RecruitingPHASE3INTERVENTIONAL

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

This study, called SHINE-ON, is for children and teenagers between 2 and 19 years old who have Ulcerative Colitis or Crohn's Disease. It's looking at a drug called Mirikizumab (pronounced Meer-ih-KIZ-uh-mab). The main goal is to see how effective this medicine is over a long period, helping young people with these bowel conditions. Participants in this study will have already been taking Mirikizumab in a previous study. The whole study will last about 172 weeks, which is over three years, and will involve around 44 visits to the clinic. If you take part, you might also have the option to keep getting the treatment afterwards.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

150

Start

26 May 2021

Estimated completion

01 Dec 2030

Ulcerative Colitis Ulcerative Colitis Chronic Inflammatory Bowel Diseases Crohn's Disease

What is this study about?

This research is focused on helping children and teenagers who have conditions called Ulcerative Colitis or Crohn's Disease. Both of these are types of inflammatory bowel disease (IBD), which means there's ongoing inflammation in the gut that can cause symptoms like tummy pain, diarrhoea, and tiredness. Dealing with these conditions can be tough for young people and their families.

The study involves a medicine called Mirikizumab. This medicine has already been studied in previous trials, and this particular study, called SHINE-ON, is designed to see how well Mirikizumab continues to work over a longer period. It's about understanding its long-term benefits and safety when used in young people.

By taking part, you or your child would be contributing valuable information that could help doctors understand how best to treat Ulcerative Colitis and Crohn's Disease in young people in the future. This kind of research is very important for improving care and finding more effective ways to manage these conditions.

Key takeaways

This study is for children and teenagers with Ulcerative Colitis or Crohn's Disease.
It tests the long-term effects of a drug called Mirikizumab.
Participants must have already been enrolled and benefiting from Mirikizumab in a previous study.
The study lasts over three years and involves about 44 clinic visits.
It aims to provide important information to help future patients with these conditions.

Who may be eligible?

This study is for young people who have already been taking Mirikizumab in one of the previous related studies for Ulcerative Colitis or Crohn's Disease. You would need to have been getting a benefit from that treatment and still be taking the medicine when this new study starts.

To join, your doctor must think that continuing with Mirikizumab would be good for your health. Female participants who can have children will need to agree to use effective contraception during the study. The study is open to both boys and girls aged between 2 and 19 years old.

You wouldn't be able to join if you had a serious health problem during the previous study that would make it risky to continue with Mirikizumab. Also, if you had to stop the medicine permanently or for a long time in the old study, restarting it might not be safe. People with unstable health conditions or certain unremoved growths (polyps) in their bowel, or who are pregnant or breastfeeding, also cannot take part.

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.

Are you between 2 and 19 years old?
Do you have Ulcerative Colitis or Crohn's Disease?
Have you been taking part in a previous Mirikizumab study and found it helpful?
Are you currently still taking Mirikizumab medication from that previous study?
If you are a girl or young woman, are you able to use contraception during the study?
Do you have any serious, unstable health conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive Mirikizumab, the same medicine you were taking in the previous study. The study is designed to last for about 172 weeks, which is approximately three and a half years. During this time, you would have around 44 visits to the clinic.

These visits will involve checks to see how you are doing, track the progress of your condition, and ensure the medicine is working well and safely. This might include physical exams, blood tests, and other assessments. After the main study finishes, there might be a chance to continue receiving the medicine if it's helping you, through something called a Continued Access Period.

Potential risks and benefits

Taking part in a study like this could offer the benefit of continuing a treatment that might be helping to manage your Ulcerative Colitis or Crohn's Disease. However, like all medicines, Mirikizumab can have side effects, and some might be serious. The study team will carefully monitor you for any problems. You will have regular check-ups to make sure you are safe. Remember, participating in any clinical trial is always voluntary, and you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (67)

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

UCSF Medical Center at Mission Bay
Verified postcode
San Francisco, United States· Recruiting
Connecticut Children's Medical Center
Verified postcode
Hartford, United States· Recruiting
Emory University School of Medicine
Verified postcode
Atlanta, United States· Recruiting
Children's Center for Digestive Health Care, LLC
Verified postcode
Atlanta, United States· Recruiting
Boston Children's Hospital
Verified postcode
Boston, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Waltham, United States· Recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Recruiting
Icahn School of Medicine at Mount Sinai
Verified postcode
New York, United States· Recruiting
Children's Hospital of Philadelphia (CHOP)
Verified postcode
Philadelphia, United States· Not yet recruiting
Cook Children's Medical Center
Verified postcode
Fort Worth, United States· Recruiting
Pediatric Specialists of Virginia
Verified postcode
Fairfax, United States· Not yet recruiting
Medizinische Universität Wien
Verified postcode
Vienna, Austria· Not yet recruiting

Common questions

What is Mirikizumab?

Mirikizumab is a specific type of medicine being studied to treat conditions like Ulcerative Colitis and Crohn's Disease, which cause inflammation in the gut.

What are Ulcerative Colitis and Crohn's Disease?

These are long-term conditions where parts of the digestive system become inflamed, leading to symptoms like stomach pain, diarrhoea, and tiredness.

How long does the study last?

The study lasts for about 172 weeks, which is roughly three and a half years, and involves around 44 clinic visits.

Do I have to pay to be in the study?

No, you do not have to pay to participate in the study. All study-related medication and procedures are provided free of charge.

Can I stop being in the study whenever I want?

Yes, you can choose to leave the study at any time, and it will not affect your future medical care.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.