I6T-MC-AMBA - A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age with Moderately to Severely Active Ulcerative Colitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502183-20-00

Acronym

I6T-MC-AMBA

Enrollment

Registered

2024-01-12

Start date

2024-02-26

Completion date

Unknown

Last updated

2025-11-27

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

Conditions

Moderately to Severely Active Ulcerative Colitis

Brief summary

Percentage of Participants with Modified Mayo Score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders

Interventions

DRUGOmvoh 300 mg concentrate for solution for infusion

DRUGOmvoh 100 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with Modified Mayo Score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders	—

Countries

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

Outcome results

None listed

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