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Trial record 1 of 1 for:    VIVID-1 Lilly
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A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-1)

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ClinicalTrials.gov Identifier: NCT03926130
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : August 9, 2022
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 see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : December 19, 2023
Estimated Study Completion Date : April 16, 2024

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

Mirikizumab given intravenously (IV) and subcutaneously (SC).

Participants in the open-label adolescent addendum will be given mirikizumab IV and SC.

 Drug: Mirikizumab
Administered IV
Other Name: LY3074828

Drug: Mirikizumab
Administered SC
Other Name: LY3074828
Active Comparator: Ustekinumab
Ustekinumab given IV and SC.
 Drug: Ustekinumab
Administered IV

Drug: Ustekinumab
Administered SC
Placebo Comparator: Placebo
Placebo given IV and SC.
 Drug: Placebo
Administered IV

Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 [ Time Frame: Baseline to Week 52 ]

    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 at Week 12 and Clinical Remission at Week 52 [ Time Frame: Baseline to Week 52 ]

    Clinical response by PRO based on SF and AP

    Clinical remission based on CDAI



Secondary 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)

  3. Percentage of Participants Achieving Endoscopic Response [ Time Frame: Week 12 ]
    Endoscopic Response based on SES-CD total score

  4. Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission based on SES-CD total score

  5. Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 12 ]
    Clinical remission based on CDAI

  6. Change from Baseline in Urgency Numeric Rating Score (NRS) [ Time Frame: Baseline, Week 12 ]
    Change from Baseline in Urgency NRS

  7. Change from Baseline in Urgency NRS [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Urgency NRS

  8. Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 [ Time Frame: Baseline to Week 52 ]
    Clinical Response and Clinical Remission based on PRO

  9. Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52 [ Time Frame: Baseline to Week 52 ]
    Clinical Response by PRO and Endoscopic Remission by SES-CD

  10. Percentage of Participants Achieving Clinical Response at Week 12 and Corticosteroid-free AND either in Clinical Remission or Endoscopic Remission at Week 52 [ Time Frame: Baseline to Week 52 ]
    Clinical Response by PRO, Clinical remission by CDAI, Endoscopic Remission by SES-CD

  11. Change from Baseline in C-Reactive Protein [ Time Frame: Baseline, Week 52 ]
    Change from baseline in C-Reactive Protein

  12. Change from Baseline in Fecal Calprotectin [ Time Frame: Baseline, Week 52 ]
    Change from baseline in fecal calprotectin

  13. Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn's Disease [ Time Frame: Week 52 ]
    Percentage of participants with EIMs of Crohn's Disease

  14. Percentage of Participants with Fistulae Response [ Time Frame: Week 52 ]
    Percentage of participants with fistulae response

  15. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab [ Time Frame: Baseline through Week 52 ]
    PK: AUC of mirikizumab

  16. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
  • 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 any monoclonal antibodies binding IL-23
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): NCT03926130


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: NCT03926130    
Other Study ID Numbers: 16590
I6T-MC-AMAM ( Other Identifier: Eli Lilly and Company )
2018-004614-18 ( EudraCT Number )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
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
Ustekinumab
Dermatologic Agents
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