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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 : Recruiting
First Posted : January 18, 2020
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Mirikizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 778 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : January 2, 2025
Estimated Study Completion Date : April 22, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mirikizumab SC
Mirikizumab given subcutaneously (SC).
 Drug: Mirikizumab
Administered SC
Other Name: LY3074828
Experimental: Mirikizumab IV and SC
Mirikizumab given intravenously (IV) and SC.
 Drug: Mirikizumab
Administered IV
Other Name: LY3074828

Drug: Mirikizumab
Administered SC
Other Name: LY3074828


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 52 ]
    Clinical remission based on Crohn's Disease Activity Index (CDAI)


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission based on SES-CD total score

  2. Percentage of Participants Achieving Clinical Response [ Time Frame: Week 52 ]
    Clinical response by patient-reported outcomes (PRO) based on stool frequency (SF) and abdominal pain (AP)

  3. Change from Baseline in C-Reactive Protein [ Time Frame: Baseline, Week 12 ]
    Change from baseline in c-reactive protein

  4. Change from Baseline in Fecal Calprotectin [ Time Frame: Baseline, Week 12 ]
    Change from baseline in fecal calprotectin

  5. Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline to Week 52 ]
    Change from baseline on the IBDQ


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) that would pose an unacceptable risk in the trial.
  • 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.

Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.

  • Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
  • Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232553


Contacts
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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

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04232553    
Other Study ID Numbers: 16628
I6T-MC-AMAX ( Other Identifier: Eli Lilly and Company )
2019-002687-27 ( EudraCT Number )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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 European Union (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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mirikizumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents