I6T-MC-AMAZ: A master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn’s disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506239-14-00

Acronym

I6T-MC-AMAZ

Enrollment

Registered

2023-10-31

Start date

2022-12-13

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn’s Disease, Inflammatory Bowel Diseases, Ulcerative Colitis, Ulcerative Colitis Chronic

Brief summary

Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission. Clinical Remission based on the MMS [Time Frame: Week 52], Percentage of Participants with CD in Pediatric Crohn’s Disease Activity Index (PCDAI) Clinical Remission. Clinical Remission based on the PCDAI [Time Frame: Week 52]

Interventions

DRUGMirikizumab

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission. Clinical Remission based on the MMS [Time Frame: Week 52], Percentage of Participants with CD in Pediatric Crohn’s Disease Activity Index (PCDAI) Clinical Remission. Clinical Remission based on the PCDAI [Time Frame: Week 52]	—

Countries

Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026