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

Ulcerative Colitis Clinical Trial

— SHINE-ON  

Official title:

A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844606
• Other study ID #: 16633
• Secondary ID: I6T-MC-AMAZ2020-
• Status: Recruiting
• Phase: Phase 3
• Start date: May 26, 2021
• Est. completion date: July 30, 2030

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLill
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 30, 2030
• Est. primary completion date: July 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 19 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Participants must not have adenomatous polyps that have not been removed.
• Participants must not be pregnant or breastfeeding.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis
• Ulcerative Colitis Chronic

Intervention

Drug:
• Mirikizumab
Administered SC
• Mirikizumab
Administered IV

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Roma	Lazio
Japan	Tokyo Medical And Dental University Medical Hospital	Bunkyo	Tokyo
Korea, Republic of	Kyungpook National University Chilgok Hospital	Deagu	Taegu-Kwangyokshi
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Poland	Centrum Zdrowia Dziecka w Warszawie	Warsaw	Mazowieckie
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Pediatric Specialists of Virginia	Fairfax	Virginia
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Children's Hospital of The King's Daughters	Norfolk	Virginia
United States	UCSF Medical Center at Mission Bay	San Francisco	California
United States	Massachusetts General Hospital	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Italy,  Japan,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission	Clinical Remission based on the MMS	Week 52
Primary	Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission	Clinical Remission based on the PCDAI	Week 52
Secondary	Percentage of Participants with UC in MMS Clinical Response	Clinical Response based on the MMS	Week 52
Secondary	Percentage of Participants with CD in PCDAI Clinical Response	Clinical Response based on the PCDAI	Week 52
Secondary	Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response	Clinical Response based on the PUCAI	Week 52
Secondary	Percentage of Participants with UC in PUCAI Clinical Remission	Clinical Response based on the PUCAI	Week 52
Secondary	Percentage of Participants with UC in Endoscopic Remission	Endoscopic Remission based on the Endoscopic Subscore (ES)	Week 52
Secondary	Percentage of Participants with CD in Endoscopic Remission	Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)	Week 52
Secondary	Percentage of Participants with UC in Endoscopic Response	Endoscopic Response in Participants based on the ES	Week 52
Secondary	Percentage of Participants with CD in Endoscopic Response	Endoscopic Response based on the SES-CD	Week 52
Secondary	Percentage of Participants with UC in having Endoscopic Subscore = 0	Endoscopic Remission when ES = 0	Week 52
Secondary	Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission	Histologic remission based on histology scoring and endoscopic remission based on endoscopy score	Week 52
Secondary	Percentage of Participants with CD Achieving Histologic Response	Histologic response based on histology scoring	Week 52
Secondary	Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery	Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery	Week 52
Secondary	Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery	Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)	Week 52

External Links

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