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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003986-33 | EudraCT Number |
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The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etrasimod 2 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod | Drug | Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission | Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Endoscopic Improvement | Endoscopic improvement was defined as an ES <= 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease. | Week 12 |
| Percentage of Participants Achieving Symptomatic Remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arena CT.gov Administrator | Arena Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | United States | ||
| East View Medical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42248437 | Derived | Danese S, Goetsch M, Peyrin-Biroulet L, Yarur AJ, Dubinsky M, Rubin DT, Feagan BG, D'Haens G, Baert F, Lazin K, Gu G, Yu J, Lawendy N, Zang C, Wang W, Menon S, Law EH, Modesto I, Wosik K, Sidhu S, Niezychowski W, Vermeire S. The Efficacy and Safety of Etrasimod in Mildly to Moderately Active Ulcerative Colitis: Results From the Phase II GLADIATOR Trial. Clin Gastroenterol Hepatol. 2026 Jun 4:S1542-3565(26)00405-2. doi: 10.1016/j.cgh.2026.05.024. Online ahead of print. | |
| 41655066 |
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During the screening period, participants were evaluated for study entry based on the inclusion and exclusion criteria. Screening procedures to evaluate participant eligibility for the study were to be conducted within 28 days prior to study intervention administration on Day 1.
The study included a screening period (up to 28 days), a double-blind induction treatment period (12 weeks), and a 2-week and a 4-week follow-up period. The target population consisted of male or female participants aged between 16 and 80 years (inclusive), with moderately to severely active ulcerative colitis (UC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Etrasimod 2 mg | Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks. |
| FG001 | Placebo | Participants were administered one tablet of placebo orally QD for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2021 | Nov 3, 2022 |
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| Placebo | Drug | Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period |
|
Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease. |
| Week 12 |
| Percentage of Participants With Mucosal Healing | Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. | Week 12 |
| Percentage of Participants Achieving Clinical Response | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a >= 2-point and >= 30 percent (%) decrease from Baseline MMS, and a >= 1-point decrease from Baseline in RB sub-score or an absolute RB sub-score <= 1. Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | Week 12 |
| Percentage of Participants Achieving Endoscopic Normalization | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease); higher score indicated more severe disease. | Week 12 |
| Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8 | Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease. | Weeks 2, 4 and 8 |
| Percentage of Participants Achieving Complete Symptomatic Remission | Complete symptomatic remission was defined as an SF sub-score = 0 and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease. | Weeks 2, 4, 8 and 12 |
| Percentage of Participants Achieving Non-invasive Clinical Response | Non-invasive clinical response was defined as a >= 30% decrease from Baseline in composite RB and SF sub-scores, and a >= 1 point decrease from Baseline in RB sub-score or RB sub-score <= 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. | Weeks 2, 4, 8 and 12 |
