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

PHASE3RECRUITING

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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Study details:

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

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
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    Eligibility

    Age eligible for study : 2 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-11-22

    Primary completion: 2026-07-20

    Study completion finish: 2027-03-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT05784246

    Intervention or treatment

    DRUG: Mirikizumab IV

    DRUG: Mirikizumab SC

    Conditions

    • Ulcerative Colitis

    Find a site

    Closest Location:

    Mater Hospital Brisbane

    Research sites nearby

    Select from list below to view details:

    • Mater Hospital Brisbane

      South Brisbane, Queensland, Australia

    • Perth Children's Hospital

      Nedlands, Western Australia, Australia

    • Women'S and Children'S Hospital, Adelaide

      North Adelaide, South Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Mirikizumab Weight-Based Group 1
    • Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
    DRUG: Mirikizumab IV
    • Administered IV
    EXPERIMENTAL: Mirikizumab Weight-Based Group 2
    • Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
    DRUG: Mirikizumab IV
    • Administered IV
    EXPERIMENTAL: Mirikizumab Weight-Based Group 3
    • Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
    DRUG: Mirikizumab IV
    • Administered IV

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical RespondersNot SpecifiedBaseline to Week 52

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Percentage of Participants in MMS Clinical RemissionNot SpecifiedWeek 12
    Percentage of Participants in MMS Clinical ResponseNot SpecifiedWeek 12
    Percentage of Participants with Endoscopic RemissionNot SpecifiedWeek 12
    Percentage of Participants with Endoscopic ImprovementNot SpecifiedWeek 12
    Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical ResponseNot SpecifiedWeek 12
    Percentage of Participants Achieving PUCAI Clinical RemissionNot SpecifiedWeek 12
    Percentage of Participants Achieving Histologic Endoscopic Mucosal ImprovementNot SpecifiedWeek 12
    Percentage of Participants Achieving MMS Clinical ResponseNot SpecifiedWeek 52
    Percentage of Participants Achieving MMS Clinical RemissionNot SpecifiedWeek 52
    Percentage of Participants Achieving PUCAI Clinical ResponseNot SpecifiedWeek 52
    Percentage of Participants Achieving PUCAI Clinical RemissionNot SpecifiedWeek 52
    Percentage of Participants Achieving Endoscopic RemissionNot SpecifiedWeek 52
    Percentage of Participants Achieving Endoscopic ImprovementNot SpecifiedWeek 52
    Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of CorticosteroidsNot SpecifiedBaseline to Week 52
    Percentage of Participants Achieving Histologic Endoscopic Mucosal ImprovementNot SpecifiedWeek 52
    Pharmacokinetics (PK): Area Under the Curve (AUC) of MirikizumabPK: AUC of MirikizumabBaseline to Week 52
    PK: Cmax of MirikizumabNot SpecifiedBaseline to Week 52

    Frequently Asked Questions

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    References

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

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