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

Phase 1

• Conditions: Crohn´s Disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-002687-27-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-09
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 778

Inclusion Criteria

1. Participants who have completed the Phase 2 Study I6T-MC-AMAG (EudraCT 2016- 002204-84), and in the opinion of the investigator, would derive clinical benefit from continued treatment with mirikizumab

2. Participants who have completed the Phase 3 Study I6T-MC-AMAM (2018-004614-18) and in the opinion of the investigator would derive clinical benefit from treatment with mirikizumab

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 708
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

-Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM)
-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
-Participants may not have received surgery for Crohn's disease in the originator study or are likely to require surgery for treatment of Crohn's disease during the study.
Note: Participants with a history of active TB with documentation of
treatment by the CDC and/or WHO criteria prior to the originator study
are not excluded from the study.
-Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.

-Participants must not have a known hypersensitivity to any component
of mirikizumab or have experienced an acute systemic hypersensitivity
event with previous study drug administration in the originating study
that precludes mirikizumab therapy.
-Participants 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Proportion of participant achieving clinical remission based on the Crohns Disease Activity Index.<br>Proportion of participants achieving endoscopic response. Endoscopic response is based on SES-CD score.;Timepoint(s) of evaluation of this end point: Week 52;Main Objective: To evaluate the long-term efficacy of mirikizumab;Secondary Objective: To evaluate the long-term effect of mirikizumab on health outcomes<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Proportion of participants with clinical response by CDAI<br>-Proportion of participants achieving clinical remission. Clinical remission is based on the Patient Reported Outcome (PRO) of stool frequency (SF) and abdominal pain (AP).<br>-Proportion of participants achieving endoscopic remission. Endoscopic remission is based on SES-CD score.<br>-IBDQ scores over time.<br>;Timepoint(s) of evaluation of this end point: Weeks 12, 52, 100, 156