| Percentage of Participants Achieving Symptomatic Response | Symptomatic response was defined as a >= 30% decrease from Baseline in composite RB and SF score. The SF sub-score ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. | Weeks 2, 4, 8 and 12 |
| Mobile |
| Alabama |
| 36606 |
| United States |
| Arizona Digestive Health | Sun City | Arizona | 85351 | United States |
| Om Research, LLC | Lancaster | California | 93534 | United States |
| Entertainment Medical Group, Inc. | Los Angeles | California | 90036 | United States |
| United Medical Doctors | Murrieta | California | 92563 | United States |
| ACRC Studies,LLC | San Diego | California | 92119 | United States |
| Paradigm Clinical Research Institute | Torrance | California | 90505 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80920 | United States |
| Gastro Florida | Clearwater | Florida | 33761 | United States |
| Gastro Florida | Clearwater | Florida | 33762 | United States |
| Florida Center for Gastroenterology | Largo | Florida | 33777 | United States |
| Global Life Research Network, LLC | Miami | Florida | 33155 | United States |
| Life Medical Center & Research, Inc | Miami Lakes | Florida | 33014 | United States |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | United States |
| NSB Research | New Smyrna Beach | Florida | 32168 | United States |
| Pediatric & Adult Research Center | Orlando | Florida | 32825 | United States |
| IMIC, Inc. | Palmetto Bay | Florida | 33157 | United States |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | United States |
| Theia Clinical Research, LLC | St. Petersburg | Florida | 33709 | United States |
| Lenus Research & Medical Group, LLC | Sweetwater | Florida | 33172 | United States |
| USF Department of Surgery | Tampa | Florida | 33606 | United States |
| GCP Clinical Research | Tampa | Florida | 33609 | United States |
| Guardian Angel Research Center | Tampa | Florida | 33614 | United States |
| Florida Medical Clinic, P.A. | Zephyrhills | Florida | 33542 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | United States |
| Children's Center for Digestive Health Care, LLC | Atlanta | Georgia | 30342 | United States |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Illinois Gastroenterology Group | Gurnee | Illinois | 60031 | United States |
| Texas Digestive Disease Consultants | Baton Rouge | Louisiana | 70809 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Gastro Center of Maryland | Columbia | Maryland | 21045 | United States |
| West Michigan Clinical Research Center | Wyoming | Michigan | 49519 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | United States |
| Las Vegas Medical Research | Las Vegas | Nevada | 89113 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Great Lakes Medical Research, LLC - Mentor | Mentor | Ohio | 44060 | United States |
| Care Access Research | Poland | Ohio | 44514 | United States |
| Great Lakes Medical Research, LLC - Harrisburg | Harrisburg | Pennsylvania | 17110 | United States |
| Tri-Cities Gastroenterology | Kingsport | Tennessee | 37663 | United States |
| GI for Kids | Knoxville | Tennessee | 37916 | United States |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | United States |
| The University of Texas at Austin Dell Medical School | Austin | Texas | 78712 | United States |
| Texas Gastroenterology Associates, PA | Cypress | Texas | 77429 | United States |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 76092 | United States |
| DHAT Research Institute | Garland | Texas | 75044 | United States |
| Baylor Gastroenterology Assoc | Houston | Texas | 77030 | United States |
| Rio Grande Gastroenterology | McAllen | Texas | 78503 | United States |
| Texas Digestive Disease Consultants - San Marcos | San Marcos | Texas | 78130 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| Victoria Gastroenterology | Victoria | Texas | 77904 | United States |
