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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03519945




Registration number
NCT03519945
Ethics application status
Date submitted
7/05/2018
Date registered
9/05/2018

Titles & IDs
Public title
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
Scientific title
A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3
Secondary ID [1] 0 0
I6T-MC-AMAP
Secondary ID [2] 0 0
16596
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

Experimental: Mirikizumab - Mirikizumab administered subcutaneously (SC).


Treatment: Drugs: Mirikizumab
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
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants in Endoscopic Remission
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants in Corticosteroid-free Remission
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
UC Symptoms: Numeric Rating Score
Timepoint [5] 0 0
Week 160
Secondary outcome [6] 0 0
Percentage of Participants Who are Hospitalized Due to UC
Timepoint [6] 0 0
Baseline to Week 160
Secondary outcome [7] 0 0
Percentage of Participants Who Undergo UC Surgeries Including Colectomy
Timepoint [7] 0 0
Baseline to Week 160

Eligibility
Key inclusion criteria
* Inclusion Criteria

* Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug.
* Female participants must agree to contraception requirements.
*
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Participants must not have developed a new condition, including cancer in the originator study.
* Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
* Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
1063
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Misericordiae Limited - Brisbane
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3065 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
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Udmurtskaya Respublika
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Russian Federation
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Serbia
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Beograd
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Serbia
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Huelva
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Berne
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Switzerland
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Switzerland
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Zürich
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Taiwan
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Taichung
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Taiwan
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Taipei
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Mersin
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State/province [223] 0 0
Poltavska Oblast
Country [224] 0 0
Ukraine
State/province [224] 0 0
Vinnytska Oblast
Country [225] 0 0
Ukraine
State/province [225] 0 0
Zakarpatska Oblast
Country [226] 0 0
Ukraine
State/province [226] 0 0
Zaporizka Oblast
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Great Britain
Country [228] 0 0
United Kingdom
State/province [228] 0 0
London, City Of
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Oxfordshire
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Waltham Forest

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
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
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?
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT03519945