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Completed

NCT Number: NCT05784246

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZA, Edegem, Belgium

Loading trial locations.

About this study

Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent for screening.
  • Have moderate to severe UC.
  • Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
  • Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.

Exclusion criteria

  • Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
  • Have immune deficiency syndrome.
  • Previous bowel resection or intestinal surgery.
  • Evidence of toxic megacolon.
  • History or current evidence of cancer of the gastrointestinal tract.

Treatment and study plan

Mirikizumab IV

Drug

Administered IV

Other names: LY3074828

Mirikizumab SC

Drug

Administered SC

Other names: LY3074828

Primary outcomes

  1. Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders

    Time frame: Baseline to Week 52

Secondary outcomes

  1. Percentage of Participants in MMS Clinical Remission

    Time frame: Week 12

  2. Percentage of Participants in MMS Clinical Response

    Time frame: Week 12

  3. Percentage of Participants with Endoscopic Remission

    Time frame: Week 12

  4. Percentage of Participants with Endoscopic Improvement

    Time frame: Week 12

  5. Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response

    Time frame: Week 12

  6. Percentage of Participants Achieving PUCAI Clinical Remission

    Time frame: Week 12

  7. Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement

    Time frame: Week 12

  8. Percentage of Participants Achieving MMS Clinical Response

    Time frame: Week 52

  9. Percentage of Participants Achieving MMS Clinical Remission

    Time frame: Week 52

  10. Percentage of Participants Achieving PUCAI Clinical Response

    Time frame: Week 52

  11. Percentage of Participants Achieving PUCAI Clinical Remission

    Time frame: Week 52

  12. Percentage of Participants Achieving Endoscopic Remission

    Time frame: Week 52

  13. Percentage of Participants Achieving Endoscopic Improvement

    Time frame: Week 52

  14. Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids

    Time frame: Baseline to Week 52

  15. Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement

    Time frame: Week 52

  16. Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab

    Time frame: Baseline to Week 52

    PK: AUC of Mirikizumab

  17. PK: Cmax of Mirikizumab

    Time frame: Baseline to Week 52

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis

Acronym: SHINE-2

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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