This clinical trial is focused on studying the effects of a new treatment for Crohn’s Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The treatment being tested is called MORF-057, which is taken in the form of a capsule. The study will compare the effects of two different doses of MORF-057 to a placebo, which looks like the treatment but does not contain the active medicine.
The purpose of the study is to evaluate the safety and effectiveness of MORF-057 in adults with moderately to severely active Crohn’s Disease. Participants will be randomly assigned to receive either MORF-057 or a placebo. The study will last for several weeks, during which participants will take the capsules and attend regular check-ups to monitor their health and the effects of the treatment.
Throughout the study, doctors will use a method called endoscopy to look inside the digestive tract and assess how well the treatment is working. The main goal is to see if MORF-057 can help reduce the inflammation and improve symptoms by the end of the study period. Participants will also be monitored for any side effects or changes in their health to ensure the treatment is safe.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
The assessment ensures that the participant has moderately to severely active Crohn’s disease, confirmed by specific scores from medical evaluations.
2treatment allocation
Participants are randomly assigned to receive either the active medication, MORF-057, or a placebo. The study is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
The medication is provided in capsule form for oral use.
3medication administration
Participants take the assigned capsule daily. The dosage and specific regimen are determined by the study protocol.
The treatment period lasts for 14 weeks, during which the participant’s response to the medication is closely monitored.
4monitoring and assessments
Regular assessments are conducted to monitor the participant’s health and response to the treatment. This includes checking for any side effects and evaluating the effectiveness of the medication.
Endoscopic evaluations are performed to assess the condition of the intestines at the end of the 14-week period.
5final evaluation
At the end of the treatment period, a final evaluation is conducted to determine the participant’s response to the treatment.
The primary goal is to assess the proportion of participants who show an endoscopic response, indicating improvement in the condition.
Who Can Join the Study?
Must be a male or female between 18 to 85 years old.
Must have been diagnosed with Crohn’s Disease (CD) for at least 3 months. This diagnosis should be supported by symptoms, an endoscopy (a procedure to look inside the digestive tract), and a biopsy (a small tissue sample).
Must have moderately to severely active Crohn’s Disease, confirmed by specific scores during the screening period.
Must have an average daily stool score of 4 or more points and/or an average daily abdominal pain score of 2 or more points.
Must have shown an inadequate response, loss of response, or intolerance to at least one treatment for Crohn’s Disease, such as corticosteroids, immunosuppressants, or advanced therapies.
Must meet specific washout criteria for previous Crohn’s Disease therapies, meaning certain medications must be stopped for a specific time before starting the study.
If taking certain non-prohibited medications for Crohn’s Disease, must stop them at least 5 half-lives before the study or agree to maintain stable doses, except for tapering oral corticosteroids after the induction period.
Must have a body mass index (BMI) of 18.0 or higher. BMI is a measure of body fat based on height and weight.
Must be able to fully participate in all aspects of the study, as determined by the investigator.
Must agree to follow guidelines regarding contraception. This includes using effective birth control methods or abstaining from sexual intercourse during the study and for a specified time after the last dose of the study medication.
Must agree not to donate sperm or eggs during the study and for a specified time after the last dose of the study medication.
Must be capable of giving signed informed consent, which means understanding and agreeing to the study’s requirements and restrictions.
MORF-057 is a medication being studied for its potential to help people with moderately to severely active Crohn’s Disease. The trial aims to see how well this medication works in reducing inflammation in the intestines, which is checked through a procedure called an endoscopy. The study will assess the effects of this medication over a period of 14 weeks to determine its safety and effectiveness in improving the symptoms of Crohn’s Disease.
Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active symptoms and remission. During active phases, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can lead to complications such as strictures or fistulas. The exact cause is unknown, but it involves an abnormal immune response. The disease can vary greatly in severity and progression among individuals.
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