A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC (NCT05291689) | Clinical Trial Compass
CompletedPhase 2
A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
United States, Poland39 participantsStarted 2022-04-13
Plain-language summary
This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC)
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening
* Has evidence of UC extending at least 15 cm from the anal verge
* Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs
* Agrees to abide by the study guidelines and requirements
* Capable of giving signed informed consent
Exclusion Criteria:
* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease
* Has positive findings on a subjective neurological screening questionnaire
* Has a concurrent, clinically significant, serious, unstable comorbidity
* Primary non-responder to vedolizumab or other integrin inhibitors
* Participation in any other interventional study or received any investigational therapy within 30 days
* Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
* Unable to attend study visits or comply with study procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Timeframe: From baseline to 12 weeks
Trial details
NCT IDNCT05291689
SponsorMorphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)