Active not recruitingPHASE2INTERVENTIONAL

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

This research study is investigating a new medicine, emvistegrast (also known as GS-1427), for people living with ulcerative colitis that is considered moderately to severely active. The main goal is to find out if emvistegrast is an effective treatment. To do this, some participants will receive emvistegrast, while others will receive a placebo – a dummy medicine that looks the same but contains no active drug. By comparing these groups, doctors hope to understand if emvistegrast can reduce symptoms and improve the health of people with this condition at 12 weeks. This is a Phase 2 study, meaning it's an earlier stage of testing to see if the medicine works and is safe.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Gilead Sciences

Enrolment target

228

Start

27 Mar 2024

Estimated completion

01 Apr 2028

Ulcerative Colitis

What is this study about?

This study is looking into a new medicine called emvistegrast, formerly known as GS-1427, for individuals who have ulcerative colitis that is causing significant symptoms. Ulcerative colitis is a long-term condition where the lining of the large bowel (colon and rectum) becomes inflamed and develops tiny open sores (ulcers). This can lead to symptoms like tummy pain, diarrhoea, and blood in your poo. When we say 'moderately to severely active,' it means your symptoms are quite noticeable and affecting your daily life.

The main aim of this study is to see if emvistegrast can help reduce these symptoms and improve your condition. Researchers will compare how well people taking emvistegrast do compared to those taking a 'placebo.' A placebo looks just like the real medicine but contains no active ingredients. This comparison is very important because it helps scientists understand if the effects they see are truly due to the medicine or to other factors.

This is a 'Phase 2' study, which means it's an earlier stage of drug development. At this stage, doctors are trying to figure out if the medicine works and learn more about its safety before it's tested in even larger groups of people. Information from this study could help pave the way for a new treatment option for people living with ulcerative colitis.

Key takeaways

This study is testing a new medicine, emvistegrast, for active ulcerative colitis.
It's for people whose current treatments haven't worked well enough.
Participants will receive either emvistegrast or a dummy medicine (placebo).
The main treatment period lasts 12 weeks with regular check-ups.
This is an early-stage study to see if the medicine works and is safe.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be aged between 18 and 75 years old. You must have been diagnosed with ulcerative colitis for at least 90 days, and doctors would need to see records confirming this diagnosis through procedures like an endoscopy (where a small camera is used to look inside your bowel) and tissue samples (biopsies).

Your ulcerative colitis needs to be 'moderately to severely active' at the time of screening. This is determined by a special scoring system used by doctors, and an endoscopy will confirm the level of inflammation. It's also important that your current treatments for ulcerative colitis, such as steroids, immune-modifying drugs, or other more advanced therapies, haven't worked well enough for you, or you haven't been able to tolerate them.

There are also some reasons why you might not be able to join. For example, if you have Crohn's disease instead of ulcerative colitis, or other specific bowel conditions like toxic megacolon. If you've previously taken certain types of medicines called 'integrin antagonists' (like vedolizumab), you wouldn't be able to participate. You also couldn't be on any other medications that are not allowed in the study.

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?
Do you have a confirmed diagnosis of ulcerative colitis?
Are your ulcerative colitis symptoms currently moderate to severe?
Have your previous ulcerative colitis treatments (like steroids or immune-modifying drugs) not worked well for you, or have you struggled with them?
Have you *not* had certain other bowel conditions like Crohn's disease?
Have you *not* previously taken medicines like vedolizumab or similar drugs?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to either receive the new medicine, emvistegrast, or a placebo (a dummy medicine). You wouldn't know which one you are taking, and neither would your study doctor, to ensure fair results. The main part of the study assessing how well the medicine works will last for 12 weeks.

During this time, you would have regular visits to the study clinic. These visits will involve various assessments, including physical examinations, blood tests, and possibly stool sample collections. You might also have further endoscopies to monitor the inflammation in your bowel. You would also need to take the study medication regularly as instructed. There would also be follow-up appointments after the main treatment period to monitor your health. The total duration of your involvement, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your health by medical professionals. However, there are also potential risks; you might experience side effects from the study medicine, or the medicine may not work for you. It's also possible to receive a placebo. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (181)

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

Onyx Clinical Research (Clinic Location)
Verified postcode
Peoria, United States
Om Research LLC
Verified postcode
Camarillo, United States
VVCRD Research
Verified postcode
Garden Grove, United States
310 Clinical Research
Verified postcode
Inglewood, United States
US San Diego Health System
Verified postcode
La Jolla, United States
Om Research LLC
Verified postcode
Lancaster, United States
UCSF Benioff Children's Hospital Oakland
Verified postcode
Oakland, United States
University Of California, Davis
Verified postcode
Sacramento, United States
SDG Clinical Research, LLC
Verified postcode
San Diego, United States
Acclaim Clinical Research
Verified postcode
San Diego, United States
Peak Gastroenterology Associates
Verified postcode
Colorado Springs, United States
Peak Gastroenterology Associates
Verified postcode
Colorado Springs, United States

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large intestine (bowel) becomes inflamed, leading to symptoms like tummy pain and diarrhoea.

What is emvistegrast?

Emvistegrast is a new medicine being tested in this study to see if it can help improve symptoms for people with moderately to severely active ulcerative colitis.

What is a 'placebo' in a study?

A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare results fairly.

What does 'moderately to severely active' mean for my ulcerative colitis?

It means your ulcerative colitis symptoms are quite noticeable and are having a significant impact on your daily life, as assessed by a doctor.

Can I still take my regular medicines if I join the study?

The study has specific rules about which other medications are allowed or not allowed. The study team will review all your current medicines with you.