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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMAN | Other Identifier | Eli Lilly and Company | |
| 2017-003229-14 | EudraCT Number |
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The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Intravenous (IV) Every 4 Weeks (Q4W) | Placebo Comparator | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
| 300 Milligram (mg) Mirikizumab IV Q4W | Experimental | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
| Placebo IV Q4W Maximum Extended Enrollment (ME2) | Placebo Comparator | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
| 300 mg Mirikizumab IV Q4W ME2 | Experimental | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission at Week 12 | Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA). 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). The confidence interval of 99.88% was chosen to match the significance level. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response at Week 12 | Clinical response at week 12 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).The MMS ranges from 0 to 9 points,with higher scores representing more severe disease. The confidence interval of 99.88% was chosen to match the significance level. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | United States | ||
| Dcr-Pi, Pc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42120652 | Derived | 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. | |
| 42104877 |
| Label | URL |
|---|---|
| An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) | View source |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
As pre-specified in the analysis plan, outcome measures were not reported for the Maximum Extended Enrollment (ME2) arms/groups, as no formal efficacy analysis was pre-specified for the ME2 cohorts but only for the main global study arms/groups
Main study: Participants were randomized in a 3:1 ratio to 300 milligrams (mg) of mirikizumab intravenously (IV) every 4 weeks (Q4W) or placebo IV Q4W.
China Maximized Extended Enrollment (ME2): This is an extension phase of the main study, with an additional 166 participants enrolled in China. Safety was monitored and data was reported under Adverse Events (AE) section.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo IV Q4W | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| FG001 | 300 mg Mirikizumab IV Q4W | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: AMAN 05 Protocol (a)_Redacted | Sep 12, 2019 |
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| Placebo | Drug | Administered IV |
|
| Week 12 |
| Percentage of Participants With Endoscopic Remission at Week 12 | Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 12. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The Mayo endoscopic score ranges from 0 to 3 points, with higher scores representing more severe disease. The confidence interval of 99.88% was chosen to match the significance level. | Week 12 |
| Percentage of Participants With Symptomatic Remission at Week 12 | Symptomatic remission at week 12 is defined as a Mayo subscore 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). The confidence interval of 99.88% was chosen to match the significance level. | Week 12 |
| Percentage of Participants With Symptomatic Response at Week 12 | Symptomatic response at week 12 is defined as ≥30% decrease from baseline in the sum of stool frequency and rectal bleeding 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). The sum of stool frequency and rectal bleeding subscores ranges from 0 to 6. | Week 12 |
| Percentage of Participants With Histologic Remission at Week 12 | 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 12 |
| Percentage of Participants With Endoscopic Response at Week 12 | Endoscopic response at week 12 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore. The Mayo endoscopic subscore ranges from 0 to 3 points, with higher scores representing more severe disease. | Week 12 |
| Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) | 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), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other). | Baseline, Week 12 |
| Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | 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 (Guyatt et al. 1989). 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), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other). | Baseline, Week 12 |
| Change From Baseline to Week 12 in Fecal Calprotectin | 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 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), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other). | Baseline, Week 12 |
| Pharmacokinetics (PK): Clearance of Mirikizumab | Clearance of mirikizumab was evaluated. Clearance is estimated based on concentration data collected in the time frame of 0-12 weeks. | Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12 |
| Litchfield Park |
| Arizona |
| 85340 |
| United States |
| Maricopa Integrated Health System | Phoenix | Arizona | 85008 | United States |
| Physicians Research Group | Tempe | Arizona | 85284 | United States |
| Yuma Gastro LLC | Yuma | Arizona | 85364 | United States |
| Valley Gastroenterology | Arcadia | California | 91006 | United States |
| Care Access Research | Berkeley | California | 94705 | United States |
| Citrus Valley Health Partners | Covina | California | 91722 | United States |
| Valley View Internal Medicine | Garden Grove | California | 92843 | United States |
| Om Research, LLC | Lancaster | California | 93534 | United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| California Medical Research Associates | Northridge | California | 91324 | United States |
| Gastroenterology Associates | Pasadena | California | 91105 | United States |
| Clinical Applications Laboratories, Inc. | San Diego | California | 92103 | United States |
