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 (SHINE-2)

NCT05784246 Phase 3 RECRUITING

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).

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	RECRUITING
Enrolment	60
Start date	2023-11-22
Completion	2026-08

Conditions

• Ulcerative Colitis

Interventions

• Mirikizumab IV
• Mirikizumab SC

Primary outcomes

• Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders — Baseline to Week 52

Countries

United States, Belgium, Canada, France, Germany, Israel, Italy, Japan, Poland, South Korea, United Kingdom