The trial is taking place at:
C

Centrum Zdrowia MDM | Gastroenterology

Veeva-enabled site

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

Lilly logo

Lilly

Status and phase

Enrolling
Phase 3

Conditions

Crohn's Disease

Treatments

Drug: Mirikizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04232553
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

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)

778 participants in 2 patient groups

Mirikizumab SC
Experimental group
Description:
Mirikizumab given subcutaneously (SC).
Treatment:
Drug: Mirikizumab
Mirikizumab IV and SC
Experimental group
Description:
Mirikizumab given intravenously (IV) and SC.
Treatment:
Drug: Mirikizumab

Trial contacts and locations

315

Loading...

Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems