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

Lilly

Status and phase: Active, not recruiting; 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

2019-002687-27 (EudraCT Number)

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: 996 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: Parallel Assignment

Masking: None (Open label)

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996 participants in 9 patient groups

AMAM Mirikizumab (Miri): Miri 300 mg SC

Experimental group

Description:

Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) for 52 weeks.

Treatment:

Drug: Mirikizumab

AMAM Miri: Miri 900 mg IV Then 300 mg SC

Experimental group

Description:

Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg intravenously (IV) Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.

Treatment:

Drug: Mirikizumab

AMAM Placebo (PBO)/Miri: Miri 300 mg SC

Experimental group

Description:

Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.

Treatment:

Drug: Mirikizumab

AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC

Experimental group

Description:

Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.

Treatment:

Drug: Mirikizumab

AMAM Ustekinumab (Uste): Miri 300 mg SC

Experimental group

Description:

Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.

Treatment:

Drug: Mirikizumab

AMAM Uste: Miri 900 mg IV Then 300 mg SC

Experimental group

Description:

Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.

Treatment:

Drug: Mirikizumab

AMAM PBO: Miri 300 mg SC

Experimental group

Description:

Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.

Treatment:

Drug: Mirikizumab

AMAM PBO: Miri 900 mg IV Then 300 mg SC

Experimental group

Description:

Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.

Treatment:

Drug: Mirikizumab

All AMAG Participants: Miri 300 mg SC

Experimental group

Description:

Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.

Treatment:

Drug: Mirikizumab