Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT04844606
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
19 Years
Study:
NCT04844606
Study Brief:
Protocol Section:
NCT04844606