Scientists are developing new treatments for ulcerative colitis (UC) through clinical trials. There are several ongoing clinical trials that someone with UC could consider joining.
Clinical trials are studies examining the effectiveness of new treatment options and how well individuals tolerate them. They can be small or large in scale, depending on their stage. Each new treatment for UC needs to pass through several stages of trials to obtain approval from the Food and Drug Administration (FDA) and become available for doctors to prescribe.
People who are interested in participating in a clinical trial can talk with their doctor about the options in their area. They can also take advantage of online resources, which we list some of later in this article, to find or sign up for studies.
Research into UC is ongoing, and several studies are underway or in the process of recruiting. These studies will help determine the safety and effectiveness of new therapies, monitoring techniques, and lifestyle changes that may positively affect outcomes.
Many researchers are seeking to explore the effectiveness of treatments for people with UC. The following are some studies that are currently recruiting participants or are ongoing.
Study comparing corticosteroids with infliximab
A study is currently recruiting to look at infliximab, a biological agent, to determine whether doctors can safely and effectively use it as a first-line therapy. The researchers intend to compare the drug with corticosteroids as a primary therapy for moderate to severe UC.
VE202
People ages 18–75 years can participate in a study observing VE202, a live biotherapeutic product a person can take orally. Researchers will look at the safety and efficacy of the drug along with the microbiota changes in participants with mild to moderate UC.
Generally, people can find information about the outcomes of UC treatment studies online. Some studies result in FDA approval of drugs.
Lattice Study
The pharmaceutical company Bristol Myers Squibb recently completed a study for a new medication to treat UC. They tested the efficacy of a medication known as BMS-986165 for treating moderate to severe UC. Participants were ages 18–65 years, had received a UC diagnosis at least 3 months prior, and had tried one other UC medication.
Gut microbiota structure and function
Researchers completed an exploratory study on people living with UC. The study looked at how KB295, a novel glycan, affects the microbiome of the gut in people living with mild to moderate UC.
Vedolizumab vs. adalimumab
In 2019, researchers published a study comparing vedolizumab with adalimumab for the treatment of moderate to severe UC. The study showed that vedolizumab was more effective for clinical remission and endoscopic improvement. However, it could not achieve corticosteroid-free clinical remission.
The FDA has approved vedolizumab, which is available under the brand name Entyvio, as a treatment for people living with UC.
In some cases, a doctor can help a person enroll in a clinical trial by:
- finding local or regional studies
- determining the individual’s eligibility
- answering questions about how it could affect the participants’ health
Recruiting studies will list their eligibility requirements online, and these can vary greatly. Some studies might only be recruiting people with moderate to severe UC, for instance, while others will be looking for those with mild to moderate UC.
It is important for a person to read all the requirements before signing up. They can ask either the researchers or a healthcare professional about whether they would qualify. For example, a person interested in the VE202 study can reach trial contacts at their email addresses.
In many cases, a person can sign up online.
Questions to consider before signing up
Participating in a clinical trial may not be the best choice for everyone. A person needs to consider a range of factors before signing up. A doctor may be able to help answer some of their questions.
Individuals interested in signing up for a clinical trial need to consider the following questions first:
- What are the costs associated with the trial?
- How safe is the trial?
- Is additional follow-up care available after the trial?
- What is the desired personal outcome from participation?
- Who is eligible to participate?
- What is the main purpose of the trial?
- What are the researchers expecting of the person?
- What effects will the trial have on the person’s regular healthcare routines?
A person can find clinical trials online. In some cases, they may not be able to participate due to the location of the study.
Two websites that a person can check out to find clinical studies are:
Crohn’s & Colitis Foundation Research Finder
This free tool, which provides a filter to help narrow down the search, can help someone find UC studies around the United States.
ClinicalTrials.gov
People can also use this free tool to look for ongoing or completed studies on UC or any other health condition. A person can type in the condition only or add additional filters to narrow down the results.
A person’s doctor may also be able to suggest new and ongoing trials in the area. At the same time, they can help individuals determine whether participating in a clinical study is likely to be safe and effective for them.
Researchers design clinical trials for UC to test the effectiveness and safety of new or existing treatment options for this condition.
People interested in participating in a clinical trial can take advantage of online resources, such as ClinicalTrials.gov, to find and sign up for trials. They can also talk with a healthcare professional about their circumstances and whether a particular trial may be suitable for them.