A continuation study of TAK-279 for adults with ulcerative colitis and Crohn's disease
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Bâle, Berne
(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)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Jens Lachmann
+41 79 593 4489
Jens.Lachmann@cluttericonplc.comICON Clinical Research (Switzerland) GmbH c/o Experfina AG, Picassoplatz 8 4052 Basel
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
26.08.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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