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Study on VE202 for Patients with Mild-to-Moderate Ulcerative Colitis

Fast replyRegistered drugNo 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 the effects of a new treatment for mild-to-moderate ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The treatment being tested is called VE202, which is a capsule containing live bacteria that are thought to help balance the gut's natural environment. The study will also use a placebo, which looks like the treatment but does not contain the active ingredients, to compare the effects of VE202.

The purpose of the study is to evaluate how effective and safe VE202 is for patients with mild-to-moderate ulcerative colitis. Participants in the study will be randomly assigned to receive either VE202 or the placebo for a period of eight weeks. During this time, they will take the capsules orally, meaning by mouth. The study will monitor participants' health and any changes in their condition, focusing on how the treatment affects the inflammation in their colon.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. This includes looking at the inside of the colon using a procedure called endoscopy, which involves a flexible tube with a camera. The study aims to see if VE202 can reduce the symptoms of ulcerative colitis and improve the overall health of the colon. The safety of the treatment will also be closely monitored to ensure that it does not cause any serious side effects.

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
Initial visit
Upon joining the study, you will attend an initial visit where you will provide written informed consent. This consent confirms your understanding of the study's potential risks and benefits.
During this visit, your eligibility will be confirmed based on criteria such as age, medical history, and current health status. You will also undergo a flexible sigmoidoscopy, a procedure to examine the lower part of your colon, to assess the severity of your ulcerative colitis.
Step 2
Randomization
After confirming eligibility, you will be randomly assigned to receive either the study medication VE202 or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.
Step 3
Treatment phase
You will begin an 8-week treatment phase. If you are assigned to the VE202 group, you will take the medication in capsule form by mouth. The exact dosage and frequency will be provided by the study team.
If you are in the placebo group, you will take placebo capsules that look like the VE202 capsules but do not contain the active medication.
Step 4
Follow-up visits
Throughout the treatment phase, you will attend regular follow-up visits. These visits are important for monitoring your health and the effects of the treatment.
You will be asked to provide blood and stool samples during these visits to help assess your response to the treatment.
Step 5
End of treatment assessment
At the end of the 8-week treatment period, you will undergo another flexible sigmoidoscopy to evaluate the response of your ulcerative colitis to the treatment.
The study team will assess the endoscopic response, which involves checking for improvements in the condition of your colon.
Step 6
Safety monitoring
Throughout the study, your safety will be closely monitored. Any side effects or adverse events will be recorded and addressed by the study team.
You will be informed about any serious adverse events related to the study medication or placebo.

Who can join the trial?

17 criteria

Able and willing to provide written informed consent before starting any study procedures or taking the study drug. This means you understand the potential risks and benefits of participating in the study. If needed, a legally authorized representative can provide consent for you.
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If you are a male (based on birth sex):
- If not vasectomized, agree to wear a condom during sexual intercourse with any partner who can become pregnant, from the time you join the study until 3 months after your last dose of the study drug.
- Agree not to donate sperm for reproduction purposes from the time you join the study until 3 months after your last dose of the study drug.
- Able and willing to follow study procedures, such as attending study visits and providing blood and stool samples.
- Between 18 to 75 years of age.
- Have a documented diagnosis of ulcerative colitis (UC) for at least 3 months before joining the study. UC is a condition that causes inflammation and sores in the colon.
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  Have active mild to moderate UC, which means:
  - The disease affects at least 15 cm from the anal verge (the opening of the anus).
  - A modified Mayo score of 4 to 8, which includes:
    
    A Mayo endoscopic subscore of 2 or more, based on a screening procedure called flexible sigmoidoscopy.
    A rectal bleeding score of 1 or more.
    Up to date with local recommendations for colorectal cancer screening, such as having a colonoscopy within the last 12 months if needed. This can be done during the screening phase of the study.
    Have never received certain types of medications for UC, such as biologic agents, Janus kinase inhibitors, or sphingosine-1-phosphate modulators.
    If taking corticosteroids (a type of medication), the dose must be stable for at least 4 weeks and no higher than 10 mg of prednisone (or equivalent) per day, or 9 mg of budesonide per day.
    Doses of other allowed UC medications must be stable for at least 8 weeks before joining the study.
    If you are a female (based on birth sex):
    
    Not of childbearing potential, which means you are post-menopausal for at least 1 year or have had surgery to remove the uterus, both ovaries, or both fallopian tubes.
    If of childbearing potential, must have a negative pregnancy test and agree to either remain celibate or use a highly effective form of birth control from the time you join the study until 3 months after your last dose of the study drug.
    Agree not to donate eggs for reproduction purposes from the time you join the study until 3 months after your last dose of the study drug.
    Not breastfeeding.

Who cannot join the trial?

8 criteria

Patients with severe forms of ulcerative colitis cannot participate. This study is only for those with mild-to-moderate ulcerative colitis.
Individuals who are not within the specified age range cannot join. The study is for certain age groups only.
Participants who are not willing or able to follow the study procedures will be excluded.
People with other significant health issues that might interfere with the study results are not eligible.
Pregnant or breastfeeding women cannot take part in the study.
Anyone who has participated in another clinical trial recently may not be eligible.
Individuals with a history of certain medical conditions that could affect the study outcomes will be excluded.
Patients who are taking medications that might interfere with the study treatment cannot participate.

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Verified sites

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Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands
Responsive
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Vilnius, Lithuania

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Investigated drugs

VE202 is a medication being studied for its potential to help people with mild-to-moderate ulcerative colitis, which is a condition that causes inflammation in the colon. The goal of this study is to see if taking VE202 for eight weeks can improve the condition of the colon as seen through a procedure called an endoscopy, which allows doctors to look inside the colon. The study also aims to ensure that VE202 is safe for patients to use. By participating in this trial, patients will help researchers understand if VE202 can be an effective treatment for ulcerative colitis.

What is already known about the treatment

VE202 – VE202 is administered orally and is currently being studied in a clinical trial for its potential use in treating mild-to-moderate ulcerative colitis. This medication is in the experimental phase, specifically a Phase 2 study, which means it is being tested for its effectiveness and safety in patients. The main therapeutic indication for VE202 is to help manage symptoms of ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. At the molecular level, VE202 is believed to work by modulating the gut microbiome, which can help reduce inflammation and improve gut health. It falls under the pharmacological classification of microbiome-based therapies.

Investigated diseases

Mild-to-moderate 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 colon. The disease typically begins in the rectum and may extend continuously to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation leads to frequent bowel movements and an urgent need to defecate. Over time, the disease can cause the colon to become less effective at absorbing water and nutrients.