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).
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Administered IV
Administered SC
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
Percentage of Participants in MMS Clinical Remission
Time frame: Week 12
Percentage of Participants in MMS Clinical Response
Time frame: Week 12
Percentage of Participants with Endoscopic Remission
Time frame: Week 12
Percentage of Participants with Endoscopic Improvement
Time frame: Week 12
Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Time frame: Week 12
Percentage of Participants Achieving PUCAI Clinical Remission
Time frame: Week 12
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Time frame: Week 12
Percentage of Participants Achieving MMS Clinical Response
Time frame: Week 52
Percentage of Participants Achieving MMS Clinical Remission
Time frame: Week 52
Percentage of Participants Achieving PUCAI Clinical Response
Time frame: Week 52
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University of California, San Francisco
San Francisco, California, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States
Riley Childrens Hospital
Indianapolis, Indiana, United States
Washington University
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
UZA
Edegem, Belgium
UZ Leuven
Leuven, Belgium
The Hospital for Sick Children
Toronto, Canada
Hôpital Necker - Enfants Malades
Paris, France
...and 24 more locations
Percentage of Participants Achieving PUCAI Clinical Remission
Time frame: Week 52
Percentage of Participants Achieving Endoscopic Remission
Time frame: Week 52
Percentage of Participants Achieving Endoscopic Improvement
Time frame: 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
Time frame: Baseline to Week 52
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Time frame: Week 52
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab
PK: AUC of Mirikizumab
Time frame: Baseline to Week 52
PK: Cmax of Mirikizumab
Time frame: Baseline to Week 52