Study of Vedolizumab With and Without Upadacitinib for Treating Adults Aged 18 to 65 With Moderate to Severe Crohns Disease Evaluating Short- and Long-Term Effects of Dual Targeted Therapy Compared to Vedolizumab Alone

What this Trial Is About

Researchers are evaluating whether combining vedolizumab and upadacitinib, called dual targeted therapy DTT, reduces bowel inflammation and ulcers more effectively than vedolizumab alone in adults with moderately to severely active Crohns Disease CD. The study also compares the safety and effectiveness of these treatments. This Phase 3b trial is conducted worldwide and sponsored by Takeda, enrolling about 396 participants. Participants are randomly assigned to receive either vedolizumab with upadacitinib or vedolizumab with a placebo for 12 weeks during the Induction Phase. Vedolizumab is given as a 300 mg intravenous infusion at Weeks 0, 2, 6, and 10 upadacitinib or placebo is taken daily by mouth. Those who respond to treatment at Week 12 will continue with vedolizumab alone every 8 weeks for 40 weeks in the Maintenance Phase. Vedolizumab dosing frequency may increase to every 4 weeks if needed. During the approximately 70-week study, participants visit the clinic 15 times for assessments including clinical evaluations, endoscopic exams, and patient-reported outcomes. Researchers measure clinical remission, endoscopic response, and safety outcomes at Week 12 and Week 52. There is also an 18-week safety follow-up after the maintenance period to monitor participants health.

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease