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Study on the Effectiveness and Safety of JNJ-77242113 for Patients with Moderate to Severe Ulcerative Colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Ulcerative Colitis, a condition that causes inflammation and sores in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The study will evaluate a new medication known by its code name, JNJ-77242113, to see how effective and safe it is for people with moderately to severely active ulcerative colitis. Participants in the study will receive either the medication or a placebo, which is a substance with no active drug, to compare the effects.

The purpose of the study is to assess whether JNJ-77242113 can help reduce the symptoms of ulcerative colitis. The study will last for a period of 76 weeks, during which participants will be monitored for their response to the treatment. The medication will be administered in the form of a film-coated tablet taken orally. Throughout the study, participants will have regular check-ups to track their progress and any changes in their condition.

In addition to JNJ-77242113, the study will also involve other medications that are commonly used to manage ulcerative colitis, such as Mercaptopurine, Methotrexate, and Azathioprine. These medications are known to help control inflammation and immune system activity. The study aims to provide valuable information on the potential benefits of JNJ-77242113 in improving the quality of life for those living with ulcerative colitis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of ulcerative colitis, which must have been documented at least 12 weeks prior to this assessment.

    A video endoscopy is performed to obtain an endoscopy subscore, which must be 2 or higher. This score is part of the modified Mayo score, which ranges from 5 to 9 for moderately to severely active ulcerative colitis.

  2. Step 2

    Baseline colonoscopy

    Participants with extensive ulcerative colitis for 8 years or more, or disease limited to the left side of the colon for 10 years or more, must undergo a complete colonoscopy to check for dysplasia.

    Participants aged 45 or older must have had a colonoscopy within the last 5 years to check for adenomatous polyps, or they must undergo one during the screening period. Any polyps found must be removed before starting the study treatment.

  3. Step 3

    Treatment phase

    The treatment phase involves the administration of the study medication, JNJ-77242113, which is provided in the form of a film-coated tablet for oral use.

    The study is designed to evaluate the efficacy of JNJ-77242113 compared to a placebo in inducing a clinical response in participants with moderately to severely active ulcerative colitis.

  4. Step 4

    Evaluation of clinical response

    The primary endpoint of the study is to assess the clinical response at Week 12. This involves evaluating the improvement in symptoms and overall condition of the ulcerative colitis.

Who can join the trial?

6 criteria

  • You must be 18 years old or older, or the legal age of consent in your area.
  • You need to have a documented diagnosis of Ulcerative Colitis (UC) for at least 12 weeks before the screening. This means your condition should have been confirmed in the past through tests like X-rays, tissue samples, or a camera examination of the colon.
  • Your UC should be moderately to severely active. This is determined by a specific score (modified Mayo score) between 5 to 9, which is based on a video examination of your colon.
  • You need to have a score of 2 or more on a part of the examination called the endoscopy subscore, which is reviewed during the screening.
  • If you have had extensive UC for 8 years or more, or if your disease is limited to the left side of the colon for 10 years or more, you must have had a complete colon examination within the last year to check for abnormal cell growth (dysplasia). Alternatively, you can have this examination during the screening period according to local guidelines.
  • If you are 45 years old or older, you must have had a full colon examination within the last 5 years to check for growths called adenomatous polyps, or you can have this examination during the screening. Any polyps found must be removed before starting the study treatment.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than Ulcerative Colitis cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not female or male cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate.
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Investigated drugs

JNJ-77242113 is a medication being studied for its potential to treat moderately to severely active ulcerative colitis. This trial aims to determine how effective and safe this medication is in helping patients achieve a clinical response, which means reducing the symptoms and inflammation associated with ulcerative colitis.

What is already known about the treatment

JNJ-77242113 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderately to severely active ulcerative colitis. It is in the investigational stage, meaning it is not yet approved for general medical use, but it is being evaluated for its potential benefits and safety. The main therapeutic indication for JNJ-77242113 is ulcerative colitis, a chronic inflammatory condition of the colon. At the molecular level, it works by modulating specific pathways involved in the inflammatory process, aiming to reduce inflammation and improve symptoms. It is classified pharmacologically as an immunomodulator, which means it helps regulate the immune system's activity.

Investigated diseases

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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504673-20-00Protocol code77242113UCO2001Estimated enrolment244 patientsSponsorJanssen - Cilag International

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