recruiting |
| EndoArt s.r.o. Coordinator of this site? Confirm its status | Slezska Ostrava | Czechia | Recruiting |
| Krajska zdravotni a.s. Coordinator of this site? Confirm its status | Usti Nad Labem | Czechia | Recruiting |
| Agaplesion Frankfurter Diakonie Kliniken gGmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| St. Marien und St. Annastiftskrankenhaus Coordinator of this site? Confirm its status | Ludwigshafen am Rhein | Germany | Recruiting |
| Heidelberg University Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Not yet recruiting |
| Esbjerg Og Grindsted Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Not yet recruiting |
| Hillerod Hospital Coordinator of this site? Confirm its status | Hilleroed | Denmark | Not yet recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Hvidovre | Denmark | Not yet recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Koege | Denmark | Not yet recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Not yet recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Not yet recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Not yet recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Not yet recruiting |
| Evaggelismos Hospital Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| General Hospital of Athens "G. Gennimatas" Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Not yet recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Not yet recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Recruiting |
| Pannonia Maganorvosi Centrum Kft. Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Recruiting |
| EURO-ENDO-MED Kft. Coordinator of this site? Confirm its status | Mohács | Hungary | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| San Camillo Forlanini Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Haeundae | South Korea | Recruiting |
| Yonsei University Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Stichting Coordinator of this site? Confirm its status | Geleen | Netherlands | Recruiting |
| Stichting Elisabeth-TweeSteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Manermed Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Centrum Medyczne Med-Gastr Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Amicare Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Medrise Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Centrum Medyczne Medyk Sp. z o.o. Coordinator of this site? Confirm its status | Rzeszow | Poland | Recruiting |
| Korczowski Bartosz, Gabinet Lekarski Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| GASTROMED Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| H-T. Centrum Medyczne Sp. z o.o. Sp.k. Coordinator of this site? Confirm its status | Tychy | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| PlanetMed Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Melita Medical Sp. z o.o. Coordinator of this site? Confirm its status | Wrocław | Poland | Recruiting |
| Etg Zamosc Sp. z o.o. Coordinator of this site? Confirm its status | Zamość | Poland | Recruiting |
| Institutul Clinic Fundeni Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Memorial Healthcare International S R L Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Monza-Ares S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Dr. I. Cantacuzino Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Delta Health Care S.R.L Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colentina Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Cabinet Particular Policlinic Algomed S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Recruiting |
| F D Roosevelt University General Hospital Of Banska Bystrica Coordinator of this site? Confirm its status | Banska Bystrica | Slovakia | Recruiting |
| Cliniq s.r.o. Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| ENDOMED, s.r.o. Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| Fakultna nemocnica s poliklinikou Nove Zamky Coordinator of this site? Confirm its status | Nové Zámky | Slovakia | Recruiting |
| Accout Center s.r.o. Coordinator of this site? Confirm its status | Šahy | Slovakia | Recruiting |
| Woodholme Gastroenterology Associates Coordinator of this site? Confirm its status | Glen Burnie | United States | Recruiting |
| Tyler Research Institute, LLC Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.