Recruiting PHASE3 INTERVENTIONAL 3-arm NCT05784246

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2)

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

Sponsor: Eli Lilly and Company

Conditions Ulcerative Colitis

Interventions Mirikizumab IV Mirikizumab SC

Updated 26 times since 2023 Last updated: Mar 2, 2026 Started: Nov 22, 2023 Primary completion: May 31, 2026 Completion: Aug 31, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Ulcerative Colitis and is currently actively recruiting participants. Eli Lilly and Company leads this study, which shows 26 recorded versions since 2023 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

26 versions recorded

Mar 2026 — Present [monthly]

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Feb 2026 — Mar 2026 [monthly]

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Jan 2026 — Feb 2026 [monthly]

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Dec 2025 — Jan 2026 [monthly]

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▶ Show 21 earlier versions

Oct 2025 — Nov 2025 [monthly]

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Sep 2025 — Oct 2025 [monthly]

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Aug 2025 — Sep 2025 [monthly]

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Jun 2025 — Aug 2025 [monthly]

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May 2025 — Jun 2025 [monthly]

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Mar 2025 — May 2025 [monthly]

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Feb 2025 — Mar 2025 [monthly]

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Jan 2025 — Feb 2025 [monthly]

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Nov 2024 — Jan 2025 [monthly]

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Sep 2024 — Nov 2024 [monthly]

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Aug 2024 — Sep 2024 [monthly]

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Jul 2024 — Aug 2024 [monthly]

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Jun 2024 — Jul 2024 [monthly]

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May 2024 — Jun 2024 [monthly]

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Mar 2024 — May 2024 [monthly]

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Feb 2024 — Mar 2024 [monthly]

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Status: Not Yet Recruiting → Recruiting
Nov 2023 — Feb 2024 [monthly]

Not Yet Recruiting PHASE3
Sep 2023 — Nov 2023 [monthly]

Not Yet Recruiting PHASE3
Jun 2023 — Sep 2023 [monthly]

Not Yet Recruiting PHASE3
May 2023 — Jun 2023 [monthly]

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Apr 2023 — May 2023 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Eli Lilly and Company

Data source: Eli Lilly and Company

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Bunkyō City, Japan , Cincinnati, United States , Daegu, South Korea , Edegem, Belgium , Florence, Italy , Indianapolis, United States , Jerusalem, Israel , Kashiwa-shi, Japan , Leuven, Belgium and 20 more locations