Enrolling

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

I6T-MC-AMAZ -

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis or Crohn's disease (CD).

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See if You May Qualify

Answer a few questions to see if you meet key criteria for this study.

Trial Summary

Age Range
2 - 19 years
Conditions the trial is for
Crohn's Disease
What the trial is testing?
Mirikizumab
Could I receive a Placebo?
No
Enrollment Goal
150
Trial Dates
May 26, 2021 - Jul 2030
How long will I be in the trial?
Your participation could last about 172 weeks and may include up to 44 visits to the study center.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab.

  • Participants from previous studies who have received at least one study drug administration and have not had an early study drug termination. 

  • Female participants must agree to contraception requirements

Participants Must Not:

  • Participants must not have developed a new condition that would have disqualified them from entry in the prior study

  • Participants must not have had any prior serious infections including Hepatitis B, C or HIV/AIDS and active tuberculosis in the prior study

  • Participants may not have received surgery for Ulcerative Colitis or Crohn's Disease in the prior study

  • Participants must not require parenteral nutrition through a vein

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Take the Next Step

Complete this Lilly Trial Connect questionnaire to find out if this clinical trial may be a good fit for you, or a loved one.
When you press Start Lilly Trial Connect, you will answer questions about relevant medical conditions and treatment history. The answers will be compared to some of the key criteria for this trial, called inclusion and exclusion criteria.

If your responses show that the trial may be a good fit, you can:
  • Select which clinical trial site works best for you.
  • Share your details and questionnaire directly with site(s) that allow this.
  • Get contact details for the site(s) of your choice.

Completing the Trial Connect questionnaire doesn’t mean that you will be enrolled in a study. There may be more eligibility criteria for the study which are assessed by the Lilly clinical team.

Clinical Trial Resources

Crohn's + Ulcerative Colitis Research

New treatments for Crohn’s Disease and Ulcerative Colitis cannot be developed without clinical trial volunteers. By volunteering to participate, you may be able to make important contributions to scientific research. Each clinical trial is different, but the information provided may help you consider whether a clinical trial may be right for you.

Learn More

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Learn About Our Pediatric Research

With the help of research study participants, we are learning about pediatric conditions and potential new approaches to treating disease.

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Clinical Trial Participation: What to Expect

A clinical trial is a scientific study. It helps us learn if a new medicine or treatment works and how it works. Clinical trials can also be called clinical research studies. Learn more about clinical research studies and what to expect when taking part in a clinical trial.