| Care Access Research LLC | Ogden | Utah | 84403 | United States |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | United States |
| Washington Gastroenterology | Bellevue | Washington | 98004 | United States |
| Virginia Mason | Seattle | Washington | 98101 | United States |
| Marshall University Department of Clinical Research | Huntington | West Virginia | 25701 | United States |
| Medical College of Wisconsin Clinical Trials Office | Milwaukee | Wisconsin | 53226-0509 | United States |
| Clinica Adventista Belgrano | CABA | Buenos Aires | C1430EGF | Argentina |
| Mautalen Salud e Investigacion | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1128AAF | Argentina |
| Fundación Respirar- Centro Médico Dra. De Salvo | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1426ABP | Argentina |
| Instituto de Investigaciones Clínicas Quilmes SRL | Quilmes | Buenos Aires | B1878GEG | Argentina |
| CICE Sanatorio 9 de Julio | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Bankstown-Lidcombe Hospital | Bankstown | New South Wales | 2200 | Australia |
| Nepean Hospital | Kingswood | New South Wales | 2747 | Australia |
| Coastal Digestive Health | Maroochydore | Queensland | 4558 | Australia |
| Coral Sea Clinical Research Institute | North Mackay | Queensland | 4740 | Australia |
| Footscray Hospital | Footscray | Victoria | 3011 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Liverpool Hospital | Liverpool | 2170 | Australia |
| Alfred Hospital | Melbourne | 3004 | Australia |
| Lkh Univ. Klinikum Graz | Graz | 8036 | Austria |
| KH der Barmherzigen Brüder Linz, Interne Abteilung | Linz | 4020 | Austria |
| AKH - Medizinische Universität Wien | Vienna | 1090 | Austria |
| Grodno City Clinical Hospital #4 | Grodno | 230026 | Belarus |
| Institution "Gomel Regional Clinical Hospital" | Homyel | 246029 | Belarus |
| Vitebsk Regional Clinical Hospital | Vitebsk | 210037 | Belarus |
| Vitebsk Regional Clinical Specialized Center | Vitebsk | 210604 | Belarus |
| University Hospital Antwerp Gastroenterology and Hepatology Department | Edegem | Antwerp | 2650 | Belgium |
| Dr. Peter Bossuyt - GI Clinical Research Center | Bonheiden | 2820 | Belgium |
| AZ Sint-Lucas & Volkskliniek | Ghent | 9000 | Belgium |
| UZ Gent - Gastroenterology | Ghent | 9000 | Belgium |
| UZ Leuven Campus Gasthuisberg | Leuven | 3000 | Belgium |
| AZ Sint-Maarten | Mechelen | 2800 | Belgium |
| ZNA Jan Palfijn | Merksem | 2170 | Belgium |
| AZ Delta | Roeselare | 8800 | Belgium |
| UMHAT "Sv. Georgi", EAD | Plovdiv | 4002 | Bulgaria |
| UMHAT Kanev AD, Ruse | Rousse | 7002 | Bulgaria |
| Diagnostic-Consultative Center I - Sliven, EOOD | Sliven | 8800 | Bulgaria |
| ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center | Sofia | 1407 | Bulgaria |
| DCC "Alexandrovska", EOOD | Sofia | 1431 | Bulgaria |
| UMHAT "Tsaritsa Yoanna-ISUL" EAD | Sofia | 1527 | Bulgaria |
| UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center | Sofia | 1606 | Bulgaria |
| Diagnostic Consultation Center CONVEX EOOD | Sofia | 1680 | Bulgaria |
| Acibadem City Clinic University Hospital EOOD | Sofia | 1784 | Bulgaria |
| Medical center "Nov Rehabilitatsionen Tsentar" EOOD | Stara Zagora | 6000 | Bulgaria |
| Medical Centre MEDICA Plus OOD | Veliko Tarnovo | 5000 | Bulgaria |
| Heritage Medical Research Clinic | Calgary | Alberta | T2N 4Z6 | Canada |
| LHSC - University Hospital | London | Ontario | N6A 5A5 | Canada |
| Enroll SpA | Santiago | 7500588 | Chile |
| Biomedica Research Group | Santiago | 7500710 | Chile |
| Hospital Sotero del Rio | Santiago | 8150000 | Chile |
| Centro de Investigación del Maule SPA | Talca | 3465586 | Chile |
| Clinical Research Chile SpA | Valdivia | 5090000 | Chile |
| Clínica de la Costa Ltda. | Barranquilla | Atlántico | 080020 | Colombia |
