This clinical trial is focused on studying the treatment of Ulcerative Colitis, a condition that causes inflammation and sores in the digestive tract. The study will explore the effectiveness of two treatments: Eltrekibart and Mirikizumab. Eltrekibart is a type of medication known as a monoclonal antibody, which is designed to target specific proteins in the body that may contribute to inflammation. Mirikizumab, also known by its code name LY3074828, is another monoclonal antibody that works by targeting different proteins involved in the inflammatory process.
The purpose of this study is to determine if Eltrekibart alone is more effective than a placebo in helping patients achieve remission, which means a reduction or disappearance of symptoms. The study will involve adult patients who have moderately to severely active Ulcerative Colitis. Participants will receive either Eltrekibart alone, Mirikizumab alone, a combination of both, or a placebo. The study will last for several weeks, with the main goal being to see how many participants achieve remission by the end of the study period.
Throughout the study, participants will receive their treatments through injections or infusions, depending on the medication. The study will monitor the participants’ health and response to the treatment over time. The results will help determine the potential benefits of using these medications for treating Ulcerative Colitis and may provide new insights into managing this condition more effectively.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm the diagnosis of ulcerative colitis and evaluate the severity of the condition. This involves reviewing medical history and current symptoms.
2medication administration
Participants receive the study medication, which may include eltrekibart alone or in combination with mirikizumab. The medication is administered as a solution for injection or solution for infusion.
The dosage and frequency of administration are determined based on the study protocol and the participant’s specific needs.
3monitoring and follow-up
Regular monitoring is conducted to assess the participant’s response to the treatment. This includes evaluating symptoms and any side effects experienced.
Follow-up visits are scheduled to ensure the participant’s safety and to adjust treatment as necessary.
4evaluation of clinical remission
At week 12, the primary endpoint is evaluated. This involves determining the proportion of participants who achieve clinical remission, which means a significant reduction or absence of symptoms.
5completion of study participation
Upon completion of the study period, participants undergo a final assessment to evaluate the overall effectiveness of the treatment and any long-term effects.
Participants are provided with information regarding their health status and any necessary follow-up care.
Who Can Join the Study?
Have had a confirmed diagnosis of Ulcerative Colitis (UC) for at least 3 months before starting the study. UC is a condition that causes inflammation and sores in the colon.
Have UC that is considered moderately to severely active, as determined by a specific scoring system used by doctors.
Have not responded well to, stopped responding to, or cannot tolerate at least one standard medication (like corticosteroids) or one advanced treatment (such as biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). These are types of medicines used to treat UC.
Are taking a stable dose of certain oral medications for UC, including corticosteroids. This means the dose of the medication has not changed recently.
Must follow specific rules regarding contraception. This means using methods to prevent pregnancy during the study.
Both males and females can participate in the study.
The study includes people from certain age groups, which are typically adults.
The study may include individuals considered part of a vulnerable population, which means they might need extra protection or care.
Who Cannot Join the Study?
Participants with other serious health conditions that could interfere with the study.
Individuals who have had recent surgery related to their digestive system.
People who are currently using certain medications that might affect the study results.
Participants who have a history of severe allergic reactions.
Individuals who are pregnant or breastfeeding.
People who have participated in another clinical trial recently.
Participants with a history of substance abuse.
Individuals who are unable to follow the study procedures.
Eltrekibart is a medication being studied to see if it can help people with moderately to severely active ulcerative colitis achieve clinical remission. It is being tested to determine its effectiveness when used alone.
Mirikizumab is another medication involved in the study. It is being tested in combination with eltrekibart to see if the combination is more effective in treating ulcerative colitis than eltrekibart alone.
Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It causes inflammation and ulcers in the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can lead to complications such as narrowing of the colon or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response.
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