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

Condition(s) studied

Investigational drug(s) / intervention(s)

Vedolizumab: Vedolizumab IV infusion.

Upadacitinib: Upadacitinib over-encapsulated tablets.

Placebo: Upadacitinib matched placebo capsules.

Study summary

The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants.

All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks.

During the study, participants will visit their study clinic 15 times.

Eligibility

Primary outcome measure(s)

• Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12 — Week 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 12 — Week 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.

Trial sites (138)

+ 98 more sites — see the full list on the official registry below.

On this site

More Takeda trials in France

Other trials for the same condition