This clinical trial is focused on studying the treatment of Moderately to Severely Active Ulcerative Colitis, a condition that causes inflammation and sores in the colon and rectum. The study will evaluate the effectiveness and safety of a combination therapy using two medications: Guselkumab and Golimumab. These medications are given as injections and are designed to help reduce inflammation in the body. The trial will also include a comparison with a placebo, which is a substance with no active medication, to better understand the effects of the treatment.
The purpose of the study is to assess how well the combination therapy works over a period of 48 weeks compared to using each medication alone. Participants will receive either the combination therapy, one of the medications alone, or a placebo. The study will monitor the participants’ health and response to the treatment throughout this period. The goal is to determine if the combination therapy can lead to clinical remission, which means a significant reduction or disappearance of symptoms, by the end of the study.
Participants in the study will receive their treatments through subcutaneous injections, which means the medication is injected under the skin. The study will use a device called the UltraSafe Plus™ Passive Needle Guard to help with self-injection and ensure safety during the process. This trial aims to provide valuable information on the potential benefits of combining Guselkumab and Golimumab for people living with Ulcerative Colitis.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of ulcerative colitis for at least three months and a certain level of disease activity.
Participants must have shown an inadequate response or intolerance to previous advanced therapies.
2initial treatment phase
Participants receive treatment with either guselkumab, golimumab, or a combination of both. These medications are administered as a subcutaneous injection.
The specific dosage and frequency of administration are determined by the study protocol.
3maintenance phase
After the initial treatment phase, participants continue with a maintenance phase where the effectiveness of the treatment is monitored.
The goal is to evaluate the efficacy of the combination therapy at Week 48 compared to each medication used alone.
4evaluation of outcomes
The primary outcome is to assess clinical remission at Week 48.
Participants’ progress is monitored throughout the study to ensure safety and effectiveness of the treatment.
Who Can Join the Study?
Have a confirmed diagnosis of ulcerative colitis (UC) for at least 3 months before starting the study. Ulcerative colitis is a condition that causes inflammation and sores in the colon.
Have moderately to severely active UC, which means the condition is more than mild, as measured by a specific scoring system called the modified mayo score.
Have shown an inadequate response, lost response, or cannot tolerate at least one advanced therapy for inflammatory bowel disease (IBD). This includes treatments like biologics or oral medications that work similarly to biologics.
If you are a female who can become pregnant, you must follow specific rules about contraception and reproduction during the study.
Who Cannot Join the Study?
Patients with other serious health conditions that could interfere with the study.
Patients who have had recent surgery or plan to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of certain infections, such as tuberculosis.
Patients who have used certain medications that might affect the study results.
Patients who have participated in another clinical trial recently.
Patients with a history of drug or alcohol abuse.
Patients who have certain allergies, especially to the study medication.
Patients who have been diagnosed with cancer in the past.
Guselkumab is a medication used in this trial to treat ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. It works by targeting specific proteins in the immune system to reduce inflammation and help control symptoms.
Golimumab is another medication used in the trial for ulcerative colitis. It is designed to block a protein in the body that causes inflammation, helping to reduce symptoms and improve the condition of the digestive tract.
JNJ-78934804 is an investigational therapy being tested in this trial. It is being studied to see how effective it is when used in combination with the other medications, guselkumab and golimumab, for treating ulcerative colitis. The goal is to determine if this combination can better manage the symptoms and inflammation associated with the condition.
Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of 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 strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in the gut.
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