Study of Vedolizumab and Adalimumab or Ustekinumab for Crohn's Disease
This study is looking at how well two different combinations of medicines work for adults with moderate to severe Crohn's disease. You might receive vedolizumab (given through a vein) plus adalimumab (given as a shot under the skin), or vedolizumab plus ustekinumab (given through a vein and then as a shot under the skin). These medicines are targeted therapies, meaning they focus on specific parts of your immune system. To join, you must be between 18 and 70 years old, have a confirmed diagnosis of Crohn's disease, and have not responded well to other treatments. The main goal is to see if these treatments improve your Crohn's disease based on endoscopy (a procedure to look inside your digestive tract) at 26 and 52 weeks. About 100 people will participate in this study.
- Study design
- This interventional study involves approximately 100 participants. It has two parts: in Part A, participants receive a combination of two drugs, and in Part B, those who responded will receive vedolizumab alone.
- What's involved
- You would receive treatment combinations in Part A, and if you respond, vedolizumab alone in Part B. You will be followed for at least 26 weeks after your last dose of treatment, with the overall study lasting about 76 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for at least 26 weeks after your last dose of treatment, with a safety follow-up period extending to Week 72.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
At a glance
Conditions
Where it's being run
48 sites across 24 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- Part A: Percentage of Participants With an Endoscopic Response Based on the Simple Endoscopic Score for (SES-CD) at Week 26At Week 26
Endoscopic response is defined by a \>=50 percent (%) reduction from baseline in the SES-CD. SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of surface area (SA) that is ulcerated, percentage of SA affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. 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 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. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.
- Part B: Percentage of Participants With an Endoscopic Response Based on the SES-CD at Week 52At Week 52
Endoscopic response is defined by a \>=50 reduction from baseline in the SES-CD. SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of surface area (SA) that is ulcerated, percentage of SA affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. 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 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. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.