A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-2)
Ulcerative colitis is a long-term condition that causes painful inflammation and ulcers in the bowel. This clinical trial is testing a new oral treatment, named MORF-057, in adults living with moderate to severe symptoms. The main goal is to find out if MORF-057 is safe and effective at calming gut inflammation compared with a dummy capsule (a placebo). Participants will take either the study drug at one of three different doses or a dummy capsule. Neither you nor the trial team will know which you receive. Doctors will track your symptoms—such as bleeding and how often you need the toilet—and look at the bowel lining using camera checks (endoscopies). The study checks whether the treatment helps bring your condition into remission after 12 weeks and whether these improvements last up to 52 weeks.
At a glance
What is this study about?
Ulcerative colitis is a lifelong illness where parts of the large bowel become swollen, inflamed, and sore. For many people, it causes exhausting symptoms, including sudden urges to rush to the toilet, painful cramps, and blood in the stool. While current treatments help many individuals, they do not work for everyone, or they can stop working over time. That is why doctors are looking for new, convenient treatment options.
This trial is testing an experimental medicine called MORF-057. It comes as a capsule you swallow, and it works by trying to stop specific inflammatory cells from moving into the gut wall. By blocking these cells, researchers hope to calm the swelling, give the lining of the bowel a chance to heal, and bring about long-lasting symptom relief, known as remission.
Taking part helps doctors answer crucial questions: does this medicine work better than a dummy pill, which dose works best, and is it safe to take? The answers could lead to new treatment options for people living with ulcerative colitis across the UK.
Key takeaways
- Testing a new daily oral capsule (MORF-057) for moderate to severe ulcerative colitis.
- Compares three different doses against an inactive dummy pill (placebo).
- Looks at gut healing and symptom relief over 12 weeks, continuing up to 52 weeks.
- Open to adults aged 18 and over who have active bowel symptoms.
- Participation is entirely voluntary and you can withdraw at any point.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with moderate to severe ulcerative colitis. To join, you should currently have active symptoms, such as frequent bowel movements or blood in your poo, showing that your bowel is currently inflamed.
Because this is a trial for people with active disease, you will need to undergo a few health checks before joining to confirm that your inflammation meets the study criteria. The trial team will review your past medications and medical history to make sure the trial is safe for you.
You might not be able to take part if you have certain other serious health issues, specific gut complications, or if you are taking medications that cannot be safely mixed with the trial drug. The trial doctors will discuss these details with you during screening.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am at least 18 years old.
- I have been diagnosed with ulcerative colitis.
- My colitis is currently active (with symptoms like bleeding or frequent loose stools).
- I am willing to swallow capsules daily.
- I am comfortable having clinic visits and camera tests (endoscopies) to check my bowel.
What does participation involve?
If you take part, you will be in the study for up to 52 weeks (around one year). You will be put into a group by chance to receive either one of three doses of MORF-057 or an inactive dummy pill (placebo). Neither you nor your doctor will get to choose or know which group you are in, which ensures the results are completely fair.
You will need to take capsules daily and attend regular hospital appointments. During these visits, doctors will monitor your health through blood and stool tests, physical exams, and questions about your daily symptoms. You will also have a camera test (endoscopy) at the start, at week 12, and at week 52 so the team can look directly at the lining of your bowel and take tiny tissue samples to see if it has healed.
Potential risks and benefits
Locations (13)
- —UnverifiedItaly
- —UnverifiedHungary
- —UnverifiedLatvia
- —UnverifiedFrance
- —UnverifiedBulgaria
- —UnverifiedCzechia
- —UnverifiedEstonia
- —UnverifiedLithuania
- —UnverifiedAustria
- —UnverifiedGermany
- —UnverifiedSlovakia
- —UnverifiedPoland
Common questions
What is a placebo?
A placebo is a dummy pill that looks identical to the real medicine but contains no active ingredients. It helps scientists prove whether any health improvements are genuinely caused by the new drug.
How is the trial drug taken?
MORF-057 is an oral capsule that you swallow with water, rather than an injection or drip.
Will I have to pay for the treatment?
No. All study medicines, appointments, and medical tests are provided free of charge, and trial sites often help cover reasonable travel expenses.
What is 'remission'?
Remission means a period where your symptoms have settled down and the lining of your gut shows little or no signs of active inflammation.
Can I leave the study early?
Yes. You have the right to withdraw from the study at any time, for any reason, and your regular doctor will support your ongoing care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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