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-SK
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Last Update Posted: 8 July 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
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
Main Objective: To assess the effect of mirikizumab in the maintenance of endoscopic response in participants from AMAM who completed treatment on blinded SC mirikizumab and achieved endoscopic response at Week 52 of AMAM;Secondary Objective: To evaluate the long-term effect of mirikizumab on health outcomes;Primary end point(s): Proportion of participants achieving clinical remission based on the Crohns Disease Activity Index (CDAI).<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

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: Week 12, 52, 100, 156