Print

Purpose

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.

Conditions

Eligibility

Eligible Ages
Between 2 Years and 19 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab - Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment. - Female participants must agree to contraception requirements.

Exclusion Criteria

  • Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant. - Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ. - Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety. - Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation. - Participants must not have adenomatous polyps that have not been removed. - Participants must not be pregnant or breastfeeding.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mirikizumab Dose 1 for UC 		Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Dose 2 for UC 		Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Dose 3 for UC 		Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Dose 4 for CD 		Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Dose 5 for CD 		Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Dose 6 for CD 		Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
Experimental
Mirikizumab Dose 7 for UC or CD 		Intravenous (IV) rescue dosing, if response is lost.
  • Drug: Mirikizumab
    Administered IV
    Other names:
    • LY3074828

Recruiting Locations

Massachusetts General Hospital
Waltham, Massachusetts 02451

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLilly (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.