Active not recruitingPHASE3INTERVENTIONAL

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

This study is designed to learn more about a medicine called mirikizumab for individuals living with Crohn's disease. Researchers want to understand if it continues to be helpful and safe over a longer period. Participants in this study have already taken part in an earlier study involving mirikizumab. By continuing to follow these individuals, the study aims to gather important information about the long-term benefits and any potential side effects of this treatment. This will help doctors and patients make informed decisions about managing Crohn's disease in the future. The study is open to adults of all genders.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

996

Start

22 Jun 2020

Estimated completion

01 Apr 2027

Crohn's Disease

Results

Results from this study

Posted December 2025

Results have been published for this study.

Primary outcome

Percentage of Participants Achieving Endoscopic Response at Week 52 (Participants Originating From AMAM Study)

Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.

Full results on the registry

What is this study about?

This study is about a medicine called mirikizumab, which is being investigated for treating Crohn's disease. Crohn's disease is a long-term condition that causes inflammation in the digestive system. This can lead to symptoms like stomach pain, diarrhoea, weight loss, and tiredness. Finding effective treatments is very important for improving the quality of life for people with Crohn's.

The main goal of this particular study is to see how well mirikizumab works and how safe it is over a longer period. Many medicines are first tested in shorter studies, but it's also important to understand their effects when used for a longer time. This helps us get a full picture of what to expect from the treatment. The participants in this study have already received mirikizumab (or a placebo) in previous studies, so this is a chance to keep track of their progress.

By carefully observing participants and gathering information on their health and any side effects, researchers hope to learn more about the long-term benefits and risks of mirikizumab. This information is really important because it helps doctors decide if a medicine is a good option for people with Crohn's disease and how it can be used safely and effectively in the long run. It also helps to build a better understanding of Crohn's disease treatments in general.

Key takeaways

This study focuses on the long-term effects of mirikizumab for Crohn's disease.
Only people who were in a previous mirikizumab study can now join this one.
The aim is to check if the medicine remains safe and effective over time.
The study includes adults of all genders.
Participants will have regular check-ups and monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, you must have already taken part in one of two previous studies involving mirikizumab. These previous studies were I6T-MC-AMAG or I6T-MC-AMAM.

There are also some important health conditions that would prevent you from taking part. For example, if you developed a new serious health condition, like cancer, during your previous study, or if you currently have certain serious infections like hepatitis B, hepatitis C, HIV/AIDS, or active tuberculosis, you wouldn't be able to join. However, if you had tuberculosis in the past and it was properly treated according to health guidelines, you might still be able to participate.

It's also important that you haven't had a severe allergic reaction to mirikizumab or any of its ingredients in the past. Women who are pregnant, breastfeeding, or planning to become pregnant during the study or shortly after would not be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Did you take part in the I6T-MC-AMAG or I6T-MC-AMAM study?
Do you have any serious infections like hepatitis B, C, HIV/AIDS, or active TB?
Have you developed any new serious health conditions, such as cancer, since your previous study?
Have you had a severe allergic reaction to mirikizumab in the past?
Are you pregnant, breastfeeding, or planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be continuing treatment with mirikizumab. The exact number and frequency of visits will depend on your individual circumstances and the study's protocol, but you can expect to have regular check-ups with the study team. These visits will involve assessments to see how you are responding to the medication and to monitor your general health. You'll likely have blood tests and other examinations to ensure the treatment is effective and safe for you. The study team will explain everything in detail, including how long your participation is expected to last, at your first visit.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit by continuing access to mirikizumab, which could help manage your Crohn's disease symptoms long-term. However, like all medicines, mirikizumab can have side effects, and these will be carefully monitored by the study team. There's also the chance that the medicine might not work for you, or you could experience side effects that make you want to stop. You are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (322)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Digestive Health Specialists
Verified postcode
Dothan, United States
Research Solutions of Arizona
Verified postcode
Litchfield Park, United States
Arizona Arthritis & Rheumatology Research, PLLC
Verified postcode
Phoenix, United States
Care Access - Gilroy
Verified postcode
Gilroy, United States
Newport Huntington Medical Group
Verified postcode
Huntington Beach, United States
California Medical Research Associates
Verified postcode
Northridge, United States
Connecticut Clinical Research Institute
Verified postcode
Bristol, United States
Gastroenterology Consultants of Clearwater
Verified postcode
Clearwater, United States
Clinical Research of West Florida, Inc. (Clearwater)
Verified postcode
Clearwater, United States
IHS Health Research
Verified postcode
Kissimmee, United States
Ezy Medical Research
Verified postcode
Miami, United States
Care Access - Orlando
Verified postcode
Orlando, United States

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition that causes inflammation in your digestive system, which can lead to symptoms like tummy pain, diarrhoea, and tiredness.

What is mirikizumab?

Mirikizumab is a medicine being studied as a possible treatment for Crohn's disease. This study is looking at its effects over a longer period.

Why is this study important?

This study is important because it helps us understand the long-term benefits and safety of mirikizumab, which can help doctors and patients make better treatment choices.

Who can join this study?

You can only join this study if you've already taken part in one of two specific previous studies (I6T-MC-AMAG or I6T-MC-AMAM) for mirikizumab.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, and it will not affect the medical care you receive.