This study is looking at a condition called Ulcerative Colitis that is moderately to severely active. Ulcerative Colitis is a long-term condition where the large intestine becomes inflamed and develops sores. The treatment being tested is icotrokinra, which is also known by its code name JNJ-77242113. Some participants will receive icotrokinra while others will receive placebo. The purpose of this study is to evaluate how well icotrokinra works and how safe it is in treating people with this condition.
The study is divided into different parts for adults and adolescents. For adults, there is an induction phase and a maintenance phase. During the induction phase, the study will look at whether icotrokinra can help bring the disease under control compared to placebo. This part lasts 12 weeks. If participants respond well to the treatment during induction, they may continue into the maintenance phase, which lasts 40 weeks. During this time, the study will check if icotrokinra can keep the disease under control. For adolescents aged 12 to 17 years, the study focuses on the maintenance phase to see if icotrokinra can keep their condition under control after they have responded to the treatment.
Participants in this study will need to have been diagnosed with Ulcerative Colitis at least 12 weeks before joining. The study will involve regular assessments to measure how active the disease is and how well the treatment is working. The medication is given as a film-coated tablet taken by mouth. The study is expected to run for several years to gather information about the long-term effects of this treatment.
1Induction phase
This phase lasts for 12 weeks.
During this phase, you will receive either icotrokinra or placebo. The placebo is an inactive tablet that looks identical to the actual medication but contains no active ingredient.
Both icotrokinra and placebo are taken as film-coated tablets by mouth.
The goal of this phase is to determine if icotrokinra can help achieve clinical remission, which means reducing the symptoms of your condition to a minimal level.
Your disease activity will be assessed using a scoring system called the modified Mayo score, which evaluates the severity of your ulcerative colitis symptoms.
2Assessment at week 12
At the end of the induction phase, your response to treatment will be evaluated.
The assessment will determine if you have achieved clinical response, meaning your symptoms have improved sufficiently.
If you have responded to the treatment with icotrokinra during the induction phase, you may continue to the next phase of the study.
3Maintenance phase
This phase lasts for 40 weeks.
If you are an adult participant who responded to icotrokinra in the induction phase, you will receive either icotrokinra or placebo during this phase.
If you are an adolescent participant aged 12 to less than 18 years who responded to icotrokinra in the induction phase, you will receive icotrokinra during this phase.
The medication continues to be taken as film-coated tablets by mouth.
The goal of this phase is to determine if icotrokinra can help maintain clinical remission over a longer period.
4Final assessment at week 40 of maintenance
At the end of the maintenance phase, your condition will be assessed to determine if you have achieved or maintained clinical remission.
This assessment marks the completion of the main treatment period of the study.
Who Can Join the Study?
You must be at least 12 years old at the time of joining the study. If you are an adult participant, you must be at least 18 years old and meet the legal age to give consent in your area.
You must have been diagnosed with ulcerative colitis, which is a condition that causes inflammation and sores in the lining of the large intestine, at least 12 weeks before the screening visit. This diagnosis must be confirmed by a camera examination of your intestine and a laboratory test of tissue samples.
Your ulcerative colitis must be moderately to severely active. This means your disease activity score, called the modified Mayo score, must be between 5 and 9 points at the start of the study. This score is based on a camera examination of your intestine reviewed by specialists.
The camera examination of your intestine must show a score of at least 2 points on the endoscopy subscore, which measures how inflamed and damaged the lining of your intestine appears.
If your ulcerative colitis has affected your entire colon for 8 years or more, or if it has affected only the left side of your colon for 10 years or more, you must have a complete colonoscopy, which is a camera examination of your entire large intestine. This examination must check for dysplasia, which means abnormal cells that could develop into cancer. This examination must have been done within 1 year before starting the study treatment, and it can be done during the screening period.
Who Cannot Join the Study?
The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why someone cannot participate are not available in this data
Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details would need to be obtained from the complete study documentation
If you have questions about whether you can participate, the research team would need to review your individual medical history and current health status
Icotrokinra is an investigational medication being studied for the treatment of moderately to severely active ulcerative colitis. Ulcerative colitis is a condition where the lining of the colon becomes inflamed and develops sores. This medication is being tested to see if it can help reduce inflammation and bring the disease under control, both when starting treatment and for keeping symptoms away over time.
Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against the actual medication to help determine if the medication is truly effective. Some participants will receive the placebo instead of the active medication.
Ulcerative Colitis – Ulcerative Colitis is a long-term condition that causes inflammation and sores in the innermost lining of the large intestine and rectum. The disease typically begins in the rectal area and may spread to involve other parts of the colon over time. Symptoms often include bloody diarrhea, abdominal pain and cramping, urgent need to have bowel movements, and fatigue. The inflammation occurs in a continuous pattern without healthy tissue in between affected areas. The condition usually develops gradually and tends to follow a pattern of flare-ups when symptoms worsen, followed by periods of remission when symptoms improve or disappear. In moderate to severe cases, the inflammation is more extensive and symptoms significantly impact daily activities and quality of life.
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