Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Long-Term Safety of Etrasimod Arginine for Patients with Moderately to Severely Active Ulcerative Colitis

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Etrasimod Arginine in individuals with Ulcerative Colitis, a condition that causes inflammation and sores in the digestive tract. The medication is provided in tablet form and is taken orally. The main goal of the study is to assess the safety of using Etrasimod Arginine over a long period in people who have moderate to severe symptoms of Ulcerative Colitis.

Participants in the study will receive Etrasimod Arginine and will be monitored for any side effects or changes in their health. The study will track the occurrence of any new health issues that arise during the treatment, as well as any changes in laboratory test results and vital signs. The study will also look at how many participants experience an improvement in their symptoms over time.

The study will continue for several years, allowing researchers to gather comprehensive data on the long-term use of Etrasimod Arginine. Participants will have regular check-ups to monitor their condition and the effects of the medication. This research aims to provide valuable information on the safety and effectiveness of Etrasimod Arginine for treating Ulcerative Colitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will begin participation in an open-label extension study designed to assess the safety of long-term administration of etrasimod for those with moderately to severely active ulcerative colitis.

    The study involves taking etrasimod arginine in the form of a tablet, administered orally.

  2. Step 2

    Medication administration

    The patient will take the etrasimod arginine tablet as prescribed by the study protocol. The specific dosage and frequency will be determined by the study guidelines and the healthcare provider overseeing the trial.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will undergo regular monitoring to assess the incidence of any treatment-emergent adverse events and serious adverse events.

    Laboratory tests will be conducted to monitor any changes in blood and urine samples, as well as vital signs, to ensure the patient's safety.

  4. Step 4

    Evaluation of treatment effectiveness

    The effectiveness of the treatment will be evaluated by measuring the proportion of patients achieving clinical remission and response at various intervals, specifically at Weeks 52 and 104.

    Changes from baseline in the Total Mayo Score and Partial Mayo Score will be assessed at specified weeks to determine the impact of the treatment on ulcerative colitis symptoms.

  5. Step 5

    Endoscopic improvement

    Endoscopic evaluations will be conducted to assess improvements in the condition of the colon lining at Weeks 52 and 104.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by June 19, 2029. The patient will continue to be monitored and assessed until the end of the study period.

Who can join the trial?

4 criteria

  • You must have been part of certain previous studies related to **ulcerative colitis** and meet specific conditions. For example, you should have completed certain visits in those studies or have a specific score from a test called an **endoscopy**.
  • If you are a woman who can have children, you need to have a negative pregnancy test and not be breastfeeding at the start of the study.
  • Women who can have children must agree to use a very effective birth control method during the study and for 30 days after. This can include certain hormonal methods, an **intrauterine device (IUD)**, or other reliable methods. Men must agree to use condoms if their partner can have children.
  • You must be able to give written consent to participate in the study. If you are under 18, a parent or guardian must give consent, and you must agree to follow the study's schedule. Participation of those under 18 is allowed only if it is acceptable by local laws.

Who cannot join the trial?

15 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe allergic reactions to medications.
  • Patients with certain infections that are not well controlled.
  • Patients who have used certain medications that might affect the study results.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years, except for some types of skin cancer.
  • Patients with certain heart conditions that are not well controlled.
  • Patients with liver or kidney problems that are not well controlled.
  • Patients who have had a blood transfusion in the past three months.
  • Patients with a history of certain autoimmune diseases, which are conditions where the body's immune system attacks its own tissues.
  • Patients who have been vaccinated with certain live vaccines in the past four weeks.
  • Patients who have a history of tuberculosis, a serious lung infection.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Etrasimod is a medication being studied for its safety in long-term use for people with moderately to severely active ulcerative colitis. Ulcerative colitis is a condition that causes inflammation and sores in the digestive tract. Etrasimod works by modulating the immune system to reduce inflammation, which may help manage the symptoms of ulcerative colitis. This study is an open-label extension, meaning all participants receive etrasimod, and the focus is on monitoring its safety over an extended period.

What is already known about the treatment

Etrasimod – Etrasimod is administered orally in the form of a tablet. It is currently being studied in clinical trials for its safety and effectiveness in treating moderately to severely active ulcerative colitis. The main therapeutic indication for etrasimod is ulcerative colitis, a chronic inflammatory condition of the colon. At the molecular level, etrasimod works by modulating the sphingosine-1-phosphate (S1P) receptor, which plays a role in immune cell movement and inflammation. It is classified pharmacologically as an S1P receptor modulator.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in genetically susceptible individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515156-21-00Protocol codeC5041012(APD334-303)Estimated enrolment885 patientsSponsorArena Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.