Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

• Register: EUCTR
• Last refreshed on: 12 December 2023
• Main ID: EUCTR2018-004614-18-PL
• Date of registration: 09/07/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease
• Scientific title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1
• Date of first enrolment: 03/09/2019
• Target sample size: 1150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004614-18
• 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: yes Other specify the comparator: Ustekinumab 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, China, Croatia, Czech Republic, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, 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:
• Diagnosis of CD for at least 3 months prior to baseline
• Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
• Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
• If female, subject must meet the contraception recommendations
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1045
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion criteria:
• Have a current diagnosis of ulcerative colitis or inflammatory bowel
disease-unclassified (formerly known as indeterminate colitis).
• Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately
treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no
anticipated need for any further surgery.
• Have a stoma, ileoanal pouch or ostomy.
• Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
• Have ever received anti-IL-23p19 antibodies



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

Health Condition(s) or Problem(s) studied

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

moderately to severely active 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-
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
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

Trade Name: STELARA 130 mg concentrate for solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: MIRIKIZUMAB
Product

Primary Outcome(s)

Main Objective: To evaluate the efficacy of mirikizumab is superior to placebo in
participants with Crohn's disease as assessed by
- clinical response by patient reported outcome (PRO) at Week 12 and
endoscopic response at Week 52
- clinical response by patient reported outcome (PRO) at Week 12 and
clinical remission by Crohn's Disease Activity Index (CDAI) at Week 52

Primary end point(s): 1. Percentage of Participants Achieving Clinical Response and
Endoscopic Response
Clinical response by Patient Reported Outcome (PRO) based on stool
frequency (SF) and abdominal pain (AP)
Endoscopic response based on Simple Endoscopic Score for Crohn's
Disease (SES-CD) total score
2. Percentage of Participants Achieving Clinical Response and Clinical
Remission
Clinical response by PRO based on SF and AP
Clinical remission based on CDAI

Secondary Objective: - To evaluate the efficacy of mirikizumab is superior to placebo as
assessed by endoscopic response, endoscopic remission, clinical
remission by CDAI, and Urgency NRS
- To evaluate the efficacy of mirikizumab in comparison to ustekinumab
as assessed by endoscopic response, endoscopic remission, clinical
remission by CDAI
- To evaluate the efficacy of mirikizumab in comparison to placebo in
health outcomes and quality of life measures, symptomatic endpoints,
inflammatory biomarkers
- To evaluate the pharmacokinetic and
pharmacokinetic/pharmacodynamic relationships of mirikizumab

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: secondary endpoint [3 ,4, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17]
Timepoints: Week 52
secondary endpoint [5 ,6, 7, 8, 9, 10, 11, 14, 15] Timepoints: Week 12
secondary endpoint [11] Timepoints: Week 40-52

Secondary end point(s): 3. Proportion of participants achieving endoscopic response based on
Simple Endoscopic Score for Crohn's Disease (SES-CD) total score
4. Proportion of participants achieving clinical remission by CDAI
5. Proportion of participants achieving endoscopic response based on
SES-CD total score
6. Proportion of participants achieving endoscopic remission based on
SES-CD total score
7. Percentage of Participants achieving clinical remission based on CDAI
8. Change from baseline in Urgency NRS
9. Percentage of Participants Achieving Clinical Response and Clinical
Remission based on PRO
10. Percentage of Participants Achieving Clinical Response by PRO and Endoscopic Remission by SES-CD
11. Percentage of Participants Who Are Corticosteroid-free AND in
Clinical Response by PRO AND either in Clinical Remission by CDAI or
Endoscopic Remission by SES-CD
12. Change from Baseline in C-Reactive Protein
13. Change from Baseline in Fecal Calprotectin
14. Percentage of Participants Achieving Clinical Response by PRO with
Extraintestinal Manifestations (EIMs) of Crohn's Disease
15. Percentage of participants achieving clinical response by PRO with
fistulae response
16. Pharmacokinetics (PK): Area Under the Concentration Time Curve
(AUC) of Mirikizumab
17. Change from Baseline in Health Related Quality of Life based on
Inflammatory Bowel Disease Questionnaire (IBDQ) score

Secondary ID(s)

I6T-MC-AMAM

2018-004614-18-AT

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 08/08/2019
Contact: