Summary
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).
Conditions
Ulcerative Colitis
Recruitment Status
RECRUITING
Detailed Description
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Eligibility Criteria
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.
Intervention
Intervention Type
Intervention Name
DRUG
Mirikizumab IV
DRUG
Mirikizumab SC
Phase
PHASE3
Gender
ALL
Min Age
2 Years
Max Age
17 Years
Download Date
2024-10-24
Principal Investigator
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
athos.bousvaros@childrens.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: