Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

C5041006 (APD334 202 or APD334-202EU): A Multicenter, Randomized, Double Blind, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

This research study is looking into a new oral medication, etrasimod, for people living with moderate to severe Crohn's disease. The main goal is to find out if this medicine can help improve symptoms and heal inflammation in the gut over a long period. Researchers will also be checking for any side effects to make sure it's safe. Participants will be given either etrasimod or a dummy pill (placebo) with no active medicine. The study will look at how well the medicine works during an initial treatment phase and then over a longer period of up to 52 weeks. It's a 'double-blind' study, meaning neither you nor your doctor will know if you're getting the active medicine or the placebo, which helps us get unbiased results.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Arena Pharmaceuticals Inc.

Enrolment target

367

Start

03 Sep 2024

Crohn's Disease

What is this study about?

This clinical trial is designed to investigate a new medication called etrasimod for adults who have moderate to severe Crohn's disease. Crohn's disease is a type of inflammatory bowel disease where parts of your digestive system become inflamed, leading to symptoms like tummy pain, diarrhoea, and weight loss. Current treatments can help, but researchers are always looking for new options that might work better or have fewer side effects.

The study aims to see how effective etrasimod is at helping people feel better and improving the health of their gut lining (which doctors call endoscopic response). They're also checking how safe the medicine is over time. The study is split into two main parts: an initial treatment phase, and then a longer-term 'maintenance' phase, where participants continue to take the study medicine for up to a year. This helps researchers understand both the short-term and long-term effects of etrasimod.

Participants will be randomly assigned to receive either etrasimod or a placebo. A placebo looks like the real medicine but contains no active drug. This is important for comparing the effects of the active medicine against no active treatment, to make sure any improvements are truly due to etrasimod and not just other factors. This study combines two phases (Phase II and Phase III), which means it's exploring both the best dose and potential benefits, and then confirming its effectiveness and safety on a larger scale.

Key takeaways

Tests a new oral medicine (etrasimod) for Crohn's disease.
Aims to improve symptoms and gut healing.
Compares etrasimod to a dummy pill (placebo).
Study lasts up to about one year.
Recruiting adults aged 18 and over.
Participation involves regular clinic visits and health checks.

Who may be eligible?

This study is looking for adults aged 18 years and older who have been diagnosed with moderate to severe Crohn's disease. Both men and women are welcome to take part.

To be considered, you will need to meet certain health requirements related to your Crohn's disease and overall health. For example, your Crohn's disease must be active enough to be considered 'moderate to severe' by the study doctors, and you shouldn't have certain other medical conditions or be taking specific medications that might interfere with the study drug or your safety.

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 Crohn's disease?
Are you able to attend regular clinic appointments?
Are you willing to potentially take either the study medicine or a placebo?
Are you generally in good health apart from your Crohn's disease (as determined by study doctors)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given either the new medicine (etrasimod) or a dummy pill (placebo) to take by mouth. The study involves regular visits to the clinic, where doctors and nurses will check your health, ask about your symptoms, and carry out tests like blood samples and possibly endoscopy (a procedure to look inside your gut) to see how you are responding to the treatment. You will also complete questionnaires about how you are feeling.

The study has different parts, starting with an 'induction' phase and then moving into a 'maintenance' phase. This means you could be in the study for a significant period, potentially up to 52 weeks (about a year). You'll have scheduled follow-up visits throughout this time. The total duration of your participation will depend on the specific part of the study you are in.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new medication that could improve your Crohn's disease symptoms, potentially helping where other treatments haven't. You will also receive close medical attention and monitoring throughout the study. However, there's always a chance you might experience side effects from the study medication, or the medication might not help your condition. If you are given the placebo, you won't receive the active medicine during that time. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

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

—
Unverified
Austria
—
Unverified
Denmark
—
Unverified
Poland
—
Unverified
Netherlands
—
Unverified
France
—
Unverified
Bulgaria
—
Unverified
Spain
—
Unverified
Italy
—
Unverified
Czechia
—
Unverified
Germany
—
Unverified
Croatia
—
Unverified
Slovakia

Common questions

What is etrasimod?

Etrasimod is a new oral medication being tested to see if it can help people with moderate to severe Crohn's disease.

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 researchers compare the real medicine's effects.

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

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you're receiving etrasimod or the placebo until the study ends. This helps ensure fair and unbiased results.

How long will I be in the study?

Your participation could last for an initial period and then potentially up to 52 weeks (around a year), depending on the specific part of the study you join.

What does 'Crohn's disease remission' mean?

In this study, 'remission' generally means that your Crohn's disease symptoms are significantly improved or have gone away, and that there are signs of healing in your gut.