A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

• Register: EUCTR
• Last refreshed on: 2 May 2022
• Main ID: EUCTR2017-003238-96-LV
• Date of registration: 21/05/2018
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS
• Scientific title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2
• Date of first enrolment: 30/08/2018
• Target sample size: 1044
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003238-96
• 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: 4
• 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, 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 and Company

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

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have completed Study AMAN, with at least 1 study drug administration, without early termination of study drug, and underwent a Visit 5 (Week 12) endoscopy.
2. Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
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 940
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 104

Exclusion criteria:
1. Participants diagnosed with Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN.
2. Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN, or are likely to require surgery for the treatment of UC during study AMBG.
3. Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN.
4. Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN.
5. Participants who initiate a new prohibited medication during the induction study AMAN.
6. Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.



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
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

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-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 40

Main Objective: To evaluate the efficacy of mirikizumab compared to placebo in percentage of participants in clinical remission at Week 40.

Primary end point(s): Percentage of participants in clinical remission at Week 40. Clinical remission is based on the Modified Mayo Score (MMS).

Secondary Objective: - To evaluate the efficacy of treatment with mirikizumab compared to placebo in percentage of participants in endoscopic remission at Week 40
- To evaluate the efficacy of treatment with mirikizumab compared to placebo in percentage of participants in corticosteroid-free remission without surgery at Week 40

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 40

Secondary end point(s): - Percentage of participants in endoscopic remission at Week 40. Endoscopic remission based on the Mayo endoscopic Score (ES)
- Percentage of participants in corticosteroid-free remission without surgery at Week 40. Corticosteroid-free remission is based on the MMS.

Secondary ID(s)

2017-003238-96-DE

I6T-MC-AMBG

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 08/06/2018
Contact: