AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

• Register: EUCTR
• Last refreshed on: 30 August 2021
• Main ID: EUCTR2017-003229-14-DE
• Date of registration: 30/04/2018
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS
• Scientific title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1
• Date of first enrolment: 15/10/2018
• Target sample size: 1160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003229-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes 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, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, 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:
Principal Inclusion Criteria are as follows:
1. Male or female patients =18 and =80 years of age at the time of initial screening
2. Diagnosis of UC for at least 3 months prior to baseline.
3. Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
4. Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
5. 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 1044
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 116

Exclusion criteria:
Principal Exclusion Criteria are as follows:
1. Patients with a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis).
2. Patients with a previous colectomy.
3. Patients with current evidence of toxic megacolon.
4. Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).


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

Health Condition(s) or Problem(s) studied

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

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

Intervention(s)

Product Name: mirikizumab
Product Code: LY3074828
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: MIRIKIZUMAB
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To test the hypothesis that mirikizumab is superior to placebo in inducing clinical remission at Week 12 in patients with moderately to severely active ulcerative colitis.

Timepoint(s) of evaluation of this end point: Week 12

Primary end point(s): Percentage of participants in clinical remission at Week 12, based on the Modified Mayo Score (MMS)

Secondary Objective: 1. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving clinical response at Week 12.
2. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving endoscopic remission at Week 12.
3. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving symptomatic remission at Week 12.

Secondary Outcome(s)

Secondary end point(s): 1. Percentage of participants achieving clinical response at Week 12 based on the MMS.
2. Percentage of participants achieving endoscopic remission at Week 12 based on the MMS .
3. Percentage of participants achieving symptomatic remission at Week 12 based on the MMS .

Timepoint(s) of evaluation of this end point: Week 12

Secondary ID(s)

I6T-MC-AMAN

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 31/01/2019
Contact: