Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1b, 2-part, placebo-controlled study to evaluate the efficacy, safety, and PK of PF-07054894 in participants with mild to severe UC.

This research study is looking at a new medicine, PF-07054894, for individuals living with ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of the large intestine. The study aims to find out if this new medicine is safe to use and if it can help improve symptoms. Researchers will also learn how the medicine behaves in the body. Some participants will receive the new medicine, while others will be given a placebo, which is a pill that looks the same but contains no active medicine. This helps researchers understand the true effect of the new treatment. The study is open to adults aged 18 and over, with different levels of ulcerative colitis severity.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

14 Mar 2023

ULCERATIVE COLITIS

What is this study about?

This study is about testing a new medicine called PF-07054894, which we hope could help people with ulcerative colitis (UC). UC is a condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops small sores, which can cause symptoms like tummy pain and frequent urges to go to the toilet. We want to find out if this new medicine is safe for people to take and if it can make a difference to their symptoms.

Part of the study involves comparing the new medicine to a 'dummy pill', also known as a placebo. A dummy pill looks just like the real medicine but doesn't have any active ingredients. This is a common way to test new medicines, as it helps researchers understand if any improvements people feel are truly due to the new medicine or if they might be due to other reasons. This type of study also helps us understand how the medicine works in the body.

This is an early-stage study, meaning it’s one of the first times this new medicine is being tested in humans. Studies like this are really important steps in developing new treatments that could one day help many people manage their ulcerative colitis more effectively.

Key takeaways

This study is testing a new medicine (PF-07054894) for ulcerative colitis.
It aims to check the medicine's safety, how it works, and what it does in the body.
Some participants will receive the new medicine, others a dummy pill (placebo).
It's an early-stage study for adults aged 18 and over with mild to severe UC.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be at least 18 years old, and there is no upper age limit. The study is open to both men and women.

You would need to have received a diagnosis of ulcerative colitis (UC) that ranges from mild to severe. This means the study is looking for people with different levels of how active their UC is.

Generally, you would need to be in good health otherwise, and meet certain other medical criteria that the study doctors will check. They will make sure the study is a safe and suitable option 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 18 years old or older?
Have you been diagnosed with ulcerative colitis?
Is your ulcerative colitis considered mild, moderate, or severe?
Are you able to attend regular clinic visits?
Are you generally in good health apart from your ulcerative colitis?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved for a specific period, which the study team will explain in detail. During this time, you would have several visits to the clinic. These visits will involve various checks, such as physical exams, blood tests, and possibly other tests related to your ulcerative colitis, to monitor your health and see how the medicine is working. You will receive either the new study medicine or a dummy pill directly from the study team. You'll be asked to take this medicine as instructed. After you finish taking the study medicine, there will be follow-up visits to ensure your well-being. The study team will provide you with a full schedule and explain everything clearly before you commit to joining.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as gaining access to a new medicine that isn't yet widely available, and helping advance medical knowledge that could benefit others with ulcerative colitis in the future. However, there are also potential risks; you might experience side effects from the medicine, or it might not help your symptoms. You will be closely monitored for any reactions, and the study team will fully explain all known risks. Remember, your participation is 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 (2)

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

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Unverified
Germany
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Unverified
Poland

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of your large intestine, leading to tummy pain, diarrhoea, and other symptoms.

What is a 'dummy pill' or placebo?

A dummy pill looks like the real medicine but contains no active ingredients. It helps researchers understand the true effect of the new treatment.

Will I definitely get the new medicine?

Because this study uses a dummy pill, you might receive the new medicine or the placebo. You won't know which one you're getting.

How long will the study last?

The full duration of your participation, including visits and follow-ups, will be clearly explained by the study team before you agree to join.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your current or future medical care.