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A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Sponsor: Takeda
Summary
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) and TAK-279-UC-2001 (NCT06254950). 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 2 years (108 weeks). During the study, participants will visit their study clinic 11 times.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 76 Years
Study Type
INTERVENTIONAL
Enrollment
183
Start Date
2025-05-28
Completion Date
2029-12-30
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Interventions
Zasocitinib
Zasocitinib capsules.
Locations (16)
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, Czechia
Pannonia Maganorvosi Centrum
Budapest, Hungary
St. Antonius Ziekenhuis
Tilburg, North Brabant, Netherlands
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne MedykSp. z o.o. Sp. K.
Lublin, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Endomed
Košice, Slovakia
Inje University Haeundae Paik Hospital
Haeundae, Busan Gwangyeogsi, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea