Phase 2 Crohn's Disease and Colitis Trial, Active, Not Recruiting NCT05611671 Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) Condition: Crohn's Disease and Colitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called MORF-057 in people with ulcerative colitis, a condition that causes inflammation in the large bowel. A total of 280 people took part, split across four groups: one group took MORF-057 at 200 mg twice daily, one took 100 mg twice daily, one took 100 mg once daily in the morning, and one took a placebo (a dummy pill with no active ingredient). The trial's main goal was to measure how many participants reached "clinical remission" — meaning their bowel symptoms and a camera examination of the bowel (endoscopy) both showed very low levels of disease activity — using a standard scoring tool called the Modified Mayo Clinic Score. The reported data shows that, for the primary goal of clinical remission at the end of the study, 31.9% of participants in the 200 mg twice-daily group, 23.9% in the 100 mg twice-daily group, and 17.1% in the 100 mg once-daily group met that definition. In the placebo group, 24.3% of participants also met the remission definition. For a secondary measure — "clinical response," meaning a meaningful improvement in symptoms and endoscopy score compared to the start of the trial — the reported figures were 62.3% for the 200 mg twice-daily group, 53.5% for the 100 mg twice-daily group, 57.1% for the 100 mg once-daily group, and 54.3% for the placebo group. No other outcome data was included in the structured results submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Crohn's Disease and Colitis Trial, Active, Not Recruiting

NCT05611671
Active, Not Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have had moderate to severe ulcerative colitis (UC) symptoms for at least 3 months before the screening visit.
  • Your UC affects a large enough portion of your colon (reaching at least 15 cm from the opening of the rectum).
  • You have tried at least one UC treatment in the past — such as aminosalicylates (e.g., mesalamine), steroids, immune-suppressing drugs (e.g., azathioprine), or advanced treatments like biologics or JAK inhibitors — and it either did not work well enough, stopped working, or you could not tolerate it.
  • You have never previously been treated with a type of medication called an "anti-integrin therapy" (either approved or experimental).
  • You are willing and able to follow all study rules and requirements.
  • You are able to give your signed, informed consent to take part.

Who may not be able to join:

  • You have been diagnosed with a different type of colitis or bowel condition, such as Crohn's disease, microscopic colitis, ischemic colitis, or radiation colitis, or you have symptoms that may suggest Crohn's disease.
  • You show positive results on a questionnaire used to screen for neurological (nerve or brain-related) symptoms.
  • You have another serious or unstable health condition occurring at the same time.
  • You have previously been treated with vedolizumab or any other approved or experimental integrin-blocking medication.
  • You are currently in another clinical trial or have received an experimental treatment within the last 30 days.
  • You have previously been given the study drug MORF-057, or you have a known allergy or sensitivity to drugs that work in a similar way.
  • You are unable to attend study appointments or follow the study procedures.

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Blacktown Hospital, Blacktown,
Concord Repatriation General Hospital, Concord,
Royal Brisbane and Women's Hospital, Herston,
Fiona Stanley Hospital, Murdoch,
Mater Adult Hospital Brisbane, South Brisbane,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Active, Not Recruiting
Phase
Phase 2
Sponsor
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Registry
ClinicalTrials.gov
Start date
21 November 2022
Est. completion
28 November 2024

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇵🇱 Poland 🇷🇴 Romania 🇷🇸 Serbia 🇸🇰 Slovakia 🇰🇷 South Korea 🇹🇼 Taiwan 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov