RecruitingPHASE3INTERVENTIONAL

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

This study is investigating a new treatment approach for adults living with moderate to severe Crohn's Disease. Researchers want to find out if using two medicines together, vedolizumab and upadacitinib, is more effective at reducing inflammation and ulcers in the bowel than using vedolizumab by itself. They will also carefully monitor the safety of this combination treatment. For the first 12 weeks, all participants will receive vedolizumab along with either upadacitinib or an inactive dummy treatment (placebo). Those who respond well will then continue on vedolizumab alone for nearly a year. The study involves regular clinic visits and aims to advance our understanding of how to best treat Crohn's Disease.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Takeda

Enrolment target

396

Start

02 Jan 2025

Estimated completion

01 Aug 2028

Crohn's Disease

What is this study about?

This research study is for adults who have Crohn's Disease that is moderately to severely active. The main goal is to explore whether combining two medications, called vedolizumab and upadacitinib, works better than vedolizumab alone to help reduce inflammation and ulcers in the bowel. Researchers will also be carefully watching for any side effects and how safe the treatments are.

For the first 12 weeks, everyone in the study will receive vedolizumab. Half of the participants will also receive upadacitinib, and the other half will receive a placebo, which looks like upadacitinib but has no active medicine. This helps researchers compare the combination treatment with vedolizumab by itself. After these 12 weeks, if a participant's Crohn's disease shows a good response, they will then continue with vedolizumab alone for about 40 more weeks.

Understanding how different treatments work, alone or in combination, is crucial for improving care for people with Crohn's Disease. This study could help doctors make more informed decisions about the best ways to manage this condition in the future.

Key takeaways

Tests vedolizumab with and without a second drug, upadacitinib.
For adults with moderate to severe Crohn's Disease.
Aims to reduce bowel inflammation and ulcers.
Involves 15 clinic visits over about 70 weeks.
Participants may receive a placebo in the initial phase.
Careful monitoring of safety and effectiveness.

Who may be eligible?

To join this study, you must be an adult between 18 and 65 years old with Crohn's Disease that has been diagnosed for at least three months. Your Crohn's disease must be considered moderately to severely active, and you should have signs of inflammation in your bowel, confirmed by special scans or tests.

It's important that previous treatments for your Crohn's disease, such as steroids, immune-suppressing drugs, or other biological medicines, haven't worked well enough for you, or you couldn't tolerate them.

There are also reasons why you might not be able to join. For example, if you have a different bowel condition like ulcerative colitis, or if you currently have a serious infection. Also, if you have certain complications from Crohn's Disease that might need surgery soon, such as blocked bowels or abscesses, or if you have severe kidney or liver problems, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Do you have a confirmed diagnosis of moderately to severely active Crohn's Disease?
Have other Crohn's treatments not worked well for you or caused problems?
Do you currently have a serious infection or severe kidney/liver problems?
Do you have any severe complications from Crohn's that might need surgery soon?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be involved for about 70 weeks, which is roughly a year and four months. For the first 12 weeks, you'll receive a combination of medicines (vedolizumab plus either upadacitinib or a placebo). If your condition improves significantly, you'll then switch to receiving vedolizumab by itself for the next 40 weeks. After finishing the treatment, there will be a follow-up period of about 18 weeks to check on your health and safety. You will need to visit the study clinic about 15 times over the course of the study for check-ups and assessments.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and close monitoring by a medical team. However, there are also potential risks, including side effects from the study medications, which will be explained in detail. Some participants will receive a placebo, meaning they won't get active treatment in one part of the study. You will be able to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (138)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UCSD Medical Center
Verified postcode
La Jolla, United States· Not yet recruiting
Keck Medicine Of USC - USC Healthcare Center 1
Verified postcode
Los Angeles, United States· Not yet recruiting
Peak Gastroenterology Associates
Verified postcode
Colorado Springs, United States· Recruiting
GI PROS, Inc.
Verified postcode
Naples, United States· Active not recruiting
Orlando Health Ambulatory Care Center
Verified postcode
Orlando, United States· Active not recruiting
USF Health Morsani Center for Advanced Healthcare
Verified postcode
Tampa, United States· Active not recruiting
Indiana University (IU) Health University Hospital
Verified postcode
Indianapolis, United States· Active not recruiting
University of Kentucky
Verified postcode
Lexington, United States· Active not recruiting
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center
Verified postcode
New York, United States· Active not recruiting
Columbia University Medical Center, New York-Presbyterian Hospital
Verified postcode
New York, United States· Not yet recruiting
Lenox Hill Hospital Northwell Health
Verified postcode
New York, United States· Active not recruiting
Gastroenterology Associates
Verified postcode
Greenville, United States· Active not recruiting

Common questions

What is Crohn's Disease?

Crohn's Disease is a long-term condition that causes inflammation in the digestive system, leading to symptoms like tummy pain, diarrhoea, and weight loss.

What are vedolizumab and upadacitinib?

These are medicines used to treat inflammatory conditions like Crohn's Disease by targeting specific parts of the immune system to reduce inflammation.

What does 'placebo' mean?

A placebo is an inactive substance or treatment that looks the same as the real medicine but contains no active drug. It helps researchers compare the effects of the active medicine.

How long will the study last?

The entire study will last for approximately 70 weeks, which is about one year and four months.

Will I know which treatment I am receiving?

During the first 12 weeks, you won't know if you're receiving upadacitinib or the placebo along with vedolizumab. This is standard in studies to ensure fair comparison of treatments.

How to find out more

Takeda Contact

medinfous@takeda.com +1-877-825-3327 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.