This study is looking at a condition called Crohn’s Disease that is moderately to severely active. Crohn’s Disease is a long-term condition that causes inflammation in the digestive system, which can lead to symptoms such as abdominal pain and frequent loose stools. The study will test a medication called icotrokinra, which is also known by its code name JNJ-77242113. This medication comes as a tablet that is taken by mouth. Some participants will receive icotrokinra while others will receive placebo tablets. The study aims to find out if icotrokinra works better than placebo in reducing the symptoms of Crohn’s Disease and in helping the disease become less active as seen during examination of the intestines.
The study is divided into different phases to test how well the medication works. In the first phase, called the induction phase, the goal is to see if icotrokinra can help reduce symptoms and improve the condition of the intestines after about 12 weeks of treatment. The study will look at whether participants have fewer symptoms and whether the inflammation in their intestines has improved. In the second phase, called the maintenance phase, participants who responded well to the treatment will continue to receive either icotrokinra or placebo for a longer period, up to about 40 weeks. This phase will check if the medication can help keep the disease under control over time and prevent symptoms from coming back.
Participants in this study must be adults who have been diagnosed with Crohn’s Disease for at least 12 weeks before joining the study. They need to have active disease with symptoms such as frequent loose stools or abdominal pain, and this must be confirmed by an examination of the intestines that shows inflammation and ulcers. Participants should have previously tried other treatments for Crohn’s Disease, such as steroids or other medications including biologics, but these treatments either did not work well enough, stopped working over time, or caused problems that made them difficult to tolerate. The study will last several years and will involve regular visits to monitor how well the treatment is working and to check for any side effects.
1Initial treatment period
This clinical trial is designed to test icotrokinra, an oral medication in the form of a film-coated tablet, for the treatment of moderately to severely active Crohn’s disease.
Crohn’s disease is a condition that causes inflammation in the digestive tract. The study will assess whether icotrokinra can help reduce symptoms and inflammation compared to a placebo, which is an inactive tablet that looks identical to the active medication but contains no active ingredient.
The trial consists of two main phases: an induction phase and a maintenance phase. The induction phase is designed to bring the disease under control, while the maintenance phase aims to keep it under control over a longer period.
2Induction phase
The induction phase lasts for 12 weeks. During this period, medication will be taken by mouth.
Participants will be randomly assigned to receive either icotrokinra tablets or placebo tablets. Neither the participant nor the treating physician will know which treatment is being given.
The primary goal of this phase is to evaluate whether icotrokinra can induce a clinical response, which means an improvement in symptoms, and achieve clinical remission, which means the disease becomes inactive or symptoms disappear.
Another important goal is to assess endoscopic response, which refers to improvement in inflammation as seen during an examination of the intestines with a camera.
At the end of the 12-week induction phase, the effectiveness of the treatment will be evaluated based on symptom improvement and findings from intestinal examination.
3Maintenance phase
The maintenance phase lasts for 40 weeks. This phase is designed to determine whether icotrokinra can maintain disease control over a longer period.
Participants who respond to treatment during the induction phase will continue in the maintenance phase. Medication will continue to be taken by mouth.
The primary goals of this phase are to evaluate whether icotrokinra can maintain clinical remission at week 40 and sustain endoscopic response at week 40.
Throughout this phase, the disease activity will be monitored to assess whether the treatment keeps symptoms under control and maintains improvement in intestinal inflammation.
4Assessment criteria
During the trial, disease activity will be measured using the CDAI score, which stands for Crohn’s Disease Activity Index. This is a scoring system that takes into account symptoms such as the number of liquid or soft stools per day and abdominal pain severity.
Another measurement tool is the SES-CD score, which stands for Simple Endoscopic Score for Crohn’s Disease. This score evaluates the size and extent of ulcers in different segments of the intestines during an examination with a camera.
These scores help determine whether the treatment is working by showing improvement in symptoms and healing of inflammation in the intestines.
Who Can Join the Study?
You must be at least 18 years old or the legal age of consent in your area.
You must have been diagnosed with Crohn’s Disease (a condition causing inflammation in the digestive tract) at least 12 weeks before the screening visit. This diagnosis must be confirmed by a camera examination of your intestines showing inflammation and a tissue sample report that supports the diagnosis.
Your Crohn’s Disease must be moderately to severely active, which means you have a score between 220 and 450 on a scale called CDAI (a scoring system that measures disease activity). You must also have either at least 4 loose or very soft bowel movements per day on average, or an average daily stomach pain score of at least 2.
Your Crohn’s Disease must show moderate to severe activity during a camera examination of your intestines. This is measured using a scoring system called SES-CD. You must have a score of at least 6 if the disease affects your colon or both your colon and small intestine, or a score of at least 4 if the disease affects only your small intestine. The examination must show ulcers (open sores) in at least one section of your intestines.
You must have previously tried standard treatments or advanced treatments for Crohn’s Disease and either did not respond well to them, stopped responding to them over time, or could not tolerate them. Standard treatments include corticosteroids (medications that reduce inflammation), thiopurines (medications that suppress the immune system), or methotrexate (another immune-suppressing medication). Advanced treatments include anti-TNF medications (drugs that block a protein causing inflammation), anti-integrin medications (drugs that prevent immune cells from entering the intestines), anti-interleukin medications (drugs that block specific inflammation signals), or JAK inhibitors (oral medications that reduce inflammation).
Who Cannot Join the Study?
The study does not list specific reasons why patients cannot participate in this clinical trial in the available information
You should discuss with your doctor whether this study is right for you based on your individual health situation
Your doctor will review your complete medical history and current health condition to determine if you can safely take part in this research
General factors that might prevent participation could include other serious health problems, certain medications you are taking, or previous treatments you have received
Women who are pregnant (carrying a baby) or breastfeeding (nursing a baby) are typically not able to join studies like this one for safety reasons
Icotrokinra is an investigational medication being studied for the treatment of moderately to severely active Crohn’s disease. Crohn’s disease is a condition that causes inflammation in the digestive tract. This medication works by blocking certain signals in the body that cause inflammation. In this study, icotrokinra is being tested to see if it can help reduce the symptoms of Crohn’s disease and keep the disease under control 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 icotrokinra to determine whether the actual medication is effective. Participants receiving placebo will not receive any active treatment for their Crohn’s disease during the study period.
Crohn’s Disease – Crohn’s disease is a chronic inflammatory condition that affects the digestive tract, most commonly the end of the small intestine and the beginning of the colon. The disease causes inflammation that extends deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The inflammation can occur in patches, with healthy tissue appearing between affected areas. Over time, the disease progresses through periods of active symptoms, called flares, and periods of remission when symptoms improve or disappear. The ongoing inflammation can lead to complications such as narrowing of the intestines, the formation of abnormal connections between different parts of the bowel, and sores or ulcers in the digestive tract. The severity of the disease varies among individuals, ranging from mild to severe cases that significantly impact daily activities.
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