Efficacy and Safety Evaluation of JNJ-77242113 in Moderate to Severe Ulcerative Colitis: A Phase 2b Randomized, Placebo-Controlled, Dose-Ranging Study

The primary objective of this study is to evaluate the **efficacy** of JNJ-77242113 compared to placebo in inducing a clinical response in patients with moderately to severely active **Ulcerative Colitis**. This is clinically relevant as it aims to determine the potential of JNJ-77242113 as a therapeutic option for managing this chronic inflammatory bowel disease, which can significantly impact patients' quality of life.

The clinical trial involves a total of **142 participants** diagnosed with **Ulcerative Colitis**. The study population includes both male and female subjects, aged 18 years and older, with a documented diagnosis of moderately to severely active Ulcerative Colitis. Participants were selected based on specific inclusion criteria, such as having a baseline modified Mayo score of 5 to 9 and an endoscopy subscore of 2 or higher. The trial also considers individuals with extensive Ulcerative Colitis for at least 8 years or disease limited to the left side of the colon for at least 10 years. Participants aged 45 years or older must have undergone a full colonoscopy to assess for adenomatous polyps. The trial population includes a vulnerable group, and lifestyle factors such as diet and physical activity are not specified. The selection process ensures a comprehensive assessment of the efficacy of JNJ-77242113 versus placebo in inducing clinical response in this patient population.

The clinical trial is designed to evaluate the efficacy and safety of **JNJ-77242113** in participants with moderately to severely active **ulcerative colitis**. This is a Phase 2b, multicenter, randomized, placebo-controlled, dose-ranging study. The trial will employ a double-blind methodology to ensure unbiased results. Participants will be randomly assigned to receive either the investigational drug or a placebo, with neither the participants nor the investigators aware of the group assignments. The trial is expected to last until January 16, 2026, with recruitment starting on November 25, 2023.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on specific criteria, such as age, documented diagnosis of ulcerative colitis, and disease activity level. The primary endpoint is the clinical response at Week 12. Follow-up visits will occur at regular intervals to monitor the participants' health and response to the treatment. The end-of-study visit will conclude the trial, assessing the overall outcomes and any long-term effects of the treatment.

The expected length of participant involvement is up to 76 weeks, depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include adverse reactions, non-compliance with study procedures, or withdrawal of consent. The trial aims to provide valuable insights into the potential benefits and risks of JNJ-77242113 for treating ulcerative colitis, contributing to the development of effective therapeutic strategies for this condition.

The clinical trial involves the evaluation of several treatments for the management of **ulcerative colitis**. The primary experimental medication under investigation is JNJ-77242113, a peptide-based compound provided in the form of a film-coated tablet. This medication is administered orally. The dosing schedule and specific dosage amounts are not specified, but the maximum treatment period is set at 76 days. The study aims to assess the efficacy and safety of JNJ-77242113 in inducing a clinical response in patients with moderately to severely active ulcerative colitis.

In addition to the experimental treatment, the trial includes a placebo group. The placebo is also provided in the form of a film-coated tablet, designed to match the appearance of JNJ-77242113 tablets but without the active substance. The placebo is administered orally, following the same schedule as the experimental medication, to maintain blinding and ensure the integrity of the study results.

Several auxiliary treatments are included in the study to provide a comprehensive evaluation of the experimental medication's efficacy. **Azathioprine** is one such auxiliary treatment, administered orally in the form of a tablet. It is a chemical compound with immunosuppressive properties, commonly used in the management of autoimmune conditions. The dosing schedule and specific dosage amounts for azathioprine are not detailed, but it is included as a standard-of-care therapy.

Another auxiliary treatment is **mercaptopurine**, also administered orally in tablet form. Mercaptopurine is a chemical compound with immunosuppressive effects, often used in the treatment of inflammatory bowel diseases. The study does not specify the dosing schedule or dosage amounts for mercaptopurine, but it is included as part of the standard-of-care therapy.

**Methotrexate** is included as an auxiliary treatment, administered via intramuscular injection. Methotrexate is a chemical compound with immunosuppressive and anti-inflammatory properties, used in various autoimmune conditions. The dosing schedule and specific dosage amounts for methotrexate are not provided, but it is part of the standard-of-care therapy in the study.

Additionally, the study includes a group receiving **aminosalicylic acid and similar agents**, administered orally. These agents are anti-inflammatory compounds used in the management of inflammatory bowel diseases. The specific dosing schedule and dosage amounts are not detailed, but they are included as part of the standard-of-care therapy.

Lastly, **corticosteroids acting locally** are included as an auxiliary treatment, administered orally. These are anti-inflammatory agents used to manage inflammation in the gastrointestinal tract. The study does not specify the dosing schedule or dosage amounts for corticosteroids, but they are part of the standard-of-care therapy.

Participant compliance with the treatment regimen is monitored throughout the study to ensure adherence to the dosing schedules and to evaluate the efficacy and safety of the experimental and auxiliary treatments. The trial is designed to provide a comprehensive assessment of JNJ-77242113 in comparison to placebo and standard-of-care therapies in the treatment of ulcerative colitis.

The efficacy of JNJ-77242113 in the treatment of moderately to severely active **Ulcerative Colitis** will be assessed in a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study. The primary endpoint for evaluating efficacy is the clinical response at Week 12. This endpoint will be measured using the modified Mayo score, which is a validated scale for assessing disease activity in ulcerative colitis. The modified Mayo score includes an endoscopy subscore, which will be obtained during the central review of the screening video endoscopy. Participants must have a baseline modified Mayo score of 5 to 9, inclusive, with an endoscopy subscore of at least 2 to qualify for the study. The clinical response will be determined by comparing the modified Mayo scores from baseline to Week 12. Data collection will occur at specified timepoints, and the analysis will focus on the change in scores to evaluate the efficacy of JNJ-77242113 compared to placebo. The study is designed to ensure rigorous assessment of the treatment's impact on disease activity, providing valuable insights into its potential benefits for patients with ulcerative colitis.