Last updated 2 months ago
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
396 patients around the world
Available in Brazil, United States
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderately to severely active CD. The study will look at the efficacy and safety of vedolizumab with and without upadacitinib. The study will enroll approximately 396 patients. Participants will be assigned in a 1:1 ratio to one of the two treatment groups in the 12-weeks Induction Phase:
- Induction Phase: Vedolizumab + Upadacitinib
- Induction Phase: Vedolizumab + Placebo
Participants who achieve a Crohn's disease activity index (CDAI) reduction of greater than or equal to (>=)70 points from baseline at Week 12 will enter the main study Maintenance Phase (40 weeks) of the study to receive vedolizumab monotherapy. Participants will be followed for a further 18-week safety follow-up period up to Week 70.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 70 weeks.
Takeda
6Research sites
396Patients around the world
This study is for people with
Crohn's disease
Requirements for the patient
To 65 Years
All Gender
Medical requirements
- The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report.The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score (excluding the presence of narrowing component) of >=6 (or >=4 for participants with isolated ileal disease), as confirmed by a central reader.The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.
- The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.The participant has infection(s) requiring treatment with IV anti-infectives within 30 days prior to baseline or oral/intramuscular anti-infectives within 14 days prior to baseline.The participant has evidence of an active infection during the screening period, or clinically significant infection within 30 days prior to screening, or ongoing chronic infection.The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study.The participant has an ostomy or ileoanal pouch.The participant has severe renal impairment, defined as an estimated glomerular filtration rate of <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2).The participant has severe (Child-Pugh C) hepatic impairment.
Sites
Hospital Universitário Clementino Fraga Filho
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Hospital das Clínicas de Ribeirão Preto
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
Pesquisare Saude
StudyVICTRIVA
SponsorTakeda
Study typeInterventional
Conditions
Crohn's disease
Requirements
To 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06227910
