A continuation study of TAK-279 for adults with ulcerative colitis and Crohn's disease

Zusammenfassung der Studie

Crohn's disease (CD) and ulcerative colitis (UC) are two forms of inflammatory bowel disease (IBD), a serious, long-term condition of the intestines that can cause pain and swelling (inflammation) in the gut. CD is a severe condition that can affect any part of the digestive tract from the mouth to the anus and typically causes inflammation of the intestines. UC causes inflammation of the inner lining of certain parts of the intestines, such as the colon and the rectum. Zasocitinib, also known as TAK-279, is an orally administered medication that inhibits inflammation. This study is an extension of the parent studies, TAK-279-CD-2001 and TAK-279-UC-2001. This means that participants who responded to treatment with Zasocitinib in either of the two parent studies can continue to benefit from treatment in this study. The main objective is to determine how safe Zasocitinib is and to assess whether it reduces intestinal inflammation and symptoms with prolonged use.

(BASEC)

Untersuchte Intervention

This is an open-label continuation study, meaning that participants are aware that they will be receiving Zasocitinib. Adults who have responded to treatment and completed week 52 in either of the two main studies can participate in this continuation study. Participants will receive Zasocitinib daily for up to 2 years (from week 0 to week 108). The maximum study duration for an individual participant is just over 2 years (112 weeks), which includes a 4-week safety follow-up period.

(BASEC)

Untersuchte Krankheit(en)

Crohn's disease (CD) and ulcerative colitis (UC)

(BASEC)

Sponsor

Sponsor: Takeda Development Center Americas Inc. Namita Singh 500 Kendall Street, Cambridge, Massachusetts, 02142, USA Email: namita.singh@takeda.com phone: 13105626094 Sponsor’s representative in Switzerland : Jens Lachmann ICON Clinical Research (Switzerland) GmbH c/o Experfina AG, Picassoplatz 8 4052 Basel Jens.Lachmann@iconplc.com phone: +41 79 593 4489

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Bern

(BASEC)

Datum der Bewilligung durch die Ethikkommission

26.08.2025

(BASEC)

Ergebnisse der Studie