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Study on the Long-Term Effects and Safety of Mirikizumab for Patients with Crohn's Disease

Verified siteInvestigationalNo 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 long-term effects of a medication called Mirikizumab in individuals with Crohn's Disease. Crohn's Disease is a chronic inflammatory condition that affects the digestive tract, causing symptoms like abdominal pain, diarrhea, and weight loss. The medication being tested, Mirikizumab, is administered as a solution for injection and is designed to help manage the symptoms of this disease.

The purpose of this study is to evaluate how effective and safe Mirikizumab is over an extended period. Participants in the study will receive Mirikizumab and will be monitored to see how well the medication works in reducing the symptoms of Crohn's Disease. The study will also assess the safety of the medication to ensure it is well-tolerated by those taking it.

Throughout the study, participants will receive regular injections of Mirikizumab and will have scheduled visits with healthcare professionals to track their progress. The study aims to provide valuable information on the long-term use of Mirikizumab for managing Crohn's Disease, helping to improve treatment options for those affected by this condition.

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

    Participation begins after completing a previous study related to Crohn's disease. Eligibility is confirmed based on prior study completion and specific criteria, such as contraception requirements for female participants.

  2. Step 2

    Initial treatment phase

    The treatment involves the administration of mirikizumab, a solution for injection. The medication is provided in a pre-filled syringe for ease of use.

  3. Step 3

    Ongoing treatment and monitoring

    Participants continue to receive mirikizumab as a solution for injection or infusion. Regular monitoring is conducted to assess the long-term efficacy and safety of the treatment.

  4. Step 4

    Evaluation of treatment response

    The primary goal is to evaluate the percentage of participants achieving an endoscopic response and clinical remission by week 52. Endoscopic response is measured using the Simple Endoscopic Score for Crohn's Disease (SES-CD), and clinical remission is assessed based on the Crohn's Disease Activity Index (CDAI).

  5. Step 5

    Completion of the study

    The study is estimated to conclude by December 20, 2026. Participants will have contributed to understanding the long-term effects of mirikizumab in managing Crohn's disease.

Who can join the trial?

4 criteria

  • Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130).
  • If the participant is female, she must meet the requirements for using birth control.
  • Both male and female participants are eligible to join the study.
  • The study includes participants from vulnerable populations, which means people who might need extra care or protection.

Who cannot join the trial?

5 criteria

  • Participants who have a different condition than Crohn's Disease cannot join. Crohn's Disease is a condition that affects the digestive system.
  • Participants who are not within the specified age range cannot join. The age range for this study is not specified here, but it is important for eligibility.
  • Participants who are not part of the specified clinical trial groups cannot join. This means the study is looking for specific types of participants.
  • Participants who are not male or female cannot join. The study is open to both males and females.
  • Participants who are considered part of a vulnerable population cannot join. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Mirikizumab is a medication being studied for its long-term effectiveness and safety in treating patients with Crohn's disease. It is designed to help reduce inflammation in the intestines, which is a common problem in people with Crohn's disease. The goal of using Mirikizumab in this trial is to see how well it works over an extended period and to monitor any potential side effects.

What is already known about the treatment

Mirikizumab – This medication is administered via injection and is currently being studied in clinical trials for its long-term efficacy and safety in treating Crohn's Disease. It is not yet widely available in medical practice, as it is still under investigation. Mirikizumab is primarily indicated for patients with Crohn's Disease, a chronic inflammatory condition of the gastrointestinal tract. It works by targeting and inhibiting specific proteins involved in the inflammatory process, thereby reducing inflammation at the molecular level. Mirikizumab is classified as a monoclonal antibody, which is a type of biologic drug designed to interact with specific components of the immune system.

Investigated diseases

Crohn's Disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. Common symptoms include abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The disease can affect any part of the digestive tract, from the mouth to the anus, but most commonly affects the end of the small intestine.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502841-91-00Protocol codeI6T-MC-AMAXEstimated enrolment780 patientsSponsorEli Lilly & Co.

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