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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMAM | Other Identifier | Eli Lilly and Company | |
| 2018-004614-18 | EudraCT Number |
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The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline. |
|
| 300 mg Mirikizumab | Experimental | Participants received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W |
|
| 90 mg Ustekinumab | Active Comparator | Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W) |
|
| 300 mg Mirikizumab (Adolescents) | Experimental | Participants received open label 900 mg Mirikizumab IV for 3 doses, then 300 mg SC Q4W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) | Clinical response by patient reported outcome (PRO) defined as ≥30% decrease in stool frequency (SF) and/or abdominal pain (AP) & neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Endoscopic response defined as ≥50% reduction from baseline in total Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence & size of ulcers (none=0; diameter 0.1-0.5 cm=1; 0.5-2 cm=2; >2 cm=3); extent of ulcerated surface (none=0; <10%=1; 10% to 30%=2; >30%=3); extent of affected surface (none=0; <50%=1; 50% to 75%=2; >75%=3); presence & type of narrowing (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. | Week 12 to Week 52 |
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab) | Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as Crohn's Disease Activity Index (CDAI) total score <150. The CDAI is an 8-item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]).. Total score range of 0 to 600 points. | Week 12 to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab) | Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. |
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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 |
|---|---|---|---|---|---|---|
| University of Alabama-The Kirklin Clinic | Birmingham | Alabama | 35233 | United States | ||
| Digestive Health Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42309525 | Derived | Jairath V, Magro F, Protic M, De Hertogh G, Harpaz N, Hisamatsu T, D'Haens G, Pai R, Yu G, Morris N, Luo WT, Hon E, Escobar R, Biedermann L, Reinisch W; VIVID Study Group. Histologic and combined histologic-endoscopic outcomes with mirikizumab in Crohn's disease: VIVID-1 trial results. J Crohns Colitis. 2026 Jun 7;20(6):jjag077. doi: 10.1093/ecco-jcc/jjag077. | |
| 40669578 |
| Label | URL |
|---|---|
| A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | 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 European Union (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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline. |
| 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: Main | Feb 23, 2022 | Jul 15, 2024 |
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| Mirikizumab | Drug | Administered SC |
|
|
| Ustekinumab | Drug | Administered IV |
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| Ustekinumab | Drug | Administered SC |
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| Placebo | Drug | Administered IV |
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| Placebo | Drug | Administered SC |
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| Week 12 |
| Percentage of Adult Participants Achieving Endoscopic Response at Week 52 | Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. | Week 52 |
| Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab) | Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points. | Week 12 |
| Percentage of Adult Participants Achieving Clinical Remission at Week 52 | Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points. | Week 52 |
| Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab) | Endoscopic remission is defined as SES-CD Total Score ≤4 and at least a 2-point reduction from baseline and no subscore >1. SES-CD evaluates 4 endoscopic variables in 5 bowel segments and each of the 20 individual variables is scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed =3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore >1 is defined as no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) >1. | Week 12 |
| Change From Baseline in Urgency Numeric Rating Scale (NRS) at Week 12 in Adult Participants (Placebo and Mirikizumab) | The Urgency NRS is a single patient-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). | Baseline, Week 12 |
| Change From Baseline in Urgency NRS at Week 52 in Adult Participants (Placebo and Mirikizumab) | The Urgency NRS is a single patient-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). | Baseline, Week 52 |
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 (Placebo and Mirikizumab) | Clinical Response by PRO defined as ≥30% decrease in SF and/or AP & neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical Remission by PRO defined as SF≤3 and not worse than baseline (as per Bristol Stool Scale Category 6 or 7) and AP ≤1 and no worse than baseline. | Week 12 to Week 52 |
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52 (Placebo and Mirikizumab) | Clinical Response by PRO defined as ≥30% decrease in SF and/or AP & neither score worse than baseline. SF (number of liquid or very soft stools) per Bristol Stool Scale Category 6 or 7 & AP (4-point scale:0=none,1=mild,2=moderate,3=severe). Endoscopic remission=SES-CD Total Score ≤4 & at least 2-point reduction from baseline & no subscore >1.SES-CD evaluates 4 endoscopic variables in 5 bowel segments & each of 20 individual variables scored 0-3: presence & size of ulcers (none=0;diameter 0.1-0.5 cm=1;0.5-2 cm=2;>2 cm=3);extent of ulcerated surface (none=0;<10%=1;10% to 30%=2;>30%=3);extent of affected surface (none=0;<50%=1;50% to 75%=2;>75%=3);presence & type of narrowing (none=0;single,can be passed=1;multiple,can be passed=2;cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56;higher scores indicating more severe disease. No subscore >1=no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) >1 | Week 12 to Week 52 |
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Corticosteroid-free Clinical Remission at Week 52 (Placebo and Mirikizumab) | Clinical response by PRO defined as ≥30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points. Corticosteroid-free clinical remission by CDAI is defined as achieving clinical remission by CDAI at Week 52 and being corticosteroid free from Week 40 to Week 52. | Week 12 to Week 52 |
| Change From Baseline in C-Reactive Protein (CRP) at Week 52 in Adult Participants (Placebo and Mirikizumab) | Change from baseline in CRP | Baseline, Week 52 |
| Change From Baseline in Fecal Calprotectin at Week 52 in Adult Participants (Placebo and Mirikizumab) | Change from baseline in Fecal Calprotectin | Baseline, Week 52 |
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Resolution of Baseline Extraintestinal Manifestations (EIMs) at Week 52 (Placebo and Mirikizumab) | Clinical response by PRO defined as ≥30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). | Week 12 to Week 52 |
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and ≥50% Reduction in Number of Draining Cutaneous Fistulae at Week 52 in Participants With Draining Cutaneous Fistulae at Baseline (Placebo and Mirikizumab) | Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). | Week 12 to Week 52 |
| Change From Baseline in Health Related Quality of Life at Week 52 in Adult Participants: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Placebo and Mirikizumab) | The IBDQ is a 32-item patient completed questionnaire that measures 4 aspects of patients' 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." IBDQ total score is calculated as the sum of all questions. Scores range from 32 to 224; a higher score indicates a better quality of life. | Baseline, Week 52 |
| Adult Population Pharmacokinetics (PopPK): Area Under the Concentration Time Curve (AUC) of Mirikizumab | PopPK: AUC of Mirikizumab | 900 mg Mirikizumab: Week 4: Predose; Week 4, Day 1: Postdose; Week 8, 12: Predose 300 mg Mirikizumab: Week 16, 24, 36: Predose; Week 52 |
| Dothan |
| Alabama |
| 36301 |
| United States |
| Lakeview Clinical Research | Guntersville | Alabama | 35976 | United States |
| Care Access Research - Tuscaloosa | Tuscaloosa | Alabama | 35406 | United States |
| Research Solutions of Arizona | Litchfield Park | Arizona | 85340 | United States |
| Central Arizona Medical Associates, PC | Mesa | Arizona | 85206 | United States |
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix | Arizona | 85037 | United States |
| Reliance Research | Scottsdale | Arizona | 85260 | United States |
| Synexus Site Network | Tempe | Arizona | 85282 | United States |
| inSite Digestive Health Care | Arcadia | California | 91006 | United States |
| B G Clinical Research, Inc. | Encinitas | California | 92024 | United States |
| Care Access - Gilroy | Gilroy | California | 95020 | United States |
| Newport Huntington Med Grp | Huntington Beach | California | 92648 | United States |
| Om Research, LLC | Lancaster | California | 93534 | United States |
| GastroIntestinal Biosciences Clinical Trials | Los Angeles | California | 90067 | United States |
| California Medical Research Associates | Northridge | California | 91324 | United States |
| University of California Irvine | Orange | California | 92868 | United States |
| inSite Digestive Health Care | Pasadena | California | 91105 | United States |
| Care Access Research - San Jose | San Jose | California | 95124 | United States |
| Wolverine Clinical Trials, LLC | Santa Ana | California | 92705 | United States |
| Fomat Medical Research, Inc. | Thousand Oaks | California | 91360 | United States |
| Connecticut Gastroenterology | Manchester | Connecticut | 06040 | United States |
| IMR of South Florida | Aventura | Florida | 33180 | United States |
| Gastroenterology Consultants of Clearwater | Clearwater | Florida | 33756 | United States |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33761 | United States |
| Inpatient Research Clinic | Hialeah | Florida | 33013 | United States |
| Doral Medical Research | Hialeah | Florida | 33016 | United States |
| C2 Research Center, LLC | Jacksonville | Florida | 32204 | United States |
| I.H.S. Health, LLC | Kissimmee | Florida | 34741 | United States |
| Central Florida Gastro Research | Kissimmee | Florida | 34744 | United States |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | United States |
| Wellness Clinical Research | Lehigh Acres | Florida | 33936 | United States |
| Columbus Clinical Services, LLC | Miami | Florida | 33125 | United States |
| Infinite Clinical Research | Miami | Florida | 33133 | United States |
| Nickalus Children's Hospital Research Institute | Miami | Florida | 33155 | United States |
| Research Associates of South Florida, LLC | Miami | Florida | 33156 | United States |
| SaludMax Medical Corp | Miami | Florida | 33165 | United States |
| Ezy Medical Research | Miami | Florida | 33175 | United States |
| Coral Research Clinic Corp | Miami | Florida | 33186 | United States |
| Goji Group - Research Trials Group | Miami Lakes | Florida | 33016 | United States |
| Wellness Clinical Research | Miami Lakes | Florida | 33016 | United States |
| Center for Interventional Endoscopy | Orlando | Florida | 32803 | United States |
| Endoscopic Research Inc | Orlando | Florida | 32803 | United States |
| Orlando Health, Inc | Orlando | Florida | 32806 | United States |
| Clintheory Healthcare | Orlando | Florida | 32819 | United States |
| Care Access Research - Orlando | Orlando | Florida | 32825 | United States |
| Digestive and Liver Center of Florida | Orlando | Florida | 32825 | United States |
| Gastroenterology Associates of Pensacola, PA | Pensacola | Florida | 32503 | United States |
| Synexus Clinical Research US, Inc. | Pinellas Park | Florida | 33781 | United States |
| USPA Advance Concept Medical Research Group LLC. | South Miami | Florida | 33143 | United States |
| Precision Clinical Research | Sunrise | Florida | 33351 | United States |
| Advanced Research | Tamarac | Florida | 33321 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Alliance Clinical Research, LLC | Tampa | Florida | 33615 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | United States |
| Grand Teton Research Group | Idaho Falls | Idaho | 83404 | United States |
| Eagle Clinical Research | Chicago | Illinois | 60621 | United States |
| Qualmedica Research, LLC | Evansville | Indiana | 47715 | United States |
| Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| Care Access Research - Terre Haute | Terre Haute | Indiana | 47802 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Robley Rex VA Medical Center | Louisville | Kentucky | 40206 | United States |
| CroNola LLC | Houma | Louisiana | 70360 | United States |
| Delta Research Partners LLC | Monroe | Louisiana | 71201 | United States |
| Nola Research Works, LLC | New Orleans | Louisiana | 70125 | United States |
| Louisiana Clinical Research, LLC | Shreveport | Louisiana | 71105 | United States |
| MGG Group, Inc.., Co., Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Woodholme Gastroenterology Associates - Glen Burnie | Glen Burnie | Maryland | 21061 | United States |
| Capital Digestive Care | Rockville | Maryland | 20850 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Revive Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Infusion Associates | Grand Rapids | Michigan | 49525 | United States |
| MNGI Digestive Health, P.A. | Plymouth | Minnesota | 55446 | United States |
| Gastrointestinal Associates | Flowood | Mississippi | 39232 | United States |
| University of Mississippi School of Medicine | Jackson | Mississippi | 39216-4500 | United States |
| Southern Therapy and Advanced Research (STAR) LLC | Jackson | Mississippi | 39216 | United States |
| Digestive Health Specialists | Tupelo | Mississippi | 38801 | United States |
| BVL Research | Liberty | Missouri | 64068 | United States |
| Advanced Biomedical Research of America - South Eastern Avenue | Las Vegas | Nevada | 89123 | United States |
| Care Access - Las Vegas | Las Vegas | Nevada | 89148 | United States |
| Lovelace Scientific Resources - Albuquerque | Albuquerque | New Mexico | 87108 | United States |
| NYU Langone Long Island Clinical Research Associates | Lake Success | New York | 11042 | United States |
| Care Access Research - Yonkers | Yonkers | New York | 10701 | United States |
| Unc Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| Javara | Charlotte | North Carolina | 28210 | United States |
| Medication Management | Greensboro | North Carolina | 27405 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| Care Access Research-Kinston | Kinston | North Carolina | 28501 | United States |
| Care Access Research-Lumberton | Lumberton | North Carolina | 28358 | United States |
| Gastroenterology Associates of the Piedmont | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Ohio State University Hospital | Columbus | Ohio | 43210 | United States |
| Ohio Gastroenterology Group Inc. | Dublin | Ohio | 43016 | United States |
| Northshore Gastroenterology Research, LLC | Westlake | Ohio | 44145 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Care Access Research LLC | Pottsville | Pennsylvania | 17901 | United States |
| Care Access Research - Scranton | Scranton | Pennsylvania | 18508 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Radiant Research | Anderson | South Carolina | 29621 | United States |
| Strand GI | Myrtle Beach | South Carolina | 29572 | United States |
| Gastroenterology Associates of Orangeburg | Orangeburg | South Carolina | 29118 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| GIA Clinical Trials, LLC | Knoxville | Tennessee | 37909 | United States |
| Amel Med LLC | Austin | Texas | 78750 | United States |
| Baylor Scott & White Center for Inflammatory Bowel Diseases | Dallas | Texas | 75246 | United States |
| Advanced Gastroenterology Associates | Decatur | Texas | 76234 | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Texas Health Services Center - Houston | Houston | Texas | 77030 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | United States |
| Katy Gastro Health & Nutrition | Katy | Texas | 77494 | United States |
| Caprock Gastro Research, LLC | Lubbock | Texas | 79424 | United States |
| Biopharma Informatic, LLC | McAllen | Texas | 78503 | United States |
| Digestive System Healthcare | Pasadena | Texas | 77505 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78229 | United States |
| VIP Trials | San Antonio | Texas | 78230 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| Care Access Research LLC - Salt Lake City | Ogden | Utah | 84403 | United States |
| Velocity Clinical Research/Gut Whisperer | Riverton | Utah | 84065 | United States |
| Kalo Clinical Research | Salt Lake City | Utah | 84102 | United States |
| Care Access Research LLC - Salt Lake City | Salt Lake City | Utah | 84124 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908-0816 | United States |
| Pediatrics Specialists of Virginia | Fairfax | Virginia | 22031 | United States |
| Children's Specialty Group, PPLC | Norfolk | Virginia | 23507 | United States |
| The Center for Gastrointestinal Health | Petersburg | Virginia | 23805 | United States |
| Clinical Research Partners, LLC | Richmond | Virginia | 23226 | United States |
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
| Virginia Gastroenterology Institute | Suffolk | Virginia | 23434 | United States |
| TPMG Clinical Research Williamsburg | Williamsburg | Virginia | 23188 | United States |
| Washington Gastroenterology, PLLC | Bellevue | Washington | 98004 | United States |
| Advanced Clinical Research-Spokane Gastroenterology | Spokane | Washington | 99202 | United States |
| Washington Gastroenterology, PLLC | Tacoma | Washington | 98405 | United States |
| Marshall Medical Center | Huntington | West Virginia | 25701 | United States |
| Care Access Research - Wyoming | Casper | Wyoming | 82601 | United States |
| DOM- Centro de Reumatologia | CABA | Buenos Aires | 1111 | Argentina |
| Mautalen Salud e Investigación | CABA | Buenos Aires | C1128AAF | Argentina |
| CEMIC- Servicio de Reumatología | CABA | Buenos Aires | C1431FWO | Argentina |
| Instituto Medico Elsa Perez SRL (IMEP) | Ciudadela | Buenos Aires | 1702 | Argentina |
| CIPREC | Ciudad Autonoma de Buenos Aire | Ciudad Autónoma de Buenos Aire | C1119ACN | Argentina |
| Centro de Investigaciones Médicas Tucuman | SAN M. de Tucuman | Tucumán Province | T4000AXL | Argentina |
| Centro de Investigaciones Metabólicas (CINME) | Buenos Aires | C1027AAP | Argentina |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| St. Vincents Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Nepean Hospital | Kingswood | New South Wales | 2747 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Coastal Digestive Health | Maroochydore | Queensland | 4558 | Australia |
| Coral Sea Clinical Research Institute | North Mackay | Queensland | 4740 | Australia |
| Emeritus Research | Camberwell | Victoria | 3124 | Australia |
| Northern Hospital | Epping | Victoria | 3076 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria |
| Universitätsklinikum Salzburg | Salzburg | 5020 | Austria |
| Krankenhaus der Barmherzigen Schwestern Wien | Vienna | 1060 | Austria |
| AKH | Vienna | 1090 | Austria |
| Imelda General Hospital | Bonheiden | Antwerpen | 2820 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará | Fortaleza | Ceará | 60430-370 | Brazil |
| Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao | Salvador | Estado de Bahia | 41500-300 | Brazil |
| L2IP - Instituto de Pesquisas Clinicas Ltda. | Brasília | Federal District | 70200-730 | Brazil |
| Chronos Pesquisa Clínica | Brasília | Federal District | 72145-450 | Brazil |
| Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda | Goiânia | Goiás | 74535-170 | Brazil |
| Hospital Felício Rocho | Belo Horizonte | Minas Gerais | 30110-934 | Brazil |
| Eurolatino Pesquisas Medicas Ltda. | Uberlândia | Minas Gerais | 38411-186 | Brazil |
| Associacao Paranaense de Cultura - PUCPR | Curitiba | Paraná | 80230-130 | Brazil |
| Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul | Caxias do Sul | Rio Grande do Sul | 95070-560 | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Hospital Ernesto Dornelles | Porto Alegre | Rio Grande do Sul | 90160-093 | Brazil |
| Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90560-030 | Brazil |
| Faculdade de Medicina de Botucatu | Botucatu | São Paulo | 18618-687 | Brazil |
| HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas | Campinas | São Paulo | 13060-904 | Brazil |
| Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-870 | Brazil |
| Pesquisare | Santo André | São Paulo | 09080-110 | Brazil |
| Praxis Pesquisa Medica | Santo André | São Paulo | 09790790 | Brazil |
| CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual | São Paulo | São Paulo | 04039-004 | Brazil |
| Hospital Gloria Dor | Rio de Janeiro | 22211-230 | Brazil |
| CPQuali Pesquisa Clínica | São Paulo | 01228-000 | Brazil |
| Hospital Sírio Libanês | São Paulo | 01308-050 | Brazil |
| Clinica Onco Star | São Paulo | 04543-000 | Brazil |
| Hepatogastro | São Paulo | 04543-001 | Brazil |
| Gastroenterology and internal medicine research institute | Edmonton | Alberta | T5R 1W2 | Canada |
| Fraser Clinical Trials Inc | New Westminster | British Columbia | V3L 3W4 | Canada |
| The Medical Arts Health Research Group | North Vancouver | British Columbia | V7L 4W8 | Canada |
| GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Milestone Clinical | Dartmouth | Nova Scotia | B2W 6L4 | Canada |
| K&M Medical | Kentville | Nova Scotia | B4N 0A3 | Canada |
| Viable Clinical Research | Greater Sudbury | Ontario | P3C 5K6 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Victoria Hospital | London | Ontario | N6A 5W9 | Canada |
| CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital | Montreal | Quebec | H1T 2M4 | Canada |
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China |
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Chongqing General Hospital | Chongqing | Chongqing Municipality | 400014 | 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 |
| The First Affiliated Hospital of Fujian Medical University | Fujian | Fuzhou | 350005 | China |
| The First People's Hospital of Foshan | Foshan | Guangdong | 528000 | China |
| First affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
| The Sixth Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510655 | China |
| Hainan General Hospital | Haikou | Hainan | 570311 | China |
| Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech | Wuhan | Hubei | 430030 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | 213003 | China |
| Changzhou No.2 People's Hospital | Changzhou | Jiangsu | China |
| Jiangsu Province Hospital of Chinese Medicine | Nanjing | Jiangsu | 210029 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215066 | China |
| Wuxi People's Hospital | Wuxi | Jiangsu | 214023 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212000 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| Shanghai East Hospital | Shanghai | Pudong District | 200120 | China |
| Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai 6th people's hospital | Shanghai | Shanghai Municipality | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| The First People's Hospital of Yunnan Province | Kunming | Yunnan | 650034 | China |
| First Affiliated Hosp of College of Med, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310016 | China |
| The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university | Wenzhou | Zhejiang | 310015 | China |
| Zhongshan Hospital Xiamen University | Xiamen | 361004 | China |
| Clinical Medical Centre Osijek | Osijek | 31000 | Croatia |
| CHC Zagreb | Zagreb | 10000 | Croatia |
| Vojenská Nemocnice Brno | Brno | Brno-město | 636 00 | Czechia |
| Krajska zdravotni, a.s.-Masarykova nemocnice Usti nad Labem | Ústí nad Labem | Czech Republic | 40113 | Czechia |
| Hepato-Gastroenterologie HK | Hradec Králové | Hradec Králové | 500 12 | Czechia |
| MUDr. Gregar, s.r.o. | Olomouc | Olomouc Region | 779 00 | Czechia |
| Institut Klinicke a Experimentalni Mediciny | Prague | Prague | 14021 | Czechia |
| Synexus Czech | Prague | Praha 2 | 120 00 | Czechia |
| Thomayerova nemocnice | Prague | Praha 4 | 14059 | Czechia |
| Nemocnice Tomase Bati ve Zline | Zlín | Zlín | 762 75 | Czechia |
| Fakultni Nemocnice U svate Anny | Brno | 65691 | Czechia |
| Oblastni nemocnice Nachod-Endoskopicke centrum | Náchod | Czechia |
| PreventaMed, s.r.o. | Olomouc | 77900 | Czechia |
| MUDr. Radka Koskova, s.r.o., Gastroenterologicka ambulance | Ostrava - Muglinov | 712 00 | Czechia |
| A-Shine, s.r.o. | Pilsen | 301 00 | Czechia |
| AXON Clinical | Prague | 150 00 | Czechia |
| Mediendo, s.r.o. | Prague | 18600 | Czechia |
| ISCARE Clinical Centre | Prague | 19000 | Czechia |
| Aarhus Universitetshospital, Skejby | Aarhus | Central Jutland | 8200 | Denmark |
| Aalborg Hospital | Aalborg | 9100 | Denmark |
| Hopital de Hautepierre - Service d'Hépatogastroentérolgie | Strasbourg | Bas Rhin | 67098 | France |
| Hôpital Saint Antoine | Paris | Cedex 12 | 75012 | France |
| Hôpital Beaujon | Clichy | Paris | 92110 | France |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre | Le Kremlin-Bicêtre | Paris | 94270 | France |
| Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - | Pierre-Bénite | Rhone | 69495 | France |
| CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie | Amiens | 80054 | France |
| Centre Hospitalier du Mans | Le Mans | 72000 | France |
| CHRU de Montpellier-Hopital St Eloi | Montpellier | 34295 | France |
| GH Necker - Enfants Malades | Paris | 75015 | France |
| CHU Bordeaux - Hôpital Haut-Lévêque | Pessac | 33604 | France |
| CHU de Poitiers- Service d'Hépato-gastro-entérologie, | Poitiers | 86021 | France |
| CHU Charles Nicolle in Rouen | Rouen | 76036 | France |
| CHU St Etienne Hopital Nord | Saint-Etienne | 42055 | France |
| CHRU de Nancy | Vand?uvre-lès-Nancy | 54511 | France |
| Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin | Pforzheim | Baden-Wurttemberg | 75179 | Germany |
| Universitätsklinikum Würzburg A. ö. R. | Würzburg | Bavaria | 97080 | Germany |
| Synexus Clinical Research GmbH | Frankfurt am Main | Hesse | 60313 | Germany |
| Krankenhaus Eichhof | Lauterbach | Hesse | 36341 | Germany |
| Medizinische Hochschule Hanover | Hanover | Lower Saxony | 30625 | Germany |
| Knappschaftskrankenhaus Bottrop | Bottrop | North Rhine-Westphalia | 46242 | Germany |
| Universitaetsklinikum Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
| Johanna Etienne Krankenhaus-Klinik für Allgemeine Innere Medizin | Neuss | North Rhine-Westphalia | 41462 | Germany |
| Gemeinschaftspraxis Jakobeit | Wipperfürth | North Rhine-Westphalia | 51688 | Germany |
| St. Marienkrankenhaus-Medizinische Klinik I | Ludwigshafen am Rhein | Rhineland-Palatinate | 67067 | Germany |
| Practice Dr.med. Denger and Dr.med. Pfitzner | Friedrichsthal | Saarland | 66299 | Germany |
| Studiengesellschaft BSF Unternehmergesellschaft | Halle | Saxony-Anhalt | 06108 | Germany |
| Synexus Clinical Research GmbH-Leipzig Research Centre | Leipzig | Saxony-Anhalt | 04103 | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
| RED-Institut GmbH | Oldenburg in Holstein | Schleswig-Holstein | 23758 | Germany |
| Charité Campus Virchow-Klinikum | Berlin | 12200 | Germany |
| Synexus Clinical Research GmbH | Berlin | 12627 | Germany |
| Florence-Nightingale-Krankenhaus | Düsseldorf | 40489 | Germany |
| HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen | Hamburg | 20251 | Germany |
| Gastroenterologische Gemeinschaftspraxis Mainz | Mainz | 55122 | Germany |
| Tumorzentrum Nordthüringen | Uslar | 99734 | Germany |
| Synexus Gyula | Gyula | Bekes County | 5700 | Hungary |
| SZTE AOK Belgyogyaszati Klinika | Szeged | Csongrád megye | 6725 | Hungary |
| DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | EU | 8230 | Hungary |
| Clinexpert Tatabánya Ltd. | Tatabánya | Komárom-Esztergom | H-2800 | Hungary |
| Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház | Békéscsaba | 5600 | Hungary |
| Clinexpert SMO | Budapest | 1033 | Hungary |
| Synexus Magyarorszag Kft. | Budapest | 1036 | Hungary |
| Pannonia Maganorvosi Centrum | Budapest | 1136 | Hungary |
| Bugát Pál Kórház | Gyöngyös | 3200 | Hungary |
| Endomedix Diagnosztikai Központ - Miskolc | Miskolc | 3526 | Hungary |
| CLINFAN Szolgáltató Kft | Szekszárd | 7100 | Hungary |
| Gujarat Hospital - Gastro and Vascular Centre | Surat | Gujarat | 395009 | India |
| International Gastro Institute | Vadodara | Gujarat | 390007 | India |
| Midas Multispeciality Hospital Pvt.Ltd. | Nagpur | Maharashtra | 440010 | India |
| Ruby Hall Clinic and Grant Medical Foundation | Pune | Maharashtra | 411001 | India |
| All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | 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 | 302006 | India |
| Apollo Speciality Hospital - Teynampet | Chennai | Tamil Nadu | 600035 | India |
| Asian Institute of Gastroenterology | Hyderabad | Telangana | 500032 | India |
| Postgraduate Institute of Medical Education & Research | Chandigarh | 160012 | India |
| Aakash Healthcare Super Speciality Hospital | New Delhi | 110075 | India |
| Gandhi Hospital | Telangana | 500003 | India |
| Yashoda Super Speciality Hospital | Telangana | 500003 | India |
| Soroka Medical Center | Beersheba | 8410101 | Israel |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Edith Wolfson Medical Center | Holon | 5822012 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Galilee Medical Center Department of Internal Medicine A | Nahariya | 22100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5262100 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Assaf Harofeh Medical Center | Ẕerifin | 70300 | Israel |
| Azienda Ospedaliera Saverio De Bellis | Castellana Grotte | Bari | 70013 | Italy |
| Università di Cagliari - Presidio Policlinico Monserrato | Monserrato | Cagliari | 09042 | Italy |
| Azienda ospedaliero-universitaria Mater Domini | Germaneto | Catanzaro | 88100 | Italy |
| Policlinico Gemelli - Università Cattolica del Sacro Cuore | Rome | Lazio | 00168 | Italy |
| Presidio di Rho | Rho | Milano | 20017 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Ospedale Clinicizzato San Donato | San Donato Milanese | Milan | 20097 | Italy |
| Istituto Mangiagalli | Milan | MI | 20122 | Italy |
| Azienda Ospedaliera Policlinico Consorziale | Bari | 70124 | Italy |
| Università degli Studi c/o Spedali Civili | Brescia | 25100 | Italy |
| Azienda Ospedaliera Giuseppe Brotzu | Cagliari | 09134 | Italy |
| Ospedale Luigi Sacco | Milan | 20157 | Italy |
| Azienda Ospedaliera Universitaria Policlinico de Modena | Modena | 41124 | Italy |
| Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli | Naples | 80131 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | 80131 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | 42123 | Italy |
| Polic.Umberto I -Univ. La Sapienza | Roma | 00161 | Italy |
| Azienda Ospedaliera Santa Maria Della Misericordia | Udine | 33100 | Italy |
| Kojunkai Daido Clinic | Nagoya | Aichi-ken | 4570818 | Japan |
| Fujita Health University | Toyoake | Aichi-ken | 470-1192 | Japan |
| National Hospital Organization Hirosaki General Medical Center | Hirosaki | Aomori | 036-8545 | Japan |
| Tsujinaka Hospital | Kashiwa | Chiba | 277 0871 | Japan |
| Fukuoka University Chikushi Hospital | Chikushino-shi | Fukuoka | Japan |
| Fukuoka University Hospital | Fukuoka, Jonan-Ku | Fukuoka | 814-0180 | Japan |
| Hoshi General Hospital | Kōriyama | Fukushima | 963-8501 | Japan |
| Isesakishimin Hospital | Isesaki | Gunma | 372-0817 | Japan |
| Kiryu Kosei Hospital | Kiryū | Gunma | 376 0024 | Japan |
| Maebashi Red Cross Hospital | Maebashi | Gunma | 371 0811 | Japan |
| National Hospital Organization Fukuyama Medical Center | Fukuyama | Hiroshima | 720-0825 | Japan |
| Asahikawa Medical College Hospital | Asahikawa | Hokkaido | 078-8510 | Japan |
| Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Chuo-ku, Sapporo-shi | Hokkaido | 060-0033 | Japan |
| Tokushukai Sapporo Tokushukai Hospital | Sapporo | Hokkaido | 004 0041 | Japan |
| Sapporo Higashi Tokushukai Hospital | Sapporo | Hokkaido | 065-0033 | Japan |
| Sapporo Medical University Hospital | Sapporo | Hokkaido | Japan |
| Hyogo College of Medicine | Nishinomiya | Hyōgo | 663-8501 | Japan |
| Ibaraki Prefectural Central Hospital | Kasama | Ibaraki | 890-8520 | Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kagawa Prefectural Central Hospital | Takamatsu | Kagawa-ken | 760-8557 | Japan |
| Ofuna Central Hospital | Kamakura | Kanagawa | 247-0056 | Japan |
| Kitasato University Hospital | Sagamihara | Kanagawa | 252-0375 | Japan |
| Matsushima Cinic | Yokohama | Kanagawa | 220-0045 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| IMS Meirikai Sendai General Hospital | Sendai | Miyagi | 980-0021 | Japan |
| Takagi Clinic - Sendai | Sendai | Miyagi | 981-3213 | Japan |
| Nagasaki Harbor Medical Center | Nagasaki | Nagasaki | 850-0842 | Japan |
| Infusion Clinic | Osaka | Osaka | 530-0011 | Japan |
| Saga-Ken Medical Center Koseikan | Saga | Saga-ken | 840 8571 | Japan |
| Matsuda Hospital | Hamamatsu | Shizuoka | 4328061 | Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | 329-0498 | Japan |
| Tokyo Medical and Dental University Hospital | Bunkyō | Tokyo | 113-8519 | Japan |
| Showa University Koto Toyosu Hospital | Koto-ku | Tokyo | 135 8577 | Japan |
| National Center for Global Health and Medicine | Shinjuku-ku | Tokyo | 162-8655 | Japan |
| JHCO Tokyo Yamate Medical Center | Shinjuku-ku | Tokyo | 169-0073 | Japan |
| Tottori University Hospital | Yonago | Tottori | 683-8504 | Japan |
| Kagoshima University Hospital | Kagoshima | 890-8520 | Japan |
| Sameshima Hospital | Kagoshima | 892-0846 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| Kyoto Furitsu Medical University Hospital | Kyoto | 602-8566 | Japan |
| Okayama Saiseikai General Hospital Outpatient Center | Okayama | 700-0013 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Tokitokai Tokito Clinic | Saitama | 336-0963 | Japan |
| Toyama Prefectural Central Hospital | Toyama | 930-8550 | Japan |
| Yamagata University Hospital | Yamagata | 990-9585 | Japan |
| Pauls Stradins Clinical Univeristy Hospital | Riga | Riga | LV-1002 | Latvia |
| Hospital of Lithuanian University of Health Sciences Kaunas | Kaunas | 50009 | Lithuania |
| PanAmerican Clinical Research S.A.de C.V. Guadalajara | Guadalajara | JA | 44670 | Mexico |
| Health Pharma Professional Research S.A. de C.V: | Mexico City | Mexico City | 03100 | Mexico |
| Grupo Medico Camino Sc | Mexico City | Mexico City | 03310 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 64460 | Mexico |
| PanAmerican Clinical Research Mexico S.A. de C.V. | Querétaro City | Querétaro | 76226 | Mexico |
| Scientia Investigacion Clinica S.C. | Chihuahua City | 31203 | Mexico |
| Instituto de Investigaciones Clínicas para la Salud | Durango | 34000 | Mexico |
| Centro de Alta Especialidad Reumatologia Inv del Potosi SC | San Luis Potosí City | 78213 | Mexico |
| Sociedad de Metabolismo y Corazon | Veracruz | 91900 | Mexico |
| ETZ Elisabeth Tilburg | Tilburg | North Brabant | 5022 GC | Netherlands |
| Bernhoven Uden | Uden | 5406 PT | Netherlands |
| Synexus Polska Sp. z o.o. Oddzial w Poznaniu | Poznan | Greater Poland Voivodeship | 60-702 | 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 |
| MED-ROZ | Karwiany | Lower Silesian Voivodeship | 52-200 | Poland |
| Dc-Med. Sp. z o.o. | Swidnica | Lower Silesian Voivodeship | 58-100 | Poland |
| M. Sklodowskiej-Curie 12 | Wroclaw | Lower Silesian Voivodeship | 50-381 | Poland |
| Melita Medical | Wroclaw | Lower Silesian Voivodeship | 50-449 | Poland |
| ZOZ Gastromed | Lublin | Lublin Voivodeship | 20-582 | Poland |
| NZOZ Vivamed | Warsaw | Masovian Voivodeship | 03-580 | Poland |
| Private Practice - Dr. Korczowski Bartosz | Rzeszów | Podkarpackie Voivodeship | 35-302 | Poland |
| Nova Reuma Społka Partnerska | Bialystok | Podlaskie Voivodeship | 15-707 | Poland |
| Synexus Polska Gdansku | Gdansk | Pomeranian Voivodeship | 80-382 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdyni | Gdynia | Pomeranian Voivodeship | 81-537 | Poland |
| Endoskopia Sp. z.o.o. | Sopot | Pomeranian Voivodeship | 81-756 | Poland |
| Centrum Medyczne SYNEXUS | Częstochowa | Silesian Voivodeship | 42-202 | Poland |
| Synexus Polska - Katowicach | Katowice | Silesian Voivodeship | 40040 | Poland |
| Kiepury Clinic | Sosnowiec | Silesian | 41-200 | Poland |
| Centrum Medyczne Medyk | Rzeszów | Subcarpathian | 35-326 | Poland |
| Sonomed Sp. z o.o. | Szczecin | West Pomeranian Voivodeship | 71-685 | Poland |
| Instytut Pomnik-Centrum Zdrowia Dziecka | Warsaw | Woj Mazowieckie | 04-730 | Poland |
| Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| NZOZ "Twoje Zdrowie EL" Sp. z o.o. | Elblag | 82-300 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska | Knurów | 44-190 | Poland |
| Synexus Polska Oddział w Lodzi | Lodz | 90-127 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 00-728 | Poland |
| ETG Zamość | Zamość | 22-400 | Poland |
| Caguas Gastroenterology and Hepatology Center, LLC | Caguas | 00726-4980 | Puerto Rico |
| Pan American Center for Oncology Trials | Rio Piedras | 00935 | Puerto Rico |
| Latin Clinical Trial Center | San Juan | 00909 | Puerto Rico |
| Wellness clinical Research Vega Baja | Vega Baja | 00694 | Puerto Rico |
| Spitalul Pelican | Oradea | Bihor County | 410450 | Romania |
| Spitalul Euroclinic | Bucureti | Bucharest | 014461 | Romania |
| Sc Tvm Med Serv | Cluj-Napoca | Cluj | 400132 | Romania |
| SC Med Life SA | Bucharest | 010719 | Romania |
| Spitalul Clinic CF 2 Bucuresti | Bucharest | 011464 | Romania |
| S.C. Centrul Medical Medicum SRL | Bucharest | 012015 | Romania |
| Institutul Clinic Fundeni | Bucharest | 022328 | Romania |
| Spitalul Universitar de Urgență București | Bucharest | 050098 | Romania |
| Spitalul Clinic Colentina | Bucharest | 21155 | Romania |
| CCBR Clinical Research | Bucharest | 30463 | Romania |
| Gastromed S.R.L. | Constanța | 900168 | Romania |
| Affidea Medical Research Center | Constanța | 900591 | Romania |
| Spitalul Clinic Judetean Targu Mures | Târgu Mureş | 540103 | Romania |
| S.C. Materna Care S.R.L. | Timișoara | 300645 | Romania |
| Scientific Centre of Reconstructive and Restorative Surgery | Irkutsk | Irkutsk Oblast | 664079 | Russia |
| Karelia Republican Hospital V.A. Baranova | Petrozavodsk | Kareliya, Respublika | 185019 | Russia |
| Olla-Med | Moscow | Moscow | 105554 | Russia |
| Nizhny Novgorod Regional Hospital N.A. Semashko | Nizhny Novgorod | Nizhny Novgorod Oblast | 603126 | Russia |
| Novosibirski Gastrocenter | Novosibirsk | Novosibirsk Oblast | 630007 | Russia |
| Rostov State Medical University | Rostov-on-Don | Rostov Oblast | 344091 | Russia |
| LLC Medical Center Reavita Med SPb | Saint Petersburg | Sankt-Peterburg | 194354 | Russia |
| Scientific research center ECO-security | Saint Petersburg | Sankt-Peterburg | 196143 | Russia |
| Multidisciplinary Medical Clinic "Anthurium" | Barnaul | 656043 | Russia |
| LLC Evimed | Chelyabinsk | 454048 | Russia |
| Medical and Sanitary Division of Severstal | Cherepovets | 162600 | Russia |
| Clinical Trials Center of Medical Institute | Kaliningrad | 236035 | Russia |
| Kazan State Medical University | Kazan' | 420029 | Russia |
| SIH Kemerovo Regional Clinical Hosptial | Kemerovo | 650066 | Russia |
| LLC ?Medsanchast No 14? | Moscow | 123022 | Russia |
| State Scientific Centre of Coloproctology | Moscow | 123423 | Russia |
| LLC "Medicine Center SibNovoMed" | Novosibirsk | 630005 | Russia |
| The University Clinic of OSMU | Omsk | 644050 | Russia |
| Pokrovskaya Municipal Hospital | Saint Petersburg | 195067 | Russia |
| Saint-Petersburg City Hospital of Saint Elizabeth | Saint Petersburg | 195257 | Russia |
| Academician I.P. Pavlov First St-Petersburg State Medical University | Saint Petersburg | 197022 | Russia |
| LLC Gastroenterology Centre Expert | Saint Petersburg | 197110 | Russia |
| SBIH City Clinical Hospital #31 | Saint Petersburg | 197110 | Russia |
| SPb SBIH "City Polyclinic # 106" | Saint Petersburg | 198328 | Russia |
| NonState Healthcare Institution Central Clinical Hospital | Samara | 443029 | Russia |
| LLC MA New Hospital | Yekaterinburg | 620109 | Russia |
| Clinical Hospital Center Zvezdara | Belgrade | Beograd | 11000 | Serbia |
| Zemun Medical Centre | Zemun | Beograd | 11080 | Serbia |
| University Medical Center "Bezanijska kosa" | Belgrade | NAP | 11080 | Serbia |
| Clinical Center Nis | Niš | Nišavski Okrug | 18000 | Serbia |
| Sremska Mitrovica Health Centre | Sremska Mitrovica | Vojvodina | 22000 | Serbia |
| General Hospital "Djordje Joanovic" | Zrenjanin | Vojvodina | 23000 | Serbia |
| Clinical Center " Dr Dragisa Misovic Dedinje" | Belgrade | 11000 | Serbia |
| Clinical Center Kragujevac Gastroenterohepatology Clinic | Kragujevac | 34000 | Serbia |
| Gastro | Prešov | Presov | 080 01 | Slovakia |
| Endomed, s.r.o. | Vranov N. Toplou | Presov | 093 01 | Slovakia |
| FNsP FDRoosevelta Banska Bystrica | Banská Bystrica | 97517 | Slovakia |
| CLINIQ, s.r.o | Bratislava | 811 09 | Slovakia |
| Gastromedic | Nové Zámky | 94002 | Slovakia |
| Gastro LM s.r.o. | Prešov | 08001 | Slovakia |
| Yonsei University Wonju Severance Christian Hospital | Gangwon-do | Gangwon-do | 26426 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Hanyang University Guri Hospital | Guri-si | Gyeonggido | 11923 | South Korea |
| Kyung Pook National University Hospital | Daegu | Korea | 41944 | South Korea |
| Kyung Hee University Hospital | Seoul | Korea | 02447 | South Korea |
| Seoul St. Mary's Hospital | Seoul | Korea | 06591 | South Korea |
| Kyunghee University Hospital at Gangdong | Seoul | Korea | 134727 | South Korea |
| Yeungnam Univeristy Medical Center | Gyeongsan-si | Kyǒngsangbuk-do | 42415 | South Korea |
| Seoul National University Hospital | Seoul | Seoul, Korea | 03080 | South Korea |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | 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 |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Kyungpook National University Medical Center Chilgok Hospital | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 15355 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Chungang University Hospital | Seoul | 06973 | South Korea |
| Seoul National University Hospital | Seoul | 3080 | South Korea |
| Clínica Gaias - Santiago | Santiago de Compostela | A Coruña [La Coruña] | 15702 | Spain |
| Hospital Universitari de Girona Dr. Josep Trueta | Girona | Barcelona | 17007 | Spain |
| Complejo Hospitalario de Navarra NAVARRABIOMED UNIDAD EC | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Complexo Hospitalario Universitario A Coruña, CHUAC | A Coruña | 15006 | Spain |
| Instituto de Ciencias Médicas | Alicante | 3004 | Spain |
| Centro Medico Teknon - DIGESTIVO | Barcelona | 8022 | Spain |
| Hospital Reina Sofia | Córdoba | 14004 | Spain |
| Hospital De Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Nuestra Señora de la Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Cantonal Hospital St.Gallen | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Gastroenterologische Praxis Balsiger, Seibold & Partner | Bern | CH-3012 | Switzerland |
| Antalya Egitim ve Arastırma Hastanesi | Kocaeli | Antalya | 7100 | Turkey (Türkiye) |
| Acibadem Universitesi - Acibadem Kozyatagi Hastanesi | Kadıköy | Istanbul | 34734 | Turkey (Türkiye) |
| Mersin University Medical Faculty | Yenişehir | Mersin | 33343 | Turkey (Türkiye) |
| Hacettepe University Faculty of Medicine | Ankara | 06100 | Turkey (Türkiye) |
| Ankara City Hospital | Ankara | 06800 | Turkey (Türkiye) |
| Gazi University Faculty of Medicine | Ankara | Turkey (Türkiye) |
| Uludag Universitesi | Bursa | 16059 | Turkey (Türkiye) |
| Trakya University | Edirne | 22030 | Turkey (Türkiye) |
| Eskisehir Osmangazi University Gastroenterology | Eskişehir | 26040 | Turkey (Türkiye) |
| Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi | Gaziantep | 27310 | Turkey (Türkiye) |
| Mustafa Kemal Universitesi Tayfur Ata Sokmen Tip Fakultesi | Hatay | 31040 | Turkey (Türkiye) |
| Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi | Istanbul | 34098 | Turkey (Türkiye) |
| Marmara University Pendik Research and Training Hospital | Istanbul | 34340 | Turkey (Türkiye) |
| Medicana Kadiköy Hastanesi | Istanbul | 34724 | Turkey (Türkiye) |
| Fulya Acıbadem | Istanbul | Turkey (Türkiye) |
| Dokuz Eylül Üniversitesi | Izmir | 35340 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty Hospital | İzmit | 41380 | Turkey (Türkiye) |
| Erciyes University Hospital | Kayseri | 38039 | Turkey (Türkiye) |
| Konya Necmettin Erbakan Gastroenterology | Konya | 42080 | Turkey (Türkiye) |
| Inonu Universitesi Turgut Ozal Tıp Merkezi | Malatya | 44280 | Turkey (Türkiye) |
| City Clinical Hospital No. 2 | Kharkiv | Kharkiv Oblast | 61037 | Ukraine |
| Medical Center of Limited Liability Company "Medical Center "Consilium Medical" | Kiev | Kyiv Oblast | 4050 | Ukraine |
| Lviv Railway Clinical Hospital | Lviv | Lviv Oblast | 79000 | Ukraine |
| Lviv Regional Endocrinology Dispensary | Lviv | Lviv Oblast | 79000 | Ukraine |
| RCI Chernivtsi Regional Clinical Hospital | Chernivtsi | 58002 | Ukraine |
| Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine | Dnipro | 49038 | Ukraine |
| Ivano-Frankivsk State Medical University | Ivano-Frankivsk | 76018 | Ukraine |
| Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | 61058 | Ukraine |
| Medical Centre of Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV | Kyiv | 01030 | Ukraine |
| International Institute of Clinical Trials LLC | Kyiv | 02091 | Ukraine |
| LLC Medbud-Clinic Medical Center | Kyiv | 03037 | Ukraine |
| Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway | Kyiv | 03049 | 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 | 65117 | Ukraine |
| A. Novak Transcarpathian Regional Clinical Hospital | Uzhhorod | 88000 | Ukraine |
| Medical Center "Health Clinic" LLC | Vinnitsa | 21009 | Ukraine |
| Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU | Vinnytsia | 21005 | Ukraine |
| Vinnytsya Regional Clinical Hospital | Vinnytsia | 21018 | Ukraine |
| CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM | Vinnytsia | 21029 | Ukraine |
| Zaporozhye City Clinical Hospital #6 | Zaporizhzhia | 69000 | Ukraine |
| Diacenter LLC | Zaporizhzhia | 69076 | Ukraine |
| Addenbrookes Hospital | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Whipps Cross University Hospital | London | England | E11 1NR | United Kingdom |
| Synexus Manchester Clinical Research Centre | Manchester | Greater Manchester | M15 6SE | United Kingdom |
| Chelsea and Westminster Hospital | Fulham | London | SW10 9NH | United Kingdom |
| Synexus Wales Clinical Research Centre | Cardiff | South Glamorgan | CF15 9SS | United Kingdom |
| Synexus Midlands Clinical Research Center | Birmingham | Wstmid | B15 2SQ | United Kingdom |
| Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust | Doncaster | DN2 5LT | United Kingdom |
| Paediatric Clinical Research Facility Royal Hospital for Children and Young People | Edinburgh | EH16 4TJ | United Kingdom |
| Synexus North East Clinical Research Centre | Hexham | NE46 1QJ | United Kingdom |
| Jairath V, D'Haens G, Sands BE, Travis S, Chaparro M, Peyrin-Biroulet L, Chen MH, Dubinsky M, Ferrante M, Schreiber S, McGinnis K, Vadhariya A, Appelmans S, Lin Z, Yu G, Protic M, Moses R, Ghosh S. Bowel Urgency in Crohn's Disease: Effects of Mirikizumab in a Randomized Controlled Phase 3 Study. Clin Gastroenterol Hepatol. 2026 Feb;24(2):463-473.e5. doi: 10.1016/j.cgh.2025.07.003. Epub 2025 Jul 14. |
| 40491246 | Derived | Regueiro M, Fischer M, Bossuyt P, Protic M, Traxler K, Yu G, Zang H, Vadhariya A, Hisamatsu T, Juillerat P, Armuzzi A, Gisbert JP, Walsh A. Impact of mirikizumab treatment on fatigue in patients with moderately to severely active Crohn's disease: results from the phase 3 VIVID-1 study. J Crohns Colitis. 2025 Jul 3;19(7):jjaf100. doi: 10.1093/ecco-jcc/jjaf100. |
| 40079470 | Derived | Lee SD, Vermeire S, Ungaro R, Vadhariya A, Durand F, Morris N, Yu G, Fisher DA, Traxler K, Long M. Mirikizumab Improves Quality of Life and Work Productivity in Patients with Moderately to Severely Active Crohn's Disease: Results from the Phase 3 VIVID-1 Study. Am J Gastroenterol. 2025 Mar 13;120(8):1809-1819. doi: 10.14309/ajg.0000000000003410. |
| 39962027 | Derived | Lewis JD, Vadhariya A, Su S, Zhou X, Durand F, Kawata AK, Stassek L, Clucas C, Schreiber S. A patient-reported outcome measure comprising the stool frequency and abdominal pain items from the Crohn's Disease Activity Index: psychometric evaluation in adults with Crohn's disease. J Patient Rep Outcomes. 2025 Feb 17;9(1):19. doi: 10.1186/s41687-025-00851-y. |
| 39692838 | Derived | Dubinsky M, Vadhariya A, Su S, Zhou X, Durand F, Clucas C, Stassek L, Kawata AK, Travis S. The Urgency Numeric Rating Scale: Psychometric Evaluation in Adults with Crohn's Disease. Adv Ther. 2025 Feb;42(2):1044-1060. doi: 10.1007/s12325-024-03081-8. Epub 2024 Dec 18. |
| 39581202 | Derived | Ferrante M, D'Haens G, Jairath V, Danese S, Chen M, Ghosh S, Hisamatsu T, Kierkus J, Siegmund B, Bragg SM, Crandall W, Durand F, Hon E, Lin Z, Lopes MU, Morris N, Protic M, Carlier H, Sands BE; VIVID Study Group. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024 Dec 14;404(10470):2423-2436. doi: 10.1016/S0140-6736(24)01762-8. Epub 2024 Nov 21. |
| 39537976 | Derived | Regueiro M, Su S, Vadhariya A, Zhou X, Durand F, Stassek L, Kawata AK, Clucas C, Jairath V. Psychometric evaluation of the Functional Assessment of chronic illness therapy-fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn's disease. Qual Life Res. 2025 Feb;34(2):509-521. doi: 10.1007/s11136-024-03829-3. Epub 2024 Nov 13. |
| FG001 | Mirikizumab | Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W |
| FG002 | Ustekinumab | Participants received 6 milligrams per kilogram (mg/kg) Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W) |
| FG003 | Mirikizumab (Adolescents) | Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W |
| Received at Least One Dose of Study Drug |
|
| Placebo Non-Responder at Week 12 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Adults: All randomized participants; Adolescents: All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. |
| BG001 | Mirikizumab | Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W |
| BG002 | Ustekinumab | Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W |
| BG003 | Mirikizumab (Adolescent) | Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W |
| 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, Categorical | Count of Participants | Participants | No |
| |||||||||||||||
| 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 Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) | Clinical response by patient reported outcome (PRO) defined as ≥30% decrease in stool frequency (SF) and/or abdominal pain (AP) & neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Endoscopic response defined as ≥50% reduction from baseline in total Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence & size of ulcers (none=0; diameter 0.1-0.5 cm=1; 0.5-2 cm=2; >2 cm=3); extent of ulcerated surface (none=0; <10%=1; 10% to 30%=2; >30%=3); extent of affected surface (none=0; <50%=1; 50% to 75%=2; >75%=3); presence & type of narrowing (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 to Week 52 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab) | Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as Crohn's Disease Activity Index (CDAI) total score <150. The CDAI is an 8-item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]).. Total score range of 0 to 600 points. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab) | Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Adult Participants Achieving Endoscopic Response at Week 52 | Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. | All randomized participants who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug per protocol. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 52 |
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| Secondary | Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab) | Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Percentage of Adult Participants Achieving Clinical Remission at Week 52 | Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points. | All randomized participants who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug per protocol. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 52 |
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| Secondary | Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab) | Endoscopic remission is defined as SES-CD Total Score ≤4 and at least a 2-point reduction from baseline and no subscore >1. SES-CD evaluates 4 endoscopic variables in 5 bowel segments and each of the 20 individual variables is scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed =3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore >1 is defined as no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) >1. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Change From Baseline in Urgency Numeric Rating Scale (NRS) at Week 12 in Adult Participants (Placebo and Mirikizumab) | The Urgency NRS is a single patient-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). | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Urgency NRS at Week 52 in Adult Participants (Placebo and Mirikizumab) | The Urgency NRS is a single patient-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). | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
|
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| Secondary | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 (Placebo and Mirikizumab) | Clinical Response by PRO defined as ≥30% decrease in SF and/or AP & neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical Remission by PRO defined as SF≤3 and not worse than baseline (as per Bristol Stool Scale Category 6 or 7) and AP ≤1 and no worse than baseline. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 to Week 52 |
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| Secondary | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52 (Placebo and Mirikizumab) | Clinical Response by PRO defined as ≥30% decrease in SF and/or AP & neither score worse than baseline. SF (number of liquid or very soft stools) per Bristol Stool Scale Category 6 or 7 & AP (4-point scale:0=none,1=mild,2=moderate,3=severe). Endoscopic remission=SES-CD Total Score ≤4 & at least 2-point reduction from baseline & no subscore >1.SES-CD evaluates 4 endoscopic variables in 5 bowel segments & each of 20 individual variables scored 0-3: presence & size of ulcers (none=0;diameter 0.1-0.5 cm=1;0.5-2 cm=2;>2 cm=3);extent of ulcerated surface (none=0;<10%=1;10% to 30%=2;>30%=3);extent of affected surface (none=0;<50%=1;50% to 75%=2;>75%=3);presence & type of narrowing (none=0;single,can be passed=1;multiple,can be passed=2;cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56;higher scores indicating more severe disease. No subscore >1=no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) >1 | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 to Week 52 |
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| Secondary | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Corticosteroid-free Clinical Remission at Week 52 (Placebo and Mirikizumab) | Clinical response by PRO defined as ≥30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points. Corticosteroid-free clinical remission by CDAI is defined as achieving clinical remission by CDAI at Week 52 and being corticosteroid free from Week 40 to Week 52. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in C-Reactive Protein (CRP) at Week 52 in Adult Participants (Placebo and Mirikizumab) | Change from baseline in CRP | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | milligram per liter (mg/L) | Baseline, Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fecal Calprotectin at Week 52 in Adult Participants (Placebo and Mirikizumab) | Change from baseline in Fecal Calprotectin | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug and had baseline fecal calprotectin. | Posted | Least Squares Mean | Standard Error | micrograms per gram (μg/g) | Baseline, Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Resolution of Baseline Extraintestinal Manifestations (EIMs) at Week 52 (Placebo and Mirikizumab) | Clinical response by PRO defined as ≥30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug and had at least one EIM at baseline. | Posted | Number | percentage of participants | Week 12 to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Adult Participants Achieving Clinical Response at Week 12 and ≥50% Reduction in Number of Draining Cutaneous Fistulae at Week 52 in Participants With Draining Cutaneous Fistulae at Baseline (Placebo and Mirikizumab) | Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug and had at least one draining cutaneous fistulae at baseline. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Related Quality of Life at Week 52 in Adult Participants: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Placebo and Mirikizumab) | The IBDQ is a 32-item patient completed questionnaire that measures 4 aspects of patients' 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." IBDQ total score is calculated as the sum of all questions. Scores range from 32 to 224; a higher score indicates a better quality of life. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adult Population Pharmacokinetics (PopPK): Area Under the Concentration Time Curve (AUC) of Mirikizumab | PopPK: AUC of Mirikizumab | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day per milliliter(ug*day/mL) | 900 mg Mirikizumab: Week 4: Predose; Week 4, Day 1: Postdose; Week 8, 12: Predose 300 mg Mirikizumab: Week 16, 24, 36: Predose; Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Percentage of Adult Participants Achieving Alternate Endoscopic Remission at Week 12 (Placebo and Mirikizumab) | Alternate endoscopic remission is defined as SES-CD Total Score ≤4 and at least a 2-point reduction from baseline and no subscore >1. SES-CD evaluates 4 endoscopic variables in 5 bowel segments and each of the 20 individual variables is scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed =3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore >1 is defined as no subscore >1 in any of the 20 individual variables. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 99.5% Confidence Interval | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Alternate Endoscopic Remission at Week 52 (Placebo and Mirikizumab) | Clinical Response by PRO defined as ≥30% decrease in SF and/or AP & neither score worse than baseline. SF (number of liquid or very soft stools) per Bristol Stool Scale Category 6 or 7 & AP (4-point scale:0=none,1=mild,2=moderate,3=severe). Alternate endoscopic remission defined as SES-CD Total Score ≤4 & at least 2-point reduction from baseline & no subscore >1.SES-CD evaluates 4 endoscopic variables in 5 bowel segments & each of 20 individual variables scored 0-3: presence & size of ulcers (none=0;diameter 0.1-0.5 cm=1;0.5-2 cm=2;>2 cm=3); extent of ulcerated surface (none=0;<10%=1;10% to 30%=2;>30%=3);extent of affected surface (none=0;<50%=1;50% to 75%=2;>75%=3); presence & type of narrowing (none=0;single,can be passed=1;multiple,can be passed=2;cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore >1 is defined as no subscore >1 in any of the 20 individual variables. | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | Posted | Mean | 99.5% Confidence Interval | percentage of participants | Week 12 to Week 52 |
|
Baseline up to follow up (up to 68 weeks)
All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
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 | Participants received Placebo IV or SC Q4W | 1 | 211 | 37 | 211 | 66 | 211 |
| EG001 | Placebo Non-Responders | Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. | 1 | 85 | 7 | 85 | 27 | 85 |
| EG002 | Mirikizumab | Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W | 0 | 630 | 65 | 630 | 300 | 630 |
| EG003 | Ustekinumab | Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W | 1 | 309 | 35 | 309 | 131 | 309 |
| EG004 | Mirikizumab (Adolescents) | Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W | 0 | 6 | 0 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anorectal disorder | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Enterocolonic fistula | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rectal stenosis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related hypersensitivity reaction | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Fournier's gangrene | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myoclonic epilepsy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 26.1 | Systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal fistula repair | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Ileectomy | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Epstein-barr virus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pustule | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Sars-cov-2 test positive | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
After enrolling 6 participants, sponsor elected to stop enrollment of adolescents in study AMAM and enroll pediatric participants in a separate, pediatric study. The 6 enrolled participants were allowed to continue treatment and finish the study.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Addendum | Oct 7, 2022 | Jul 15, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Main | Aug 23, 2023 | Jul 15, 2024 | SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Addendum | Oct 3, 2023 | Jul 15, 2024 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000708407 | mirikizumab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| Russia |
|
| Austria |
|
| Latvia |
|
| Netherlands |
|
| South Korea |
|
| China |
|
| Brazil |
|
| Poland |
|
| Slovakia |
|
| France |
|
| Lithuania |
|
| Serbia |
|
| Croatia |
|
| Argentina |
|
| Romania |
|
| Hungary |
|
| Japan |
|
| Ukraine |
|
| United Kingdom |
|
| Switzerland |
|
| India |
|
| Spain |
|
| Canada |
|
| Turkey |
|
| Belgium |
|
| Denmark |
|
| Italy |
|
| Mexico |
|
| Israel |
|
| Australia |
|
| Germany |
|
Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W.
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Ustekinumab |
Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
|
|
|
Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W.
|
|
|
|
|
|
|
| Participants |
|
|
|
| OG001 | Mirikizumab | Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W. |
|
|
|
| OG001 |
| Mirikizumab |
Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W. |
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W.
|
|
|
| OG001 | Mirikizumab | Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W. |
|
|
|