Recruiting

Study on Etrasimod for Adolescents with Moderate to Severe Ulcerative Colitis

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The study is specifically looking at adolescents aged 12 to 17 who have moderately to severely active ulcerative colitis. The treatment being tested is a medication called Etrasimod, which is taken as a capsule. Etrasimod is being evaluated for its ability to help achieve clinical remission, which means reducing or eliminating the symptoms of ulcerative colitis.

The purpose of the study is to assess how effective Etrasimod is in helping adolescents with ulcerative colitis achieve clinical remission after 52 weeks of treatment. Participants in the study will take Etrasimod daily, and their progress will be monitored over the course of the study. The study will also look at how the body processes the medication and its safety in this age group. Some participants may receive a placebo, which is a capsule that looks like the medication but does not contain the active ingredient.

Throughout the study, researchers will check for improvements in symptoms and any side effects. They will also conduct tests to see how the medication is working in the body. The study aims to provide valuable information on the potential benefits and safety of Etrasimod for treating ulcerative colitis in adolescents. The study is expected to continue until 2028, allowing researchers to gather comprehensive data on the long-term effects of the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the study, the patient will begin treatment with etrasimod. This medication is provided in the form of a capsule and is taken orally.
The patient will be required to take the prescribed dosage of etrasimod as directed by the study team. The specific dosage and frequency will be communicated by the healthcare provider overseeing the trial.
Step 2
Treatment duration
The treatment with etrasimod will continue for a total of 52 weeks. During this period, the patient will be monitored regularly to assess the effectiveness and safety of the medication.
Regular check-ups and assessments will be scheduled to track the patient's progress and any changes in their condition.
Step 3
Midpoint assessment
At week 12, an assessment will be conducted to evaluate the patient's response to the treatment. This will include checking for clinical remission and any improvements in symptoms.
The study team will also monitor for any side effects or adverse reactions to the medication.
Step 4
End of treatment assessment
At the end of the 52-week treatment period, a final assessment will be conducted. This will determine the overall effectiveness of etrasimod in achieving clinical remission and improving the patient's condition.
The study team will also evaluate any long-term effects or changes in the patient's health status.

Who can join the trial?

4 criteria

The patient must have moderately to severely active ulcerative colitis. This means the condition is more than mild but not the most severe.
The patient must be between 12 and 17 years old.
The patient can be male or female.
The patient is allowed to be taking certain medications for ulcerative colitis at a therapeutic dose. This means the medication is being used at a dose that is intended to treat the condition.

Who cannot join the trial?

7 criteria

Patients who do not have moderately to severely active ulcerative colitis cannot participate. This means the condition must be at a certain level of activity.
Patients who are not between the ages of 12 and 18 years old are excluded. The study is only for adolescents in this age range.
Patients who are not able to follow the study procedures or take the study medication as required will not be able to participate.
Patients who have other health conditions that might interfere with the study or make participation unsafe will be excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have a history of certain medical conditions or treatments that could affect the study results will be excluded.

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Verified sites

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

Verified
Hospital Vall d’Hebron
Barcelona, Spain
Verified
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

Etrasimod is a medication being studied for its potential to help people with ulcerative colitis, a condition that causes inflammation and sores in the colon. This medication works by targeting specific parts of the immune system to reduce inflammation. In this clinical trial, researchers are looking at how well etrasimod can help adolescents with moderate to severe ulcerative colitis achieve clinical remission, which means that the symptoms of the disease are reduced or disappear. The study aims to understand the effectiveness, how the body processes the medication, and its safety over a period of 52 weeks.

Etrasimod Arginine

What is already known about the treatment

Etrasimod – Etrasimod is administered orally in the form of a tablet and is currently being studied in clinical trials for its effectiveness in treating adolescents with moderately to severely active ulcerative colitis. This medication is not yet widely available in medical practice, as it is still under investigation. Etrasimod works by modulating the immune system to reduce inflammation in the colon, which is the main therapeutic goal for patients with ulcerative colitis. It belongs to a class of drugs known as sphingosine-1-phosphate (S1P) receptor modulators, which help control immune cell movement and activity.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to the formation of ulcers. The disease typically begins in the rectum and may extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can cause frequent and urgent bowel movements, often with blood or pus. Over time, the disease can lead to complications such as severe bleeding or perforation of the colon.