Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

This research study, called LUCENT 3, is investigating how well a new drug, mirikizumab, works over a long period for people living with moderately to severely active ulcerative colitis. It also aims to understand its safety when used for an extended time. The study will run for up to three years. Patients who complete the three-year study might be able to continue taking mirikizumab after the study ends, either until the drug becomes widely available in their country or if specific reasons arise that mean they can no longer participate. This helps us learn more about mirikizumab's sustained benefits and potential side effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

1,058

Start

18 Jul 2018

Estimated completion

01 Dec 2027

Ulcerative Colitis

What is this study about?

This study is called LUCENT 3, and it's looking into a new treatment for ulcerative colitis called mirikizumab. Ulcerative colitis is a long-term condition where the lining of the large intestine and rectum becomes inflamed, leading to symptoms like tummy pain, diarrhoea, and bleeding.

The main goal of this study is to find out how effective mirikizumab is in the long run for people whose ulcerative colitis is moderate to severe, meaning their symptoms are quite bothersome. It also aims to carefully check for any side effects and understand how safe the drug is when used over several years. This kind of long-term information is really important because it helps doctors and patients make informed decisions about treatments for chronic conditions like ulcerative colitis.

Participants in this study have already been involved in previous studies (AMAC or AMBG) for mirikizumab. By continuing to follow these participants, researchers hope to gather valuable information about the lasting benefits and safety profile of mirikizumab, which could eventually help many more people living with ulcerative colitis.

Key takeaways

Study focuses on long-term effects of mirikizumab for ulcerative colitis.
Specifically for those already in previous mirikizumab trials.
Aims to understand both effectiveness and safety over several years.
Study duration is up to three years, with potential for continued treatment.
Participation involves ongoing monitoring and clinic visits.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you must have previously taken part in one of two earlier mirikizumab studies (AMAC or AMBG) and received at least one dose of the study drug. You also must not have stopped your involvement in those studies early.

There are also some important reasons why you wouldn't be able to join. For example, if you developed a new medical condition, including cancer, during your previous study, or if you had certain infections like hepatitis B, C, HIV/AIDS, or active tuberculosis at any point during those studies, you would not be eligible.

Additionally, if you had surgery for your ulcerative colitis during the previous study, or if it's thought you might need surgery during this new study, you would not be able to participate. Also, if any risky growths (adenomatous polyps) were found during the previous study and haven't been removed, you wouldn't be able to join. All participants must be between 18 and 80 years old, and women who could become pregnant must agree to use reliable contraception.

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.

Have I previously participated in the AMAC or AMBG mirikizumab study?
Did I receive at least one dose of the study drug in that past study?
Am I between 18 and 80 years old?
Have I NOT developed any new cancers or serious infections (like Hepatitis B/C, HIV, active TB) since my previous study?
Have I NOT had surgery for ulcerative colitis, or likely need surgery soon?
If I am a woman who could become pregnant, am I willing to use contraception?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, you will continue to receive the study medication, mirikizumab. The study is designed to run for up to three years. Throughout this time, you'll have regular hospital or clinic visits where the study team will monitor your health, check how your ulcerative colitis is responding to treatment, and look for any potential side effects. These visits will likely include physical examinations, blood tests, and other assessments relevant to your condition and the study drug. At the end of the three-year study, you may have the option to continue taking mirikizumab if it's not yet available to the public in your country, or until other reasons might mean you need to stop. The exact number and type of visits will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as continuing to receive mirikizumab, which could help manage your ulcerative colitis symptoms and potentially improve your quality of life over a longer period. However, like all medications, mirikizumab carries potential risks, including side effects that may be mild or serious. The research team will explain all known side effects and monitor you closely. It's important to remember that participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (352)

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
Valleywise Health Medical Center
Verified postcode
Phoenix, United States
InSite Digestive Health Care
Verified postcode
Arcadia, United States
Care Access - Berkeley
Verified postcode
Berkeley, United States
Om Research LLC
Verified postcode
Lancaster, United States
California Medical Research Associates
Verified postcode
Northridge, United States
Inland Empire Clinical Trials, LLC
Verified postcode
Rialto, United States
Clinical Applications Laboratories, Inc.
Verified postcode
San Diego, United States
Direct Helpers Research Center
Verified postcode
Hialeah, United States
Encore Borland-Groover Clinical Research
Verified postcode
Jacksonville, United States
Wellness Clinical Research
Verified postcode
Miami Lakes, United States

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large intestine and rectum becomes inflamed and develops small sores, leading to symptoms like tummy pain, diarrhoea, and bleeding.

What is mirikizumab?

Mirikizumab is the name of the investigational drug being studied. It's a new treatment being explored for ulcerative colitis.

How long will the study last?

The main part of this study will last for up to three years. After that, some participants might be able to continue on mirikizumab under certain conditions.

Who can join this study?

This study is specifically for people who have already taken part in previous mirikizumab studies for ulcerative colitis (AMAC or AMBG) and meet other specific health requirements.

What does 'long-term efficacy and safety' mean?

It means the study is looking at how well the drug works over a long period (efficacy) and whether it causes any unwanted effects when used for an extended time (safety).