I6T-MC-AMAY - A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn’s Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511472-32-00

Acronym

I6T-MC-AMAY

Enrollment

Registered

2024-07-31

Start date

2024-03-12

Completion date

Unknown

Last updated

2026-01-23

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

Conditions

Crohn's Disease

Brief summary

Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and endoscopic response based on SES-CD, Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and clinical remission based on PCDAI

Interventions

DRUGMirikizumab

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and endoscopic response based on SES-CD, Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and clinical remission based on PCDAI	—

Measure

Time frame

—

Countries

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

Outcome results

None listed

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