A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-1)
This study, called EMERALD-1, is looking at a new medicine called MORF-057 for adults who have moderately to severely active ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the large intestine. The main goal is to find out if MORF-057 can reduce the inflammation in the gut within 12 weeks, as measured by special tests. Researchers will also be checking how safe the medicine is by looking at any side effects people might have. They will also see how well people tolerate the medicine and how much of it stays in the body. This is an early stage study to understand if MORF-057 could be a helpful treatment option in the future.
At a glance
What is this study about?
This study is called EMERALD-1 and it's looking into a new medicine, MORF-057, for adults who have a form of inflammatory bowel disease called ulcerative colitis. Ulcerative colitis causes long-lasting inflammation and sores (ulcers) in the lining of your large intestine. The symptoms can include tummy pain, diarrhoea, and blood in your poo. This study is for people whose ulcerative colitis is currently active, meaning their symptoms are flaring up.
The main aim of this study is to see if MORF-057 can reduce the amount of inflammation in the gut after 12 weeks. Researchers will do this by looking at special tissue samples from the intestine. They also want to understand if the medicine is safe to use and if people can take it without too many problems. This type of study (Phase 2a) is an early step in testing a new medicine, helping doctors learn if it might be an effective treatment and how it works in the body.
By taking part, individuals help doctors learn more about ulcerative colitis and potential new ways to treat it. The results of this study will help decide if MORF-057 should be tested in larger studies with more people in the future. Finding new and better treatments is very important for people living with ulcerative colitis.
Key takeaways
- This study is testing a new medicine, MORF-057, for active ulcerative colitis.
- It's open to adults aged 18 and over with moderate to severe symptoms.
- The main goal is to see if MORF-057 reduces gut inflammation over 12 weeks.
- Researchers will also carefully check for safety and side effects.
- This is an early-stage study to understand if the medicine could be helpful.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.
The most important health requirement is that you must have ulcerative colitis that is currently active, and the doctors must consider it to be moderately to severely active. This means your symptoms are noticeable and affecting your daily life.
It's important to remember that there will be other specific medical checks to make sure the study medicine is right and safe for you. These will be explained by the study doctors if you are interested in taking part.
- Are you 18 years old or older?
- Do you have a diagnosis of ulcerative colitis?
- Is your ulcerative colitis currently active and causing moderate to severe symptoms?
- Are you willing and able to attend regular clinic appointments for 12 weeks?
- Are you comfortable taking a new investigational medicine?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would be given the new medicine, MORF-057, in capsule form. You would take this medicine for 12 weeks. During this time, you would have several visits to the clinic so that the study team can monitor your health, check for any changes in your symptoms, and see how you are reacting to the medicine. These visits would likely involve answering questions about your health, having physical examinations, and providing blood samples so researchers can measure the medicine in your body. Tissue samples from your gut would also be taken at the beginning and end of the study to check for changes in inflammation. After the 12 weeks of treatment, there would be a follow-up period to check on your health.
Potential risks and benefits
Locations (1)
- —Poland
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the large intestine (colon and rectum) becomes inflamed and develops small sores or ulcers. This can cause tummy pain, diarrhoea, and blood in your poo.
What does 'moderately to severely active' mean?
It means your ulcerative colitis symptoms are currently active and significant enough to affect your daily life, not just mild symptoms.
What is MORF-057?
MORF-057 is the new medicine being tested in this study. It's in capsule form and aims to reduce inflammation caused by ulcerative colitis.
How long does the study last?
The main treatment part of the study lasts for 12 weeks, with follow-up appointments afterwards.
What is a Phase 2a study?
This is an early stage of testing a new medicine. It helps researchers learn if the medicine is likely to work, how safe it is, and what dose might be best, before it's tested in larger groups of people.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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