Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

This research is a 'Phase 3' study, which means it's one of the final steps before a new medicine, Ozanimod, could be approved for general use. It's for adults in the UK who have moderate to severe ulcerative colitis. The main goal is to see how effective Ozanimod is at improving symptoms, helping the gut lining heal, and allowing people to stop using steroids. We also want to understand any side effects the medicine might have. This study builds on earlier research and aims to confirm that Ozanimod is both effective and safe for people living with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Celgene International II SARL

Enrolment target

223

Start

22 Aug 2024

Ulcerative colitis

What is this study about?

Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the lining of your large intestine. This can lead to symptoms like tummy pain, diarrhoea, and needing to go to the toilet urgently. It can significantly affect your daily life. This study is looking at a new medicine called Ozanimod as a potential treatment for people in the UK who have moderate to severe forms of this condition.

This is a 'Phase 3' trial, which means the medicine has already gone through earlier stages of testing and shown promise. In this phase, researchers want to confirm how well Ozanimod works. They'll be looking at whether it can help people achieve 'remission' (where symptoms greatly reduce or disappear) and if it helps the lining of the gut to heal. They also want to see if people can reduce or stop taking steroid medications, which often have side effects when used long-term.

Along with checking how effective the medicine is, a very important part of the study is to carefully monitor for any side effects. Researchers will be tracking these to make sure the medicine is not only helpful but also safe for people to use. The findings from this study will help decide if Ozanimod could become a new treatment option for ulcerative colitis.

Key takeaways

Tests a new medicine, Ozanimod, for moderate to severe ulcerative colitis.
Aims to confirm how well the medicine works and identify any side effects.
Open to adults aged 18 and over.
Involves regular clinic visits and health monitoring.
Could offer a new treatment option for ulcerative colitis.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. It's open to both men and women.

The study is specifically designed for people who have been diagnosed with moderate to severe ulcerative colitis. This means your condition is causing significant symptoms and might not be well controlled by your current treatments.

Because this is an extension study, it's likely you would have participated in a previous study involving Ozanimod to be eligible for this particular trial. Full details would be discussed with you by the study team.

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 you previously participated in a study involving Ozanimod?
Are you able to attend regular clinic appointments for the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the study medicine, Ozanimod. You'll have regular visits to the clinic where the study doctors and nurses will monitor your health very closely. These visits will involve various checks, including blood tests, physical examinations, and sometimes other tests like ECGs (to check your heart) or lung function tests.

The team will look at how your symptoms are changing and might also perform procedures like endoscopies to look directly at the lining of your bowel. You'll be asked to report any changes in your health or any side effects you experience. The exact number of visits, tests, and the total length of your participation would be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could potentially offer you a new treatment for your ulcerative colitis that might improve your symptoms and gut health. However, as with any medicine, there's always a possibility of experiencing side effects. These could range from mild to more serious, and the study team will monitor you closely for them. You are always in control and have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

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Unverified
Belgium
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Unverified
Romania
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Unverified
Poland
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Unverified
Czechia
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Unverified
Hungary
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Unverified
Italy
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Unverified
Bulgaria

Common questions

What is Ozanimod?

Ozanimod is the name of the investigational medicine being tested in this study for ulcerative colitis.

What does 'Phase 3' mean?

Phase 3 is a late stage of clinical research. It's when a new medicine is tested on a larger group of people to confirm its effectiveness and safety before it can be approved for wider use.

What is 'remission' in ulcerative colitis?

Remission means that your ulcerative colitis symptoms have significantly reduced or disappeared, and signs of inflammation in your bowel are also much lower or gone.

Will I have to pay to be part of the study?

No, you will not have to pay for the study medicine or study-related assessments.

Can I continue my other medicines if I join?

This will depend on your current medications and will be carefully reviewed by the study doctors to ensure your safety and the accuracy of the study results.