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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03926130




Registration number
NCT03926130
Ethics application status
Date submitted
23/04/2019
Date registered
24/04/2019

Titles & IDs
Public title
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
I6T-MC-AMAM
Secondary ID [2] 0 0
16590
Universal Trial Number (UTN)
Trial acronym
VIVID-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mirikizumab
Treatment: Drugs - Mirikizumab
Treatment: Drugs - Ustekinumab
Treatment: Drugs - Ustekinumab
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: Mirikizumab - Mirikizumab given intravenously (IV) and subcutaneously (SC).

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

Active comparator: Ustekinumab - Ustekinumab given IV and SC.

Placebo comparator: Placebo - Placebo given IV and SC.


Treatment: Drugs: Mirikizumab
Administered IV

Treatment: Drugs: Mirikizumab
Administered SC

Treatment: Drugs: Ustekinumab
Administered IV

Treatment: Drugs: Ustekinumab
Administered SC

Treatment: Drugs: Placebo
Administered IV

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52
Timepoint [1] 0 0
Baseline to Week 52
Primary outcome [2] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Response
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving Clinical Remission
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving Endoscopic Response
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving Endoscopic Remission
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving Clinical Remission
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Change from Baseline in Urgency Numeric Rating Score (NRS)
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Change from Baseline in Urgency NRS
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52
Timepoint [8] 0 0
Baseline to Week 52
Secondary outcome [9] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52
Timepoint [9] 0 0
Baseline to Week 52
Secondary outcome [10] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Corticosteroid-free AND either in Clinical Remission or Endoscopic Remission at Week 52
Timepoint [10] 0 0
Baseline to Week 52
Secondary outcome [11] 0 0
Change from Baseline in C-Reactive Protein
Timepoint [11] 0 0
Baseline, Week 52
Secondary outcome [12] 0 0
Change from Baseline in Fecal Calprotectin
Timepoint [12] 0 0
Baseline, Week 52
Secondary outcome [13] 0 0
Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn's Disease
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Percentage of Participants with Fistulae Response
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab
Timepoint [15] 0 0
Baseline through Week 52
Secondary outcome [16] 0 0
Change from Baseline in Health Related Quality of Life
Timepoint [16] 0 0
Baseline, Week 52

Eligibility
Key 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
Minimum age
15 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/10/2023
Sample size
Target
Accrual to date
Final
1158
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Concord Repatriation General Hospital - Concord
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St. Vincents Hospital Sydney - Darlinghurst
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Nepean Hospital - Kingswood
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Liverpool Hospital - Liverpool
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Royal Brisbane and Women's Hospital - Herston
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Coastal Digestive Health - Maroochydore
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Coral Sea Clinical Research Institute - North Mackay
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Emeritus Research - Camberwell
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Northern Hospital - Epping
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The Royal Melbourne Hospital - Parkville
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Fiona Stanley Hospital - Murdoch
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2139 - Concord
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2010 - Darlinghurst
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2747 - Kingswood
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2170 - Liverpool
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4029 - Herston
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4558 - Maroochydore
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4740 - North Mackay
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3124 - Camberwell
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3076 - Epping
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3050 - Parkville
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6150 - Murdoch
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Hexham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03926130