| UCSF Medical Center at Mission Bay | San Francisco | California | 94158 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Delta Waves Sleep Disorders and Research Center | Colorado Springs | Colorado | 80918 | United States |
| Gastroenterology Consultants of Clearwater | Clearwater | Florida | 33756 | United States |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33761 | United States |
| Clinical Research of West Florida, Inc. (Clearwater) | Clearwater | Florida | 33765 | United States |
| Pioneer Clinical Research | Coral Springs | Florida | 33067 | United States |
| Direct Helpers Medical Center | Hialeah | Florida | 33012 | United States |
| The Center for Gastrointestinal Disorders | Hollywood | Florida | 33021 | United States |
| Nature Coast Clinical Research, LLC | Inverness | Florida | 34452 | United States |
| SIH Research, LLC | Kissimmee | Florida | 34741 | United States |
| Columbus Clinical Services, LLC | Miami | Florida | 33125 | United States |
| Research Associates of South Florida, LLC | Miami | Florida | 33134 | United States |
| IMIC, Inc. | Miami | Florida | 33176 | United States |
| Inpatient Research Clinic, LLC | Miami Lakes | Florida | 33014 | United States |
| Life Medical Center & Research, Inc | Miami Lakes | Florida | 33014 | United States |
| Wellness Clinical Research | Miami Lakes | Florida | 33016 | United States |
| Pharma Research International, Inc. | Naples | Florida | 34110 | 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 Digestive Specialist | St. Petersburg | Florida | 33709 | United States |
| Florida Medical Clinic LLC | Zephyrhills | Florida | 33542-7505 | United States |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | United States |
| Gastrointestinal Diseases Research | Columbus | Georgia | 31904 | United States |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | 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 |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | 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 |
| Clinical Trials of SWLA, LLC | Lake Charles | Louisiana | 70601 | United States |
| Delta Research Partners LLC | Monroe | Louisiana | 71201 | United States |
| Tulane Univ School of Med | New Orleans | Louisiana | 70112 2715 | 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 |
| Washington University Medical School | St Louis | Missouri | 63110 | United States |
| Capital Health Medical Center Hopewell | Pennington | New Jersey | 08534 | United States |
| Northwell Health | Great Neck | New York | 11021 | United States |
| NYU Langone Long Island Clinical Research Associates | Lake Success | New York | 11042 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Carolina Digestive Diseases and Endoscopy Center | Greenville | North Carolina | 27834 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157-1045 | United States |
| Trinity Health Center Medical Arts | Minot | North Dakota | 58701 | United States |
| META Medical Research Institute, LLC | Dayton | Ohio | 45432 | United States |
| Paramount Medical Research | Middleburg Heights | Ohio | 44130 | United States |
| Care Access Research - Youngstown | Poland | Ohio | 44514 | United States |
| Great Lakes Medical Research, LLC | Westlake | Ohio | 44145 | 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 |
| Ocean State Clinical Research Partners | Lincoln | Rhode Island | 02865 | United States |
| Invocare Clinical Research Center | Mauldin | South Carolina | 29662 | United States |
| Invocare Clinical Research Center | West Columbia | South Carolina | 29169 | 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 |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | United States |
| Digestive Health Associates of Texas | Garland | Texas | 75044 | United States |
| Houston Methodist Research Ins | Houston | Texas | 77030 | United States |
| Biopharma Informatic, Inc. | 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 |
| Bandera Family Health Care | San Antonio | Texas | 78249 | United States |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | United States |
| GI and Liver Research, LLC | Webster | Texas | 77598 | United States |
| Care Access Research LLC - Salt Lake City | Ogden | Utah | 84403 | United States |
| Care Access Research LLC - Salt Lake City | Salt Lake City | Utah | 84124 | United States |
| Emeritas Research Group | Leesburg | Virginia | 20176 | United States |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | United States |
| The Gastroenterology Group, P.C. | Reston | Virginia | 20191 | United States |
| Carilion Clinic | Roanoke | Virginia | 24016 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-6424 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| Allegiance Research Specialists, LLC | Milwaukee | Wisconsin | 53226 | 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 |
| Instituto de Investigaciones Clinicas Quilmes | Quilmes | Buenos Aires | B1878GEG | 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 |
| John Hunter Hospital | Newcastle | New South Wales | 2305 | 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 |
| Northern Hospital | Melbourne | Victoria | 3076 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Krankenhaus der Barmherzigen Schwestern Wien | Vienna | State of Vienna | 1060 | Austria |
| 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 | Tournai | Wallonne, Région | 7500 | Belgium |
| AZ Klina | Brasschaat | 2930 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Gastroenterology and internal medicine research institute | Edmonton | Alberta | T5R 1W2 | Canada |
| The Gordon and Leslie Diamond Health Care Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
| GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| PerCuro Clinical Research | Victoria | British Columbia | V8V 3M9 | Canada |
| Victoria Hospital | London | Ontario | N6A 4G5 | Canada |
| University of Western Ontario | London | Ontario | N6A 5G1 | Canada |
| Centre de santé et de services sociaux Champlain-Charles-Le Moyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hopital Maisonneure-Rosemount | Montreal | Quebec | H1T 2M4 | Canada |
| Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC | Montreal | Quebec | H3G 1A4 | Canada |
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China |
| The First Affiliated Hospital of Anhui Medical University | HefeiCity | Anhui | 230022 | China |
| Beijing Friendship Hospital | Beijing | Beijing Municipality | 100050 | China |
| Xiangya Hospital Central South University | Kaifu District | Changsha City | 410008 | China |
| The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA | Chongqing | Chongqing Municipality | 400037 | China |
| The First Hospital Affiliated to AMU (Southwest Hospital) | Chongqing | Chongqing Municipality | 400038 | China |
| Fujian Province Hospital | Fuzhou | Fujian | 350001 | China |
| The First Affiliated Hospital Of Fujian Medical University | Fujian | Fuzhou | 350005 | China |
| The Sixth Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510655 | China |
| The University of Hong Kong-Shenzhen Hospital | Shenzhen | Guangdong | 518053 | China |
| Hainan General Hospital | Haikou | Hainan | 570311 | China |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450014 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| ZhuZhou Central Hospital | Zhuzhou | Hunan | 412007 | China |
| Changzhou No.2 People's Hospital | Changzhou | Jiangsu | 213003 | China |
| The Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu | 210008 | China |
| Jiangsu Province Hospital of Chinese Medicine | Nanjing | Jiangsu | 210029 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210029 | China |
| Nanjing Medical University - Nanjing Jiangning Hospital | Nanjing | Jiangsu | 211106 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Jiangxi Pingxiang People's Hospital | Pingxiang | Jiangxi | 337055 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Jilin Central General Hospital | Jilin City | Jilin | 132011 | China |
| The Second Hospital of Dalian Medical University | Dalian | Lianing | 116000 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110022 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250001 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250014 | China |
| Liaocheng People's hospital | Liaocheng | Shandong | 252000 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| Taian City Central Hospital | Taian | Shandong | 271000 | China |
| Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| Renji Hospital Affliated to Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200127 | China |
| West China Hospital Sichuan University | Chengdu | Sichuan | 610041 | China |
| No.1 Hospital Affiliated to Xinjiang Medical University | Ürümqi | Urumchi | 830054 | China |
| Kunming Medical College Affiliated First Hospital | Kunming | Yunnan | 650032 | China |
| The First People's Hospital of Yunnan Province | Kunming | Yunnan | 650034 | China |
| The Second Affiliated Hospital of Zhejiang University School of Med | Hangzhou | Zhejiang | 310000 | China |
| First Affiliated Hosp of College of Med, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310016 | China |
| The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university | Wenzhou | Zhejiang | 325027 | China |
| Tongji Hospital of Tongji University | Wuhan | 430030 | China |
| University Hospital Center Osijek | Osijek | 31000 | Croatia |
| CHC Zagreb | Zagreb | 10000 | Croatia |
| Polyclinic Bonifarm | Zagreb | 10000 | Croatia |
| Vojenska nemocnice Brno | Brno | Brno-město | 636 00 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Hl. M. Praha | 100 34 | Czechia |
| Hepato-gastroenterologie HK | Hradec Králové | Hradec Králové | 50012 | Czechia |
| Klinika ResTrial | Prague | Modrany | 14300 | Czechia |
| MUDr. Gregar, s.r.o. | Olomouc | Olomouc Region | 779 00 | Czechia |
| A-Shine | Pilsen | Plzeň-město | 301 00 | Czechia |
| Mediendo | Prague | Praha 8 | 18600 | Czechia |
| Fakultni nemocnice u sv. Anny v Brne | Brno | 65691 | Czechia |
| PreventaMed, s.r.o. | Olomouc | 779 | Czechia |
| ISCARE Clinical Centre | Prague | 19000 | Czechia |
| Sydvestjysk Sygehus Esbjerg | Esbjerg | 6700 | Denmark |
| Herlev and Gentofte Hospital | Herlev | 2730 | Denmark |
| Zealand University Hospital Køge | Køge | 4600 | Denmark |
| Hopital de Hautepierre - Service d'Hépatogastroentérolgie | Strasbourg | Bas Rhin | 67098 | France |
| Hopital Saint-Louis | Paris | Cedex 10 | 75475 | France |
| CHU Lille - Hôpital Claude Huriez | Lille | Nord | 59037 | France |
| Hopital Beaujon | Clichy | Paris | 92110 | France |
| Centre Hospitalier de Pau | Pau | Pyrénées-Atlantiques | 64046 | France |
| Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - | Pierre-Bénite | Rhone | 69495 | France |
| CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro | Amiens | Somme | 80480 | France |
| CHU Tours - Hôpital Trousseau | Chambray-lès-Tours | 37170 | France |
| Assistance Publique Hôpitaux de Marseille - Hôpital Nord | Marseille | 13915 | France |
| Hopital Saint Eloi | Montpellier | 34295 | France |
| Hopital L'Archet 2 | Nice | 06200 | France |
| CHU Bordeaux - Hôpital Haut-Lévêque | Pessac | 33604 | France |
| CHU de Poitiers- Service d'Hépato-gastro-entérologie, | Poitiers | 86021 | France |
| Robert Debre Hospital | Reims | 51092 | France |
| CHU de Saint Etienne Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| CHRU Nancy Brabois - Hôpital d'Enfants | Vandœuvre-lès-Nancy | 54500 | France |
| Medizinische Hochschule Hanover | Hanover | Lower Saxony | 30625 | Germany |
| Gastro Campus Research GbR | Münster | North Rhine-Westphalia | 48159 | Germany |
| Haus der Gesundheit | Ludwigshafen am Rhein | Rhineland-Palatinate | 67067 | Germany |
| Studiengesellschaft BSF Unternehmergesellschaft | Halle | Saxony-Anhalt | 06108 | Germany |
| Universitätsklinikum Halle | Halle | Saxony-Anhalt | 06120 | Germany |
| Charité Campus Virchow-Klinikum | Berlin | 12203 | Germany |
| Krankenhaus Waldfriede | Berlin | 14163 | Germany |
| Staedisches Klinikum Brandenburg | Brandenburg | 14770 | Germany |
| HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen | Hamburg | 20251 | Germany |
| Praxiszentrum Alte Maelzerei | Regensburg | 93053 | Germany |
| Internistische Praxisgemeinschaft | Weyhe | 28844 | Germany |
| DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | EU | 8230 | Hungary |
| Jávorszky Ödön Kórház | Vác | Pest County | 2600 | Hungary |
| Óbudai Egészségügyi Centrum | Budapest | 1036 | Hungary |
| Semmelweis Egyetem | Budapest | 1088 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Endomedix Diagnosztikai Központ - Miskolc | Miskolc | 3526 | Hungary |
| Karolina Korhaz-Rendelointezet | Mosonmagyaróvár | 9200 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika | Szeged | 6720 | Hungary |
| Clinfan Szolgaltato Kft. | Szekszárd | 7100 | Hungary |
| Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre | Hyderabad | Andhra Pradesh | 500058 | India |
| Institute of Digestive and Liver Diseases | Guwahati | Assam | 781 006 | India |
| Apollo Research and Innovations, Apollo Hospitals International Ltd | Gandhinagar | Gujarat | 382428 | India |
| Shree Giriraj Multispeciality Hospital | Rajkot | Gujarat | 360005 | India |
| Nirmal Hospital | Surat | Gujarat | 395002 | India |
| Bangalore Medical College and Research Institute | Bangalore | Karnataka | 560 002 | India |
| M S Ramaiah Medical College Hospital | Bangalore | Karnataka | 560054 | India |
| Lokmanya Hospital | Mumbai | Maharashtra | 400022 | India |
| Midas Multispecilaity Hopsital Pvt Ltd | Nagpur | Maharashtra | 440010 | India |
| Poona Medical Foundation. Ruby Hall Clinic | Pune | Maharashtra | 411 001 | India |
| K E M Hospital and Research Centre | Pune | Maharashtra | 411011 | India |
| Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital | Wardha | Maharashtra | 442004 | India |
| Escorts Heart Institute and Research Centre Ltd | New Delhi | National Capital Territory of Delhi | 110 025 | India |
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Dayanand Medical College and Hospital | Ludhiana | Punjab | 141001 | India |
| SR Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | 302001 | India |
| Asian Institute of Gastroenterology | Hyderabad | Telangana | 500032 | India |
| King George Medical University | Lucknow | Uttar Pradesh | 226003 | India |
| Fortis Hospital | Noida | Uttar Pradesh | 201301 | India |
| SSKM Post Graduate Hospital | Kolkata | West Bengal | 700020 | India |
| Nil Ratan Sircar Medical College | Kolkata | West Bengal | 700073 | India |
| Gandhi Hospital | Telangana | 500003 | India |
| Beaumont Hospital, Dublin | Dublin | D9 | Ireland |
| Meir Medical Center | Kfar Saba | Central District | 4428164 | Israel |
| Shaare Zedek Medical Center | Bait Vagan | Jerusalem | 91031 | Israel |
| Soroka Medical Center - Pediatric Outpatient Clinic | Beersheba | 8410101 | Israel |
| Galilee Medical Center Department of Internal Medicine A | Nahariya | 2210001 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5262100 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| King Fahad Medical City | Ẕerifin | 70300 | Israel |
| Presidio di Rho | Rho | Milano | 20017 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Ospedale Sandro Pertini | Rome | Roma | 00157 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Torre | Roma | 00133 | Italy |
| I.R.C.C.S Policlinico San Donato | San Donato Milanese (MI) | San Donato Milanese (MI) | 20097 | Italy |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Brescia | 25123 | Italy |
| Azienda ospedaliero-universitaria Mater Domini | Catanzaro | 88100 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Azienda Ospedaliero Universitaria San Martino | Genova | 16132 | Italy |
| Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation | Milan | 20122 | Italy |
| Azienda Ospedaliera Universitaria Policlinico de Modena | Modena | 41124 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | 56124 | Italy |
| Policlinico Gemelli - Università Cattolica del Sacro Cuore | Roma | 00168 | Italy |
| Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona Medicina Interna | Salerno | 84131 | Italy |
| Ospedale Mauriziano Umberto I | Torino | 10128 | Italy |
| Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia | Udine | 33100 | Italy |
| Aichi Medical University Hospital | Nagakute-shi | Aichi-ken | 480-1195 | Japan |
| Fujita Health University | Toyoake | Aichi-ken | 470-1192 | Japan |
| National Hospital Organization Hirosaki National Hospital | Hirosaki | Aomori | 036-8545 | Japan |
| Toho University Sakura Medical Center | Sakura | Chiba | 285-8741 | Japan |
| Kitakyushu Municipal Medical Center | Kitakyusyu-shi | Fukoka | 802-0077 | Japan |
| Fukuoka University Chikushi Hospital | Chikushino-shi | Fukuoka | 818 8502 | Japan |
| Yukinoseibokai St. Mary's Hospital | Kurume-shi | Fukuoka | 830 8543 | Japan |
| Hidaka Coloproctology Clinic | Kurume-shi | Fukuoka | 839 0809 | Japan |
| Gunma University Hosptial | Maebashi | Gunma | 371-8511 | Japan |
| National Hospital Organization Takasaki General Medical Centar | Takasaki | Gunma | 370-0829 | Japan |
| NHO Mito Medical Center | Ibaraki-machi | HigaShiibaraki-Gun | 311 3193 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Asahikawa City Hospital | Asahikawa | Hokkaido | 070-8610 | Japan |
| Tokushukai Sapporo Tokushukai Hospital | Sapporo | Hokkaido | 004 0041 | Japan |
| Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Sapporo | Hokkaido | 060 0033 | Japan |
| Sapporo Higashi Tokushukai Hospital | Sapporo | Hokkaido | 065-0033 | Japan |
| Aoyama Clinic GI Endoscopy & IBD Center | Kobe | Hyōgo | 650 0015 | Japan |
| Takamatsu Red Cross Hospital | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Kagawa Prefectural Central Hospital | Takamatsu | Kagawa-ken | 760-8557 | Japan |
| Ofuna Central Hospital | Kamakura | Kanagawa | 247-0056 | Japan |
| Kawasaki Municipal Hospital | Kawasaki | Kanagawa | 210-0013 | Japan |
| Kitasato University Hospital | Sagamihara | Kanagawa | 252-0375 | Japan |
| Sankikai Yokohama Shin midori General Hospital | Yokohama | Kanagawa | 226 0025 | Japan |
| Yokohama City University Medical Center | Yokohama | Kanagawa | 232-0024 | Japan |
| Showa University Northern Yokohama Hospital | Yokohama | Kanagawa | 234-0032 | Japan |
| Kumamoto University Hospital | Kumamoto | Kumamoto | 860-0012 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| Takagi Clinic - Sendai | Sendai | Miyagi | 981 3213 | Japan |
| Nagaoka Chuo General Hospital | Nagaoka-shi | Niigata | 940-8653 | Japan |
| Ishida Clinic of IBD and Gastroenterology | Ōita | Oita Prefecture | 870 0823 | Japan |
| Sai Gastroenterology, proctology | Fujiidera | Osaka | 583-0027 | Japan |
| NHO Osaka National Hospital | Osaka | Osaka | 540 0006 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Saga-Ken Medical Center Koseikan | Saga | Saga-ken | 840-8571 | Japan |
| Kumagaya General Hospital | Kumagaya-shi | Saitama | 360-8567 | Japan |
| Matsuda Hospital | Hamamatsu | Shizuoka | 4328061 | Japan |
| Jichi Medical University Hospital | Shimotsuke-shi | Tochigi | 329-0498 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Tokyo Medical And Dental University Medical Hospital | Bunkyō | Tokyo | 113-8519 | Japan |
| Showa University Koto Toyosu Hospital | Koto-ku | Tokyo | 135 8577 | Japan |
| Kitasato University Kitasato Institute Hospital | Minato-Ku | Tokyo | 108 8642 | Japan |
| Kyorin University Hospital | Mitaka | Tokyo | 181-8611 | Japan |
| JHCO Tokyo Yamate Medical Center | Shinjuku-ku | Tokyo | 169-0073 | Japan |
| Mitsui Memorial Hospital | Chiyoda-ku | Tokyo-To | 101-8643 | Japan |
| Center Hospital of the National Center for Global Health and Medicine | Shinjuku-ku | Tokyo-To | 162 8655 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Sameshima Hospital | Kagoshima | 892-0846 | Japan |
| National Hospital Organization Kyoto Medical Center | Kyoto | 612-8555 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Infusion Clinic | Osaka | 530-0011 | Japan |
| Tokitokai Tokito Clinic | Saitama | 336 0963 | Japan |
| Toyama Prefectural Central Hospital | Toyama | 930-8550 | Japan |
| Pauls Stradins Clinical Univeristy Hospital | Riga | Riga | LV-1002 | Latvia |
| Digestive Diseases Center "Gastro" | Riga | 1079 | Latvia |
| Riga Eastern Clinical University Hospital | Riga | LV-1038 | Latvia |
| Respublikine Panevezio Ligonine | Panevezys | Panevėžys | LT-35144 | Lithuania |
| Hospital of Lithuanian University of Health Sciences Kaunas | Kaunas | 50009 | Lithuania |
| Republic Hospital of Klaipeda | Klaipėda | 92231 | Lithuania |
| Klaipeda Seamen's Hospital | Klaipėda | 92288 | Lithuania |
| Vilnius University Hospital Santariskiu Clinics | Vilnius | LT-08661 | Lithuania |
| Hospital Sultanah Bahiyah | Alor Star | Kedah | 05460 | Malaysia |
| Universiti Sains Malaysia | Kubang Kerian | Kelantan | 16150 | Malaysia |
| University Malaya Medical Centre | Lembah Pantai | Kuala Lumpur | 59100 | Malaysia |
| Hospital Pulau Pinang | George Town | Pulau Pinang | 10450 | Malaysia |
| Hospital Ampang | Ampang | Selangor | 68000 | Malaysia |
| Clinical Research Institute S C | Tlalnepantla | Edo de Mex | 54055 | Mexico |
| Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. | Zapopan | Jalisco | 45030 | Mexico |
| Clinicos Asociados BOCM, S.C. | Mexico City | Mexico City | 03300 | Mexico |
| Centro de Investigación Clínica Acelerada | Mexico City | Mexico City | 07020 | Mexico |
| Centro Para el Desarrollo de la Medicina y de Asistencia Med S.C | Culiacán | Sinaloa | 80230 | Mexico |
| Scientia Investigacion Clinica S.C. | Chihuahua City | 31203 | Mexico |
| Sociedad de Metabolismo y Corazon | Veracruz | 91900 | Mexico |
| St Elisabeth Ziekenhuis | Tilburg | North Brabant | 5022 GC | Netherlands |
| Amsterdam UMC, locatie AMC | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Bernhoven Ziekenhuis | Uden | 5406 PT | Netherlands |
| UMC Utrecht, Dept. of Internal Medicine, MDL | Utrecht | 3584 CX | Netherlands |
| Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-168 | Poland |
| Centrum Medyczne Pratia Bydgoszcz | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Topolowa Medicenter | Krakow | Lesser Poland Voivodeship | 31-506 | Poland |
| Medicenter Nowy Targ | Nowy Targ | Lesser Poland Voivodeship | 34-400 | Poland |
| Nzoz Formed | Wadowice | Lesser Poland Voivodeship | 34-100 | Poland |
| LexMedica | Wroclaw | Lower Silesian Voivodeship | 53-114 | Poland |
| ZOZ Gastromed | Lublin | Lublin Voivodeship | 20-582 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | Lublin Voivodeship | 20-954 | Poland |
| NZOZ Vivamed | Warsaw | Masovian Voivodeship | 03-580 | Poland |
| Endoskopia sp z o. o | Sopot | Pomeranian Voivodeship | 81-756 | Poland |
| SONOMED Centrum Medyczne | Szczecin | West Pomeranian Voivodeship | 71-685 | Poland |
| Promedica Dental Clinic | Będzin | 42-500 | Poland |
| All-Medicus | Katowice | 40-660 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska | Knurów | 44-190 | Poland |
| Wojewodzki Specjalistyczny Szpital w Olsztynie | Olsztyn | 10-561 | Poland |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii | Torun | 87-100 | Poland |
| Warsaw IBD Point Profesor Kierkus | Warsaw | 00-728 | Poland |
| Centrum Zdrowia MDM | Warsaw | 00635 | Poland |
| Centrum Medyczne NeuroProtect | Warsaw | 01-697 | Poland |
| Centralny Szpital Kliniczny MSWiA | Warsaw | 02-507 | Poland |
| PlanetMed Sp.z o.o. | Wroclaw | 52-210 | Poland |
| ETG Zamosc | Zamość | 22-400 | Poland |
| KO-Med Centrum Medyczne | Staszów | Świętokrzyskie Voivodeship | 28-200 | Poland |
| CCBR Clinical Research | Bucharest | Bucharest | 030463 | Romania |
| MedLife Grivita | Bucharest | 010719 | Romania |
| Spitalul Clinic Colentina | Bucharest | 020125 | Romania |
| Institutul Clinic Fundeni | Bucharest | 022328 | Romania |
| Hifu Terramed Conformal SRL | Bucharest | 031864 | Romania |
| Centrul Medical Unirea SRL | Bucharest | 040055 | Romania |
| Spital Pelican Oradea | Oradea | 410469 | Romania |
| Scientific Centre of Reconstructive and Restorative Surgery | Irkutsk | Irkutsk Oblast | 664079 | Russia |
| Karelia Republican Hospital V.A. Baranova | Petrozavodsk | Kareliya, Respublika | 185019 | Russia |
| Nizhny Novgorod Regional Hospital N.A. Semashko | Nizhny Novgorod | Nizhny Novgorod Oblast | 603126 | Russia |
| Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod | Nizhny Novgorod | Nizhny Novgorod Oblast | 603140 | Russia |
| Novosibirsk GastroCenter | Novosibirsk | Novosibirsk Oblast | 630007 | Russia |
| Rostov State Medical University | Rostov-on-Don | Rostov Oblast | 344091 | Russia |
| Scientific research center ECO-security | Saint Petersburg | Sankt-Peterburg | 196143 | Russia |
| Multidisciplinary Medical Clinic "Anthurium" | Barnaul | 656043 | Russia |
| Medical and Sanitary Division of Severstal | Cherepovets | 162600 | Russia |
| Alliance Biomedical URAL Group | Izhevsk | 426061 | Russia |
| Clinical Trials Center of Medical Institute | Kaliningrad | 236035 | Russia |
| State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan" | Kazan' | 420064 | Russia |
| SIH Kemerovo Regional Clinical Hosptial | Kemerovo | 650066 | Russia |
| SBHI Regional Clinical Hospital #2 MoH of Krasnodar region | Krasnodar | 350000 | Russia |
| Medical rehabilitation center | Moscow | 125367 | Russia |
| LLC "Medicine Center SibNovoMed" | Novosibirsk | 630005 | Russia |
| Clinical Diagnostic Center Ultramed | Omsk | 644024 | Russia |
| City Mariinskaya Hospital | Saint Petersburg | 191104 | Russia |
| Pokrovskaya Municipal Hospital | Saint Petersburg | 195067 | Russia |
| Saint-Petersburg City Hospital of Saint Elizabeth | Saint Petersburg | 195257 | Russia |
| Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways" | Saint Petersburg | 195271 | Russia |
| Saint Petersburg State Medical University n.a. Pavlov I.P. | Saint Petersburg | 197022 | Russia |
| LLC Gastroenterology Centre Expert | Saint Petersburg | 197110 | Russia |
| SBIH City Clinical Hospital #31 | Saint Petersburg | 197110 | Russia |
| OOO "OrKli" | Saint Petersburg | 199147 | Russia |
| Medical Institute REAVIZ | Samara | 443001 | Russia |
| Stavropol State Medical Academy | Stavropol | 355018 | Russia |
| SBI of Healthcare of Leningrad region "Clinical Interregional Hospital of Tosno | Tosno | 187000 | Russia |
| Yaroslavl Municipal HI Clinical Hospital #8 | Yaroslavl | 150030 | Russia |
| LLC MA New Hospital | Yekaterinburg | 620109 | Russia |
| Zemun Medical Centre | Zemun | Beograd | 11080 | Serbia |
| University Medical Center "Bezanijska kosa" | Belgrade | NAP | 11080 | Serbia |
| Regional Hospital Dr Radivoj Simonovic Sombor | Sombor | Vojvodina | 25000 | Serbia |
| Sremska Mitrovica Health Centre | Sremska Mitrovica | Vojvodina | 22000 | Serbia |
| General Hospital "Djordje Joanovic" | Zrenjanin | Vojvodina | 23000 | Serbia |
| Clinical Hospital Center Zvezdara | Belgrade | 11000 | Serbia |
| Clinical Center Kragujevac Gastroenterohepatology Clinic | Kragujevac | 34000 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| General Hospital Uzice | Užice | 31000 | Serbia |
| KM Management | Nitra | Nitra Region | 94901 | Slovakia |
| Gastro | Prešov | Presov | 08001 | Slovakia |
| Endomed, s.r.o. | Vranov N. Toplou | Presov | 09301 | Slovakia |
| Alian, s.r.o. | Bardejov | Slovak Republic | 08501 | Slovakia |
| Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica | Banská Bystrica | 975 17 | Slovakia |
| Univerzitna nemocnica Bratislava-Nemocnica Stare Mesteo | Bratislava | 813 69 | Slovakia |
| Univerzitna nemocnica Bratislava | Bratislava | 82007 | Slovakia |
| Severance Hospital, Yonsei University Health System | Wŏnju | Gangwon-do | 26426 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Kyung Hee University Hospital | Seoul | Korea | 02447 | South Korea |
| Asan Medical Center | Seoul | Korea | 05505 | South Korea |
| Dong-A University Hospital | Busan | Pusan-Kwangyǒkshi | 49201 | South Korea |
| Kangbuk Samsung Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 03181 | South Korea |
| Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
| The Catholic University of Korea, Daejeon St. Mary's Hospital | Daejeon | Taejǒn-Kwangyǒkshi | 34943 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Kyungpook National University Medical Center Chilgok Hospital | Daegu | 41404 | South Korea |
| Yeungnam Univeristy Medical Center | Daegu | 42415 | South Korea |
| Hospital Universitario Virgen Del Rocio | Seville | Andalusia | 41013 | Spain |
| Hospital Universitari Son Espases | Palma de Mallorca | Baleares Islands | 07120 | Spain |
| Hospital Universitario Marques De Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital De Fuenlabrada | Fuenlabrada | Madrid | 28942 | Spain |
| Complejo Hospitalario De Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 3306 | Spain |
| Hospital de Sagunto y C.E. | Sagunto | Valencia | 46520 | Spain |
| Complexo Hospitalario Universitario A Coruña, CHUAC | A Coruña | 15006 | Spain |
| Instituto de Ciencias Médicas | Alicante | 03004 | Spain |
| Hospital Universitario Reina Sofia Comite Etico | Córdoba | 14004 | Spain |
| Hospital Universitari de Girona | Girona | 17007 | Spain |
| Hospital Universitario Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Hospital De Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Gastroenterologische Praxis Balsiger, Seibold & Partner | Bern | 3012 | Switzerland |
| Kantonsspital St.Gallen | Sankt Gallen | 9007 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| Changhua Christian Hospital | Changhua | 500 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Health management center | Taipei | 10002 | Taiwan |
| Gazi University Faculty of Medicine | Beşevler | Ankara | 65600 | Turkey (Türkiye) |
| Hacettepe University Faculty of Medicine | Sihhiye | Ankara | 6100 | Turkey (Türkiye) |
| Antalya Egitim ve Arastırma Hastanesi | Kocaeli | Antayla | 7100 | Turkey (Türkiye) |
| Acibadem Universitesi - Acibadem Kozyatagi Hastanesi | Kadıköy | Istanbul | 34734 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty Hospital | İzmit | Kocaeli | 41380 | Turkey (Türkiye) |
| Mersin University Medical Faculty | Yenişehir | Mersin | 33110 | Turkey (Türkiye) |
| Ege Universitesi Hastanesi | Izmir | 35100 | Turkey (Türkiye) |
| Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76008 | Ukraine |
| City Clinical Hospital #2 | Kharkiv | Kharkiv Oblast | 61037 | Ukraine |
| Kherson City Clinical Hospital | Kherson | Kherson Oblast | 73000 | Ukraine |
| Medical Center of Limited Liability Company "Medical Center "Consilium Medical" | Kiev | Kyiv Oblast | 04050 | Ukraine |
| Lviv Railway Clinical Hospital | Lviv | Lviv Oblast | 79000 | Ukraine |
| Lviv Regional Endocrinology Dispensary | Lviv | Lviv Oblast | 79000 | Ukraine |
| Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T | Lviv | Lviv Oblast | 79000 | Ukraine |
| Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho | Poltava | Poltava Oblast | 36000 | Ukraine |
| Diaservis - Medical and Diagnostic Center | Zaporizhzhia | Zaporizhzhia Oblast | 69076 | Ukraine |
| Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine | Dnipro | 49038 | Ukraine |
| Kharkiv City Student Hospital | Kharkiv | 61002 | Ukraine |
| GI L.T. Malaya TI Namsu | Kharkiv | 61039 | Ukraine |
| Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus | Kropyvnytskyi | 25006 | Ukraine |
| Kyiv Municipal Clinical Hospital #1 | Kyiv | 02091 | Ukraine |
| Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv | 04078 | Ukraine |
| Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv | 04107 | Ukraine |
| Communal Enterprise "Odesa Regional Clinical Hospital" | Odesa | 65000 | Ukraine |
| 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 |
| Private Small Enterprise, Medical Center Pulse | 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 |
| Royal Hampshire County Hospital | Winchester | Hants | SO22 5DG | United Kingdom |
| St Thomas' Hospital | Great Maze Pond | London | SE1 9RT | United Kingdom |
| Ninewells Hospital | Dundee | Scotland | DD1 9SY | 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 |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | 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. |
| 40591171 | Derived | Clemow DB, Dubinsky MC, Baygani SK, Sands BE, Keohane A, Danese S, Schreiber S, Walsh AJ, Hibi T, Gibble TH, Moses RE, Travis SPL. Bowel urgency in ulcerative colitis: effect of baseline urgency and change in urgency in response to mirikizumab. J Patient Rep Outcomes. 2025 Jul 1;9(1):75. doi: 10.1186/s41687-025-00906-0. |
| 40589947 | Derived | 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. |
| 39448057 | Derived | Sands BE, D'Haens G, Clemow DB, Irving PM, Johns JT, Gibble TH, Abreu MT, Lee SD, Hisamatsu T, Kobayashi T, Dubinsky MC, Vermeire S, Siegel CA, Peyrin-Biroulet L, Moses RE, Milata J, Panaccione R, Dignass A. Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm Bowel Dis. 2025 Jul 7;31(7):1876-1890. doi: 10.1093/ibd/izae253. |
| 38869019 | Derived | 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. |
| 38313767 | Derived | 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. |
| 38034882 | Derived | 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. |
| 37610533 | Derived | 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. |
| 37379135 | Derived | D'Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, Krueger K, Laskowski J, Li X, Lissoos T, Milata J, Morris N, Arora V, Milch C, Sandborn W, Sands BE; LUCENT Study Group. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940. |
| 37057827 | Derived | 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. |
| FG002 | Placebo IV Q4W ME2 Cohort | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| FG003 | 300 mg Mirikizumab IV Q4W ME2 Cohort | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo IV Q4W | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| BG001 | 300 mg Mirikizumab IV Q4W | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| BG002 | Placebo IV Q4W ME2 Cohort | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| BG003 | 300 mg Mirikizumab IV Q4W ME2 Cohort | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 With Clinical Remission at Week 12 | Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA). 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). The confidence interval of 99.88% was chosen to match the significance level. | Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Number | 99.88% Confidence Interval | percentage of participants | Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response at Week 12 | Clinical response at week 12 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).The MMS ranges from 0 to 9 points,with higher scores representing more severe disease. The confidence interval of 99.88% was chosen to match the significance level. | mITT Population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Number | 99.88% Confidence Interval | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Remission at Week 12 | Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 12. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The Mayo endoscopic score ranges from 0 to 3 points, with higher scores representing more severe disease. The confidence interval of 99.88% was chosen to match the significance level. | mITT Population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Number | 99.88% Confidence Interval | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Symptomatic Remission at Week 12 | Symptomatic remission at week 12 is defined as a Mayo subscore 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). The confidence interval of 99.88% was chosen to match the significance level. | mITT population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Number | 99.88% Confidence Interval | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Symptomatic Response at Week 12 | Symptomatic response at week 12 is defined as ≥30% decrease from baseline in the sum of stool frequency and rectal bleeding 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). The sum of stool frequency and rectal bleeding subscores ranges from 0 to 6. | mITT population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Histologic Remission at Week 12 | 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). | mITT population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Response at Week 12 | Endoscopic response at week 12 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore. The Mayo endoscopic subscore ranges from 0 to 3 points, with higher scores representing more severe disease. | mITT population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) | 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), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other). | mITT population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline urgency NRS measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | 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 (Guyatt et al. 1989). 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), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other). | mITT population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline IBDQ measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Fecal Calprotectin | 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 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), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other). | mITT population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline fecal calprotectin measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | milligram per kilogram (mg/kg) | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Clearance of Mirikizumab | Clearance of mirikizumab was evaluated. Clearance is estimated based on concentration data collected in the time frame of 0-12 weeks. | All randomized participants who received at least one dose of study drug and had evaluable PK data. As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per Hour (L/h) | Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12 |
|
|
Baseline Up to week 32
All randomized participants who received at least one dose of study drug. MedDRA 24.0 was used for the main global study arms/groups, and MedDRA 26.1 was used for the ME2 arms/groups.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo IV Q4W | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. | 0 | 321 | 17 | 321 | 18 | 321 |
| EG001 | 300 Mirikizumab IV Q4W | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. | 0 | 958 | 27 | 958 | 31 | 958 |
| EG002 | Placebo IV Q4W ME2 Cohort | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. | 0 | 41 | 7 | 41 | 11 | 41 |
| EG003 | 300 mg Mirikizumab IV Q4W ME2 Cohort | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. | 0 | 125 | 10 | 125 | 25 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ovarian enlargement | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Penile vein thrombosis | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Jan 12, 2022 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: AMAN 05 ME2 Protocol Addenda (5)_Redacted | Mar 19, 2018 | Jan 12, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan | Jan 14, 2021 | Jan 12, 2022 | SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: I6T-MC-AMAN ME2 Statistical Analysis Plan Addendum Version 1 | Mar 2, 2021 | May 14, 2025 | SAP_003.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000708407 | mirikizumab |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Australia |
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| Austria |
|
| Belgium |
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| Canada |
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| China |
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| Croatia |
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| Czechia |
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| Denmark |
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| France |
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| Germany |
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| Hungary |
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| India |
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| Ireland |
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| Israel |
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| Italy |
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| Japan |
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| Latvia |
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| Lithuania |
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| Malaysia |
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| Mexico |
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| Netherlands |
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| Poland |
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| Romania |
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| Russia |
|
| Serbia |
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| Slovakia |
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| South Korea |
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| Spain |
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| Switzerland |
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| Taiwan |
|
| Turkey |
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| Ukraine |
|
| United Kingdom |
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| United States |
|
| OG001 | 300 mg Mirikizumab IV Q4W | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Counts |
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| Participants |
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300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
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| 300 mg Mirikizumab IV Q4W |
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
|
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