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

• Register: EUCTR
• Last refreshed on: 9 December 2024
• Main ID: EUCTR2019-002687-27-HR
• Date of registration: 14/03/2022
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
• Scientific title: A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2
• Date of first enrolment: 10/03/2022
• Target sample size: 778
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002687-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Crohn´s Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: MIRIKIZUMAB
Product Code: LY3074828
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MIRIKIZUMAB
CAS Number: 1884201-71-1
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Product Name: MIRIKIZUMAB
Product Code: LY3074828
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MIRIKIZUMAB
CAS Number: 1884201-71-1
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Product Name: MIRIKIZUMAB
Product Code: LY3074828
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Mirikizumab
CAS Number: 1884201-71-1
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: To evaluate the long-term efficacy of mirikizumab

Primary end point(s): Proportion of participants achieving clinical remission based on the Crohns Disease Activity Index (CDAI)
Proportion of participants achieving endoscopic response. Endoscopic response is based on SES-CD score.

Secondary Objective: To evaluate the long-term effect of mirikizumab on health outcomes

Timepoint(s) of evaluation of this end point: Week 52

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 12, 52, 100, 156

Secondary end point(s): -Proportion of participants with clinical response by CDAI
-Proportion of participants achieving clinical remission. Clinical remission is based on the Patient Reported Outcome (PRO) of stool frequency (SF) and abdominal pain (AP).
-Proportion of participants achieving endoscopic remission. Endoscopic remission is based on SES-CD score.
-IBDQ scores over time.

Secondary ID(s)

I6T-MC-AMAX

2019-002687-27-HU

NCT04232553

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 30/12/2021
Contact: