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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)
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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
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Secondary ID [1]
0
0
I6T-MC-AMAP
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Secondary ID [2]
0
0
16596
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
0
0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Mirikizumab
Experimental: Mirikizumab - Mirikizumab administered subcutaneously (SC).
Treatment: Drugs: Mirikizumab
Administered SC.
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
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Percentage of Participants in Clinical Remission
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Assessment method [1]
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Clinical remission based on the modified Mayo Score (MMS).
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants in Endoscopic Remission
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Assessment method [1]
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Endoscopic remission based on the MMS Endoscopic Subscore (ES).
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Timepoint [1]
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0
Week 52
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Secondary outcome [2]
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0
Percentage of Participants in Corticosteroid-free Remission
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Assessment method [2]
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Participants in corticosteroid-free remission.
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Timepoint [2]
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0
Week 52
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Secondary outcome [3]
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Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52
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Assessment method [3]
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Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.
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Timepoint [3]
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0
Week 52
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Secondary outcome [4]
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0
Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score
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Assessment method [4]
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Health Related Quality of Life based on IBDQ score.
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Timepoint [4]
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0
Baseline to Week 52
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Secondary outcome [5]
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UC Symptoms: Numeric Rating Score
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Assessment method [5]
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UC symptoms based on numeric rating score.
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Timepoint [5]
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Week 160
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Secondary outcome [6]
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0
Percentage of Participants Who are Hospitalized Due to UC
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Assessment method [6]
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Participants who are hospitalized due to UC.
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Timepoint [6]
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Baseline to Week 160
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Secondary outcome [7]
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0
Percentage of Participants Who Undergo UC Surgeries Including Colectomy
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Assessment method [7]
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Participants who undergo UC surgeries including colectomy.
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Timepoint [7]
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0
Baseline to Week 160
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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.
*
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
20/12/2027
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Actual
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Sample size
Target
1063
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Mater Misericordiae Limited - Brisbane
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Princess Alexandra Hospital - Brisbane
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Coastal Digestive Health - Maroochydore
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Recruitment hospital [4]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [5]
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Box Hill Hospital - Box Hill
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Recruitment hospital [6]
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St Vincent's Hospital - Fitzroy
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Recruitment hospital [7]
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The Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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4101 - Brisbane
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Recruitment postcode(s) [2]
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4102 - Brisbane
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Recruitment postcode(s) [3]
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4558 - Maroochydore
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment outside Australia
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Saitama-Ken
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0
Japan
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State/province [130]
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0
Shizuoka
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0
Japan
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Tochigi
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Japan
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Tokyo
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Japan
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Fukuoka
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Japan
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Kagoshima
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Japan
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Kyoto
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Japan
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Okayama
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Japan
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Saga
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Japan
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Saitama
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Japan
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Toyama
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Korea, Republic of
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Kang-won-do
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Korea, Republic of
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Kyongsangbuk-do
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Korea, Republic of
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Pusan-Kwangyokshi
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Korea, Republic of
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Taejon-Kwangyokshi
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Latvia
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Riga
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Lithuania
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Klaipedos Miestas
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Lithuania
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Panevežio Apskritis
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Malaysia
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Kedah
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Malaysia
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Kelantan
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Malaysia
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Kuala Lumpur
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Malaysia
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Wilayah Persekutuan Kuala Lumpur
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Malaysia
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Selangor
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Mexico
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Sinaloa
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Mexico
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Chihuahua
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Mexico
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Veracruz
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Moldova, Republic of
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Chisinau
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Netherlands
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Noord-Brabant
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Netherlands
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Noord-Holland
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Netherlands
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Utrecht
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Poland
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Dolnoslaskie
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Poland
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Kujawsko-pomorskie
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Poland
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Lubelskie
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Poland
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Mazowieckie
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Poland
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Malopolskie
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Poland
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Podkarpackie
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Poland
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Pomorskie
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Poland
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Warminsko-mazurskie
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Poland
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Zachodniopomorskie
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Poland
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Slaskie
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Romania
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Bihor
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Romania
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Bucure?ti
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Romania
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Bucuresti
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Russian Federation
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Altayskiy Kray
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Russian Federation
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Irkutskaya Oblast'
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Russian Federation
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Kareliya, Respublika
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Russian Federation
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Kemerovskaya Oblast'
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Russian Federation
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Leningradskaya Oblast'
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Russian Federation
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Nizhegorodskaya Oblast'
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Russian Federation
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Novosibirskaya Oblast'
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Russian Federation
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Omskaya Oblast
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Russian Federation
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Rostovskaya Oblast'
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Stavropol'skiy Kray
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Russian Federation
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Sverdlovskaya Oblast'
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Russian Federation
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Tatarstan, Respublika
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Russian Federation
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Udmurtskaya Respublika
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Russian Federation
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Yaroslavskaya Oblast'
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Russian Federation
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Saint Petersburg
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Serbia
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Beograd
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Serbia
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Vojvodina
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Serbia
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Šumadijski Okrug
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Slovakia
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Banskobystrický Kraj
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Slovakia
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Bratislavský Kraj
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Slovakia
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Nitriansky Kraj
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Slovakia
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Prešovský Kraj
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Spain
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Asturias
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Spain
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Cantabria
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Spain
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Girona [Gerona]
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Spain
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Las Palmas
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Spain
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Madrid
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Spain
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València
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Country [205]
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Spain
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Alicante
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Country [206]
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0
Spain
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Huelva
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Country [207]
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Switzerland
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Berne
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Switzerland
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Sankt Gallen
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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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Turkey
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Izmir
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Country [213]
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Turkey
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Antalya
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Country [214]
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Turkey
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Kocaeli
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Country [215]
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Turkey
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Mersin
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Ukraine
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Ivano-Frankivska Oblast
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Ukraine
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Kharkivska Oblast
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Ukraine
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Khersonska Oblast
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Ukraine
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Kirovohradska Oblast
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Ukraine
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Kyiv
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Ukraine
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Lvivska Oblast
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Ukraine
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Odeska Oblast
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Ukraine
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Poltavska Oblast
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Ukraine
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Vinnytska Oblast
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Ukraine
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Zakarpatska Oblast
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Ukraine
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Zaporizka Oblast
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Country [227]
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United Kingdom
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Great Britain
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Country [228]
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0
United Kingdom
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London, Ci
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Country [229]
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0
United Kingdom
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0
Oxfordshire
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Country [230]
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0
United Kingdom
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0
Waltham Forest
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.
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Trial website
https://clinicaltrials.gov/study/NCT03519945
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Trial related presentations / publications
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Public notes
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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)
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Address
0
0
Eli Lilly and Company
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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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
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-317-615-4559
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
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