#1 Clinical Trials Search in Europe

Clostridia, Cluster Xiva, Strain Relative Anaerostipes Hominis, Live

A new clinical trial is investigating the use of VE202, a novel drug containing multiple strains of live bacteria, for the treatment of mild to moderate ulcerative colitis. This Phase 2 study aims to evaluate the efficacy and safety of VE202 in patients who have not previously received certain types of treatments for their condition. The trial will assess the drug’s ability to improve endoscopic response and monitor any potential side effects over an 8-week treatment period.

Table of Contents

What is VE202?

VE202 is an investigational drug being studied for the treatment of mild-to-moderate ulcerative colitis[1]. It is a capsule containing live bacteria strains, specifically designed to target the digestive system[1]. VE202 is also known by its sponsor product code JNJ-72537634[1].

The drug consists of multiple strains of live bacteria, including:

  • Clostridia, cluster XIVA, strain relative Anaerostipes hominis, live
  • Clostridia, cluster XIVA, strain relative Blautia coccoides, live
  • Clostridia, cluster XIVA, strain relative Hungatella effluvii, live
  • Bacilli, cluster XVIII, strain relative Thomasclavelia sp000508865, live
  • And several other bacterial strains[1]

Target Condition: Mild-to-Moderate Ulcerative Colitis

VE202 is being studied for the treatment of mild-to-moderate ulcerative colitis (UC)[1]. Ulcerative colitis is a type of inflammatory bowel disease (IBD) 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].

How VE202 Works

VE202 is a type of treatment known as a live biotherapeutic product. It contains live bacteria that are thought to help restore balance to the gut microbiome – the community of microorganisms living in our digestive tract. In ulcerative colitis, this balance is often disrupted. By introducing beneficial bacteria, VE202 may help reduce inflammation and improve symptoms of UC[1].

Clinical Trial Details

VE202 is currently being studied in a Phase 2 clinical trial[1]. This means that while it has shown promise in earlier studies, it is still being tested to determine its effectiveness and safety. Key details of the trial include:

  • It is a randomized, double-blind, placebo-controlled study[1]. This means that participants are randomly assigned to receive either VE202 or a placebo, and neither the participants nor the researchers know who is receiving which treatment.
  • The treatment period is 8 weeks[1].
  • The main goal is to evaluate how well VE202 improves the appearance of the colon lining (endoscopic response) after 56 days of treatment[1].
  • The study is also assessing the safety of VE202[1].

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key eligibility factors include:

  • Age 18 to 75 years[1]
  • Diagnosed with ulcerative colitis at least 3 months before the study[1]
  • Have active mild to moderate UC, as determined by specific scoring systems[1]
  • Have not previously received certain types of treatments for UC (such as biologic agents)[1]

There are also several exclusion criteria, such as having other digestive conditions or recent use of antibiotics[1].

Potential Benefits

While the effectiveness of VE202 is still being studied, the hope is that it may provide several benefits for people with mild-to-moderate ulcerative colitis:

  • Improvement in the appearance of the colon lining (endoscopic response)[1]
  • Reduction in UC symptoms, such as diarrhea and rectal bleeding
  • A new treatment option for those who haven’t responded well to other therapies

Safety Considerations

As with any investigational treatment, the safety of VE202 is a key focus of the clinical trial. The study is specifically monitoring for:

  • Any serious side effects related to VE202[1]
  • Any moderate to severe side effects that may be related to the treatment[1]

It’s important to note that as an investigational treatment, not all potential side effects of VE202 may be known at this time. Patients considering participating in the trial should discuss the potential risks and benefits with their healthcare provider.

Aspect Details
Study Type Phase 2, randomized, double-blind, placebo-controlled
Medication VE202 (capsule containing multiple strains of live bacteria)
Condition Mild to moderate ulcerative colitis
Primary Objectives Evaluate efficacy (endoscopic response) and safety
Treatment Duration 8 weeks
Key Inclusion Criteria Adults 18-75, UC diagnosis for ≥3 months, no prior biologic treatment
Key Exclusion Criteria Active infections, recent antibiotic use, allergy to VE202 components
Primary Endpoints Endoscopic response rate, treatment-related adverse events

FAQ

  • What is VE202 and how does it work? VE202 is a capsule containing multiple strains of live bacteria, including various Clostridia and Bacilli clusters. It is designed to potentially help restore balance to the gut microbiome, which may play a role in managing ulcerative colitis symptoms.
  • Who is eligible to participate in this clinical trial? The trial is open to adults aged 18-75 with a documented diagnosis of mild to moderate ulcerative colitis for at least 3 months. Participants must not have previously received biologic agents, Janus kinase inhibitors, or sphingosine-1-phosphate modulators for UC treatment.
  • How long does the treatment last in this study? The treatment period in this study lasts for 8 weeks, during which participants will receive either VE202 or a placebo.
  • What are the main goals of this clinical trial? The primary objectives are to evaluate the efficacy of VE202 in terms of endoscopic response after 8 weeks of treatment and to assess the safety of the drug throughout the study.
  • Are there any restrictions on medications during the trial? Participants on corticosteroids must be on a stable dose for at least 4 weeks prior to the trial, not exceeding 10 mg daily of prednisone or equivalent. Other allowable UC medications must be stable for at least 8 weeks before randomization. The use of antibiotics, probiotics, and certain herbal preparations is restricted before and during the study period.

Ongoing Clinical Trials on Clostridia, Cluster Xiva, Strain Relative Anaerostipes Hominis, 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 (UC): A chronic inflammatory bowel disease that affects the lining of the large intestine (colon) and rectum, causing inflammation and ulcers.
  • Endoscopic Response: An improvement in the appearance of the colon lining as observed through a flexible tube with a camera (endoscope) inserted into the rectum.
  • Mayo Score: A scoring system used to assess the severity of ulcerative colitis, which includes factors such as stool frequency, rectal bleeding, and endoscopic findings.
  • Biologic Agent: A type of medication derived from living organisms, often used to treat autoimmune diseases like ulcerative colitis.
  • Janus Kinase (JAK) Inhibitor: A class of medications that work by blocking specific enzymes involved in inflammation.
  • Sphingosine-1-Phosphate (S1P) Modulator: A type of medication that affects how immune cells move through the body, potentially reducing inflammation in conditions like ulcerative colitis.
  • Corticosteroids: A class of anti-inflammatory medications, such as prednisone, often used to treat flare-ups in ulcerative colitis.
  • Microbiome: The collection of microorganisms, including bacteria, that live in the human gut and play a role in digestive health.
  • Colony Forming Unit (CFU): A measure used to estimate the number of viable bacteria or fungal cells in a sample.
  • Placebo: An inactive substance that looks like the real medication but has no therapeutic effect, used as a control in clinical trials.

References

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