Good bacteria aid in gut health. We are seeking to determine whether they could be the key to finding new treatments for ulcerative colitis (UC).
Learn about an investigational oral drug product for UC based on essential human bacteria.
OVERVIEW
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.
To take part in the study, you must meet the following basic requirements:
- 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 you are able to participate in the study.
ABOUT THE STUDY DRUG
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.
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. The placebo is designed to look just like VE202, but it contains no active medication. Neither you nor the study staff will know when you are taking VE202 and when you are taking placebo.
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 it is considered part of the investigational treatment in this study.
TAKING PART
Approximately 100 people are expected to join the study at about 70 sites around the world. If you decide to enroll in the study, there will be a total of 17 study visits over the course of about a year. Several of these visits can take place at your home, at another place of your choosing, or virtually (by video or phone).
The study is divided into 4 main parts:
(up to 1 month)
Part 1
(about 2 months)
If you qualify for the study, you will receive vancomycin and then be randomly assigned to receive a daily dose of VE202 or placebo for 8 weeks.
You will take your assigned study medication every day and return to the study site periodically to check on your health. At the end of this period, you will have another flexible sigmoidoscopy.
Part 2
(about 2 months)
In this part, you will receive vancomycin or vancomycin placebo and then either VE202 or placebo (whichever you did not receive in Part 1). In this part of the study, you will take the capsules every day for 2 weeks.
After you stop taking the VE202 or placebo, you will continue to have follow-up visits for about 6 weeks. At the end of this period, you will have a third flexible sigmoidoscopy.
Follow up
(about 8 months)
(up to 1 month)
(about 2 months)
If you qualify for the study, you will receive vancomycin and then be randomly assigned to receive a daily dose of VE202 or placebo for 8 weeks.
You will take your assigned study medication every day and return to the study site periodically to check on your health. At the end of this period, you will have another flexible sigmoidoscopy.
(about 2 months)
In this part, you will receive vancomycin or vancomycin placebo and then either VE202 or placebo (whichever you did not receive in Part 1). In this part of the study, you will take the capsules every day for 2 weeks.
After you stop taking the VE202 or placebo, you will continue to have follow-up visits for about 6 weeks. At the end of this period, you will have a third flexible sigmoidoscopy.
(about 8 months)
ABOUT CLINICAL STUDIES
What is a clinical study?
A clinical study (also known as a clinical trial) is designed to learn more about a drug’s ability to treat a specific disease or condition. Regulatory agencies use the results of clinical studies to decide if an investigational drug should be made available to patients. Clinical studies are the only way we can develop new and better treatments and improve patient care.
How are my rights protected?
Clinical studies are conducted by experienced and trained medical professionals who monitor the health of patients throughout the study. Also, every clinical study is reviewed by an Institutional Review Board (IRB)/Ethics Committee (EC), which helps ensure that the study is conducted safely and that the rights of study participants are protected. All participants will need to review and sign an Informed Consent Form, which explains the study in more detail, including risks, potential side effects, and procedures, as well as the rights and responsibilities of participants.