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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04844606
Collaborator
(none)
185
Enrollment
17
Locations
6
Arms
75.9
Anticipated Duration (Months)
10.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
185 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 26, 2021
Anticipated Primary Completion Date :
Sep 23, 2025
Anticipated Study Completion Date :
Sep 23, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mirikizumab Dose 1 for UC

Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.

Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828

    		•
    Experimental: Mirikizumab Dose 2 for UC

    Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Drug: Mirikizumab
    Administered SC
    Other Names:
  • LY3074828

    		•
    Experimental: Mirikizumab Dose 3 for UC

    Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Drug: Mirikizumab
    Administered SC
    Other Names:
  • LY3074828

    		•
    Experimental: Mirikizumab Dose 4 for CD

    Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Drug: Mirikizumab
    Administered SC
    Other Names:
  • LY3074828

    		•
    Experimental: Mirikizumab Dose 5 for CD

    Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Drug: Mirikizumab
    Administered SC
    Other Names:
  • LY3074828

    		•
    Experimental: Mirikizumab Dose 6 for CD

    Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Drug: Mirikizumab
    Administered SC
    Other Names:
  • LY3074828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission [Week 52]

      Clinical Remission based on the MMS

    2. Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission [Week 52]

      Clinical Remission based on the PCDAI

    Secondary Outcome Measures

    1. Percentage of Participants with UC in MMS Clinical Response [Week 52]

      Clinical Response based on the MMS

    2. Percentage of Participants with CD in PCDAI Clinical Response [Week 52]

      Clinical Response based on the PCDAI

    3. Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response [Week 52]

      Clinical Response based on the PUCAI

    4. Percentage of Participants with UC in PUCAI Clinical Remission [Week 52]

      Clinical Response based on the PUCAI

    5. Percentage of Participants with UC in Endoscopic Remission [Week 52]

      Endoscopic Remission based on the Endoscopic Subscore (ES)

    6. Percentage of Participants with CD in Endoscopic Remission [Week 52]

      Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)

    7. Percentage of Participants with UC in Endoscopic Response [Week 52]

      Endoscopic Response in Participants based on the ES

    8. Percentage of Participants with CD in Endoscopic Response [Week 52]

      Endoscopic Response based on the SES-CD

    9. Percentage of Participants with UC in having Endoscopic Subscore = 0 [Week 52]

      Endoscopic Remission when ES = 0

    10. Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission [Week 52]

      Histologic remission based on histology scoring and endoscopic remission based on endoscopy score

    11. Percentage of Participants with CD Achieving Histologic Response [Week 52]

      Histologic response based on histology scoring

    12. Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery [Week 52]

      Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery

    13. Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery [Week 52]

      Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)

    14. Percentage of Participants who had UC-related Surgeries in Participants with UC [Week 52]

      Percentage of Participants Who had UC-related Surgeries in Participants with UC

    15. Percentage of Participants who had Crohn's disease-related Surgeries in Participants with CD [Week 52]

      Percentage of Participants Who had Crohn's disease-related Surgeries in Participants with CD

    16. Change from Baseline in Body Weight in Participants with UC [Baseline, Week 52]

      Change from baseline in body weight at Week 52

    17. Change from Baseline in Body Weight in Participants with CD [Baseline, Week 52]

      Change from baseline in body weight at Week 52

    18. Change from Baseline in Height Velocity in Participants with UC [Baseline, Week 52]

      Change from baseline in Height Velocity at Week 52

    19. Change from Baseline in Height Velocity in Participants with CD [Baseline, Week 52]

      Change from baseline in Height Velocity at Week 52

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    • Participants from prior studies who have had at least one study drug administration and have not had early termination of study drug.

    • Female participants must agree to contraception requirements.

    Exclusion Criteria:

    • Participants must not have developed a new condition, including cancer in the originator study.

    • Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study.

    • Participants must not have received surgery for UC or CD as applicable in the originator study or are likely to require surgery for treatment of UC or CD during the study.

    • Participants must not require parenteral nutrition delivered by central vein and/or central venous catheter for venous access.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSF Medical Center at Mission Bay San Francisco California United States 94158
    2 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    3 Emory University School of Medicine Atlanta Georgia United States 30322
    4 Boston Children's Hospital Boston Massachusetts United States 02115
    5 MGH for Children - Waltham Waltham Massachusetts United States 02451
    6 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    7 Cook Children's Medical Center Fort Worth Texas United States 76104
    8 Pediatric Specialists of Virginia Fairfax Virginia United States 22031
    9 Children's Specialty Group, PPLC Norfolk Virginia United States 23507
    10 The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center Jerusalem Israel
    11 Policlinico Umberto I Roma Lazio Italy 00161
    12 Juntendo University Hospital Bunkyo-ku Tokyo Japan 113-8431
    13 Tokyo Medical and Dental University Hospital Bunkyō Tokyo Japan 113-8519
    14 Kyungpook National University Chilgok Hospital Daegu Kwangyǒkshi Korea, Republic of 41404
    15 Samsung Medical Center Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 06351
    16 Seoul National University Hospital Seoul Seoul-teuk Korea, Republic of
    17 Centrum Zdrowia Dziecka w Warszawie Warsaw Mazowieckie Poland 04-746

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04844606
    Other Study ID Numbers:
    • 16633
    • I6T-MC-AMAZ
    • 2020-005311-49
    • ISA-1 UC
    • ISA-2 CD
    First Posted:
    Apr 14, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Pediatric Ulcerative Colitis
    Pediatric Crohn's Disease
    Pediatric UC
    Pediatric CD
    Additional relevant MeSH terms:
    Crohn Disease
    Colitis
    Colitis, Ulcerative
    Inflammatory Bowel Diseases
    Ulcer
    Mirikizumab

    Study Results

    No Results Posted as of Aug 18, 2022