Crohn's Disease · Inflammatory Bowel Diseases · Ulcerative Colitis · Ulcerative Colitis Chronic
Long-term mirikizumab study for young people with ulcerative colitis or Crohn's
This phase 3 extension study is evaluating the long-term effects of mirikizumab in participants ages 2 to 19 with ulcerative colitis or Crohn's disease who continue from specified earlier studies.
Registry title: A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
11 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–19 Years
- Treatment
- Mirikizumab
- Design
- Non Randomized
- Central study contact
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559LillyTrials@Lilly.com
- Sponsor
- Eli Lilly and Company
Research question
What are the long-term efficacy and safety outcomes of mirikizumab treatment in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's disease?
Participant snapshot
Who the study is looking for
- The study is looking for participants ages 2 to 19.
- Participants have ulcerative colitis or Crohn's disease.
- Participants must come from one of four specified earlier mirikizumab studies.
- Participants must have completed the final assessments and procedures in the earlier study and remain on study-drug treatment.
- The investigator must believe the participant could derive clinical benefit from further mirikizumab treatment; the study team must confirm this requirement.
Participation overview
What participation may involve
Participants continue mirikizumab in a long-term extension study. Subcutaneous dosing is weight-based, and intravenous rescue dosing may be used if response is lost. What participation may involve: - Receive mirikizumab by subcutaneous injection in a weight-based dose group. - Participants who lose response may receive intravenous mirikizumab rescue dosing. - Study assessments include measures of clinical remission and response for ulcerative colitis or Crohn's disease. - Reported outcomes may involve endoscopic, histologic, and high-sensitivity C-reactive protein assessments. The registry says the study will last about 172 weeks, with a possible Continued Access Period for additional treatment. The registry says participation may include up to 44 visits but does not provide the visit schedule.
Study interventions
What participants may receive or do
- Mirikizumab: Mirikizumab is administered by subcutaneous injection. The study has several ulcerative-colitis and Crohn's-disease dose groups, with dosing based on the participant's weight.
- Mirikizumab: Mirikizumab may be administered intravenously as rescue dosing if a participant loses response.
Study design
How the comparison works
This is a phase 3, non-randomized, open-label extension study with parallel mirikizumab dose groups. The registry does not describe a separate comparator or placebo group. Participants are not randomly assigned, according to the registry. The study is open-label, meaning the registry reports no masking. The registry lists only experimental mirikizumab groups and does not describe a separate control or active-comparator group. No placebo group or placebo intervention is described in the registry.
Reported activities
Procedures and tests
- Ulcerative colitis activity may be assessed with the Modified Mayo Score and Pediatric Ulcerative Colitis Activity Index.
- Crohn's disease activity may be assessed with the Pediatric Crohn's Disease Activity Index.
- Endoscopic response and remission are assessed as study outcomes for ulcerative colitis and Crohn's disease.
- Histologic remission is assessed as an outcome, including a combined histologic-endoscopic outcome for ulcerative colitis.
- High-sensitivity C-reactive protein is measured from baseline through week 52.
- The study tracks corticosteroid-free remission without disease-related surgery and, for some participants with ulcerative colitis, time to a first corticosteroid dose.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must come from one of four specified earlier studies, and the investigator must believe further mirikizumab treatment could provide clinical benefit.
- Participants must have completed the final assessments and procedures in the earlier study and remain on study-drug treatment.
- Female participants must agree to the study's contraception requirements.
Possible reasons someone may not be able to join
- A serious adverse event, other adverse event, or other condition arising before this study excludes a participant if continued mirikizumab would present an unreasonable risk.
- Participants are excluded if study drug was stopped temporarily or permanently in the earlier study and restarting mirikizumab would pose an unacceptable risk.
- Participants must not have an unstable or uncontrolled illness that could affect their safety.
- Participants are excluded if study participation could compromise their safety or make the study data difficult to interpret.
- Participants must not have adenomatous polyps that have not been removed.
- Participants who are pregnant or breastfeeding are excluded.
Important unknowns
What the record does not make clear
- The registry reports up to 44 visits but does not provide their timing, length, or which visits must occur in person.
- The registry does not explain which other inflammatory bowel disease medicines may continue during the extension study.
- The registry does not report medication washout requirements.
- Intravenous mirikizumab rescue dosing is described if response is lost, but the criteria, timing, and alternatives are not reported.
- Endoscopic outcomes are listed at week 52, but the registry does not give the full endoscopy schedule or procedural details.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation or reimbursement.
- The registry does not state whether travel or lodging support is available.
- The registry does not state whether any visits or assessments can be completed remotely or locally.
- A Continued Access Period may provide additional treatment, but eligibility, length, and access after that period are not described.
- The study is recruiting overall, but listed locations have different recruitment statuses and the registry does not establish whether a particular disease or dose cohort is open at each site.
Before contacting the site
Questions for the study team
- Which originating-study participants are currently being enrolled at my preferred site, and is the relevant disease cohort open?
- What is the schedule for the up to 44 visits, and which visits require travel to the study site?
- How are the subcutaneous dose group and weight-based dose determined, and can they change during the study?
- What criteria define loss of response, and how is intravenous rescue dosing given and monitored?
- What endoscopies, biopsies, blood tests, and disease-activity assessments are required, and when?
- Which current medicines may continue, and are there any washout or corticosteroid-taper requirements?
- Which costs are covered, and is reimbursement available for travel, lodging, meals, or caregiver expenses?
- What are the eligibility rules and treatment arrangements for the Continued Access Period?
