Scientists are developing new treatments for ulcerative colitis (UC) through clinical trials. There are several ongoing clinical trials that a person with UC could consider joining.
Clinical trials are studies that look at how effectively new treatment options work 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 studies or sign up.
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, as well as monitoring techniques and lifestyle changes that may positively affect outcomes.
Many researchers are seeking to find out more about the effectiveness of treatments for people with UC. The following are some studies that are currently recruiting participants, are ongoing, or have recently finished.
Lattice Study
The pharmaceutical company Bristol Myers Squibb is currently recruiting for a study of a new medication to treat UC. They are testing the efficacy of a medication known as BMS-986165 for the treatment of moderate-to-severe UC. Participants must be aged 18–65 years, have received a UC diagnosis at least 3 months ago, and have tried one other UC medication.
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 in leading to both 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.
5-ASA Treatment Study
A study in Denmark is currently recruiting. The trial’s primary purpose is to see whether using a single daily dose of oral mesalazine (5-ASA) in place of multiple tablets a day will help improve adherence to treatment without sacrificing effectiveness. If the study is successful, it could help make treatment easier for people living with moderate-to-severe UC.
Study comparing corticosteroids with infliximab
A new study will look at infliximab, a biological agent, to determine whether doctors can safely and effectively use it as a first-line therapy. The study is currently recruiting participants. The researchers intend to compare the drug with corticosteroids as a primary therapy for moderate-to-severe UC.
Gut microbiota structure and function
Researchers are currently recruiting people living with UC to participate in an exploratory study. The study will look at how KB295, a novel glycan, affects the microbiome of the gut in people living with mild-to-moderate 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 people 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.
In many cases, a person can sign up online. For example, a person interested in the Lattice Study can fill out the pre-screening questionnaire here.
Questions to consider before signing up
Participating in a clinical trial may not be the best choice for everyone. A person should bear a range of factors in mind before signing up. A doctor may be able to help answer some of their questions.
Individuals who are interested in signing up for a clinical trial should 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 several filters to help narrow down the search, can help a person find UC studies around the United States.
ClinicalTrials.gov
People can also use this free tool to look for 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 primary care provider may also be able to suggest new and ongoing trials in the area. At the same time, they can help a person determine whether participating in a clinical study is likely to be safe and effective for them.
Clinical trials for UC are designed to test the effectiveness and safety of new or existing treatment options for this condition.
People who are 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 individual circumstances and whether a particular trial may be a good idea for them.