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Study on the Effects of MORF-057 for Adults with Moderate to Severe Ulcerative Colitis

InvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The treatment being tested is called MORF-057, which is taken as a capsule. The purpose of the study is to evaluate how well this treatment works, as well as its safety and how well it is tolerated by patients.

Participants in the study will take MORF-057 for a period of time, and researchers will monitor changes in their condition. The study will look at improvements in the colon's tissue health after 12 weeks of treatment. Participants will also be observed for any side effects or adverse reactions to the treatment. The study aims to provide valuable information on whether MORF-057 can be an effective treatment option for those with moderately to severely active ulcerative colitis.

Throughout the study, participants will have regular check-ups to assess their health and the treatment's impact. The study will also measure the concentration of MORF-057 in the blood to understand how the body processes the medication. This research is important for developing new treatments that can help manage ulcerative colitis more effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will start the trial by taking the medication MORF-057 in the form of a capsule. This medication is taken orally.
The purpose of this trial is to evaluate the effects of MORF-057 on improving the condition of moderately to severely active ulcerative colitis.
Step 2
Medication schedule
You will be required to take the MORF-057 capsule as directed by the study team. The specific dosage and frequency will be provided to you at the start of the trial.
The treatment period will last for 12 weeks, during which you will continue taking the medication as instructed.
Step 3
Monitoring and assessments
Throughout the trial, your health and response to the medication will be closely monitored. This includes regular assessments to evaluate the safety and effectiveness of the treatment.
You will undergo various tests and evaluations, such as blood tests and other necessary examinations, to track your progress and any changes in your condition.
Step 4
End of treatment period
At the end of the 12-week treatment period, a final assessment will be conducted to determine the overall impact of the medication on your condition.
You will be asked to provide feedback on your experience during the trial, including any side effects or changes in symptoms.
Step 5
Follow-up
After completing the treatment period, there will be a follow-up phase to ensure your continued well-being. This may include additional visits or communications with the study team.
During this time, you will be advised on any further steps or precautions to take after the trial has concluded.

Who can join the trial?

13 criteria

Must be between 18 and 85 years old.
Must have had symptoms of moderately to severely active ulcerative colitis for at least 3 months before the study starts.
Must have a confirmed diagnosis of ulcerative colitis with specific test scores.
Must have ulcerative colitis affecting at least 15 cm from the anal verge (the end of the digestive tract).
Must have a body mass index (BMI) between 18.0 and 40.0. BMI is a measure of body fat based on height and weight.
Must be able to give informed consent, meaning you understand and agree to the study's requirements.
Must agree to follow guidelines about birth control during the study.
Men must agree not to donate sperm, and women must agree not to donate eggs during the study and for 28 days after the last dose of the study drug.
Must be able to fully participate in all parts of the study, as judged by the study doctor.
Must have either never used certain ulcerative colitis medications or had an inadequate response, loss of response, or intolerance to no more than 3 drugs in 2 classes of specific medications.
Must meet specific time requirements for stopping certain ulcerative colitis medications before starting the study.
If taking certain non-prohibited ulcerative colitis medications, must stop them at least 5 half-lives before the study or agree to keep the dose stable during the study, except for tapering oral corticosteroids after 12 weeks.
For the exploratory group, must have had a reaction or no longer respond to a specific medication called vedolizumab within the last 5 years and have stopped it at least 6 weeks before the study starts.

Who cannot join the trial?

15 criteria

Patients with any other serious health condition that could affect their safety or the results of the study.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medication or its ingredients.
Patients who have a history of certain types of cancer.
Patients who have a history of heart problems, such as heart attack or heart failure.
Patients who have uncontrolled high blood pressure.
Patients who have a history of liver or kidney disease.
Patients who have a history of blood disorders.
Patients who have a history of mental health disorders that are not well controlled.
Patients who have a history of certain autoimmune diseases.
Patients who are unable to comply with the study procedures or follow-up visits.

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Investigated drugs

MORF-057 is a medication being studied for its potential to help people with ulcerative colitis, a condition that causes inflammation and sores in the colon. This medication is being tested to see if it can improve the health of the colon tissue over a period of 12 weeks. The goal is to find out if MORF-057 can reduce the inflammation and help the colon heal, making it easier for people with ulcerative colitis to manage their symptoms and improve their quality of life.

Morf-057

What is already known about the treatment

MORF-057 – MORF-057 is administered orally in the form of tablets and is currently being studied in clinical trials for its potential use in treating moderately to severely active ulcerative colitis. This medication is in the experimental phase, and its effects are being evaluated for safety and effectiveness in medical research. The main therapeutic indication for MORF-057 is to help improve the condition of the colon in patients with ulcerative colitis. At the molecular level, MORF-057 works by targeting specific pathways in the body to reduce inflammation in the colon. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon, also known as the large intestine. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. The inflammation causes the colon to empty frequently, resulting in diarrhea. Over time, the inflammation can lead to the formation of ulcers, which are small open sores that can produce pus and mucus. The progression of ulcerative colitis can vary, with periods of active symptoms followed by times of remission.