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A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926130
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE July 23, 2019
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Percentage of Participants Achieving Endoscopic Response [ Time Frame: Week 52 ]
    Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score
  • Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 52 ]
    Clinical remission by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission based on SES-CD total score
  • Percentage of Participants Achieving Clinical Remission or Endoscopic Remission who were Corticosteroid Free [ Time Frame: Week 52 ]
    Clinical remission by PRO based on SF and AP and endoscopic remission based on SES-CD total score
  • Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 12 ]
    Clinical remission by PRO is based on SF and AP
  • Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 52 ]
    Clinical remission based on CDAI
  • Change from Baseline in C-Reactive Protein [ Time Frame: Baseline, Week 52 ]
    Change from baseline in C-Reactive Protein
  • Change from Baseline in Fecal Calprotectin [ Time Frame: Baseline, Week 52 ]
    Change from baseline in fecal calprotectin
  • Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn's Disease [ Time Frame: Week 52 ]
    Percentage of participants with EIMs of Crohn's Disease
  • Percentage of Participants with Fistulae Response [ Time Frame: Week 52 ]
    Percentage of participants with fistulae response
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab [ Time Frame: Baseline through Week 52 ]
    PK: AUC of mirikizumab
  • Change from Baseline in Health Related Quality of Life [ Time Frame: Baseline, Week 52 ]
    Health related quality of life based on Inflammatory Bowel Disease Questionnaire (IBDQ) score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Official Title  ICMJE 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
Brief Summary The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Mirikizumab
    Administered IV
    Other Name: LY3074828
  • Drug: Mirikizumab
    Administered SC
    Other Name: LY3074828
  • Drug: Ustekinumab
    Administered IV
  • Drug: Ustekinumab
    Administered SC
  • Drug: Placebo
    Administered IV
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: Mirikizumab
    Mirikizumab given intravenously (IV) and subcutaneously (SC).
    Interventions:
    • Drug: Mirikizumab
    • Drug: Mirikizumab
  • Active Comparator: Ustekinumab
    Ustekinumab given IV and SC.
    Interventions:
    • Drug: Ustekinumab
    • Drug: Ustekinumab
  • Placebo Comparator: Placebo
    Placebo given IV and SC.
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
1100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 25, 2023
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Croatia,   Czechia,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT03926130
Other Study ID Numbers  ICMJE 16590
I6T-MC-AMAM ( Other Identifier: Eli Lilly and Company )
2018-004614-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 1, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP