#1 Clinical Trials Search in Europe

Clostridia, Cluster Xiva, Strain Relative Enterocloster Pacaense, Live

A new drug called VE202 is being studied in clinical trials for the treatment of mild to moderate ulcerative colitis. This article explores the ongoing research on VE202, a capsule containing live bacterial strains, and its potential to help patients with this inflammatory bowel condition. We’ll discuss the trial’s objectives, eligibility criteria, and what this could mean for future ulcerative colitis treatments.

Table of Contents

What is VE202?

VE202 is an investigational drug being studied for the treatment of mild-to-moderate ulcerative colitis. It is a capsule that contains live bacteria, specifically various strains of Clostridia and Bacilli.[1] These bacteria are naturally found in the human gut and are believed to play a role in maintaining a healthy digestive system.

How Does VE202 Work?

VE202 is a type of treatment known as a live biotherapeutic product. It works by introducing beneficial bacteria into the gut. These bacteria are thought to help restore balance to the gut microbiome, which is the community of microorganisms living in our digestive tract. In people with ulcerative colitis, this balance is often disrupted.[1]

What Condition Does VE202 Treat?

VE202 is being studied as a treatment for mild-to-moderate ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine (colon) and rectum. Symptoms can include diarrhea, abdominal pain, and rectal bleeding.[1]

Current Research on VE202

VE202 is currently being studied in a Phase 2 clinical trial. This means that while it has shown promise in earlier studies, it is still considered experimental and is not yet approved for general use. The main goals of this study are:

  • To evaluate how effective VE202 is in improving the appearance of the colon lining (as seen during an endoscopy) after 8 weeks of treatment[1]
  • To assess the safety of VE202[1]

Who Can Participate in the VE202 Study?

The study is looking for participants who meet certain criteria, including:

  • Adults aged 18 to 75 years[1]
  • Diagnosed with mild-to-moderate ulcerative colitis for at least 3 months[1]
  • Have not previously received certain types of treatments for ulcerative colitis (such as biologic agents or JAK inhibitors)[1]

There are also several factors that would exclude someone from participating, such as having Crohn’s disease or certain other medical conditions.[1]

What to Expect During the Study

If you participate in the study, you can expect:

  • To take VE202 or a placebo (a capsule without active ingredients) for 8 weeks[1]
  • To undergo various tests and procedures, including blood tests and endoscopies (a procedure where a camera is used to look inside your colon)[1]
  • Regular check-ups and monitoring by the study doctors[1]

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to participating in this study:

Potential benefits:

  • You may experience an improvement in your ulcerative colitis symptoms[1]
  • You will contribute to the advancement of medical knowledge and potentially help future patients[1]

Potential risks:

  • VE202 may cause side effects, which are not yet fully known[1]
  • The treatment may not be effective for you[1]

It’s important to discuss these potential benefits and risks with your doctor and the study team before deciding to participate in any clinical trial.

Aspect Details
Drug Name VE202 (also known as JNJ-72537634)
Drug Type Live bacterial strains in capsule form
Target Condition Mild to moderate ulcerative colitis
Trial Phase Phase 2
Main Objective Evaluate efficacy in terms of endoscopic response after 8 weeks
Key Eligibility Criteria Adults 18-75, diagnosed UC for 3+ months, active disease, no prior biologic treatment
Treatment Duration 8 weeks
Primary Endpoints Endoscopic response rate, safety (Grade ≥3 TEAEs and SAEs related to VE202)
Key Exclusions History of Crohn’s disease, recent FMT, antibiotic use, active infections

FAQ

  • What is VE202 and how does it work? VE202 is a capsule containing multiple strains of live bacteria, including various Clostridia and Bacilli species. It's designed to potentially improve the gut microbiome and reduce inflammation in patients with ulcerative colitis.
  • Who is eligible to participate in the VE202 clinical trial? Eligible participants are adults aged 18-75 with a documented diagnosis of mild to moderate ulcerative colitis for at least 3 months. They must have active disease and not have received certain previous treatments like biologics or JAK inhibitors.
  • What is the main goal of the VE202 clinical trial? The primary objective is to evaluate the efficacy of VE202 in terms of endoscopic response after 8 weeks of treatment. This means checking if there's an improvement in the appearance of the colon lining when examined with a flexible sigmoidoscopy.
  • How long does the VE202 treatment last in the trial? The treatment period in the trial lasts for 8 weeks. During this time, participants will receive either VE202 or a placebo, and their response to the treatment will be monitored.
  • What are the potential benefits and risks of participating in this trial? Potential benefits include access to a new treatment that may improve ulcerative colitis symptoms. Risks may include side effects from the medication, which are being closely monitored in the trial. The study also looks at the safety of VE202 as one of its primary endpoints.

Ongoing Clinical Trials on Clostridia, Cluster Xiva, Strain Relative Enterocloster Pacaense, Live

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Hungary Lithuania The Netherlands Poland

Glossary

  • Ulcerative Colitis: A chronic inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine (colon) and rectum.
  • Endoscopic Response: An improvement in the appearance of the colon lining when examined through a flexible sigmoidoscopy, which is a type of endoscopy procedure.
  • Mayo Score: A scoring system used to assess the severity of ulcerative colitis, which takes into account stool frequency, rectal bleeding, endoscopic findings, and a physician's overall assessment.
  • Flexible Sigmoidoscopy: A medical procedure that allows doctors to view the lower part of the colon using a flexible tube with a camera on the end.
  • Placebo: An inactive substance that looks like the drug being tested but contains no active medication, used as a control in clinical trials.
  • Microbiome: The collection of all microbes, such as bacteria, fungi, viruses, and their genes, that naturally live in and on the human body, particularly in the gut.
  • Colony Forming Unit (CFU): A unit used to estimate the number of viable bacteria or fungal cells in a sample.
  • Biologic Agent: A type of medication made from living organisms or their products, used to treat various conditions including inflammatory bowel diseases.
  • Janus Kinase (JAK) Inhibitor: A class of medications that work by blocking specific enzymes involved in the inflammatory process.
  • Fecal Microbiota Transplantation (FMT): A procedure in which fecal matter from a healthy donor is transferred to a recipient to treat certain gut disorders.

References

  1. http://clinicaltrials.eu/trial/study-on-ve202-for-patients-with-mild-to-moderate-ulcerative-colitis/