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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 : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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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
Estimated Study Start Date : April 16, 2020
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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




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


Secondary Outcome Measures :
  1. 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)

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

  3. Percentage of Participants Achieving Clinical Response [ Time Frame: Week 52 ]
    Clinical response by PRO based on SF and AP

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

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

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



Information from the National Library of Medicine

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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)
  • 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

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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Austria
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Contact    0043 512 5040      
Principal Investigator: Robert Koch         
KH der Barmherzigen Schwestern Wien BetriebsGesmbH
Wien, Austria, 1060
Contact    43 1 599 88 2119      
Principal Investigator: Franz Pfeffel         
Hungary
Dr. Rethy Pal Korhaz es Rendelointezet
Bekescsaba, Bekes, Hungary, 5600
Contact    36309159350      
Principal Investigator: Marta Varga         
Komarom-Eszetergom Megyei Onkormanyzat Szent Borbala Korhaza
Tatabanya, Komarom-Esztergom, Hungary, 2800
Contact    36 30 957 8269      
Principal Investigator: Andras Kafony         
Clinexpert SMO
Budapest, Hungary, 1033
Contact    36703622417      
Principal Investigator: Zsanett Heringh         
Bugat Pal Korhaz
Gyongyos, Hungary, 3200
Contact    36703916537      
Principal Investigator: Gyula Horvat         
SZTE I. sz. Belgyogyaszati Klinika
Szeged, Hungary, 6720
Contact    3662545185      
Principal Investigator: Zoltan Szepes         
Clinfan Szolgaltato Kft.
Szekszard, Hungary, 7100
Contact    36302777114      
Principal Investigator: Agnes Salamon         
Javorszky Odon Hospital
Vac, Hungary, 2600
Contact    3627620620      
Principal Investigator: Tibor Szaloki         
Italy
Ospedale di Rho
Rho, Milano, Italy, 20017
Contact    393479030959      
Principal Investigator: Simone Saibeni         
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Contact    390282245555      
Principal Investigator: Silvio Danese         
Policlinico Mater Domini
Catanzaro, Italy, 88100
Contact    3909613647113      
Principal Investigator: Francesco Luzza         
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

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: February 5, 2020
Last Verified: February 1, 2020
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 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