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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Ssxovrdazfhwmwv Pgaupmwk Lsenwqsz dr mqgd Myquj Hlqmxhue Sopot Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
26.07.2022

Trial locations

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.

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.

Trial ID:
2024-516960-27-00
Protocol code:
MORF-057-201
NCT ID:
NCT05291689
Trial Phase:
Therapeutic exploratory (Phase II)

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