A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
This study is for adults aged 18 to 65 with moderately to severely active Crohn's Disease (CD). It aims to see if combining two targeted therapies, vedolizumab and upadacitinib, is better at reducing bowel inflammation and ulcers than vedolizumab alone. You would have a confirmed diagnosis of CD and a specific score (CDAI of 220-450) for your disease activity. The study will measure success by looking at the percentage of participants who achieve clinical remission (feeling better) and endoscopic response (healing of the bowel lining) at 12 weeks. The study is currently recruiting about 396 participants worldwide.
- Study design
- This interventional study will enroll about 396 participants. You would be assigned to receive either vedolizumab plus upadacitinib or vedolizumab plus a placebo (an inactive substance) for 12 weeks.
- What's involved
- You would visit the study clinic 15 times over approximately 70 weeks. If you respond to the initial treatment, you would then receive vedolizumab alone for an additional 40 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for an additional 18 weeks after the main treatment period, up to Week 70.
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A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
At a glance
Conditions
Where it's being run
138 sites across 50 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12Week 12
Clinical remission is defined as a CDAI score of less than (\<) 150 points. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.
- Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12Week 12
Endoscopic response per SES-CD is defined as decrease in SES CD greater than (\>) 50% from baseline (or for participants with isolated ileal disease, SES-CD \<=4 or a \>=2-point reduction in SES-CD from baseline) read centrally. SES-CD evaluates 4 endoscopic variables (ulcer size,percentage of ulcerated and affected surface area, presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy (ileum,right,transverse,and left colon,rectum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. Overall SES-CD score ranges from 0 to 56 and is sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.