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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
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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)
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Secondary ID [1]
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I6T-MC-AMBG
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Secondary ID [2]
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16823
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Universal Trial Number (UTN)
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Trial acronym
LUCENT 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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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
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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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 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants in Clinical Remission at Week 40
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Assessment method [1]
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Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with = 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability).
Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); Endoscopy Subscore, based on central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
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Timepoint [1]
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Week 40
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Secondary outcome [1]
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Percentage of Participants in Endoscopic Remission at Week 40
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Assessment method [1]
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Endoscopic remission at week 40 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 40. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
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Timepoint [1]
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Week 40
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Secondary outcome [2]
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Percentage of Participants With Histologic Remission at Week 40
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Assessment method [2]
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Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis. Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration).
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Timepoint [2]
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Week 40
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Secondary outcome [3]
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Percentage of Participants in Symptomatic Remission at Week 40
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Assessment method [3]
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Symptomatic remission at week 40 is defined as a Mayo score for rectal bleeding=0, stool frequency=0 or 1 with = 1 point decrease from baseline.
Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).
Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).
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Timepoint [3]
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Week 40
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Secondary outcome [4]
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Percentage of Participants in Endoscopic Response at Week 40
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Assessment method [4]
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Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.
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Timepoint [4]
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Week 40
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Secondary outcome [5]
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Percentage of Participants in Clinical Response at Week 40
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Assessment method [5]
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Clinical response at week 40 is defined as a decrease in the 9-point modified Mayo score (MMS) \[rectal bleeding, stool frequency and the endoscopic findings\] inclusive of \>= 2 points and \>=30% from baseline with either a decrease of rectal bleeding subscore of \>=1 or rectal bleeding subscore of 0 or 1.The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration).
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Timepoint [5]
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Week 40
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Secondary outcome [6]
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Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
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Assessment method [6]
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The IBDQ is a 32-item participant-completed questionnaire that measures 4 aspects of subjects' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function. Responses are graded on a 7-point. Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).
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Timepoint [6]
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Induction Baseline, Week 40
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Secondary outcome [7]
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Change From Baseline to Week 40 in Fecal Calprotectin
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Assessment method [7]
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Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Least square (LS) Mean was calculated using ANCOVA model for post-baseline measures: The ANCOVA model includes treatment, baseline value, prior biologic or tofacitinib failure (yes/no), corticosteroid use (yes/no) at AMAN baseline, region (North America/Europe/Other), Clinical Remission status (yes/no) at AMAN Week 12.
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Timepoint [7]
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Induction Baseline, Week 40
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Secondary outcome [8]
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Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
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Assessment method [8]
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The Urgency NRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).
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Timepoint [8]
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Induction Baseline, Week 40
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Secondary outcome [9]
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Percentage of Participants Hospitalized for Ulcerative Colitis (UC)
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Assessment method [9]
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Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with \>=24 hours stay were recorded.
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Timepoint [9]
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Week 40
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Secondary outcome [10]
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Pharmacokinetics (PK): Clearance of Mirikizumab
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Assessment method [10]
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Clearance of mirikizumab was evaluated.
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Timepoint [10]
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Predose: Weeks 0, 4, 12, 24 and 40
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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.
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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
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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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
Active, not 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
19/10/2018
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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
20/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
1177
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Recruitment in Australia
Recruitment state(s)
EssexQLD,SA,VIC
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Recruitment hospital [1]
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Princess Alexandra Hospital - Harlow
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Recruitment hospital [2]
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Coastal Digestive Health - Maroochydore
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Recruitment hospital [3]
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Mater University Hospital - South Brisbane
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [5]
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Box Hill Hospital Outpatients - Box Hill
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Melbourne Gastrointestinal Investigation Unit (MGIU) - Malvern
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Recruitment hospital [7]
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The Alfred Hospital - Melbourne
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Recruitment hospital [8]
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The Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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CM20 1QX - Harlow
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Recruitment postcode(s) [2]
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4558 - Maroochydore
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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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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3144 - Malvern
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Recruitment postcode(s) [7]
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3004 - Melbourne
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Recruitment postcode(s) [8]
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3050 - Parkville
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Recruitment outside Australia
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Country [86]
0
0
France
Query!
State/province [86]
0
0
Saint Priest en Jarez
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Vandoeuvre les Nancy
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Niedersachsen
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Rheinland-Pfalz
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Sachsen-Anhalt
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Berlin
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Brandenburg
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Hamburg
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Weyhe
Query!
