A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04232553

2022-502841-91-00 (EU Trial (CTIS) Number)

I6T-MC-AMAX (Other Identifier)

16628

Details and patient eligibility

About

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

Enrollment: 778 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
• If female, participant must meet the contraception requirements

Exclusion criteria

• Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
• Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.

Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.

• Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
• Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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778 participants in 2 patient groups

Mirikizumab SC

Experimental group

Description:

Mirikizumab given subcutaneously (SC).

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab

Mirikizumab IV and SC

Experimental group

Description:

Mirikizumab given intravenously (IV) and SC.

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab