Clinical Research Directory

Inclusion Criteria: * Male or female subjects who are more than 18 years of age, on the day of signing informed consent * Documented diagnosis of IBD, established on the basis of standard clinical, endoscopic and/or histological criteria. * CD or UC remission defined per clinical assessment as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients and a Partial Mayo Score (PMS) \< 2 with each sub-score of 1 or less for UC and/or according to ECCO classification within previous 3 months * Currently treated with IV vedolizumab * Patients agreeing to switch from IV to SC formulation * Receiving or not the concomitant following drugs (but must remain on stable dose for 12 weeks): * Oral 5-aminosalicylates (5ASA) compounds or rectal formulations of 5ASA provided the dose to be stable at least 4 weeks before switching * Azathioprine, 6-Mercaptopurine or methotrexate provided the dose has been stable for 4 weeks prior to inclusion • Each patient is required to provide written informed consent in order to be included in the study Exclusion Criteria: * Current use of adalimumab, infliximab, golimumab or ustekinumab * Current use of JAK inhibitors or S1P modulators * Current use of steroids or within the last three months for IBD * Treatment with any investigational agent in the past 30 days or five half-lives prior to the screening visit (whichever is longer) * Active clinically significant infection or HIV, Hep B, Hep C, untreated tuberculosis * Female subjects with pregnancy or breastfeeding