RecruitingPHASE2INTERVENTIONAL

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

This research study is for individuals aged 18 to 75 who have Crohn's disease that is currently active and not responding well to other treatments. The main goal is to find out if a new drug called TAK-279 can help reduce the swelling and ulcers in the gut caused by Crohn's disease. We'll be comparing TAK-279 to a 'dummy' drug (placebo) to see if it works and what side effects it might have. Participants will receive either TAK-279 or the placebo for a year, with regular check-ups at the clinic. The study will also look at how well people tolerate any side effects. An endoscopy will be used to check healing in the bowel.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Takeda

Enrolment target

268

Start

05 Mar 2024

Estimated completion

23 Jul 2027

Crohn's Disease

What is this study about?

If you have Crohn's disease, you know it's a long-term condition that causes inflammation, or swelling, anywhere in your digestive system. This can lead to pain, discomfort, and other difficult symptoms. When Crohn's is active, it means the inflammation is flaring up.

This study is testing a new medication called TAK-279. We want to see if this drug can help people with moderately to severely active Crohn's disease. The main things we're looking for are: can it reduce the inflammation and ulcers (sores) in the bowel, and is it safe to use? To figure this out, some people in the study will get TAK-279, and others will get a 'placebo', which looks like the drug but contains no active medicine. This helps us see if TAK-279 is truly making a difference.

Researchers will be giving out three different doses of TAK-279 to see which one works best. We will check your bowel using a special camera (called an endoscopy) after 12 weeks to see if the inflammation and ulcers have improved. We'll also be carefully tracking any side effects or medical problems people experience with either TAK-279 or the placebo, and how well they cope with them. The total treatment period for participants will be about one year.

Key takeaways

This study is testing a new drug for active Crohn's disease symptoms.
It aims to see if the drug reduces inflammation and is safe over a year.
You might receive the new drug or a dummy pill (placebo).
You'll have regular clinic visits and tests, including endoscopies.
The study is for adults whose Crohn's hasn't responded well to previous treatments.

Who may be eligible?

This study is for adults, generally between 18 and 75 years old, who have been diagnosed with Crohn's disease for at least a month. Your Crohn's needs to be active and causing moderate to severe symptoms right now. Importantly, you should have tried at least one other treatment for your Crohn's (like a conventional medicine, a 'biologic' drug, or another advanced therapy) that didn't work well, stopped working, or caused problems you couldn't tolerate.

There are some reasons why you might not be able to join. For example, if you have other types of bowel inflammation like ulcerative colitis, or if your Crohn's has led to complications that might need surgery soon. People who currently have an ostomy (a surgical opening to remove waste) or who have already tried and failed three or more types of advanced Crohn's treatments would also not be able to participate.

Quick self-check

Are you between 18 and 75 years old?
Do you have an active diagnosis of Crohn's disease?
Has your Crohn's disease been moderate to severe recently?
Have other Crohn's treatments not worked well for you?
Do you not have other types of inflammatory bowel disease, like ulcerative colitis?
Have you not needed surgery for Crohn's complications recently or foresee needing one soon?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you'll be treated with either TAK-279 or a placebo for about one year (52 weeks). During this time, neither you nor your study doctor will know whether you are receiving the actual drug or the placebo, unless there's a serious medical reason to find out. You'll need to visit the study clinic 15 times over this year. The entire study, including a final safety check a few weeks after your last dose, will last about 60 weeks in total.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. Potential benefits of this study include receiving a new, experimental treatment that might help your Crohn's disease, or contributing to medical knowledge that could help others in the future. However, there's no guarantee that TAK-279 will improve your condition, and like all medications, it could have side effects. Potential risks include those related to the study drug itself (whether TAK-279 or placebo) and the various tests and procedures, like endoscopies, involved. Your safety and well-being will be closely monitored throughout. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (193)

GastroIntestinal BioSciences
Los Angeles, United States· Recruiting
United Medical Doctors
Murrieta, United States· Recruiting
UCI Health
Orange, United States· Recruiting
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, United States· Recruiting
Auzmer Research
Lakeland, United States· Recruiting
Wellness Clinical Research
Miami Lakes, United States· Recruiting
GI PROS, Inc.
Naples, United States· Recruiting
AdventHealth (Florida Hospital) Medical Group
Orlando, United States· Not yet recruiting
USF Health Morsani Center for Advanced Healthcare
Tampa, United States· Recruiting
Emory University Hospital, The Emory Clinic
Atlanta, United States· Recruiting
Atlanta Center For Gastroenterology, P.C.
Decatur, United States· Recruiting
The University of Iowa Hospitals & Clinics
Iowa City, United States· Recruiting

+181 more sites — see the official record for the full list.

Common questions

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real drug but contains no active medicine. It helps researchers see if the real drug works better than nothing at all.

Will I know if I'm getting the real drug or the placebo?

No, neither you nor your study doctor will know who is getting the real drug and who is getting the placebo during the study, unless there's an urgent medical need to find out.

How long will I be in the study?

You will receive the study treatment for about one year (52 weeks). The total study participation, including follow-up, will be around 60 weeks.

What does a 'moderately to severely active' Crohn's disease mean?

It means your Crohn's disease is currently causing significant symptoms and inflammation, as assessed by doctors using specific tools.

What is an endoscopy and why is it needed?

An endoscopy uses a thin, flexible tube with a camera to look inside your bowel. In this study, it's used to check how much inflammation and how many ulcers are present, and if they've improved with treatment.

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.