A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis
Date de révision : 24/04/2026
Homme Femme
Tout âge
Date de début de recrutement : 18/07/2024
Date de fin de recrutement : 25/07/2024
Critères :
Critères d'inclusion :
- Entry and completion of Study M16-067. Completion includes the final endoscopy of Study M16 067. If the final endoscopy for Study M16-067 is missing during the COVID-19 pandemic due to local regulation prohibiting endoscopy, or due to the geo-political conflict in Ukraine and surrounding impacted regions, subjects may be allowed to enroll in Substudy 3 should they meet clinical response.
- Achieved clinical response at the last visit of Study M16-067.
Critères d'exclusion :
- Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
- Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Study M16-067 that in the Investigator's judgment makes the subject unsuitable for this study.
Lieux et contacts
Informations pratiques pour participer à cet essai.
Sites des essais
Adresse
Centre Medico Chirurgical Ambroise Pare Hartmann
92200 Neuilly-sur-Seine France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".