| Clinica de la Mujer Centro de Investigaciones | Bogota | Cundinamarca | 110221 | Colombia |
| Hospital San Juan de Dios Fundacion Cardiomet-Cequin | Armenia | Quindío Department | 630004 | Colombia |
| Clinica farallones centro de investigaciones clinicas CIC | Cali | Valle del Cauca Department | 760044 | Colombia |
| General Hospital "Dr. Tomislav Bardek" Koprivnica | Koprivnica | 48000 | Croatia |
| Clinical Hospital Centre Osijek | Osijek | 31000 | Croatia |
| General Hospital Zadar | Zadar | 23000 | Croatia |
| Clinical Hospital Sveti Duh | Zagreb | 10000 | Croatia |
| University hospital centre Zagreb | Zagreb | 10000 | Croatia |
| Fakultni nemocnice u svate Anny v Brne | Brno | 656 91 | Czechia |
| Hepato Gastroenterologie HK s.r.o. | Hradec Králové | 500 12 | Czechia |
| GASTRO JeKa s.r.o. | Klatovy | 339 01 | Czechia |
| PreventaMed s.r.o. | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| Axon Clinical s. r. o. | Prague | 150 00 | Czechia |
| ISCARE I.V.F. a.s. | Prague | 170 04 | Czechia |
| Nemocnice Na Bulovce | Prague | 180 81 | Czechia |
| Oblastni nemocnice Pribram a.s. | Příbram | 261 01 | Czechia |
| Nemocnice Slany | Slaný | 274 01 | Czechia |
| Aalborg University Hospital, department of medical gastroenterology | Aalborg | North Denmark | 9000 | Denmark |
| Herlev Hospital, Gastroenheden, 54Q2 | Herlev | 2730 | Denmark |
| Innomedica OÜ | Tallinn | 10117 | Estonia |
| West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| North Estonia Medical Centre Foundation | Tallinn | 13419 | Estonia |
| Tartu University Hospital | Tartu | 50406 | Estonia |
| CHU Nice - Hôpital de l'Archet 2 | Nice | Alpes Maritimes | 06202 | France |
| CHU Dijon - Hôpital Bocage Central | Dijon | Côte-d'Or | 21079 | France |
| Hôpital Rangueil Service Gastro-entérologie et pancreatologie | Toulouse | Haute Garonne | 31059 | France |
| CHU Montpellier - Hopital Saint Eloi | Montpellier | Herault | 34295 | France |
| Chu Pontchaillou Rennes | Rennes | Ille Et Vilaine | 35033 | France |
| CHU Nantes Hôtel-Dieu | Nantes | Loire Atlantique | 44000 | France |
| CHRU-Nancy Brabois | Vandœuvre-lès-Nancy | Meurthe Et Moselle | 54511 | France |
| CHU Lille - Hôpital Claude Huriez | Lille | Nord | 59037 | France |
| CHU Clermont Ferrand - Hôpital d'Estaing | Clermont-Ferrand | Puy De Dome | 63003 | France |
| Unite de Recherche Clinique-Urc | Montfermeil | Seine Saint Denis | 93370 | France |
| Chu Amiens Picardie-Sit Sud | Amiens | Somme | 80054 | France |
| Groupement Hospitalier Sud - Hôpital Bicêtre | Le Kremlin-Bicêtre | Val De Marne | 94275 | France |
| CHU Grenoble Alpes - Hôpital Michallon | Grenoble | 38043 | France |
| LTD Acad. F. Todua Medical Centre, LTD. Research Institution of Clinical Medicine | Tbilisi | 0112 | Georgia |
| LTD Israeli-Georgian medical research clinic Helsicore | Tbilisi | 0112 | Georgia |
| LLC Vivamedi | Tbilisi | 0131 | Georgia |
| LTD Institute of Clinical Cardiology | Tbilisi | 0159 | Georgia |
| JSC Infectious Diseases, AIDS and Clinical Immunology Research Center | Tbilisi | 0160 | Georgia |
| LTD Aversi Clinic | Tbilisi | 0160 | Georgia |
| LTD Central University Clinic After Academic N. Kipshidze | Tbilisi | 0160 | Georgia |
| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center | Tbilisi | 0172 | Georgia |
| Praxis Dr. Joergensen | Remscheid | North Rhine-Westphalia | 42859 | Germany |
| Schwerpunktpraxis Bonn | Bonn | Rhineland-Palatinate | 53123 | Germany |
| Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charité Universitätsmedizin Berlin - Campus Charité Mitte | Berlin | 10117 | Germany |
| Krankenhaus Waldfriede | Berlin | 14163 | Germany |
| Florence-Nightingale-Krankenhaus | Düsseldorf | 40489 | Germany |
| Johanna Etienne Krankenhaus | Neuss | 41462 | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | 19055 | Germany |
| DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | 8230 | Hungary |
| Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia | Békéscsaba | 5600 | Hungary |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | 1036 | Hungary |
| Endoexpert Egeszsegugyi Szolgaltato Kft | Budapest | 1054 | Hungary |
| Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika | Budapest | 1088 | Hungary |
| Pannonia Maganorvosi Centrum | Budapest | 1136 | Hungary |
| Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia | Debrecen | 4032 | Hungary |
| Bugat Pal Korhaz | Gyöngyös | 3200 | Hungary |
| SZTE AOK I.st dept. of Internal Medicine. | Szeged | 6720 | Hungary |
| Clinfan Ltd. Outpatient Clinic | Szekszárd | 7100 | Hungary |
| Dept of Gastroenterology, Szent Gyorgy Hospital | Székesfehérvár | 8000 | Hungary |
| Szent Borbala Korhaz | Tatabánya | 2800 | Hungary |
| Nirmal Hospitals Pvt Ltd | Surat | Gujarat | 395002 | India |
| Surat Institute of Digestive Sciences | Surat | Gujarat | 395002 | India |
| Fortis Memorial Research Institute | Gurgaon | Haryana | 122002 | India |
| All India Institute of Medical Sciences | Kochi | Kerala | 682027 | India |
| Aster Medcity,Aster DM healthcare Ltd | Kochi | Kerala | 682027 | India |
| Government Medical College and Super Speciality Hospital | Nagpur | Maharashtra | 440009 | India |
| Midas Multispeciality Hospital Pvt.Ltd. | Nagpur | Maharashtra | 440010 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Shweta Paliwal/Vipin Kumar Jain | Jaipur | Rajasthan | 302001 | India |
| Postgraduate department of Medicine, GSVM Medical college | Kanpur | Uttar Pradesh | 208002 | India |
| HaEmek Medical Center | Afula | 1834111 | Israel |
| Bnei Zion Medical Center | Haifa | 3339419 | Israel |
| Wolfson Medical Center | Holon | 5810001 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Galilee Medical Center | Nahariya | 2210001 | Israel |
| Rabin Medical Center-Beilinson Campus | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5262000 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Azienda Ospedaliera Saverio De Bellis | Castellana Grotte | Bari | 70013 | Italy |
| Ospedale di Circolo | Rho | Milano | 20017 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| I.R.C.C.S Policlinico San Donato | San Donato Milanese | Milano | 20097 | Italy |
| Ospedale Sacro Cuore Don Calabria | Negrar | Verona | 37024 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Brescia | 25123 | Italy |
| Azienda Ospedaliera Ospedale Cannizzaro | Catania | 95126 | Italy |
| Azienda Ospedaliero Universitaria Mater Domini | Catanzaro | 88100 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| A.O.U. Policlinico di Modena | Modena | 41124 | Italy |
| Ospedale Sandro Pertini | Roma | 00157 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD | Roma | 00168 | Italy |
| A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I | Torino | 10128 | Italy |
| Centro Ricerche Cliniche di Verona | Verona | 37134 | Italy |
| Ospedale San Bortolo di Vicenza | Vicenza | 36100 | Italy |
| Koujunkai Daido Clinic | Nagoya | Aichi-ken | 457-8511 | Japan |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| Toyohashi Municipal Hospital | Toyohashi | Aichi-ken | 441-8570 | Japan |
| NHO Hirosaki National Hospital | Hirosaki-shi | Aomori | 036-8545 | Japan |
| Hirosaki University Hospital | Hirosaki-shi | Aomori | 036-8563 | Japan |
| Tsujinaka Hospital Kashiwanoha | Kashiwa | Chiba | 277-0871 | Japan |
| Saiseikai Matsuyama Hospital | Matsuyama | Ehime | 791-8026 | Japan |
| Ehime University Hospital | Toon-shi | Ehime | 791-0295 | Japan |
| Fukuoka Tokushukai Hospital | Kasuga | Fukuoka | 816-0864 | Japan |
| JCHO Kyushu Hospital | Kitakyushu-shi | Fukuoka | 806-8501 | Japan |
| Kurume University Hospital | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Fukushima Medical University Hospital | Fukushima | Fukushima | 960-1247 | Japan |
| Gifu University Hospital | Gifu | Gifu | 501-1194 | Japan |
| Ogaki Municipal Hospital | Ogaki-shi | Gifu | 503-8502 | Japan |
| SUBARU Health Insurance Society Ota Memorial Hospital | Ota-shi | Gunma | 373-8585 | Japan |
| NHO Fukuyama Medical Center | Fukuyama-shi | Hiroshima | 720-8520 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | Hiroshima | 730-8518 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Asahikawa City Hospital | Asahikawa-shi | Hokkaido | 070-8610 | Japan |
| Tokushukai Sapporo Tokushukai Hospital | Sapporo | Hokkaido | 004-0041 | Japan |
| Sapporo-Kosei General Hospital | Sapporo | Hokkaido | 060-0033 | Japan |
| NHO Mito Medical Center | Higashi | Ibaraki | 311-3193 | Japan |
| Yuai Memorial Hospital | Koga-shi | Ibaraki | 306-0232 | Japan |
| Tsuchiura Kyodo General Hospital | Tsuchiura-shi | Ibaraki | 300-0028 | Japan |
| NHO Kanazawa Medical Center | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Iwate Medical University Uchimaru Medical Center | Morioka | Iwate | 020-8505 | Japan |
| Takamatsu Red Cross Hospital | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Kagawa Prefectural Central Hospital | Takamatsu | Kagawa-ken | 760-8557 | Japan |
| Jiaikai Izuro Imamura Hospital | Kagoshima | Kagoshima-ken | 892-0824 | Japan |
| Sameshima Hospital | Kagoshima | Kagoshima-ken | 892-0846 | Japan |
| Gokeikai Ofuna Chuo Hospital | Kamakura-shi | Kanagawa | 247-0056 | Japan |
| Sagamihara Kyodo Hospital | Sagamihara-shi | Kanagawa | 252-5188 | Japan |
| NHO Yokohama Medical Center | Yokohama | Kanagawa | 245-8575 | Japan |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | Kumamoto | 861-8520 | Japan |
| NHO Kyoto Medical Center | Kyoto | Kyoto | 612-8555 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| Mie Prefectural General Medical Center | Yokkaichi | Mie-ken | 510-8561 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| JOHAS Tohoku Rosai Hospital | Sendai | Miyagi | 981-8563 | Japan |
| Sendai City Hospital | Sendai | Miyagi | 982-8502 | Japan |
| Nara Medical University Hospital | Kashihara | Nara | 634-8522 | Japan |
| Saiseikai Niigata Hospital | Niigata | Niigata | 950-1104 | Japan |
| Kansai Medical University Hospital | Hirakata-shi | Osaka | 573-1191 | Japan |
| Tokushukai Kishiwada Tokushukai Hospital | Kishiwada-shi | Osaka | 596-8522 | Japan |
| Osaka City University Hospital | Osaka | Osaka | 545-8586 | Japan |
| Japan Community Health care Organization Osaka Hospital | Osaka | Osaka | 553-0003 | Japan |
| Osaka Medical College Hospital | Takatsuki-shi | Osaka | 569-8686 | Japan |
| Saga University Hospital | Saga | Saga-ken | 849-8501 | Japan |
| JCHO Saitama Medical Center | Saitama-shi | Saitama | 330-0074 | Japan |
| Shiga University of Medical Science Hospital | Ōtsu | Shiga | 520-2192 | Japan |
| St. Luke's International Hospital | Chuo -ku | Tokyo | 104-8560 | Japan |
| Teikyo University Hospital | Itabashi-ku | Tokyo | 173-8606 | Japan |
| Showa General Hospital | Kodaira-shi | Tokyo | 187-0002 | Japan |
| Jikei University Hospital | Minato-ku | Tokyo | 105-8471 | Japan |
| Kitasato University Kitasato Institute Hospital | Minato-ku | Tokyo | 108-8642 | Japan |
| NTT Medical Center Tokyo | Shinagawa-ku | Tokyo | 141-8625 | Japan |
| JCHO Tokyo Yamate Medical Center | Shinjuku-ku | Tokyo | 169-0073 | Japan |
| Toyama Prefectural Central Hospital | Toyama | Toyama | 930-8550 | Japan |
| Wakayama Medical University Hospital | Wakayama | Wakayama | 641-8510 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Saint George Hospital University Medical Center | Beirut | 1100-2807 | Lebanon |
| American University of Beirut Medical Center | Beirut | 1107-2020 | Lebanon |
| Hotel Dieu de France Hospital | Beirut | 16-6830 | Lebanon |
| Republican Panevezys Hospital, Department of Gastroenterology | Panevezys | LT-35144 | Lithuania |
