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Study on the Safety and Effectiveness of Lutikizumab and Adalimumab for Adults with Moderate to Severe Ulcerative Colitis

Verified siteRegistered drugNo placebo
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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 effects of a medication called lutikizumab in adults with ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The study will compare the safety and effectiveness of lutikizumab to another medication known as adalimumab, which is already used to treat this condition. Participants in the study will receive either lutikizumab, adalimumab, or a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how well lutikizumab works in reducing the symptoms of ulcerative colitis and to monitor any side effects. The study will involve both intravenous (IV) and subcutaneous (SC) forms of lutikizumab, meaning the medication will be administered either through a vein or under the skin. Participants will be monitored over a period of time to assess changes in their disease activity and any adverse events they may experience.

Throughout the study, participants will undergo regular assessments to track their progress. The study aims to determine the percentage of participants who show improvement in their condition by week 12. This includes looking at endoscopic improvement, which involves examining the inside of the colon, as well as clinical remission and response, which refer to the reduction or disappearance of symptoms. The study is expected to last for up to 52 weeks, providing valuable information on the long-term effects of lutikizumab in treating ulcerative colitis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is confirmed to have a diagnosis of ulcerative colitis for at least 90 days. This includes documentation of biopsy results consistent with the diagnosis.

    The participant must have active ulcerative colitis with a Modified Mayo Score (mMS) of 5 to 9 points and a Mayo Endoscopic Subscore (ESS) of 2 to 3.

  2. Step 2

    Initial treatment phase

    The participant receives adalimumab or lutikizumab as part of the treatment. Adalimumab is administered as a 40 mg solution for injection under the skin (subcutaneous) using a pre-filled syringe.

    Lutikizumab is administered either as a subcutaneous injection or as an intravenous infusion, depending on the specific treatment plan.

  3. Step 3

    Treatment administration

    The participant receives the medication according to the study's schedule. The frequency and dosage are determined by the study protocol and may vary between participants.

    The treatment aims to evaluate the safety and effectiveness of lutikizumab compared to adalimumab in managing ulcerative colitis.

  4. Step 4

    Monitoring and assessment

    Throughout the study, the participant's health and response to the treatment are closely monitored. This includes regular assessments of disease activity and any side effects experienced.

    The primary goal is to determine the percentage of participants who achieve endoscopic improvement at week 12.

  5. Step 5

    Evaluation of results

    At week 12, the participant's progress is evaluated to determine if there has been clinical remission or response according to the Modified Mayo Score.

    The study also assesses the percentage of participants who achieve endoscopic remission at this time.

Who can join the trial?

5 criteria

  • The participant must have been diagnosed with Ulcerative Colitis (UC) for at least 90 days before starting the study. There should be proper documentation, like biopsy results, that confirms this diagnosis.
  • The participant must have active UC, which means their condition is currently causing symptoms. This is measured using a Modified Mayo Score (mMS) of 5 to 9 points and a Mayo Endoscopic Subscore (ESS) of 2 to 3. These scores are confirmed by a central review.
  • The participant must have shown an inadequate response, lost response, or been intolerant to at least one of the following treatments: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies. This means the treatments did not work well enough, stopped working, or caused side effects that could not be tolerated.
  • Both male and female participants are eligible to join the study.
  • The study does not include vulnerable populations, which means it is not designed for groups that might need special protection or care.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a history of heart disease or other serious heart conditions.
  • Patients who have a history of liver or kidney disease.
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Investigated drugs

  • Lutikizumab

    is a medication being studied for its potential to help people with moderately to severely active ulcerative colitis. It is being tested to see if it can reduce inflammation in the colon and improve symptoms of this condition. The study aims to determine how safe and effective this medication is for patients.

  • Adalimumab

    is a medication already used to treat various inflammatory conditions, including ulcerative colitis. In this trial, it serves as a comparison to evaluate the effectiveness and safety of lutikizumab. Adalimumab works by blocking a specific protein in the body that causes inflammation, helping to reduce symptoms and improve quality of life for patients with ulcerative colitis.

What is already known about the treatment

  • Lutikizumab

    Lutikizumab is administered via injection and is currently being studied in clinical trials for its safety and effectiveness in treating moderately to severely active ulcerative colitis. It is not yet widely used in medical practice, as it is still under investigation. The medication works by targeting specific proteins in the immune system to reduce inflammation in the colon. Lutikizumab is classified as a monoclonal antibody, which is a type of biologic drug designed to interfere with the body's inflammatory response.

  • Adalimumab

    Adalimumab is administered through subcutaneous injection and is an established medication used to treat various inflammatory conditions, including ulcerative colitis. It is well-documented in medical literature and widely used in clinical practice. The drug works by blocking a protein called tumor necrosis factor (TNF), which plays a role in inflammation. Adalimumab is classified as a TNF inhibitor, a type of biologic therapy that helps reduce inflammation and manage symptoms in patients with autoimmune diseases.

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 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505678-14-00Protocol codeM23-703Estimated enrolment207 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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