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RECRUITING
NCT06764615
PHASE2

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

Sponsor: Takeda

View on ClinicalTrials.gov

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

Interventions

DRUG

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