A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 14 October 2024
• Main ID: EUCTR2017-004092-31-FR
• Date of registration: 18/04/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis
• Scientific title: I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3
• Date of first enrolment: 21/05/2019
• Target sample size: 840
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004092-31
• 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: 1
• 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, Czech Republic, Denmark, France, Georgia, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Moldova, Republic of, Netherlands, Poland, Romania, Russian Federation, Saudi Arabia, 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. Patients from the Phase 2 Study AMAC who in the opinion of the investigator, would derive benefit from
treatment with mirikizumab
2. Patients from the Phase 3 Study AMBG who in the opinion of the investigator, would derive benefit from
treatment with mirikizumab.
3. If female, must meet the contraception requirements.

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 756
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion criteria:
1. Would not, in the opinion of the investigator, derive clinical benefit
from open-label treatment with mirikizumab.
2. Had a reported SAE in originator study or developed other condition
prior to Week 0 visit that would disqualify them from treatment with
mirikizumab according to originator study criteria.
3. Are diagnosed with any medical condition including developing
malignancy or suspicion of active malignant disease during the
originator study or prior to Week 0, which would have precluded
enrollment in a prior mirikizumab study or would have required
discontinuation.
4. Participants diagnosed with clinically important infection including,
but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active
tuberculosis (TB) during either originator study.


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

Health Condition(s) or Problem(s) studied

moderately to severely active Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

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

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-

Primary Outcome(s)

Primary end point(s): Percentage of participants in clinical remission. Clinical remission is
based on the modified Mayo Score (MMS).

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

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)

Secondary end point(s): - Percentage of participants in endoscopic remission, based on the
Mayo Endoscopic Score (ES).
- Percentage of participants who are hospitalized due to UC over time.
- Percentage of participants who undergo UC surgeries over time.
- IBDQ scores over time

Timepoint(s) of evaluation of this end point: Weeks 52, 100 or 160

Secondary ID(s)

I6T-MC-AMAP

2017-004092-31-GB

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 21/05/2019
Contact: