Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b Multicenter, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis

We are conducting a research study in the UK to investigate a new medication called JNJ-77242113 for adults suffering from moderately to severely active ulcerative colitis. Ulcerative colitis is a long-term condition affecting the bowel. This study aims to find out how well JNJ-77242113 works to improve symptoms, like urgent trips to the toilet or blood in your poo. We also want to understand its safety. Some participants will receive the new medicine at different doses, while others will get a placebo (a pill with no medicine). We will compare results after 12 weeks to see if the new medicine is beneficial.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Janssen - Cilag International

Enrolment target

102

Start

27 Nov 2023

Ulcerative Colitis

What is this study about?

Ulcerative colitis is a condition that causes inflammation and sores (ulcers) in the lining of your large intestine. This can lead to symptoms like stomach pain, urgent need to go to the toilet, and blood in your poo. We know that these symptoms can really impact your daily life, and finding effective treatments is very important.

This study, called a Phase 2b trial, is an important step in developing new medicines. It means we're past the very early stages of testing and are now looking more closely at how well a new medicine, JNJ-77242113, works and how safe it is for people with ulcerative colitis. We will be comparing different amounts (doses) of this new medicine to a 'placebo', which looks like the real medicine but contains no active drug. This helps us understand if any improvements are genuinely due to the study medicine.

The main goal is to see if JNJ-77242113 can help reduce your ulcerative colitis symptoms and improve your condition after 12 weeks. We want to find the right dose that works best while keeping side effects to a minimum. Information from this study will help decide if this medicine should be tested in even larger studies in the future.

Key takeaways

This study is testing a new medicine (JNJ-77242113) for moderate to severe ulcerative colitis.
It aims to find out if the medicine is effective and safe.
Some participants will receive the new medicine, others a dummy pill (placebo).
Participation involves regular clinic visits and health checks.
The main results will be observed after 12 weeks of treatment.
You can stop participating at any time if you wish.

Who may be eligible?

This study is open to adults aged 18 and over, regardless of whether you are male or female. You must have been diagnosed with ulcerative colitis that is currently moderate to severe and has not responded well to, or you haven't been able to tolerate, other standard treatments.

There are certain health conditions or medications that might mean you can't join the study, as they could affect how safe or effective the new medicine is for you, or might interfere with test results. These details will be discussed fully with you by the study team if you are interested in taking part.

It's important that you are willing and able to follow all the study procedures, including regular hospital visits and taking the study medicine as instructed.

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?
Do you have a diagnosis of moderate to severe ulcerative colitis?
Have other standard treatments for your ulcerative colitis not worked well for you, or were you unable to take them?
Are you able and willing to attend regular clinic visits?
Are you willing to take the study medicine as instructed?
Are you happy to undergo various health checks and tests, including blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for a certain period of time, which will involve regular visits to the clinic. During these visits, the study team will carry out health checks, take blood samples, and ask you about your symptoms. You will be given either the new medicine, JNJ-77242113 (at one of several possible doses), or a placebo (a dummy pill with no active drug) to take. You will be told how to take this treatment.

Throughout the study, you will have check-ups to see how you are doing, how your symptoms are changing, and to monitor for any side effects. The main period we are looking at is the first 12 weeks, where we will check how your symptoms respond. After this, there might be further follow-up periods. The study team will explain the full schedule of visits and procedures to you before you agree to participate.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits. You will receive regular medical check-ups and close monitoring of your ulcerative colitis, which could include access to a new medicine that isn't yet widely available. However, there's no guarantee that the new medicine will improve your condition, as some participants will receive a placebo. There are also potential risks involved. Like all medicines, JNJ-77242113 may cause side effects, some of which we might not fully know yet. The study team will provide you with detailed information about known side effects. There are also risks associated with study procedures, such as blood tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

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

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Unverified
Czechia
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Unverified
Spain
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Unverified
Poland
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Unverified
France
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Unverified
Belgium
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Unverified
Hungary
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Unverified
Italy
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Unverified
Germany
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Unverified
Romania

Common questions

What is ulcerative colitis?

It's a long-term condition that causes inflammation and sores in the lining of your large intestine, leading to symptoms like stomach pain, urgency, and bloody stools.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps us compare the new medicine's effects accurately.

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

No, during the main part of the study, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps prevent bias in the results.

How long will the study last for me?

The main part of the study will focus on results after 12 weeks, but your full participation, including follow-up, will be explained by the study team.

Can I stop participating in the study if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.