A Study to Compare Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-Controlled Phase 3b Study to Evaluate the Short- and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab Monotherapy for the Treatment of Adult Participants With Moderately to Severely Active Crohn’s Disease
IRAS ID
1011177
Contact name
Pooja Oberai
Contact email
Sponsor organisation
Takeda Development Center Americas Inc.
Clinicaltrials.gov Identifier
Vedolizumab-3043
Research summary
The study is a research study for an investigational treatment for Crohn’s Disease (CD). CD is a long-term disease that can cause diarrhoea & lower abdominal pain, fatigue, weight loss & loss of appetite. There is an unmet medical need in the CD community for patients with moderately to severely active disease who may not respond to the current treatments of monotherapy or combination of a biologic with an immunosuppressant.
This study will combine 2 drugs, vedolizumab & upadacitinib. Both are drugs that have been approved separately for treatment of participants with moderately to severely active CD who have had an inadequate response, lost response, or were intolerant to other treatments. However, in this study these drugs will be combined and this combination, called dual targeted therapy, is investigational.
This study will split the participants into 2 treatment groups for the first 12 weeks of the treatment phase of the study. One of the groups will receive vedolizumab combined with upadacitinib and the other group will receive vedolizumab combined with a placebo. After the first 12 weeks both groups will then receive vedolizumab only for 40 weeks to maintain participants in an inactive disease state, and with a goal of reducing the chance of further relapse.
All participants will be assessed using the Crohn’s Disease Activity Index (CDAI). If a participant’s CDAI does not achieve a reduction of ≥70 from their baseline score at Week 12 they will move to the rescue sub-study for 12 weeks after which their score may allow continuation of study drug at a lower frequency until the end of the 40 week main study or they will be discontinued from treatment & into safety follow-up.
Participants at selected sites will be offered the option to participate in the Intestinal Ultrasound sub-study to evaluate the inflammation of their intestines.
The study will be made up of male & female participants between 18 & 65 years old with moderately to severely active CD.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0010
Date of REC Opinion
3 Apr 2025
REC opinion
Further Information Favourable Opinion