Country [95]
0
0
Hungary
Query!
State/province [95]
0
0
EU
Query!
Country [96]
0
0
Hungary
Query!
State/province [96]
0
0
Pest
Query!
Country [97]
0
0
Hungary
Query!
State/province [97]
0
0
Budapest
Query!
Country [98]
0
0
Hungary
Query!
State/province [98]
0
0
Debrecen
Query!
Country [99]
0
0
Hungary
Query!
State/province [99]
0
0
Miskolc
Query!
Country [100]
0
0
Hungary
Query!
State/province [100]
0
0
Mosonmagyarovar
Query!
Country [101]
0
0
Hungary
Query!
State/province [101]
0
0
Szeged
Query!
Country [102]
0
0
Hungary
Query!
State/province [102]
0
0
Szekszard
Query!
Country [103]
0
0
India
Query!
State/province [103]
0
0
Andhra Pradesh
Query!
Country [104]
0
0
India
Query!
State/province [104]
0
0
Delhi
Query!
Country [105]
0
0
India
Query!
State/province [105]
0
0
Gujarat
Query!
Country [106]
0
0
India
Query!
State/province [106]
0
0
Karnataka
Query!
Country [107]
0
0
India
Query!
State/province [107]
0
0
Maharashtra
Query!
Country [108]
0
0
India
Query!
State/province [108]
0
0
Punjab
Query!
Country [109]
0
0
India
Query!
State/province [109]
0
0
Rajasthan
Query!
Country [110]
0
0
India
Query!
State/province [110]
0
0
Telangana
Query!
Country [111]
0
0
India
Query!
State/province [111]
0
0
Uttar Pradesh
Query!
Country [112]
0
0
Ireland
Query!
State/province [112]
0
0
Dublin
Query!
Country [113]
0
0
Israel
Query!
State/province [113]
0
0
Jerusalem
Query!
Country [114]
0
0
Israel
Query!
State/province [114]
0
0
Beer-Sheva
Query!
Country [115]
0
0
Israel
Query!
State/province [115]
0
0
Nahariya
Query!
Country [116]
0
0
Israel
Query!
State/province [116]
0
0
Rehovot
Query!
Country [117]
0
0
Israel
Query!
State/province [117]
0
0
Tel Aviv
Query!
Country [118]
0
0
Israel
Query!
State/province [118]
0
0
Zerifin
Query!
Country [119]
0
0
Italy
Query!
State/province [119]
0
0
Milano
Query!
Country [120]
0
0
Italy
Query!
State/province [120]
0
0
Roma
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Brescia
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Catanzaro
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Genova
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Modena
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Pisa
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Torino
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Udine
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Aichi-ken
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Aichi
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Aomori
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Chiba
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Fukoka
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Fukuoka-Ken
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Fukuoka
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Gunma
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
HigaShiibaraki-Gun
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Hokkaido
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Hyogo-Ken
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Kagawa
Query!
Country [140]
0
0
Japan
Query!
State/province [140]
0
0
Kanagawa-Ken
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Kanagawa
Query!
Country [142]
0
0
Japan
Query!
State/province [142]
0
0
Kumamoto
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Mie
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Miyagi-Ken
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Niigata
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Oita-Ken
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Osaka
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Saga-Ken
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Saitama-Ken
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Shizuoka-Ken
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Tochigi-Ken
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Tokyo-To
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Tokyo
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Hiroshima
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Kagoshima
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Kyoto
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Okayama
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Saitama
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Toyama
Query!
Country [160]
0
0
Korea, Republic of
Query!
State/province [160]
0
0
Gangwon-do
Query!
Country [161]
0
0
Korea, Republic of
Query!
State/province [161]
0
0
Korea
Query!
Country [162]
0
0
Korea, Republic of
Query!
State/province [162]
0
0
Pusan-Kwangyokshi
Query!
Country [163]
0
0
Korea, Republic of
Query!
State/province [163]
0
0
Seoul-teukbyeolsi [Seoul]
Query!
Country [164]
0
0
Korea, Republic of
Query!
State/province [164]
0
0
Taejon-Kwangyokshi
Query!
Country [165]
0
0
Korea, Republic of
Query!
State/province [165]
0
0
Busan
Query!
Country [166]
0
0
Korea, Republic of
Query!
State/province [166]
0
0
Daegu
Query!
Country [167]
0
0
Latvia
Query!
State/province [167]
0
0
Riga
Query!
Country [168]
0
0
Lithuania
Query!
State/province [168]
0
0
Panevežio Apskritis
Query!
Country [169]
0
0
Lithuania
Query!
State/province [169]
0
0
Kaunas
Query!
Country [170]
0
0
Lithuania
Query!
State/province [170]
0
0
Klaipeda
Query!
Country [171]
0
0
Lithuania
Query!
State/province [171]
0
0
Vilnius
Query!
Country [172]
0
0
Malaysia
Query!
State/province [172]
0
0
Kelantan
Query!
Country [173]
0
0
Malaysia
Query!
State/province [173]
0
0
Kuala Lumpur
Query!
Country [174]
0
0
Malaysia
Query!
State/province [174]
0
0
Selangor
Query!
Country [175]
0
0
Mexico
Query!
State/province [175]
0
0
Distrito Federal
Query!
Country [176]
0
0
Mexico
Query!
State/province [176]
0
0
Jalisco
Query!
Country [177]
0
0
Mexico
Query!
State/province [177]
0
0
Sinaloa
Query!
Country [178]
0
0
Mexico
Query!
State/province [178]
0
0
Chihuahua
Query!
Country [179]
0
0
Mexico
Query!
State/province [179]
0
0
Veracruz
Query!
Country [180]
0
0
Netherlands
Query!
State/province [180]
0
0
Noord Brabant
Query!
Country [181]
0
0
Netherlands
Query!
State/province [181]
0
0
Noord-Holland
Query!
Country [182]
0
0
Netherlands
Query!
State/province [182]
0
0
Uden
Query!
Country [183]
0
0
Netherlands
Query!
State/province [183]
0
0
Utrecht
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Dolnoslaskie
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Kujawsko-pomorskie
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Lubelskie
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Mazowieckie
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Malopolskie
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Zachodniopomorskie
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Katowice
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Olsztyn
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Szczecin
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Torun
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Warszawa
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Wroclaw
Query!
Country [196]
0
0
Poland
Query!
State/province [196]
0
0
Zamosc
Query!
Country [197]
0
0
Poland
Query!
State/province [197]
0
0
Slaskie
Query!
Country [198]
0
0
Poland
Query!
State/province [198]
0
0
Swietokrzyskie
Query!
Country [199]
0
0
Romania
Query!
State/province [199]
0
0
Bucure?ti
Query!
Country [200]
0
0
Romania
Query!
State/province [200]
0
0
Bucuresti
Query!
Country [201]
0
0
Romania
Query!
State/province [201]
0
0
Oradea
Query!
Country [202]
0
0
Russian Federation
Query!
State/province [202]
0
0
Irkutskaya Oblast'
Query!
Country [203]
0
0
Russian Federation
Query!
State/province [203]
0
0
Kareliya, Respublika
Query!
Country [204]
0
0
Russian Federation
Query!
State/province [204]
0
0
Nizhegorodskaya Oblast'
Query!
Country [205]
0
0
Russian Federation
Query!
State/province [205]
0
0
Novosibirskaya Oblast'
Query!
Country [206]
0
0
Russian Federation
Query!
State/province [206]
0
0
Rostovskaya Oblast'
Query!
Country [207]
0
0
Russian Federation
Query!
State/province [207]
0
0
Sankt-Peterburg
Query!
Country [208]
0
0
Russian Federation
Query!
State/province [208]
0
0
Barnaul
Query!
Country [209]
0
0
Russian Federation
Query!
State/province [209]
0
0
Cherepovets
Query!
Country [210]
0
0
Russian Federation
Query!
State/province [210]
0
0
Ekaterinburg
Query!
Country [211]
0
0
Russian Federation
Query!
State/province [211]
0
0
Izhevsk
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Kaliningrad
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Kazan
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Kemerovo
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Moscow
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Novosibirsk
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Omsk
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Saint Petersburg
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Saint-Petersburg
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Samara
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
St. Petersburg
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
Stavropol
Query!
Country [223]
0
0
Russian Federation
Query!
State/province [223]
0
0
Yaroslavl
Query!
Country [224]
0
0
Serbia
Query!
State/province [224]
0
0
Beograd
Query!
Country [225]
0
0
Serbia
Query!
State/province [225]
0
0
NAP
Query!
Country [226]
0
0
Serbia
Query!
State/province [226]
0
0
Vojvodina
Query!
Country [227]
0
0
Serbia
Query!
State/province [227]
0
0
Kragujevac
Query!
Country [228]
0
0
Slovakia
Query!
