A continuation study of TAK-279 for adults with ulcerative colitis and Crohn's disease
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Crohn's disease (CD) and ulcerative colitis (UC)
(BASEC)
Adults aged 18 to 75 years who suffer from IBD and have responded to treatment in the main study (TAK-279-CD-2001 or TAK-279-UC-2001) can participate in this study. (BASEC)
Criteri di esclusione
Potential study participants who have been diagnosed with abnormal cell growth at any time during the main study or at the beginning of this continuation study during an endoscopy cannot participate. (BASEC)
Luogo dello studio
Basilea, Berna
(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)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Jens Lachmann
+41 79 593 4489
Jens.Lachmann@cluttericonplc.comICON Clinical Research (Switzerland) GmbH c/o Experfina AG, Picassoplatz 8 4052 Basel
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
26.08.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Offene Verlängerungsstudie der Phase II zur Beurteilung der langfristigen Sicherheit und Verträglichkeit von oral verabreichtem Zasocitinib (TAK-279) bei Patienten mit mässiger bis schwerer aktiver Colitis ulcerosa und mässigem bis schwerem aktivem Morbus Crohn (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile