RecruitingPHASE2INTERVENTIONAL

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

We're investigating a new medicine called Tilpisertib Fosmecarbil for people in the UK aged 18 to 75 who have moderately to severely active ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and ulcers in your digestive tract. The study wants to find out if this new drug can help reduce symptoms and improve the condition more effectively and safely than a placebo (a treatment with no active medicine). Participants will be assigned to either receive the new drug or the placebo, and their progress will be carefully monitored over 12 weeks to see if their symptoms improve.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Gilead Sciences

Enrolment target

176

Start

05 Dec 2023

Estimated completion

01 Feb 2028

Ulcerative Colitis

What is this study about?

This study is looking at a new medication called Tilpisertib Fosmecarbil (you might also see it referred to as GS-5290) for adults with ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease where the lining of the large intestine (colon and rectum) becomes inflamed and develops tiny sores or ulcers, leading to symptoms like tummy pain, urgent bowel movements, and blood in your poo.

The main goal of this study is to see if Tilpisertib Fosmecarbil is an effective and safe treatment for people who have moderate to severe ulcerative colitis. This means that if you join the study, you'll either receive the new medication or a 'placebo' – which looks exactly like the study drug but contains no active medicine. This allows the researchers to fairly compare how well the new drug works against not taking the study drug.

Researchers will closely monitor how participants' symptoms change over 12 weeks to see if the new medication helps improve ulcerative colitis more than the placebo. This study is in 'Phase 2', which means it's one of the earlier stages of drug development, where we're learning more about the drug’s effectiveness and how safe it is for people.

Key takeaways

Tests a new medication for moderate to severe ulcerative colitis.
Compares the new drug to a placebo (dummy pill).
Aims to improve symptoms over 12 weeks.
For adults aged 18-75 with specific UC history.
Close medical monitoring throughout the study.
Participation is voluntary, you can leave at any time.

Who may be eligible?

This study is looking for men and women, aged between 18 and 75, who have been diagnosed with ulcerative colitis for at least 3 months. Your ulcerative colitis needs to be considered 'moderately to severely active' by the study doctors, and it must affect a certain length of your bowel.

To be considered, you should have tried at least one other approved ulcerative colitis medication in the past but it didn't work well enough, or you couldn't tolerate it. However, if you've already tried more than three different types of advanced ulcerative colitis treatments, this study might not be suitable for you.

There are also reasons why you might not be able to join, such as if you have Crohn's disease, only have inflammation in your rectum, currently have a serious infection, or have a history of certain types of infections. The medical team will check all these details carefully to make sure the study is right and safe for you.

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 75 years old?
Have you been diagnosed with ulcerative colitis for at least 3 months?
Do you have moderately to severely active ulcerative colitis?
Have you tried at least one other approved UC treatment that didn't work well, but no more than three different advanced therapies?
Do you currently have any serious infections or conditions like Crohn's disease or only inflammation in your rectum?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study clinic regularly. During these visits, the study team will carry out health checks, like taking blood samples, checking your vital signs, and asking about your symptoms. You'll receive either the study medication or the placebo, which you'll take as instructed. The main part of the study will involve monitoring your health and symptoms for 12 weeks to see how you respond to the treatment. There will also be follow-up appointments after this main treatment period.

Potential risks and benefits

Taking part in a study like this could potentially offer new ways to manage your ulcerative colitis if the new drug proves effective. However, there's no guarantee it will work for you, and like all medications, Tilpisertib Fosmecarbil could have side effects, some of which might not be known yet. The study team will explain all known risks and monitor you closely for any unwanted effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (129)

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

GI Alliance
Verified postcode
Sun City, United States· Recruiting
GastroSb Weight Loss Clinic
Verified postcode
Chula Vista, United States· Recruiting
Southern California Research Centers
Verified postcode
Coronado, United States· Recruiting
VVCRD Research
Verified postcode
Garden Grove, United States· Recruiting
UC San Diego Health System
Verified postcode
La Jolla, United States· Recruiting
Gastro Care Institute
Verified postcode
Lancaster, United States· Recruiting
Om Research LLC
Verified postcode
Lancaster, United States· Recruiting
United Medical Doctors
Verified postcode
Murrieta, United States· Withdrawn
University of California, Davis
Verified postcode
Sacramento, United States· Recruiting
University of California San Francisco
Verified postcode
San Francisco, United States· Recruiting
Amicis Research Center
Verified postcode
Valencia, United States· Withdrawn
Luna Research
Verified postcode
Coral Gables, United States· Recruiting

Common questions

What is a placebo?

A placebo is a 'dummy' treatment that looks like the study drug but contains no active medicine. It helps researchers understand if the new drug is truly making a difference.

How long will the study last for me?

The main treatment part of the study is 12 weeks, during which your condition will be closely monitored. There will also be a period of follow-up after this.

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

No, you won't know during the study which treatment you are receiving. This is a common practice in clinical trials to ensure fair results.

What if I feel worse during the study?

Your health and safety are a priority. The study team will monitor you closely, and you should tell them immediately if you feel worse or develop new symptoms. You can also leave the study at any time.

What does 'Phase 2' mean?

Phase 2 means this is an earlier stage of testing where researchers are trying to learn more about whether the drug works and what side effects it might have, in a larger group of people than in initial tests.

How to find out more

Gilead Clinical Study Information Center

GileadClinicalTrials@gilead.com 1-833-445-3230 (GILEAD-0) Official trial record

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