A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
This research study is for adults who have a type of bowel disease called ulcerative colitis, specifically if it's moderate to severe. The study is investigating two new potential medicines, Eltrekibart and Mirikizumab. The main goal is to find out how safe these medicines are and how well they work to help people with their symptoms. There's also a 'placebo' group, where some people will receive a dummy treatment instead of the active medicine. This helps researchers compare the real drug's effects. The study will last for about 4-5 years in total, with each person taking part for around 69 weeks, including initial checks.
At a glance
What is this study about?
This research study is focused on adults who are living with ulcerative colitis (UC), a long-term condition that causes inflammation and sores in the lining of the large intestine. When UC is moderate to severe, it can cause uncomfortable symptoms like tummy pain, urgent trips to the toilet, and tiredness. For many, existing treatments don't always work as well as hoped, or they might stop working over time. That's why researchers are constantly looking for new and better ways to manage the condition.
In this study, doctors are testing two new potential medicines called Eltrekibart and Mirikizumab. They want to understand if these medicines can help reduce the inflammation in the bowel and improve symptoms, ultimately making a real difference to people's quality of life. They will compare these new treatments against a 'placebo', which is a dummy treatment that looks like the real medicine but contains no active drug. This comparison is really important for understanding if the new medicines are truly effective.
The study aims to gather important information about how safe Eltrekibart and Mirikizumab are and how well they can help people with moderate to severe UC. The information collected from studies like this helps doctors decide if new treatments are good enough to be used more widely in the future to help many more people living with ulcerative colitis.
Key takeaways
- This study evaluates new treatments (Eltrekibart and Mirikizumab) for moderate to severe ulcerative colitis.
- It aims to find out if these medicines are safe and effective.
- Participants will receive either an active medicine or a placebo.
- The study involves regular visits and lasts about 69 weeks for each person.
- Participation holds potential benefits like access to new treatments, but also potential risks from side effects.
- You can withdraw from the study at any time.
Who may be eligible?
To be part of this study, you need to be an adult between 18 and 75 years old and have been diagnosed with ulcerative colitis for at least three months. Your UC symptoms should be considered moderate to severe by the study doctors. Also, previous treatments you've tried, like certain medicines or advanced therapies, either haven't worked well, stopped working, or caused you problems.
There are also some reasons why you might not be able to join. For example, if you've recently had a blood clot or if you have Crohn's disease, which is another inflammatory bowel disease. Also, if you've recently had certain surgeries or are likely to need surgery for your UC during the study, you probably won't be able to take part. Researchers also need to make sure you're not pregnant or planning to become so during the study.
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.
- Are you an adult between 18 and 75 years old?
- Have you been diagnosed with ulcerative colitis for at least 3 months?
- Has your ulcerative colitis been rated as moderate to severe by a doctor?
- Have previous ulcerative colitis treatments not worked well for you, stopped working, or caused problems?
- Are you not currently pregnant, breastfeeding, or planning to become pregnant during the study?
- Have you not had certain other medical conditions or surgeries recently?
What does participation involve?
If you decide to take part, the first step is a 'screening' process to check if the study is right for you. This must happen within 35 days before you officially join. Once enrolled, you'll be in the study for about 69 weeks (around 16 months). During this time, you'll receive either one of the new study medicines or a placebo. You'll have regular appointments at the clinic for assessments, which might include health checks, blood tests, and discussions about how you're feeling and any changes in your symptoms. The exact number of visits will be explained by the study team, but they're important for the doctors to monitor your health and how the treatment is working.
Potential risks and benefits
Locations (207)
- AZ Gastro Care - ChandlerVerified postcodeChandler, United States· Not yet recruiting
- Applied Research Center of ArkansasVerified postcodeLittle Rock, United States· Recruiting
- Preferred Research PartnersVerified postcodeLittle Rock, United States· Not yet recruiting
- Erick Alayo Medical Corp/Gastro SB ClinicVerified postcodeChula Vista, United States· Recruiting
- Southern California GI and Liver Centers (SCLC)Verified postcodeCoronado, United States· Recruiting
- Valley View ResearchVerified postcodeGarden Grove, United States· Recruiting
- Om Research, LLCVerified postcodeLancaster, United States· Recruiting
- United Medical DoctorsVerified postcodeLos Alamitos, United States· Recruiting
- Clinnova ResearchVerified postcodeOrange, United States· Recruiting
- Prospective Research InnovationsVerified postcodeRancho Cucamonga, United States· Recruiting
- Clinical Trials Management Services, LLCVerified postcodeThousand Oaks, United States· Recruiting
- Om Research LLCVerified postcodeVictorville, United States· Recruiting
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops small sores, causing symptoms like abdominal pain and frequent bowel movements.
What does 'moderately to severely active' mean?
This means your ulcerative colitis symptoms are causing a significant impact on your daily life, and your doctor would rate your condition as not mild.
What is a 'placebo'?
A placebo is an inactive substance that looks just like the real medicine. It helps researchers compare how well the actual new medicines work.
How long will I be in the study if I join?
If you are eligible and decide to join, you will be part of the study for about 69 weeks, which is roughly 16 months.
Can I stop being part of the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and it will not affect your ongoing medical care.
How to find out more
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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