Ongoing Clinical Trials for Colitis
Two clinical trials are currently ongoing to study different treatments for colitis. One trial focuses on severe colitis caused by cancer treatments, while the other investigates treatment for ulcerative colitis. These studies are taking place across several European countries and are testing medications aimed at reducing inflammation in the colon.
Clinical trial locations
- Bulgaria
- Czechia
- Denmark
- France
- Hungary
- Poland
- Slovakia
- Spain
Study on Infliximab and Corticosteroids for Treating Severe Colitis Caused by Immune Checkpoint Inhibitors in Patients
This trial is investigating treatment options for a specific type of inflammation in the colon that occurs as a side effect of certain cancer treatments called immune checkpoint inhibitors. The study compares two approaches: using corticosteroids alone versus combining corticosteroids with a medication called infliximab.
Main inclusion criteria: Participants must be at least 18 years old and have untreated or persistent diarrhea or inflammation of the colon at a certain level of severity. They must have been diagnosed with a solid tumor cancer and treated with immune checkpoint inhibitors within the past 12 weeks. Women who can become pregnant must have a negative pregnancy test within 72 hours before joining and use effective birth control throughout the study and for at least 6 months after the last treatment. Participants must be able to understand the study procedures, sign a consent form, and complete study questionnaires and a daily diary.
Main exclusion criteria: Patients cannot participate if they have other types of inflammation in the colon not related to immune checkpoint inhibitors, are pregnant or breastfeeding, have had a recent infection or illness that could affect the study, are currently participating in another clinical trial, belong to a vulnerable population unable to give consent, or have other medical conditions that might interfere with the study.
Focus and goal: The study aims to determine which treatment approach is more effective in managing severe inflammation and diarrhea. Participants are randomly assigned to receive either corticosteroids alone or a combination of infliximab and corticosteroids. The treatment phase lasts up to seven weeks, with regular monitoring of symptoms and health status. Quality of life is assessed at multiple time points over one year. The study will continue until 2029 to gather comprehensive data on treatment effectiveness and safety.
Investigational drugs: Infliximab is given intravenously and works by blocking a protein called tumor necrosis factor-alpha, which plays a key role in causing inflammation. Corticosteroids, specifically prednisolone given orally, help reduce inflammation and suppress the immune system. The study tests whether combining these medications is more effective than using corticosteroids alone.
Study on Mesalazine for Patients with Mild to Moderate Ulcerative Colitis
This clinical trial studies the effectiveness of mesalazine in patients with ulcerative colitis, a disease that causes inflammation and sores in the lining of the large intestine. The study is designed to see if mesalazine can help patients achieve remission, meaning a reduction or elimination of symptoms.
Main inclusion criteria: Participants must be at least 18 years old and willing to follow all study instructions, complete assessments, use an electronic diary, and attend all study visits. They must have had symptoms for at least 3 months before the study starts, with inflammation extending at least 15 centimeters from the end of the rectum. The disease must be active and mild to moderate at the time of screening, confirmed by specific scores and a recent endoscopy. Patients can be either new to treatment or currently taking mesalazine at specified doses. Women of childbearing potential must agree to pregnancy tests and use effective birth control throughout the study. Men with female partners who can have children must agree to use birth control methods during the study and for 2.5 months after the last dose.
Main exclusion criteria: Patients cannot participate if they have other serious health conditions that could interfere with the study, are currently in another clinical trial, have had recent surgery related to their condition, are pregnant or breastfeeding, have a history of not following medical advice, have allergies to the study medication, have used certain medications that could affect results, have a history of drug or alcohol abuse, have an infection requiring antibiotics, or have a history of cancer except for certain types of skin cancer.
Focus and goal: This double-blind study lasts eight weeks, during which participants receive either mesalazine or a placebo by mouth. Neither the participants nor the researchers know who is receiving the actual medication. The goal is to determine how many patients experience reduced symptoms such as stool frequency and rectal bleeding, as well as improvements seen during endoscopy. The study also monitors safety and any side effects of the treatment.
Investigational drug: Mesalazine is taken orally as granules or gastro-resistant tablets. It works by reducing inflammation in the colon through the inhibition of certain chemicals in the body that cause inflammation. Mesalazine belongs to a class of medications called aminosalicylates, which are known for their anti-inflammatory properties and are well-established in treating ulcerative colitis.
Summary
Two distinct clinical trials are currently investigating treatments for different types of colitis. The first trial, conducted in Denmark, focuses on a rare but serious complication of cancer treatment, testing whether adding infliximab to standard corticosteroid therapy can improve outcomes. This study will run until 2029, reflecting the long-term follow-up needed for this condition.
The second trial has a broader geographic scope, taking place across seven European countries including Poland, Slovakia, Czechia, Hungary, Bulgaria, France, and Spain. This study examines mesalazine for the more common condition of ulcerative colitis and uses a shorter eight-week treatment period. The wide geographic distribution of this trial may help ensure diverse patient participation.
Both trials emphasize the importance of careful patient monitoring and use established anti-inflammatory approaches, though targeting different aspects of colon inflammation. These studies aim to provide clearer guidance on treatment effectiveness and safety for patients experiencing these challenging conditions.
