Active not recruitingPHASE3INTERVENTIONAL

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

This study is an ongoing extension for individuals in the UK living with moderately to severely active ulcerative colitis. Participants have previously taken part in main etrasimod trials where they received either the study medicine or a dummy treatment. The main goal of this extension is to continue monitoring the safety and how well etrasimod works over a longer period. It's a chance for participants to keep receiving the treatment they may have found helpful and for doctors to learn more about its long-term effects. This type of study is really important for understanding how new medicines can help people in the real world.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

896

Start

05 Sep 2019

Estimated completion

19 Jun 2029

Ulcerative Colitis

What is this study about?

You might have heard of or even taken part in a clinical trial looking into a medicine called etrasimod for ulcerative colitis. This particular study is an 'extension study', which means it's for people who have already been in one of the main etrasimod trials. These previous trials were designed to see if etrasimod is better than a dummy treatment for active ulcerative colitis.

Now that those initial trials are complete or nearing completion, researchers want to continue gathering information. This extension study is called 'open-label', which means everyone involved – both you and the study team – will know that you are receiving etrasimod. The main aim is to understand the long-term safety of etrasimod and how well it helps manage moderately to severely active ulcerative colitis over a longer period than the initial trials.

Having longer-term information about new medicines is really important. It helps doctors understand how safe they are when used for longer, what side effects might appear over time, and if the benefits continue for people living with conditions like ulcerative colitis. This helps ensure that new treatments are thoroughly understood before they become widely available.

Key takeaways

This study is an extension for previous participants of etrasimod trials.
It aims to gather long-term safety and effectiveness data for etrasimod in ulcerative colitis.
All participants will receive etrasimod.
Participation involves regular clinic visits for monitoring.
Your health and safety are the top priorities.
You can withdraw from the study at any time.

Who may be eligible?

This study is specifically for people who have already taken part in certain previous etrasimod studies (known as APD334-301, APD334-302, or APD334-210) for ulcerative colitis.

To be eligible, you must have completed a certain point in your previous study. For example, if you were in study APD334-301 or APD334-210, you needed to have completed at least week 12 and your ulcerative colitis was still active or had worsened, or you completed the full 52 weeks of the study. If you were in study APD334-302, you needed to have completed at least week 12.

You would not be able to join this extension study if your doctor felt it wasn't suitable for you for any reason, or if you had to stop your previous study due to a serious side effect.

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.

Have you previously taken part in an etrasimod study (APD334-301, APD334-302, or APD334-210)?
Did you complete at least the Week 12 visit in your previous study?
If you were in APD334-301 or APD334-210, was your ulcerative colitis still active or worsening at Week 12, or did you complete the full 52 weeks?
Are you between 16 and 80 years old?
Has your doctor confirmed you are suitable to continue in an extension study?

Answer every question to see your result.

What does participation involve?

As this is an extension study, you will continue to receive etrasimod. You will have regular visits to your study clinic, which will involve check-ups with the doctor, blood tests, and discussions about how you're feeling and any changes in your ulcerative colitis or any side effects. It’s important that you keep taking your study medicine as instructed. The specific number and timing of visits will be explained by the study team, but they are designed to continuously monitor your health, how the medicine is working, and to ensure your safety throughout the study’s duration. The total duration of your participation in this extension study will be discussed with you.

Potential risks and benefits

Potential benefits of taking part in this study include continuing to receive etrasimod, which may help manage your ulcerative colitis, and contributing to important long-term knowledge about this medication. As with all medications, etrasimod carries potential risks and side effects, and these will be thoroughly explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (211)

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

Center for Digestive Health (Colonoscopy Location)
Verified postcode
Dothan, United States
Flowers Hospital (PFT Location)
Verified postcode
Dothan, United States
Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address)
Verified postcode
Dothan, United States
Inland Pulmonary Specialists [PFT Only]
Verified postcode
Lake Elsinore, United States
Advanced Endoscopy and Pain Center(Colonoscopy)
Verified postcode
Lancaster, United States
Antelope Valley Eye Care(Ophthalmologist)
Verified postcode
Lancaster, United States
Renaissance Imaging Center(Chest X-Ray only)
Verified postcode
Lancaster, United States
Advanced Imaging (Chest X-Ray)
Verified postcode
Palmdale, United States
California Eye Professionals [OCT Only]
Verified postcode
Temecula, United States
West Coast Endoscopy Center (Endoscopy Procedures)
Verified postcode
Clearwater, United States
Northwood Vision- Optical Coherence Tomography (OCT)
Verified postcode
Clearwater, United States
Northwood Vision-Optical Coherence Tomography-(OCT)
Verified postcode
Clearwater, United States

Common questions

What is an 'extension study'?

An extension study is a follow-up for people who have already been in an earlier trial for the same medicine. It allows researchers to gather more long-term information.

Will I receive etrasimod in this study?

Yes, in this open-label extension study, everyone involved, including you and the doctors, will know that you are receiving etrasimod.

Why is long-term information important for a medicine?

Long-term information helps doctors understand how safe a medicine is over a longer period, what side effects might emerge, and if the benefits continue to help people manage their condition effectively.

Is there a cost to me for taking part?

No, participating in a clinical trial like this should not cost you anything.

Can I leave the study at any time?

Yes, you are always free to withdraw from the study at any point, and this will not affect your relationship with your medical team or your usual care.