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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).
Study details:
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: Mirikizumab IV
|
EXPERIMENTAL: Mirikizumab Weight-Based Group 2
| DRUG: Mirikizumab IV
|
EXPERIMENTAL: Mirikizumab Weight-Based Group 3
| DRUG: Mirikizumab 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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