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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004614-18-FR

Enrollment

1100

Registered

2019-06-20

Start date

2019-09-11

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 descriptiv

Eligibility

Sex/Gender

All

Inclusion 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? 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 1045 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: • Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis), abdominal or perianal abscess or short bowel syndrome • Have a stoma 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 any monoclonal antibodies binding IL-23

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether treatment with mirikizumab is superior to placebo as assessed by endoscopic response at Week 52 and clinical remission by PRO at Week 52;Secondary Objective: - To evaluate the efficacy of treatment with mirikizumab compared to placebo in endoscopic response at Week 12 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in clinical remission by PRO at Week 12 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in endoscopic remission at Week 52 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in corticosteroid-free clinical remission by PRO or endoscopic remission at Week 52 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in the stability of clinical remission by PRO through Week 52 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in the durability of endoscopic response at Week 52 - To evaluate whether mirikizumab is superior to ustekinumab in achieving endoscopic response at Week 52 - To evaluate whether mirikizumab is noninferior to ustekinumab in clinical remission by CDAI at Week 52;Primary end point(s): 1. Percentage of Participants Achieving Endoscopic Response Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score [Time Frame: Week 52] 2. Percentage of Participants Achieving Clinical Remission Clinical remission by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP) [Time Frame: Week 52];Timepoint(s) of evaluation of this end point: Week 52	—

Measure

Time frame

Main Objective: To evaluate whether treatment with mirikizumab is superior to placebo as assessed by endoscopic response at Week 52 and clinical remission by PRO at Week 52;Secondary Objective: - To evaluate the efficacy of treatment with mirikizumab compared to placebo in endoscopic response at Week 12 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in clinical remission by PRO at Week 12 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in endoscopic remission at Week 52 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in corticosteroid-free clinical remission by PRO or endoscopic remission at Week 52 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in the stability of clinical remission by PRO through Week 52 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in the durability of endoscopic response at Week 52 - To evaluate whether mirikizumab is superior to ustekinumab in achieving endoscopic response at Week 52 - To evaluate whether mirikizumab is noninferior to ustekinumab in clinical remission by CDAI at Week 52;Primary end point(s): 1. Percentage of Participants Achieving Endoscopic Response Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score [Time Frame: Week 52] 2. Percentage of Participants Achieving Clinical Remission Clinical remission by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP) [Time Frame: Week 52];Timepoint(s) of evaluation of this end point: Week 52

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Secondary

Measure	Time frame
Secondary end point(s): 3. Percentage of Participants Achieving Endoscopic Remission Endoscopic remission based on SES-CD total score [Time Frame: Week 52] 4. Percentage of Participants Achieving Clinical Remission or Endoscopic Remission who were Corticosteroid Free Clinical remission by PRO based on SF and AP and endoscopic remission based on SES-CD total score [Time Frame: Week 52] 5. Percentage of Participants Achieving Clinical Remission Clinical remission by PRO is based on SF and AP [Time Frame: Week 12] 6. Percentage of Participants Achieving Clinical Remission Clinical remission based on CDAI [Time Frame: Week 52] 7. Change from Baseline in C-Reactive Protein Change from baseline in C-Reactive Protein [Time Frame: Baseline, Week 52] 8. Change from Baseline in Fecal Calprotectin Change from baseline in fecal calprotectin [Time Frame: Baseline, Week 52] 9. Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn’s Disease Percentage of participants with EIMs of Crohn’s Disease [Time Frame: Week 52] 10. Percentage of Participants with Fistulae Response Percentage of participants with fistulae response [Time Frame: Week 52] 11. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab PK: AUC of mirikizumab [Time Frame: Baseline through Week 52] 12. Change from Baseline in Health Related Quality of Life Health related quality of life based on Inflammatory Bowel Disease Questionnaire (IBDQ) score [Time Frame: Baseline, Week 52];Timepoint(s) of evaluation of this end point: secondary endpoint [3, 4, 6, 9, 10] Timepoints: Week 52 secondary endpoint [5] Timepoints: Week 12 secondary endpoint [7, 8, 11, 12] Timepoints: Baseline - Week 52	—

Measure

Time frame

Secondary end point(s): 3. Percentage of Participants Achieving Endoscopic Remission Endoscopic remission based on SES-CD total score [Time Frame: Week 52] 4. Percentage of Participants Achieving Clinical Remission or Endoscopic Remission who were Corticosteroid Free Clinical remission by PRO based on SF and AP and endoscopic remission based on SES-CD total score [Time Frame: Week 52] 5. Percentage of Participants Achieving Clinical Remission Clinical remission by PRO is based on SF and AP [Time Frame: Week 12] 6. Percentage of Participants Achieving Clinical Remission Clinical remission based on CDAI [Time Frame: Week 52] 7. Change from Baseline in C-Reactive Protein Change from baseline in C-Reactive Protein [Time Frame: Baseline, Week 52] 8. Change from Baseline in Fecal Calprotectin Change from baseline in fecal calprotectin [Time Frame: Baseline, Week 52] 9. Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn’s Disease Percentage of participants with EIMs of Crohn’s Disease [Time Frame: Week 52] 10. Percentage of Participants with Fistulae Response Percentage of participants with fistulae response [Time Frame: Week 52] 11. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab PK: AUC of mirikizumab [Time Frame: Baseline through Week 52] 12. Change from Baseline in Health Related Quality of Life Health related quality of life based on Inflammatory Bowel Disease Questionnaire (IBDQ) score [Time Frame: Baseline, Week 52];Timepoint(s) of evaluation of this end point: secondary endpoint [3, 4, 6, 9, 10] Timepoints: Week 52 secondary endpoint [5] Timepoints: Week 12 secondary endpoint [7, 8, 11, 12] Timepoints: Baseline - Week 52

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hungary, 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

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026