RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY OF VE202 IN PATIENTS WITH MILD-TO-MODERATE ULCERATIVE COLITIS
Published: 06/02/2023
General Information:
The goal of this study is to see if VE202 can help reduce inflammation in the large intestine and restore overall gut health in patients with mild to moderate ulcerative colitis. To study this, VE202 will be compared with a placebo.
Eligibility:
- Be 18 to 75 years old
- Have mild to moderate UC that was diagnosed at least 3 months before joining the study
- Have not taken certain medications for UC, such as a biologic agent or Janus kinase (JAK) inhibitor
- Do not have Crohn’s disease, indeterminate colitis, or primary sclerosing cholangitis (swelling and scarring of the liver’s bile ducts)
- Do not have a known allergy to Vancomycin
Your medical history and other aspects of your health will also be reviewed to determine if they are able to participate in the study.
Study Details:
Study description/explanation of participation:
The COLLECTiVE202 study is testing an investigational drug product called VE202 for patients with mild to moderate ulcerative colitis (UC). VE202 has not been approved by the U.S. Food and Drug Administration. This study will help to find out if VE202 can be used safely and effectively for people with UC. If you decide to participate in the study, there will be a total of 17 study visits over the course of about one year. Several of these visits can take place at your home, at another place of your choosing, or virtually (by video or phone).
Description of treatment or intervention (mechanism of action):
UC causes inflammation of the large intestine (colon). Some patients with UC have an abnormal balance of bacteria in their colon. VE202 is designed to rebalance the bacteria in your intestine and, when used in combination with your other UC treatment, return your intestinal tract to a healthier state.
VE202 is given as oral capsules that contain bacteria often found in the normal human intestine, where they are thought to contribute to health. The bacteria in VE202 do not come from human donor stool; rather, they were specifically selected by scientists and are manufactured in a laboratory. This study is being conducted to see if the bacteria in VE202 can be used to control your UC.
As part of the study and before you receive VE202, an antibiotic called vancomycin will be given by mouth to eliminate some of the bacteria that live in the intestine to make room for the bacteria in VE202. Vancomycin is approved to treat certain types of infections, but is considered part of the investigational treatment in this study.
The study is being conducted in multiple parts. Everyone who enrolls and continues in the study will receive VE202 in one part and a placebo in another part
Patient Participation Requirements:
The study is divided into 4 main parts. Screening is up to 1 month, which may require 1 to 2 patient visits. Study Treatment (Part 1) is about 2 months, and study treatment (Part 2) is about 2 months. Then there is a long-term follow up which last about 8 months, with 5 study visits over this 8 month period. These visits may take place at your home or on the phone.
It is not expected to cost you anything to participate in the study. The study-related medications will be provided at no charge to you, and you will not be charged for any visits or procedures performed for this study. You may also be reimbursed for reasonable expenses such as your travel costs for attending the study visits.
Possible risks and side effects:
VE202 Risks:
VE202 has been given to healthy volunteers and has not yet been studied in patients with ulcerative colitis.
The side effects reported in >1 subject who received VE202 were headache, abdominal discomfort, diarrhea, weight loss, upper respiratory infection, fatigue, and joint pain. The side effects were generally mild or moderate, went away without the need for treatment, and did not last for a long time.
Vancomycin Risks:
The most commonly reported risks with the antibiotic vancomycin are:
- Nausea and stomach/abdominal discomfort or pain
- Fever
- Muscle or bone pain
- Diarrhea
- Swelling in the hands or feet
- Fatigue
- Headache
- Vomiting
- Urinary tract infection
Other information:
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