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A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2)

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: NCT04232553
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE January 15, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date March 17, 2020
Estimated Study Start Date  ICMJE April 16, 2020
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
  • 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)
  • Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission based on SES-CD total score
  • Percentage of Participants Achieving Clinical Response [ Time Frame: Week 52 ]
    Clinical response by PRO based on SF and AP
  • Change from Baseline in C-Reactive Protein [ Time Frame: Baseline, Week 12 ]
    Change from baseline in c-reactive protein
  • Change from Baseline in Fecal Calprotectin [ Time Frame: Baseline, Week 12 ]
    Change from baseline in fecal calprotectin
  • Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline to Week 52 ]
    Change from baseline on the IBDQ
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 Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Official Title  ICMJE A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease
Brief Summary The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Mirikizumab
    Administered IV
    Other Name: LY3074828
  • Drug: Mirikizumab
    Administered SC
    Other Name: LY3074828
Study Arms  ICMJE
  • Experimental: Mirikizumab SC
    Mirikizumab given subcutaneously (SC).
    Intervention: Drug: Mirikizumab
  • Experimental: Mirikizumab IV and SC
    Mirikizumab given intravenously (IV) and SC.
    Interventions:
    • Drug: Mirikizumab
    • Drug: Mirikizumab
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2020)
778
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2023
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
  • If female, participant must meet the contraception requirements

Exclusion Criteria:

  • Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM)
  • Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study
  • Participants may not have received surgery for Crohn's disease in the originator study or are likely to require surgery for treatment of Crohn's disease during the study
  • Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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,   Austria,   Belgium,   Czechia,   Germany,   Hungary,   Israel,   Italy,   Japan,   Netherlands,   Romania,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04232553
Other Study ID Numbers  ICMJE 16628
I6T-MC-AMAX ( Other Identifier: Eli Lilly and Company )
2019-002687-27 ( 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 15, 2020

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