State/province [228]
0
0
Nitriansky Kraj
Query!
Country [229]
0
0
Slovakia
Query!
State/province [229]
0
0
Prešovský Kraj
Query!
Country [230]
0
0
Slovakia
Query!
State/province [230]
0
0
Banska Bystrica
Query!
Country [231]
0
0
Slovakia
Query!
State/province [231]
0
0
Bratislava
Query!
Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Andalucía
Query!
Country [233]
0
0
Spain
Query!
State/province [233]
0
0
Baleares Islands
Query!
Country [234]
0
0
Spain
Query!
State/province [234]
0
0
Cantabria
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
Madrid
Query!
Country [236]
0
0
Spain
Query!
State/province [236]
0
0
Valencia
Query!
Country [237]
0
0
Spain
Query!
State/province [237]
0
0
Alicante
Query!
Country [238]
0
0
Spain
Query!
State/province [238]
0
0
Girona
Query!
Country [239]
0
0
Spain
Query!
State/province [239]
0
0
Huelva
Query!
Country [240]
0
0
Spain
Query!
State/province [240]
0
0
La Coruña
Query!
Country [241]
0
0
Spain
Query!
State/province [241]
0
0
Las Palmas de Gran Canaria
Query!
Country [242]
0
0
Spain
Query!
State/province [242]
0
0
Oviedo
Query!
Country [243]
0
0
Switzerland
Query!
State/province [243]
0
0
Berne
Query!
Country [244]
0
0
Switzerland
Query!
State/province [244]
0
0
St.Gallen
Query!
Country [245]
0
0
Switzerland
Query!
State/province [245]
0
0
Zürich
Query!
Country [246]
0
0
Taiwan
Query!
State/province [246]
0
0
Taichung
Query!
Country [247]
0
0
Taiwan
Query!
State/province [247]
0
0
Taipei
Query!
Country [248]
0
0
Turkey
Query!
State/province [248]
0
0
Antalya
Query!
Country [249]
0
0
Turkey
Query!
State/province [249]
0
0
Istanbul
Query!
Country [250]
0
0
Turkey
Query!
State/province [250]
0
0
Kocaeli
Query!
Country [251]
0
0
Turkey
Query!
State/province [251]
0
0
Mersin
Query!
Country [252]
0
0
Turkey
Query!
State/province [252]
0
0
Izmir
Query!
Country [253]
0
0
Ukraine
Query!
State/province [253]
0
0
Ivano-Frankivsk Region
Query!
Country [254]
0
0
Ukraine
Query!
State/province [254]
0
0
Kharkivska Oblast
Query!
Country [255]
0
0
Ukraine
Query!
State/province [255]
0
0
Khersonska Oblast
Query!
Country [256]
0
0
Ukraine
Query!
State/province [256]
0
0
Kyiv
Query!
Country [257]
0
0
Ukraine
Query!
State/province [257]
0
0
Lvivska Oblast
Query!
Country [258]
0
0
Ukraine
Query!
State/province [258]
0
0
Poltavska Oblast
Query!
Country [259]
0
0
Ukraine
Query!
State/province [259]
0
0
Zaporizka Oblast
Query!
Country [260]
0
0
Ukraine
Query!
State/province [260]
0
0
Kharkiv
Query!
Country [261]
0
0
Ukraine
Query!
State/province [261]
0
0
Kropyvnytskyi
Query!
Country [262]
0
0
Ukraine
Query!
State/province [262]
0
0
Odesa
Query!
Country [263]
0
0
Ukraine
Query!
State/province [263]
0
0
Uzhgorod
Query!
Country [264]
0
0
Ukraine
Query!
State/province [264]
0
0
Vinnytsia
Query!
Country [265]
0
0
Ukraine
Query!
State/province [265]
0
0
Vinnytsya
Query!
Country [266]
0
0
Ukraine
Query!
State/province [266]
0
0
Zaporizhzhia
Query!
Country [267]
0
0
United Kingdom
Query!
State/province [267]
0
0
Essex
Query!
Country [268]
0
0
United Kingdom
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Great Britain
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United Kingdom
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London
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United Kingdom
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Surrey
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United Kingdom
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Swansea [Abertawe Gb-ata]
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United Kingdom
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Vinnytsia
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
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Trial website
https://clinicaltrials.gov/study/NCT03524092
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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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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Eli Lilly and Company
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Contact person for public queries
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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
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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)
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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.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/92/NCT03524092/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/92/NCT03524092/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03524092