Before changing care
Questions for your gastroenterologist
- How stable is the ulcerative colitis or Crohn's disease now, and what signs would indicate that continuing mirikizumab is no longer appropriate?
- How might the study affect current medicines, including corticosteroids, and what changes should be coordinated with the research team?
- What approved treatment alternatives should we compare with continued mirikizumab, considering the participant's disease history and prior response?
- What risks or monitoring needs are especially relevant given the participant's medical history and any adverse events in the originating study?
- How should routine gastroenterology care, laboratory monitoring, endoscopies, and urgent flare care be coordinated with the research site?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Eli Lilly and Company
- Organization class
- Industry
- Organization study ID
- 16633
- Lead sponsor
- Eli Lilly and Company
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child, Adult
Study arms
Experimental
Mirikizumab Dose 1 for UC
Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.
Interventions: Drug: Mirikizumab
Experimental
Mirikizumab Dose 2 for UC
Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Interventions: Drug: Mirikizumab
Experimental
Mirikizumab Dose 3 for UC
Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Interventions: Drug: Mirikizumab
Experimental
Mirikizumab Dose 4 for CD
Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Interventions: Drug: Mirikizumab
Experimental
Mirikizumab Dose 5 for CD
Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Interventions: Drug: Mirikizumab
Experimental
Mirikizumab Dose 6 for CD
Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Interventions: Drug: Mirikizumab
Experimental
Mirikizumab Dose 7 for UC or CD
Intravenous (IV) rescue dosing, if response is lost.
Interventions: Drug: Mirikizumab
Interventions
Drug
Mirikizumab
Administered SC
Drug
Mirikizumab
Administered IV
Eligibility
2 Years–19 Years
All
Not accepted
Inclusion criteria (3)
- 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 mirikizumabRegistry-derived · unreviewed
- Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.Registry-derived · unreviewed
- Female participants must agree to contraception requirements.Registry-derived · unreviewed
Exclusion criteria (6)
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants must not have adenomatous polyps that have not been removed.Registry-derived · unreviewed
- Participants must not be pregnant or breastfeeding.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
Time frame: Week 52
Clinical Remission based on the MMS
Primary outcome
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Time frame: Week 52
Clinical Remission based on the PCDAI
Secondary outcome
Percentage of Participants with UC in MMS Clinical Response
Time frame: Week 52
Clinical Response based on the MMS
Secondary outcome
Percentage of Participants with CD in PCDAI Clinical Response
Time frame: Week 52
Clinical Response based on the PCDAI
Secondary outcome
Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Time frame: Week 52
Clinical Response based on the PUCAI
Secondary outcome
Percentage of Participants with UC in PUCAI Clinical Remission
Time frame: Week 52
Clinical Response based on the PUCAI
Secondary outcome
Percentage of Participants with UC in Endoscopic Remission
Time frame: Week 52
Endoscopic Remission based on the Endoscopic Subscore (ES)
Secondary outcome
Percentage of Participants with CD in Endoscopic Remission
Time frame: Week 52
Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)
Secondary outcome
Percentage of Participants with UC in Endoscopic Response
Time frame: Week 52
Endoscopic Response in Participants based on the ES
Secondary outcome
Percentage of Participants with CD in Endoscopic Response
Time frame: Week 52
Endoscopic Response based on the SES-CD
Secondary outcome
Percentage of Participants with UC in having Endoscopic Subscore = 0
Time frame: Week 52
Endoscopic Remission when ES = 0
Secondary outcome
Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission
Time frame: Week 52
Histologic remission based on histology scoring and endoscopic remission based on endoscopy score
Secondary outcome
Percentage of Participants with CD Achieving Histologic Remission
Time frame: Week 52
Histologic remission based on histology scoring
Secondary outcome
Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery
Time frame: Week 52
Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery
Secondary outcome
Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery
Time frame: Week 52
Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)
Secondary outcome
Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids
Time frame: Week 0 to Week 52
Secondary outcome
Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response
Time frame: Week 52
Secondary outcome
Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP)
Time frame: Baseline, Week 0 to Week 52
Recruiting locations in the United States
UCSF Medical Center at Mission Bay
RecruitingSan Francisco, California, 94158, United States
Sofia Verstraete
Connecticut Children's Medical Center
RecruitingHartford, Connecticut, 06106, United States
Jeffrey Hyams
Children's Center for Digestive Health Care, LLC
RecruitingAtlanta, Georgia, 30342, United States
Jeffery Lewis
Emory University School of Medicine
RecruitingAtlanta, Georgia, 30322, United States
subra kugathasan
Boston Children's Hospital
RecruitingBoston, Massachusetts, 02115, United States
Athos Bousvaros
Massachusetts General Hospital
RecruitingWaltham, Massachusetts, 02451, United States
Jess Kaplan
Washington University School of Medicine
RecruitingSt Louis, Missouri, 63110, United States
Charles Samson
Icahn School of Medicine at Mount Sinai
RecruitingNew York, New York, 10029, United States
David Dunkin
Children's Hospital of Philadelphia (CHOP)
Not Yet RecruitingPhiladelphia, Pennsylvania, 19104, United States
Arthur Kastl
Cook Children's Medical Center
RecruitingFort Worth, Texas, 76104, United States
Clifton Huang
Pediatric Specialists of Virginia
Not Yet RecruitingFairfax, Virginia, 22031, United States
Peter Lee
This study also lists 57 locations outside the United States. They are not shown here.
Central study contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
Physicians interested in becoming principal investigators please contact
Contact
Registry dates
- First posted
- Apr 14, 2021
- Primary completion
- Dec 2030
- Overall completion
- Dec 2030
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.