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NCT06226883

NCT06226883
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have had signs or symptoms of Crohn's disease (CD) for at least 90 days before the screening visit.
  • Your Crohn's disease is considered moderately to severely active, based on a specific scoring system called the CDAI (with a score between 220 and 450), and you have frequent loose stools and/or significant abdominal pain on a daily basis.
  • A camera examination of your gut (such as a colonoscopy) shows a certain level of active inflammation, based on a scoring system called the SES-CD (confirm with trial site for exact score details).
  • Previous treatments for Crohn's disease have not worked well enough for you, stopped working over time, or caused side effects you could not tolerate — this includes steroids, medications that suppress the immune system (such as azathioprine, 6-mercaptopurine, or methotrexate), or more advanced treatments like biologic medicines or JAK inhibitors.

Who may not be able to join:

  • You have been diagnosed with a different type of bowel condition, such as ulcerative colitis, microscopic colitis, ischemic colitis, or radiation colitis, or your symptoms suggest you might have ulcerative colitis.
  • Your Crohn's disease only affects certain parts of the digestive tract (such as the mouth, stomach, or the area around the back passage), without involving the large or small intestine.
  • You have had a large section of your bowel removed (more than 100 cm), more than 3 bowel surgeries, or have been diagnosed with short bowel syndrome.
  • You are currently being fed through a tube or a drip directly into a vein (intravenous nutrition), or are on a liquid-only formula diet.
  • You have certain concerns flagged on a neurological (brain and nerve) screening questionnaire (confirm with trial site).
  • You have another serious or unstable health condition alongside your Crohn's disease.
  • You have previously been treated with a medicine called vedolizumab or any similar type of drug known as an integrin inhibitor.
  • You are currently taking part 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 are known to be allergic or sensitive to drugs that work in a similar way.
  • You are unable to attend the required study visits or follow the study procedures.
  • You have a history of a major neurological condition, such as a stroke, multiple sclerosis, a brain tumour, or a disease affecting the nerves or brain.

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.

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.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Registry
clinicaltrials_gov
Start date
18 July 2024
Est. completion
1 September 2028

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria Bosnia and Herzegovina 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇯🇵 Japan 🇰🇿 Kazakhstan 🇱🇻 Latvia 🇲🇽 Mexico Moldova 🇵🇱 Poland 🇷🇴 Romania 🇷🇸 Serbia 🇸🇰 Slovakia 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov