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
Have moderate to severe UC
Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, 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
Phase 3
Gender
All
Min Age
2 Years
Max Age
17 Years
Download Date
April 16, 2024
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: