A Maintenance Study of Mirikizumab in Participants With M... | NCT03524092 | Trialant
NCT03524092
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
May 13, 2026Actual
Enrollment
1,328Actual
Phase
Phase 3
Conditions
Ulcerative Colitis
Interventions
Mirikizumab SC
Mirikizumab IV
Placebo SC
Countries
United States
Argentina
Australia
Austria
Belgium
Canada
China
Czechia
Denmark
France
Germany
Hungary
India
Ireland
Israel
Italy
Japan
Latvia
Lithuania
Malaysia
Mexico
Netherlands
Poland
Romania
Russia
Serbia
Slovakia
South Korea
Spain
Switzerland
Taiwan
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03524092
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16823
Secondary IDs
ID
Type
Description
Link
I6T-MC-AMBG
Other Identifier
Eli Lilly and Company
2017-003238-96
EudraCT Number
Brief Title
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official 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)
Acronym
LUCENT 2
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 19, 2018Actual
Primary Completion Date
Nov 3, 2021Actual
Completion Date
Feb 17, 2025Actual
First Submitted Date
May 10, 2018
First Submission Date that Met QC Criteria
May 10, 2018
First Posted Date
May 14, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 2, 2022
Results First Submitted that Met QC Criteria
Nov 2, 2022
Results First Posted Date
Nov 25, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 12, 2026
Last Update Posted Date
May 13, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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).
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.
Drug: Placebo SC
Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
Experimental
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.
Drug: Mirikizumab SC
Maintenance Period: PBO IR - PBO SC
Experimental
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.
Drug: Placebo SC
Maintenance Period: Miri IR - PBO SC - ME2 Cohort
Experimental
Participants in the ME2 Cohort 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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Mirikizumab SC
Drug
Administered SC
Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
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).
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of mirikizumab and who had a correctly measured Modified Mayo Score at baseline. Participants were analyzed according to the treatment arm to which they were randomized, regardless of the treatment actually received.
Week 40
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
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).
Week 40
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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)
Ran Z, Chen Y, Miao Y, Wang Y, Gao X, Zhong J, Ding X, Wang C, Zhang X, Ding Y, Hu N, Tang D, Yu J, Qian C, Shen J. Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials. BioDrugs. 2026 Jul;40(4):733-745. doi: 10.1007/s40259-026-00776-y. Epub 2026 May 12.
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.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
China Maximized Extended Enrollment (ME2):This is an extension phase of the main study,with an additional 151 participants enrolled in China.Safety was monitored and data was reported under Adverse Events (AE) section.
Per global SAP and China ME2 SAP addendum,ME2 participants were included in a combined China population;China analyses pre-specified as descriptive, i.e.,exploratory, non-inferential (no multiplicity control/p-values); hence outcomes not reported separately by ME2 treatment arms.
Recruitment Details
A total of 1177 Participants (pts) enrolled in study of which 716 pts entered to Blinded Maintenance Period as Induction Responder (IR) and 461 pts entered into open label extended Induction period as Induction Nonresponders.
This LUCENT-2 (I6T-MC-AMBG, NCT03524092) study was designed to evaluate safety and efficacy of mirikizumab (miri) in achieving remission at Week (Wk) 40 in pts who completed the 12-wk induction study LUCENT-1 (I6T-MC-AMAN,NCT03518086) as clinical responders to mirikizumab.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Maintenance Period: Miri 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.
Participants in the ME2 Cohort 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.
Drug: Mirikizumab SC
Maintenance Period: PBO IR - PBO SC - ME2 Cohort
Experimental
Participants in the ME2 Cohort 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.
Drug: Mirikizumab IV
Drug: Placebo SC
Loss of Response (LOR) Rescue Period: LOR Cohort-300 mg Miri IV
Experimental
Participants who received blinded PBO SC or blinded 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.
Drug: Mirikizumab IV
LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort
Experimental
Participants in the ME2 Cohort who received blinded PBO SC or blinded 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.
Drug: Mirikizumab IV
Extended Induction: Induction Nonresponders - 300mg Miri IV
Experimental
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.
Participants in the ME2 Cohort 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.
Drug: Mirikizumab IV
Open Label Maintenance: Delayed Responders - 200 mg Miri SC
Experimental
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 or until early termination (rescue was not available for these participants).
Participants in the ME2 Cohort 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 or until early termination (rescue was not available for these participants).
Drug: Mirikizumab SC
Open Label Maintenance: Delayed Responders - 200 mg Miri SC
Percentage of Participants With Histologic Remission at Week 40 (Mirikizumab Induction Responders)
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).
Week 40
Percentage of Participants in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders)
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).
Week 40
Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders)
Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.
Week 40
Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders)
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).
Week 40
Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders)
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).
Induction Baseline, Week 40
Change From Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders)
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.
Induction Baseline, Week 40
Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders)
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).
Induction Baseline, Week 40
Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders)
Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
Week 40
Pharmacokinetics (PK): Clearance of Mirikizumab
Clearance of mirikizumab was evaluated.
Predose: Weeks 0, 4, 12, 24 and 40
Litchfield Park
Arizona
85340
United States
Maricopa Integrated Health System
Phoenix
Arizona
85008
United States
Physicians Research Group
Tempe
Arizona
85284
United States
Valley Gastroenterology
Arcadia
California
91006
United States
Care Access Research
Berkeley
California
94705
United States
Om Research, LLC
Lancaster
California
93534
United States
California Medical Research Associates
Northridge
California
91324
United States
Clinical Applications Laboratories, Inc.
San Diego
California
92103
United States
UCSF Medical Center at Mission Bay
San Francisco
California
94158
United States
Direct Helpers Research Center
Hialeah
Florida
33012
United States
Nature Coast Clinical Research, LLC
Inverness
Florida
34452
United States
SIH Research, LLC
Kissimmee
Florida
34741
United States
Research Associates of South Florida, LLC
Miami
Florida
33134
United States
Wellness Clinical Research
Miami Lakes
Florida
33016
United States
Center for Interventional Endoscopy
Orlando
Florida
32803
United States
Clintheory Healthcare
Orlando
Florida
32818
United States
Gastroenterology Associates of Pensacola, PA
Pensacola
Florida
32503
United States
Florida Medical Clinic LLC
Zephyrhills
Florida
33542-7505
United States
Digestive Healthcare of Georgia
Atlanta
Georgia
30309
United States
Grand Teton Research Group
Idaho Falls
Idaho
83404
United States
NorthShore University HealthSystem
Evanston
Illinois
60201
United States
Indiana University School of Medicine
Indianapolis
Indiana
46202
United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka
Kansas
66606
United States
Texas Digestive Disease Consultants
Baton Rouge
Louisiana
70809
United States
Delta Research Partners LLC
Monroe
Louisiana
71201
United States
Nola Research Works, LLC
New Orleans
Louisiana
70125
United States
Clinical Research Institute of Michigan, LLC
Chesterfield
Michigan
48047
United States
Henry Ford Health System
Novi
Michigan
48377
United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming
Michigan
49519
United States
Huron Gastroenterology Associates
Ypsilanti
Michigan
48197
United States
MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
Plymouth
Minnesota
55446
United States
Care Access Research LLC
Jackson
Mississippi
39206
United States
Digestive Health Specialists
Tupelo
Mississippi
38801
United States
Northwell Health
Great Neck
New York
11021
United States
Weill Cornell Medical College
New York
New York
10021
United States
University of North Carolina Center for Inflammatory Bowel Disease
Chapel Hill
North Carolina
27599
United States
Carolina Digestive Diseases and Endoscopy Center
Greenville
North Carolina
27834
United States
Paramount Medical Research
Middleburg Heights
Ohio
44130
United States
Care Access - Youngstown
Poland
Ohio
44514
United States
Central Sooner Research
Norman
Oklahoma
73071
United States
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma
73104
United States
Digestive Disease Associates
Wyomissing
Pennsylvania
19610
United States
Midwest Medical Care
Sioux Falls
South Dakota
57108
United States
Gastro One
Germantown
Tennessee
38138
United States
Galen Medical Group
Hixson
Tennessee
37343
United States
Digestive Health Associates of Texas
Garland
Texas
75044
United States
Houston Methodist Research Ins
Houston
Texas
77030
United States
Biopharma Informatic, LLC
Houston
Texas
77043
United States
Gastroenterology Research of San Antonio
San Antonio
Texas
78229
United States
Southern Star Research Institute, LLC
San Antonio
Texas
78229
United States
Texas Digestive Disease Consultants
Southlake
Texas
76092
United States
Care Access Research LLC - Salt Lake City
Ogden
Utah
84403
United States
Emeritas Research Group
Leesburg
Virginia
20176
United States
The Gastroenterology Group, P.C.
Reston
Virginia
20191
United States
Carilion Clinic
Roanoke
Virginia
24016
United States
Wisconsin Center for Advanced Research
Milwaukee
Wisconsin
53215
United States
Centro de Investigaciones Metabólicas (CINME)
CABA
Buenos Aires
C1027AAP
Argentina
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
Ciudad Autonoma de Buenos Air
Buenos Aires
C1128AAF
Argentina
CER Instituto Medico
Quilmes
Buenos Aires
B1878DVC
Argentina
Fundación de Estudios Clínicos
Rosario
Santa Fe Province
S2000DEJ
Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman
Tucumán Province
T4000AXL
Argentina
C.I.C.E. 9 de Julio
San Miguel de Tucumán
Tucumán Province
4000
Argentina
Hospital Privado Centro Medico de Cordoba SA
Córdoba
X5016KEH
Argentina
Princess Alexandra Hospital
Harlow
Essex
CM20 1QX
Australia
Coastal Digestive Health
Maroochydore
Queensland
4558
Australia
Mater University Hospital
South Brisbane
Queensland
4101
Australia
Royal Adelaide Hospital
Adelaide
South Australia
5000
Australia
Box Hill Hospital Outpatients
Box Hill
Victoria
3128
Australia
Melbourne Gastrointestinal Investigation Unit (MGIU)
Malvern
Victoria
3144
Australia
The Alfred Hospital
Melbourne
Victoria
3004
Australia
The Royal Melbourne Hospital
Parkville
Victoria
3050
Australia
Medizinische Universität Innsbruck
Innsbruck
6020
Austria
Universitätsklinikum Salzburg
Salzburg
5020
Austria
Medical University of Vienna
Vienna
1090
Austria
Universitair Ziekenhuis Gent
Ghent
Oost-Vlaanderen
9000
Belgium
Centre Hospitalier de Wallonie Picarde - Site Notre Dame
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod
88000
Ukraine
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia
21005
Ukraine
MCIC MC LLC Health Clinic
Vinnytsia
21009
Ukraine
M.I. Pyrogov Regional Clinical Hospital
Vinnytsia
21018
Ukraine
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia
21029
Ukraine
Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
Zaporizhzhia
69104
Ukraine
Queens Hospital
Romford
Essex
RM7 0AG
United Kingdom
Fairfield General Hospital
Bury
Great Britain
BL9 7TD
United Kingdom
St Thomas' Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Whipps Cross University Hospital
London
Surrey
E11 1NR
United Kingdom
Morriston Hospital
Swansea
Swansea [Abertawe Gb-ata]
SA6 6SG
United Kingdom
St James's University Hospital
Leeds
Vinnytsia
LS9 7TF
United Kingdom
Derived
Hart A, Navabi S, D'Haens G, Matsuoka K, Martin-Arranz MD, Atreya R, Samaan KH, Dhesi E, Redondo I, Zhu B, Paulissen J, Zaremba-Pechmann L, Baygani S, Limdi J, Laharie D, Danese S. Effect of Mirikizumab on Clinical and Endoscopic Outcomes Based on Prior Advanced Therapy Failure in Patients With Moderately to Severely Active Ulcerative Colitis. United European Gastroenterol J. 2026 May;14(4):e70214. doi: 10.1002/ueg2.70214.
Panaccione R, Chan-Diehl F, Baygani S, Fisher DA, Moses RE, Siegmund B, Walsh A, Kobayashi T, Dulai PS, Travis S. Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis. Crohns Colitis 360. 2025 Jun 14;7(2):otaf043. doi: 10.1093/crocol/otaf043. eCollection 2025 Apr.
Lee SD, Ehrlich AC, Pellanda P, Kaiser C, Todd K, Moses R, Walsh A. Long-Term Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis: An Integrated 2-Year Safety Analysis. Am J Gastroenterol. 2025 Dec 1;120(12):2857-2866. doi: 10.14309/ajg.0000000000003407. Epub 2025 Mar 12.
Danese S, Dignass A, Matsuoka K, Ferrante M, Long M, Redondo I, Moses R, Maier S, Hunter Gibble T, Morris N, Milch C, Abreu MT. Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Programme. J Crohns Colitis. 2024 Nov 4;18(11):1845-1856. doi: 10.1093/ecco-jcc/jjae088.
Long MD, Schreiber S, Hibi T, Gibble TH, Fisher DA, Park G, Moses RE, Higgins PDR, Lindsay JO, Lee SD, Escobar R, Jairath V. Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies. Crohns Colitis 360. 2024 Jan 6;6(1):otae001. doi: 10.1093/crocol/otae001. eCollection 2024 Jan.
Sands BE, Feagan BG, Hunter Gibble T, Traxler KA, Morris N, Eastman WJ, Schreiber S, Jairath V, Long MD, Armuzzi A. Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies. Crohns Colitis 360. 2023 Nov 7;5(4):otad070. doi: 10.1093/crocol/otad070. eCollection 2023 Oct.
Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.
Magro F, Pai RK, Kobayashi T, Jairath V, Rieder F, Redondo I, Lissoos T, Morris N, Shan M, Park M, Peyrin-Biroulet L. Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. J Crohns Colitis. 2023 Oct 20;17(9):1457-1470. doi: 10.1093/ecco-jcc/jjad050.
FG001
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.
FG002
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.
FG003
Maintenance Period: Miri IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort 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.
Participants in the ME2 Cohort 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.
FG005
Maintenance Period: PBO IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort 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.
FG006
Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV
Participants who received blinded PBO SC or blinded 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.
FG007
LOR Rescue Period:LOR Cohort-300 mg Miri IV - ME2 Cohort
Participants in the ME2 Cohort who received blinded PBO SC or blinded 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.
FG008
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.
Participants in the ME2 Cohort 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.
FG010
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 or until early termination (rescue was not available for these participants).
Participants in the ME2 Cohort 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 or until early termination (rescue was not available for these participants).
FG000192 subjects
FG001389 subjects
FG002135 subjects
FG00321 subjects
FG00452 subjects
FG00512 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Received at Least One Dose of Study Drug
FG000192 subjects
FG001389 subjects
FG002135 subjects
FG00321 subjects
FG00452 subjects
FG00512 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG000119 subjects
FG001347 subjects
FG00290 subjects
FG00312 subjects
FG00446 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG00073 subjects
FG00142 subjects
FG00245 subjects
FG0039 subjects
FG0046 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Adverse Event
FG00016 subjects
FG0016 subjects
FG0021 subjects
FG0032 subjects
FG0044 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Lack of Efficacy
FG0008 subjects
FG0016 subjects
FG0027 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0007 subjects
FG0018 subjects
FG0026 subjects
FG0031 subjects
FG004
Loss of Response Rescue Period
FG00042 subjects
FG00119 subjects
FG00229 subjects
FG0036 subjects
FG004
Loss of Response Rescue Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants were assigned to this arm only after at least 12 weeks of blinded maintenance period.
FG0010 subjectsParticipants were assigned to this arm only after at least 12 weeks of blinded maintenance period.
FG0020 subjectsParticipants were assigned to this arm only after at least 12 weeks of blinded maintenance period.
FG0030 subjectsParticipants were assigned to this arm only after at least 12 weeks of blinded maintenance period.
FG0040 subjectsParticipants were assigned to this arm only after at least 12 weeks of blinded maintenance period.
FG0050 subjectsParticipants were assigned to this arm only after at least 12 weeks of blinded maintenance period.
FG00690 subjectsIncluded only participants who experienced loss of response and were eligible for loss of response rescue induction.
FG00712 subjectsIncluded only participants who experienced loss of response and were eligible for loss of response rescue induction.
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Open Label Extended Induction (Wk 0-12)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjectsParticipants were assigned to this arm only during loss of response rescue period.
FG0070 subjectsParticipants were assigned to this arm only during loss of response rescue period.
FG008461 subjectsIncluded only participants who entered open label extended induction period.
FG00966 subjectsIncluded only participants who entered open label extended induction period.
FG0100 subjects
FG0110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Open Label Maintenance Period (Wk 12-40)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjectsParticipants were assigned to this arm only during open label extended induction period.
FG0090 subjectsParticipants were assigned to this arm only during open label extended induction period.
FG010271 subjectsIncluded only participants who entered open label maintenance period.
FG01133 subjectsIncluded only participants who entered open label maintenance period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Maintenance Period: Miri IR - PBO 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.
BG001
Maintenance Period: Miri IR - 200 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.
BG002
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.
BG003
Maintenance Period: Miri IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort 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.
Participants in the ME2 Cohort 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.
BG005
Maintenance Period: PBO IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort 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.
BG006
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.
Participants in the ME2 Cohort 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.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000192
BG001389
BG002135
BG00321
BG00452
BG00512
BG006461
BG00766
BG0081328
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041.20± 12.88
BG00143.30± 14.13
BG00240.80± 13.40
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00078
BG001160
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG00112
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0013
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
China
Title
Measurements
BG0003
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
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).
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of mirikizumab and who had a correctly measured Modified Mayo Score at baseline. Participants were analyzed according to the treatment arm to which they were randomized, regardless of the treatment actually received.
Modified intention-to-treat (mITT): All randomized participants receiving at least one dose of mirikizumab with baseline Modified Mayo Score; analyzed by randomized arm. Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately
Posted
Number
95% Confidence Interval
percentage of participants
Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
OG001
Maintenance Period: Miri IR - 200 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.
Units
Counts
Participants
OG000179
OG001365
Title
Denominators
Categories
Title
Measurements
OG00025.1(18.8 to 31.5)
OG00149.9(44.7 to 55.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
Risk Difference (RD)
23.2
2-Sided
95
15.2
31.2
Superiority
Secondary
Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
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).
Modified intention-to-treat (mITT): All randomized participants receiving at least one dose of mirikizumab with baseline Modified Mayo Score; analyzed by randomized arm. Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately
Posted
Number
95% Confidence Interval
percentage of participants
Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
OG001
Maintenance Period: Miri IR - 200 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.
Secondary
Percentage of Participants With Histologic Remission at Week 40 (Mirikizumab Induction Responders)
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).
Modified intention-to-treat (mITT): All randomized participants receiving at least one dose of mirikizumab with baseline Modified Mayo Score; analyzed by randomized arm. Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately
Posted
Number
95% Confidence Interval
percentage of participants
Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
OG001
Maintenance Period: Miri IR - 200 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.
Secondary
Percentage of Participants in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders)
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).
Modified intention-to-treat (mITT): All randomized participants receiving at least one dose of mirikizumab with baseline Modified Mayo Score; analyzed by randomized arm. Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately.
Posted
Number
95% Confidence Interval
percentage of participants
Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
OG001
Maintenance Period: Miri IR - 200 mg Miri SC
Secondary
Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders)
Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.
Modified intention-to-treat (mITT): All randomized participants receiving at least one dose of mirikizumab with baseline Modified Mayo Score; analyzed by randomized arm. Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately.
Posted
Number
95% Confidence Interval
percentage of participants
Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
OG001
Maintenance Period: Miri IR - 200 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.
Secondary
Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders)
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).
Modified intention-to-treat (mITT): All randomized participants receiving at least one dose of mirikizumab with baseline Modified Mayo Score; analyzed by randomized arm. Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately.
Posted
Number
95% Confidence Interval
percentage of participants
Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
Secondary
Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders)
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).
mITT: All randomized participants receiving at least one dose of mirikizumab with baseline and at least one post-baseline IBDQ measurement; analyzed by randomized arm. Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately.
Posted
Least Squares Mean
Standard Error
score on a scale
Induction Baseline, Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
Secondary
Change From Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders)
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.
mITT: All randomized participants receiving at least one dose of mirikizumab with baseline and at least one post-baseline fecal calprotectin measurement; analyzed by randomized arm. Per Global SAP v4 and China ME2 Addendum, ME2 participants included in a combined China population.China analyses were pre-specified as descriptive,i.e.,exploratory,non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately
Posted
Least Squares Mean
Standard Error
milligram per kilogram (mg/kg)
Induction Baseline, Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
OG001
Maintenance Period: Miri IR - 200 mg Miri SC
Secondary
Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders)
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).
mITT: All randomized participants receiving at least one dose of mirikizumab with baseline and at least one post-baseline urgency NRS measurement; analyzed by randomized arm.Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values).These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately
Posted
Least Squares Mean
Standard Error
score on a scale
Induction Baseline, Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
Secondary
Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders)
Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
Modified intention-to-treat (mITT): All randomized participants receiving at least one dose of mirikizumab; analyzed by randomized arm. Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately.
Posted
Number
percentage of participants
Week 40
ID
Title
Description
OG000
Maintenance Period: Miri IR - PBO 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.
OG001
Maintenance Period: Miri IR - 200 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.
Secondary
Pharmacokinetics (PK): Clearance of Mirikizumab
Clearance of mirikizumab was evaluated.
All randomized participants receiving at least one dose of mirikizumab subcutaneously (both induction responders and nonresponders) and had evaluable PK data. Per Global SAP v4 and China ME2 Addendum, ME2 participants were included in a combined China population. China analyses were pre-specified as descriptive, i.e., exploratory, non-inferential (no multiplicity control/p-values). These are not part of confirmatory primary/secondary analyses; hence ME2 arms not reported separately.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per Hour (L/h)
Predose: Weeks 0, 4, 12, 24 and 40
ID
Title
Description
OG000
200 Milligram (mg) Miri SC
Participants who received 200 mg mirikizumab SC every Q4W.
Units
Counts
Participants
OG000
Time Frame
Baseline Up to week 56
Description
All randomized participants who received at least one dose of study drug. Gender-specific events occurring exclusively in female participants have had the number of participants at risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Maintenance Period: Miri IR - PBO 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.
1
192
16
192
82
192
EG001
Maintenance Period: Miri IR - 200 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.
0
389
13
389
143
389
EG002
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.
0
135
8
135
58
135
EG003
Maintenance Period: Miri IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort 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.
Participants in the ME2 Cohort 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.
0
52
7
52
32
52
EG005
Maintenance Period: PBO IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort 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.
0
12
1
12
10
12
EG006
LOR Rescue Period: LOR Cohort-300 mg Miri IV
Participants who received blinded PBO SC or blinded 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 IV Q4W for 3 doses.
0
90
3
90
18
90
EG007
LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort
Participants in the ME2 Cohort who received blinded PBO SC or blinded 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 IV Q4W for 3 doses
0
12
2
12
4
12
EG008
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.
Participants in the ME2 Cohort 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.
0
66
4
66
22
66
EG010
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 or until early termination (rescue was not available for these participants).
Participants in the ME2 Cohort 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 or until early termination (rescue was not available for these participants).
0
33
3
33
13
33
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG0030 events0 affected21 at risk
EG004
Acute coronary syndrome
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Maculopathy
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Anorectal polyp
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0007 events7 affected192 at risk
EG0010 events0 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Bacillus infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Covid-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Influenza
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Sepsis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Anastomotic fistula
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Brain contusion
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Blood glucose increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Human chorionic gonadotropin increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Sacral pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Colorectal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Kaposi's sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Neuroendocrine tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Plasmablastic lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Headache
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Migraine
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Abortion missed
Pregnancy, puerperium and perinatal conditions
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0010 events0 affected160 at risk
EG0021 events1 affected61 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Neurologic somatic symptom disorder
Psychiatric disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Rectocele
Reproductive system and breast disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected78 at risk
EG0011 events1 affected160 at risk
EG0020 events0 affected61 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Xanthelasma
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Colectomy total
Surgical and medical procedures
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Proctocolectomy
Surgical and medical procedures
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Retinopexy
Surgical and medical procedures
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Granulomatosis with polyangiitis
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG00012 events9 affected192 at risk
EG0018 events8 affected389 at risk
EG00211 events8 affected135 at risk
EG0033 events3 affected21 at risk
EG0042 events2 affected52 at risk
EG0053 events2 affected12 at risk
EG0065 events5 affected90 at risk
EG0070 events0 affected12 at risk
EG0087 events7 affected461 at risk
EG0094 events4 affected66 at risk
EG0109 events9 affected271 at risk
EG0111 events1 affected33 at risk
Sinus bradycardia
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Thyroiditis subacute
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected192 at risk
EG00113 events11 affected389 at risk
EG0023 events3 affected135 at risk
EG003
Anorectal polyp
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG00035 events35 affected192 at risk
EG00130 events26 affected389 at risk
EG00218 events17 affected135 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG00110 events10 affected389 at risk
EG0023 events3 affected135 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected192 at risk
EG0015 events5 affected389 at risk
EG0022 events2 affected135 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected192 at risk
EG0013 events3 affected389 at risk
EG0022 events1 affected135 at risk
EG003
Oedema peripheral
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0012 events2 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Pyrexia
General disorders
MedDRA 28.0
Systematic Assessment
EG0007 events5 affected192 at risk
EG00114 events13 affected389 at risk
EG0028 events6 affected135 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0014 events4 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0004 events3 affected192 at risk
EG0011 events1 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Covid-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected192 at risk
EG0018 events8 affected389 at risk
EG0025 events5 affected135 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Influenza
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0013 events3 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Localised infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG00011 events11 affected192 at risk
EG00138 events28 affected389 at risk
EG00212 events9 affected135 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0006 events5 affected192 at risk
EG0019 events7 affected389 at risk
EG0022 events2 affected135 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0014 events4 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0013 events3 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected192 at risk
EG0011 events1 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0006 events5 affected192 at risk
EG00111 events10 affected389 at risk
EG0025 events5 affected135 at risk
EG003
Weight decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0022 events2 affected135 at risk
EG003
Weight increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected389 at risk
EG0021 events1 affected135 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0002 events1 affected192 at risk
EG0014 events3 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0002 events2 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0012 events2 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0008 events8 affected192 at risk
EG00127 events26 affected389 at risk
EG0024 events4 affected135 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0004 events4 affected192 at risk
EG0016 events6 affected389 at risk
EG0024 events4 affected135 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected192 at risk
EG0013 events3 affected389 at risk
EG0021 events1 affected135 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected192 at risk
EG0012 events2 affected389 at risk
EG0020 events0 affected135 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Completed Rescue Treatment and Rolled Over to Study I6T-MC-AMAP (NCT03519945)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008271 subjects
FG00933 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008190 subjects
FG00933 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00811 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
Covid-19 related study disruption
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008162 subjects
FG00926 subjects
FG0100 subjects
FG0110 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0085 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0086 subjects
FG0095 subjects
FG0100 subjects
FG0110 subjects
Lack of capacity due to lack of staff
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG010256 subjects
FG01130 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG01015 subjects
FG0113 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0104 subjects
FG0111 subjects
Covid-19 related study disruption
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0109 subjects
FG0110 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
49.10
± 10.71
BG00442.50± 13.90
BG00556.20± 14.01
BG00643.40± 13.86
BG00744.40± 14.82
BG00843.0± 13.85
61
BG0036
BG00423
BG0055
BG006166
BG00718
BG008517
Male
BG000114
BG001229
BG00274
BG00315
BG00429
BG0057
BG006295
BG00748
BG008811
2
BG0030
BG0040
BG0050
BG00611
BG0070
BG00827
Not Hispanic or Latino
BG00018
BG00133
BG0028
BG0030
BG0040
BG0050
BG00653
BG0070
BG008112
Unknown or Not Reported
BG000172
BG001344
BG002125
BG00321
BG00452
BG00512
BG006397
BG00766
BG0081189
2
BG0030
BG0040
BG0050
BG0064
BG0070
BG00810
Asian
BG00051
BG00193
BG00228
BG00321
BG00452
BG00512
BG00687
BG00766
BG008410
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0081
Black or African American
BG0000
BG0016
BG0020
BG0030
BG0040
BG0050
BG0066
BG0070
BG00812
White
BG000138
BG001285
BG002103
BG0030
BG0040
BG0050
BG006358
BG0070
BG008884
More than one race
BG0000
BG0010
BG0022
BG0030
BG0040
BG0050
BG0061
BG0070
BG0083
Unknown or Not Reported
BG0002
BG0012
BG0020
BG0030
BG0040
BG0050
BG0064
BG0070
BG0088
1
BG00321
BG00452
BG00512
BG0067
BG00766
BG008166
Argentina
Title
Measurements
BG0001
BG0015
BG0020
BG0030
BG0040
BG0050
BG0065
BG0070
BG00811
Australia
Title
Measurements
BG0000
BG0013
BG0020
BG0030
BG0040
BG0050
BG0069
BG0070
BG00812
Austria
Title
Measurements
BG0002
BG0012
BG0020
BG0030
BG0040
BG0050
BG0064
BG0070
BG0088
Belgium
Title
Measurements
BG0001
BG0012
BG0022
BG0030
BG0040
BG0050
BG0064
BG0070
BG0089
Canada
Title
Measurements
BG0003
BG0015
BG0022
BG0030
BG0040
BG0050
BG00621
BG0070
BG00831
Czechia
Title
Measurements
BG0007
BG00119
BG00211
BG0030
BG0040
BG0050
BG00615
BG0070
BG00852
Denmark
Title
Measurements
BG0003
BG0013
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0087
France
Title
Measurements
BG00010
BG00118
BG0026
BG0030
BG0040
BG0050
BG00623
BG0070
BG00857
Germany
Title
Measurements
BG0005
BG00113
BG0023
BG0030
BG0040
BG0050
BG00616
BG0070
BG00837
Hungary
Title
Measurements
BG0001
BG0018
BG0022
BG0030
BG0040
BG0050
BG00612
BG0070
BG00823
India
Title
Measurements
BG00018
BG00125
BG00216
BG0030
BG0040
BG0050
BG00613
BG0070
BG00872
Ireland
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
Israel
Title
Measurements
BG0003
BG0016
BG0021
BG0030
BG0040
BG0050
BG0065
BG0070
BG00815
Italy
Title
Measurements
BG0003
BG00112
BG0024
BG0030
BG0040
BG0050
BG00617
BG0070
BG00836
Japan
Title
Measurements
BG00025
BG00147
BG0028
BG0030
BG0040
BG0050
BG00643
BG0070
BG008123
Latvia
Title
Measurements
BG0008
BG00110
BG0023
BG0030
BG0040
BG0050
BG0068
BG0070
BG00829
Lithuania
Title
Measurements
BG0006
BG0014
BG0025
BG0030
BG0040
BG0050
BG0067
BG0070
BG00822
Malaysia
Title
Measurements
BG0000
BG0013
BG0020
BG0030
BG0040
BG0050
BG0063
BG0070
BG0086
Mexico
Title
Measurements
BG0001
BG0013
BG0022
BG0030
BG0040
BG0050
BG0064
BG0070
BG00810
Netherlands
Title
Measurements
BG0001
BG0016
BG0020
BG0030
BG0040
BG0050
BG0063
BG0070
BG00810
Poland
Title
Measurements
BG00015
BG00132
BG00213
BG0030
BG0040
BG0050
BG00662
BG0070
BG008122
Romania
Title
Measurements
BG0004
BG0012
BG0020
BG0030
BG0040
BG0050
BG0068
BG0070
BG00814
Russia
Title
Measurements
BG00019
BG00136
BG00216
BG0030
BG0040
BG0050
BG00629
BG0070
BG008100
Serbia
Title
Measurements
BG0001
BG0019
BG0024
BG0030
BG0040
BG0050
BG0067
BG0070
BG00821
Slovakia
Title
Measurements
BG0006
BG0017
BG0021
BG0030
BG0040
BG0050
BG0067
BG0070
BG00821
South Korea
Title
Measurements
BG0003
BG0018
BG0021
BG0030
BG0040
BG0050
BG00613
BG0070
BG00825
Spain
Title
Measurements
BG0001
BG0016
BG0024
BG0030
BG0040
BG0050
BG0069
BG0070
BG00820
Switzerland
Title
Measurements
BG0000
BG0014
BG0020
BG0030
BG0040
BG0050
BG0066
BG0070
BG00810
Taiwan
Title
Measurements
BG0001
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0083
Turkey
Title
Measurements
BG0000
BG0015
BG0022
BG0030
BG0040
BG0050
BG0061
BG0070
BG0088
Ukraine
Title
Measurements
BG00018
BG00131
BG00216
BG0030
BG0040
BG0050
BG00628
BG0070
BG00893
United Kingdom
Title
Measurements
BG0002
BG0014
BG0022
BG0030
BG0040
BG0050
BG0066
BG0070
BG00814
United States
Title
Measurements
BG00021
BG00145
BG00210
BG0030
BG0040
BG0050
BG00664
BG0070
BG008140
Units
Counts
Participants
OG000179
OG001365
Title
Denominators
Categories
Title
Measurements
OG00029.1(22.4 to 35.7)
OG00158.6(53.6 to 63.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
Risk Difference (RD)
28.5
2-Sided
95
20.2
36.8
Superiority
Units
Counts
Participants
OG000179
OG001365
Title
Denominators
Categories
Title
Measurements
OG00024.6(18.3 to 30.9)
OG00148.5(43.4 to 53.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
Risk Difference (RD)
22.5
2-Sided
95
14.5
30.5
Superiority
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.
Units
Counts
Participants
OG000179
OG001365
Title
Denominators
Categories
Title
Measurements
OG00039.7(32.5 to 46.8)
OG00171.0(66.3 to 75.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
Risk Difference (RD)
30.2
2-Sided
95
21.9
38.6
Superiority
Units
Counts
Participants
OG000179
OG001365
Title
Denominators
Categories
Title
Measurements
OG00040.8(33.6 to 48.0)
OG00172.6(68.0 to 77.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
Risk Difference (RD)
31.0
2-Sided
95
22.4
39.6
Superiority
OG001
Maintenance Period: Miri IR - 200 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.
Units
Counts
Participants
OG000179
OG001365
Title
Denominators
Categories
Title
Measurements
OG00049.2(41.8 to 56.5)
OG00180.3(76.2 to 84.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
Risk Difference (RD)
30.6
2-Sided
95
22.3
38.9
Superiority
OG001
Maintenance Period: Miri IR - 200 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.
Units
Counts
Participants
OG000179
OG001365
Title
Denominators
Categories
Title
Measurements
OG00024.51± 2.767
OG00149.75± 2.102
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with modified baseline observation carried forward (mBOCF).
<0.001
LS Mean difference (Final Values)
25.24
Standard Error of the Mean
3.094
2-Sided
95
19.16
31.32
Superiority
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.
Units
Counts
Participants
OG000179
OG001365
Title
Denominators
Categories
Title
Measurements
OG000-1155.82± 221.394
OG001-1995.47± 172.443
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA with modified baseline observation carried forward (mBOCF).
<0.001
LS Mean difference (Final Values)
-839.64
Standard Error of the Mean
245.990
2-Sided
95
-1323.08
-356.21
Superiority
OG001
Maintenance Period: Miri IR - 200 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.