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Study of Orismilast for Treating Moderate to Severe Ulcerative Colitis in Adults

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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 the effects of a medication called Orismilast for treating ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The study aims to explore how effective Orismilast is when taken orally in the form of modified-release tablets. Participants will take the medication twice daily for up to 12 weeks. The trial will compare the effects of Orismilast with a placebo to determine its impact on the symptoms of ulcerative colitis.

Throughout the study, participants will be monitored to see if they achieve clinical remission, which means a significant reduction in symptoms. The study will also track changes in certain markers of inflammation, such as high-sensitivity C-reactive protein and fecal calprotectin, at various points during the trial. Additionally, the study will assess improvements in endoscopic scores, which are used to evaluate the severity of inflammation in the colon, and changes in symptoms like stool frequency and rectal bleeding.

Participants' overall well-being will be evaluated using questionnaires that measure quality of life and levels of anxiety and depression. The study will also monitor any side effects or adverse events that may occur during the trial. The goal is to gather evidence on the effectiveness and safety of Orismilast for people with moderate to severe 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.

Step 1
Beginning of the trial
Upon joining the clinical trial, you will receive a detailed explanation of the study, including its purpose and what to expect. You will be asked to sign a consent form, confirming your understanding and agreement to participate.
You will be required to provide information about your medical history, specifically related to your diagnosis of ulcerative colitis. This includes confirming that you have had the condition for at least three months.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status. This includes a Mayo endoscopic subscore test, which helps determine the severity of your condition.
Your current treatment regimen will be reviewed to ensure it has been stable for at least three months. This includes medications such as 5-ASA, mercaptopurine, methotrexate, or azathioprine.
Step 3
Medication administration
You will begin taking the study medication, orismilast, in the form of a modified-release tablet. This medication is taken orally, twice daily, for a duration of up to 12 weeks.
The purpose of this medication is to explore its effectiveness in treating moderate to severe ulcerative colitis.
Step 4
Regular monitoring
Throughout the trial, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will occur at weeks 2, 4, 6, and 12.
During these visits, various tests will be conducted, including measuring levels of high-sensitivity C-reactive protein and fecal calprotectin, which are indicators of inflammation.
Step 5
End of trial assessment
At the end of the 12-week period, a final assessment will be conducted to evaluate the overall effectiveness of the treatment. This includes a review of your Total Mayo score to determine if clinical remission has been achieved.
Additional assessments will include changes in stool frequency, rectal bleeding, and overall quality of life as measured by specific questionnaires.
Step 6
Post-trial follow-up
After completing the trial, you will be monitored for any ongoing effects of the medication. This includes a follow-up period of 16 weeks to ensure your safety and well-being.
You will be advised on any necessary steps to take regarding your ongoing treatment for ulcerative colitis.

Who can join the trial?

7 criteria

Must be a male or female adult, 18 years of age or older.
Women who can have children must be ready and able to use highly effective birth control methods that have a very low chance of failure (less than 1% per year) during the trial and for 16 weeks after the last dose.
Must have a diagnosis of ulcerative colitis for at least 3 months.
Must have a Mayo endoscopic subscore of 2 or 3 at screening. This is a score used to assess the severity of ulcerative colitis during an endoscopy.
Must be currently treated with 5-ASA (such as mesalazine or sulfazalazine), mercaptopurine (6-MP), methotrexate (MTX), or azathioprine.
Must have been on a stable medication regimen for at least the last 3 months, but now need a higher dose or additional therapy.
Must provide signed and dated written informed consent before starting any screening procedures. This means you agree to participate in the study after being informed about it.

Who cannot join the trial?

10 criteria

Patients who have other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or take the study medication as directed.
Patients who have an allergy or sensitivity to the study medication or its ingredients.
Patients who have been diagnosed with a different type of inflammatory bowel disease, such as Crohn's disease.
Patients who have an active infection that requires treatment with antibiotics.
Patients who have received certain medications that could affect the study results.

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Verified sites

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Herlev Hospital
Herlev, Denmark
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Hvidovre Hospital
Hvidovre, Denmark

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Investigated drugs

Orismilast is a medication being studied for its potential to help people with moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the colon. This medication is taken by mouth twice a day. The goal of the study is to see if orismilast can effectively reduce the symptoms of ulcerative colitis over a period of up to 12 weeks. By participating in this trial, researchers hope to gather evidence on how well orismilast works in improving the health of patients with this condition.

Orismilast

What is already known about the treatment

Orismilast – Orismilast is an oral medication currently being studied for its effectiveness in treating moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the colon. It is taken by mouth twice daily for up to 12 weeks. The drug is still under investigation, and researchers are exploring its potential benefits in medical literature. Orismilast works by targeting specific molecules in the body to reduce inflammation, which is a key factor in ulcerative colitis. It belongs to a class of drugs known as anti-inflammatory agents.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon, also known as the large intestine. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. The inflammation causes the colon to empty frequently, resulting in diarrhea. Over time, the inflammation can lead to the formation of ulcers, which are small open sores that can bleed and produce pus. The progression of ulcerative colitis can vary, with periods of active symptoms followed by times of remission.