Health Trials

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

ConditionsUlcerative ColitisUlcerative Colitis ChronicInflammatory Bowel DiseasesCrohn's Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-19
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.

Female participants must agree to contraception requirements.

Disqualifiers

Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.

Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.

Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.

Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirikizumab

    Drug

    Administered SC

  • Mirikizumab

    Drug

    Administered IV

Treatment groups

150 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Mirikizumab Dose 1 for UCExperimental treatment 1 intervention
Group B: Mirikizumab Dose 2 for UCExperimental treatment 1 intervention
Group C: Mirikizumab Dose 3 for UCExperimental treatment 1 intervention
Group D: Mirikizumab Dose 4 for CDExperimental treatment 1 intervention
Group E: Mirikizumab Dose 5 for CDExperimental treatment 1 intervention
Group F: Mirikizumab Dose 6 for CDExperimental treatment 1 intervention
Group G: Mirikizumab Dose 7 for UC or CDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission

Clinical Remission based on the MMS

Time frame
Week 52
2

Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission

Clinical Remission based on the PCDAI

Time frame
Week 52

Secondary outcomes

1

Percentage of Participants with UC in MMS Clinical Response

Clinical Response based on the MMS

Time frame
Week 52
2

Percentage of Participants with CD in PCDAI Clinical Response

Clinical Response based on the PCDAI

Time frame
Week 52
3

Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response

Clinical Response based on the PUCAI

Time frame
Week 52
4

Percentage of Participants with UC in PUCAI Clinical Remission

Clinical Response based on the PUCAI

Time frame
Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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