Trials / Recruiting
RecruitingNCT05784246
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
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
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
Detailed description
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mirikizumab IV | Administered IV |
| DRUG | Mirikizumab SC | Administered SC |
Timeline
- Start date
- 2023-11-22
- Primary completion
- 2026-05-01
- Completion
- 2026-08-01
- First posted
- 2023-03-24
- Last updated
- 2026-03-03
Locations
34 sites across 11 countries: United States, Belgium, Canada, France, Germany, Israel, Italy, Japan, Poland, South Korea, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05784246. Inclusion in this directory is not an endorsement.