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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

TREATMENT

Phase

PHASE3

Trial ID

NCT05784246

Intervention or treatment

DRUG: Mirikizumab IV

DRUG: Mirikizumab SC

Conditions

• Ulcerative Colitis

Condition: Ulcerative Colitis
DRUG: Mirikizumab IV and other drugs
South Brisbane, Queensland, Australia and more
Sponsor: Eli Lilly and Company

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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

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/Arm	Intervention/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 Measure	Primary Outcome Description	Primary Outcome Time Frame
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders	Not Specified	Baseline to Week 52

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Percentage of Participants in MMS Clinical Remission	Not Specified	Week 12
Percentage of Participants in MMS Clinical Response	Not Specified	Week 12
Percentage of Participants with Endoscopic Remission	Not Specified	Week 12
Percentage of Participants with Endoscopic Improvement	Not Specified	Week 12
Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response	Not Specified	Week 12
Percentage of Participants Achieving PUCAI Clinical Remission	Not Specified	Week 12
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement	Not Specified	Week 12
Percentage of Participants Achieving MMS Clinical Response	Not Specified	Week 52
Percentage of Participants Achieving MMS Clinical Remission	Not Specified	Week 52
Percentage of Participants Achieving PUCAI Clinical Response	Not Specified	Week 52
Percentage of Participants Achieving PUCAI Clinical Remission	Not Specified	Week 52
Percentage of Participants Achieving Endoscopic Remission	Not Specified	Week 52
Percentage of Participants Achieving Endoscopic Improvement	Not Specified	Week 52
Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids	Not Specified	Baseline to Week 52
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement	Not Specified	Week 52
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab	PK: AUC of Mirikizumab	Baseline to Week 52
PK: Cmax of Mirikizumab	Not Specified	Baseline to Week 52

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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