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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 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 lining of the large intestine. The treatment being tested is called MORF-057, which is taken as a capsule. The study aims to evaluate how well this treatment works in helping patients achieve a state where their symptoms are significantly reduced or gone, known as clinical remission, by the 12th week of the study.

Participants in the study will be randomly assigned to receive either the MORF-057 capsule or a placebo, which looks like the treatment but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations about the treatment's effectiveness.

The study will last for up to 52 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The main goal is to see how many participants achieve clinical remission by the 12th week, with additional observations continuing throughout the study period to assess longer-term effects and safety. This research is important for understanding how MORF-057 might help people with moderately to severely active ulcerative colitis manage their condition 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.

  1. Step 1

    Beginning of the trial

    Upon joining the study, you will be randomly assigned to receive either the investigational medication MORF-057 or a placebo. A placebo is a capsule that looks like the medication but does not contain the active substance.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This is to ensure unbiased results.

  2. Step 2

    Medication administration

    You will take the assigned capsule orally. The dosage and frequency will be determined by the study protocol, and you will be informed of these details at the start of the trial.

    The treatment period is planned to last for 12 weeks, during which you will continue taking the capsules as instructed.

  3. Step 3

    Regular assessments

    Throughout the trial, you will undergo regular assessments to monitor your health and the effects of the treatment. These assessments may include physical exams, blood tests, and questionnaires about your symptoms.

    The primary goal is to evaluate the effects of MORF-057 on achieving clinical remission by Week 12.

  4. Step 4

    End of treatment period

    At the end of the 12-week treatment period, your response to the medication will be evaluated using the Modified Mayo Clinic Score (mMCS), which assesses stool frequency, rectal bleeding, and endoscopic findings.

    You may be asked to continue with follow-up visits to monitor your condition and any long-term effects of the treatment.

  5. Step 5

    Follow-up period

    After completing the treatment period, there will be a follow-up period to observe your health status and any changes in your condition.

    This period may include additional assessments at specified intervals, such as Weeks 52 and 104, to gather further data on the long-term effects of the treatment.

Who can join the trial?

13 criteria

  • Must be a male or female aged between 18 and 85 years old.
  • Must agree to follow the study's guidelines on contraception (methods to prevent pregnancy) during the study and for a short period after.
  • Must agree not to donate sperm or eggs during the study and for a short period after.
  • Must be able to give informed consent, meaning you understand the study and agree to participate.
  • Must have been diagnosed with ulcerative colitis (UC) for at least 3 months before the study starts.
  • Must have moderately to severely active UC, confirmed by specific medical tests.
  • Must have UC that affects at least 15 cm from the anal verge (the end of the digestive tract).
  • Must have tried and not responded well to, or not tolerated, at least one previous treatment for UC, such as certain medications or therapies.
  • Must meet specific washout criteria, meaning you have stopped certain UC medications for a specified time before starting the study.
  • If taking certain allowed medications for UC, must either stop them before the study or agree to keep the dose stable during the study.
  • If you have had UC for more than 7 years, must have had a full colonoscopy (a test to look inside the colon) in the last 2 years or agree to have one at the start of the study.
  • Must be considered able to fully participate in the study by the study doctor.
  • Must have a body mass index (BMI) of at least 18.0, which is a measure of body weight based on height and weight.

Who cannot join the trial?

13 criteria

  • Patients with other serious health conditions that could interfere with 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 severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a history of heart disease or stroke.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of liver or kidney disease.
  • Patients who have a history of mental health disorders that are not well controlled.
  • 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 tested to see if it can help people with ulcerative colitis, which is a condition that causes inflammation and sores in the colon. The trial is looking at how well this medication can help patients achieve clinical remission, meaning that their symptoms are reduced or disappear, after 12 weeks of treatment. The study is designed to compare different amounts of MORF-057 to see which one works best and is safest for patients.

What is already known about the treatment

MORF-057 – MORF-057 is administered orally and is currently being studied in a clinical trial for its potential to treat moderately to severely active ulcerative colitis. This medication is in the experimental phase, specifically a Phase 2b trial, which means it is being tested for safety and effectiveness in humans but is not yet approved for general medical use. The main goal of the trial is to see if MORF-057 can help patients achieve clinical remission, meaning a reduction or disappearance of symptoms, by Week 12 of treatment. The exact mechanism of action at the molecular level is not detailed in the provided information, but it is being evaluated for its therapeutic effects in the area of ulcerative colitis.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. The disease typically begins in the rectum and can extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can lead to frequent and urgent bowel movements. Over time, the disease can cause the colon to lose its ability to function properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500953-17-00Protocol codeMORF-057-202Estimated enrolment292 patientsSponsorMorphic Therapeutic Inc.

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