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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03518086




Registration number
NCT03518086
Ethics application status
Date submitted
4/05/2018
Date registered
8/05/2018

Titles & IDs
Public title
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Secondary ID [1] 0 0
I6T-MC-AMAN
Secondary ID [2] 0 0
16591
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

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

Placebo comparator: Placebo Intravenous (IV) Every 4 Weeks (Q4W) - Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Experimental: 300 Milligram (mg) Mirikizumab IV Q4W - 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Placebo comparator: Placebo IV Q4W Maximum Extended Enrollment (ME2) - Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Experimental: 300 mg Mirikizumab IV Q4W ME2 - 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.


Treatment: Drugs: Mirikizumab
Administered IV

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants With Symptomatic Remission at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants With Symptomatic Response at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants With Histologic Remission at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants With Endoscopic Response at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
Change From Baseline to Week 12 in Fecal Calprotectin
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Pharmacokinetics (PK): Clearance of Mirikizumab
Timepoint [10] 0 0
Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12

Eligibility
Key inclusion criteria
* Diagnosis of UC for at least 3 months prior to baseline.
* Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
* Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
* If female, must meet the contraception requirements.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
* Participants with a previous colectomy.
* Participants with current evidence of toxic megacolon.
* Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

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 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
18/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2024
Sample size
Target
Accrual to date
Final
1281
Recruitment in Australia
Recruitment state(s)
EssexNSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Harlow
Recruitment hospital [2] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [3] 0 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [4] 0 0
Mater University Hospital - South Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Box Hill Hospital Outpatients - Box Hill
Recruitment hospital [7] 0 0
Melbourne Gastrointestinal Investigation Unit (MGIU) - Malvern
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Northern Hospital - Melbourne
Recruitment hospital [10] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
CM20 1QX - Harlow
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2305 - Newcastle
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4558 - Maroochydore
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4101 - South Brisbane
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5000 - Adelaide
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3128 - Box Hill
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3144 - Malvern
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3076 - Melbourne
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment outside Australia
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Glasgow

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 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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03518086