A placebo-controlled study of mirikizumab and vedolizumab in participants with moderately to severely active ulcerative colitis

• Register: EUCTR
• Last refreshed on: 7 June 2021
• Main ID: EUCTR2019-001653-99-FR
• Date of registration: 12/10/2020
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A placebo-controlled study of mirikizumab and vedolizumab in participants with moderately to severely active ulcerative colitis
• Scientific title: A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants with Moderately to Severely Active Ulcerative Colitis - LUCENT-ACT
• Date of first enrolment: 26/11/2020
• Target sample size: 1100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001653-99
• 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: 3
• 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, Croatia, Czech Republic, Denmark, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, 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:
• Participants must have a diagnosis of UC for at least 3 months prior to baseline
• Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
• Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC
• Participants must, if female, 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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
• Participants must not have a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis)
• Participants must not have had a previous colectomy
• Participants must not have current evidence of toxic megacolon
• Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab
• Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy



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 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-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

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-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Entyvio
Product Name: vedolizumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: vedolizumab
CAS Number: 943609-66-3
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): • Percentage of Participants in Histologic Remission based on histology.

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

Secondary Objective: To evaluate the efficacy of mirikizumab on endoscopic improvement.
To evaluate the efficacy of mirikizumab on histo-endo improvement.

Main Objective: To evaluate the efficacy of mirikizumab on histologic improvement

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 52
Week 12 for Percentage of Participants with Clinical Response Clinical response based on MMS.

Secondary end point(s): Percentage of Participants in Symptomatic Remission
Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.

Percentage of Participants in Clinical Remission
Clinical remission based on MMS.

Percentage of Participants in Endoscopic Remission
Endoscopic remission based on MMS ES.

Percentage of Participants with Clinical Response
Clinical response based on MMS.

Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)
CS free remission without surgery based on clinical remission, symptomatic remission and no CS use.

Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline
Percentage of participants with resolution of EIMs among those that had them at baseline.

Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Change from baseline on the IBDQ score.

Percentage of Participants Undergoing Surgery for UC (Including Colectomy)

Percentage of Participants Hospitalized for UC

Secondary ID(s)

2019-001653-99-CZ

I6T-MC-AMBI

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 26/11/2020
Contact: