RecruitingPHASE4INTERVENTIONAL

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

This study is for adults with moderate to severe ulcerative colitis, especially those who haven't responded well to previous treatments. We're testing a combination of two medicines, vedolizumab and tofacitinib, to see how effective they are when used together. For the first eight weeks, all participants will receive both medicines. After this initial period, if their condition has improved, they will continue with only vedolizumab for a further 44 weeks. The main goal is to understand how well this combined approach works in helping people with ulcerative colitis. The study will also follow participants for several months after their last dose to check on their health and safety.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Takeda

Enrolment target

Start

12 Jun 2024

Estimated completion

09 Jul 2027

Ulcerative Colitis

What is this study about?

If you have ulcerative colitis (UC), you know it can be a challenging condition to manage. This study is looking into a new way to treat adults who have moderate to severe UC, especially if other treatments haven't worked well for them. We're investigating if combining two existing medicines, vedolizumab and tofacitinib, can be a more effective way to help people feel better.

The study aims to understand how well this combination works and if it can help more people achieve 'remission' – a time when symptoms are much reduced or disappear. After an initial period where both medicines are given together, we'll see if continuing with just one of the medicines (vedolizumab) can maintain these improvements. This is about finding the best strategies to help people living with UC lead more comfortable lives.

It's important to know that this is a 'Phase 4' study. This typically means the medicines involved are already approved for use, but researchers want to learn more about how they work together, in different groups of people, or over longer periods. The goal is always to improve understanding of how to best treat conditions like UC.

Key takeaways

Tests a combination of two medicines (vedolizumab and tofacitinib) for ulcerative colitis.
Aimed at adults with moderate to severe UC who haven't responded to previous treatments.
Initial 8 weeks of both medicines, then 44 weeks of one if you respond well.
Study duration up to 76 weeks (about 1.5 years) with follow-up.
Participation is voluntary; you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 65 years old and have been diagnosed with ulcerative colitis for at least three months. Your UC should be considered moderate to severe at the time of screening.

A key requirement is that you've already tried and not responded well to, stopped responding to, or couldn't tolerate at least one, but no more than two, specific types of medicines called TNF antagonists. If you haven't tried any 'biologic' medicines before, you generally won't be able to join this study, unless specific conditions are met and discussed with the medical team.

Also, if you're currently taking steroid medications, your dose needs to have been stable for at least two weeks before your initial screening appointment. The study also has some rules about colonoscopies and checking for bowel cancer risk, depending on your personal medical history.

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 an adult aged between 18 and 65?
Do you have a confirmed diagnosis of moderate to severe ulcerative colitis?
Have you tried and not responded well to at least one, but no more than two, TNF antagonist medications?
If you're on steroids for UC, has your dose been stable for at least 2 weeks?
Are you able to attend regular appointments and follow the study schedule?

Answer every question to see your result.

What does participation involve?

If you join this study, it could last for up to 76 weeks, which is about a year and a half. For the first 8 weeks, you will receive both vedolizumab and tofacitinib. These will be given to you as directed by the study team. After these 8 weeks, your progress will be carefully checked. If your condition has improved, you will then continue taking only vedolizumab for another 44 weeks.

Throughout the study, you'll have regular appointments and checks to see how you're responding to the treatment and to monitor your health. These visits will help the doctors understand if the treatment is working and if there are any side effects. Even after you stop taking the study medicine, you'll be followed up for at least 26 weeks (about six months) to ensure your continued well-being. The study will take place in medical centres in the United States and Canada.

Potential risks and benefits

Taking part in a clinical study means you might experience potential benefits, such as receiving close medical care and access to new treatment approaches that might help your ulcerative colitis. However, there are also potential risks involved, as with any medical treatment. The medicines used can have side effects, and not everyone will respond positively to the treatment. The research team will carefully monitor you for any side effects and ensure your safety throughout the study. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (49)

Digestive Health Specialsits
Verified postcode
Dothan, United States· Recruiting
GI Alliance Sun City
Verified postcode
Sun City, United States· Recruiting
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Hoag Hospital Newport Beach
Verified postcode
Newport Beach, United States· Recruiting
Endoscopic Research Inc
Verified postcode
Orlando, United States· Recruiting
Alliance Clinical Research of Tampa, LLC
Verified postcode
Tampa, United States· Recruiting
Gastroenterology Consultants, P.C.
Verified postcode
Roswell, United States· Recruiting
University of Chicago Medicine
Verified postcode
Chicago, United States· Recruiting
GI Alliance - Illinois Gastroenterology Group - Glenview
Verified postcode
Glenview, United States· Recruiting
GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
Verified postcode
Gurnee, United States· Recruiting
University of Kansas Medical Center
Verified postcode
Kansas City, United States· Recruiting
University of Louisville
Verified postcode
Louisville, United States· Recruiting

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of the large intestine (colon and rectum) becomes inflamed and develops tiny open sores (ulcers).

What are vedolizumab and tofacitinib?

These are types of medicine used to treat ulcerative colitis. Vedolizumab is given through a drip (IV), and tofacitinib is taken as a tablet.

Why combine these two medicines?

Researchers want to see if using both medicines together works better for people with ulcerative colitis, especially those who haven't responded well to other treatments before.

How long will I be in the study?

If you take part, you could be in the study for up to about a year and a half, with medicine given for up to 52 weeks and follow-up checks after that.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and it won't affect your regular medical care.

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.