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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03524092




Registration number
NCT03524092
Ethics application status
Date submitted
10/05/2018
Date registered
14/05/2018

Titles & IDs
Public title
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
Secondary ID [1] 0 0
I6T-MC-AMBG
Secondary ID [2] 0 0
16823
Universal Trial Number (UTN)
Trial acronym
LUCENT 2
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 SC
Treatment: Drugs - Mirikizumab IV
Treatment: Drugs - Placebo SC

Placebo comparator: Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC) - Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.

Experimental: Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC - Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

Other: Maintenance Period: PBO IR - PBO SC - Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

Other: Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV - Participants who received PBO SC or 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.

Other: Extended Induction: Induction Nonresponders - 300mg Miri IV - Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.

Other: Open Label Maintenance: Delayed Responders - 200 mg Miri SC - Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40.


Treatment: Drugs: Mirikizumab SC
Administered SC

Treatment: Drugs: Mirikizumab IV
Administered IV

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants in Clinical Remission at Week 40
Timepoint [1] 0 0
Week 40
Secondary outcome [1] 0 0
Percentage of Participants in Endoscopic Remission at Week 40
Timepoint [1] 0 0
Week 40
Secondary outcome [2] 0 0
Percentage of Participants With Histologic Remission at Week 40
Timepoint [2] 0 0
Week 40
Secondary outcome [3] 0 0
Percentage of Participants in Symptomatic Remission at Week 40
Timepoint [3] 0 0
Week 40
Secondary outcome [4] 0 0
Percentage of Participants in Endoscopic Response at Week 40
Timepoint [4] 0 0
Week 40
Secondary outcome [5] 0 0
Percentage of Participants in Clinical Response at Week 40
Timepoint [5] 0 0
Week 40
Secondary outcome [6] 0 0
Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Timepoint [6] 0 0
Induction Baseline, Week 40
Secondary outcome [7] 0 0
Change From Baseline to Week 40 in Fecal Calprotectin
Timepoint [7] 0 0
Induction Baseline, Week 40
Secondary outcome [8] 0 0
Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
Timepoint [8] 0 0
Induction Baseline, Week 40
Secondary outcome [9] 0 0
Percentage of Participants Hospitalized for Ulcerative Colitis (UC)
Timepoint [9] 0 0
Week 40
Secondary outcome [10] 0 0
Pharmacokinetics (PK): Clearance of Mirikizumab
Timepoint [10] 0 0
Predose: Weeks 0, 4, 12, 24 and 40

Eligibility
Key inclusion criteria
* Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
* Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
* 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 diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
* Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
* Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
* Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
* Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
* Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
1177
Recruitment in Australia
Recruitment state(s)
EssexQLD,SA,VIC
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Princess Alexandra Hospital - Harlow
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Coastal Digestive Health - Maroochydore
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Mater University Hospital - South Brisbane
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Royal Adelaide Hospital - Adelaide
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Box Hill Hospital Outpatients - Box Hill
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Melbourne Gastrointestinal Investigation Unit (MGIU) - Malvern
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The Alfred Hospital - Melbourne
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The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
CM20 1QX - Harlow
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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
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3004 - Melbourne
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3050 - Parkville
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Vinnytsia

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: http://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/NCT03524092