| UAB "Inlita", Santaros Clinical Trials Centre | Vilnius | LT-08406 | Lithuania |
| Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology | Vilnius | LT-08661 | Lithuania |
| Consultorio Medico, InvesclinicMX | Irapuato | Guanajuato | 36650 | Mexico |
| Centro de Investigacion Medico Biologica y Terapia Avanzada s.c. | Guadalajara | Jalisco | 44130 | Mexico |
| InspirePharma S. de R. L. de C.V. | Monterrey | Nuevo León | 64660 | Mexico |
| Scientia Investigación Clínica S.C. | Chihuahua City | 31203 | Mexico |
| Hospital Angeles Chihuahua | Chihuahua City | 31238 | Mexico |
| Faicic S. de R.L. de Cv | Veracruz | 91900 | Mexico |
| Republican Clinical Hospital, ARENSIA Exploratory Medicine | Chisinau | MD-2025 | Moldova |
| Rtl Sm Srl | Chisinau | MD-2025 | Moldova |
| Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology | Chisinau | MD-2025 | Moldova |
| RTL SM SRL, Institutia Medico- Sanitara Publica Spitalul Clinic, Sectia Proctologie | Chisinau | MD-2068 | Moldova |
| Zuyderland Medisch Centrum - Sittard-Geleen | Geleen | 6162 BG | Netherlands |
| Radboudumc | Nijmegen | 6525 GA | Netherlands |
| ETZ Elisabeth | Tilburg | 5022 GC | Netherlands |
| Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz | Będzin | 42-500 | Poland |
| Gastromed Kralisz, Romatowski, Stachurska sp.j | Bialystok | 15-322 | Poland |
| Centrum Medyczne Pratia Czestochowa | Częstochowa | 42-200 | Poland |
| Karkonoskie Centrum Badan Klinicznych Lexmedica | Jelenia Góra | 58-500 | Poland |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna | Krakow | 31-506 | Poland |
| AmiCare Sp. z O.O. Sp.K. | Lodz | 90-644 | Poland |
| IP Clinic | Lodz | 90-752 | Poland |
| Allmedica Badania Kliniczne Sp. z o.o. Sp.k. | Nowy Targ | 34-400 | Poland |
| Medicome Sp. Zo.O. | Oświęcim | 32-600 | Poland |
| Centrum Medyczne Grunwald | Poznan | 60-369 | Poland |
| SOLUMED Centrum Medyczne | Poznan | 60-529 | Poland |
| Korczowski Bartosz, Gabinet Lekarski | Rzeszów | 35-302 | Poland |
| Centrum Medyczne Medyk | Rzeszów | 35-326 | Poland |
| ENDOSKOPIA Sp.zo.o | Sopot | 81-756 | Poland |
| DC-MED | Swidnica | 58-100 | Poland |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| Centrum Zdrowia MDM | Warsaw | 00-635 | Poland |
| Centralny Szpital Kliniczny MSW w Warszawie | Warsaw | 02-507 | Poland |
| EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji | Wroclaw | 144-148 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 52-416 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia | Coimbra | 3000-075 | Portugal |
| Hospital da Senhora da Oliveira Guimarães | Guimarães | 4835-044 | Portugal |
| Hospital da Luz Lisboa | Lisbon | 1500-650 | Portugal |
| Centro Hospitalar de São João, EPE | Porto | 4200-319 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E | Vila Nova de Gaia | 4434-502 | Portugal |
| S.C MedLife SA | Bucharest | 10719 | Romania |
| S.C Delta Health Care S.R.L, Ponderas Academic Hospital | Bucharest | 14142 | Romania |
| S.C Euroclinic Hospital S.A | Bucharest | 14461 | Romania |
| Spitalul Clinic Colentina | Bucharest | 20125 | Romania |
| Institutul Clinic Fundeni | Bucharest | 22328 | Romania |
| S.C Policlinica CCBR S.R.L | Bucharest | 30463 | Romania |
| S.C. Centrul Medical Unirea SRL | Bucharest | 540136 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj Napoca | Cluj-Napoca | 400006 | Romania |
| Spitalul Clinic Judetean de Urgenta Craiova | Craiova | 200640 | Romania |
| S.C Pelican Impex S.R.L | Oradea | 410469 | Romania |
| LLC "Multidisciplinary Medical Clinic "Anthurium" | Barnaul | 656043 | Russia |
| LLC "Alyans Biomedical- Ural Group" | Izhevsk | 664049 | Russia |
| Kazan State Medical University | Kazan' | 420012 | Russia |
| SAIH "Kemerovo Regional Clinical Hospital" | Kemerovo | 650066 | Russia |
| SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko" | Nizhny Novgorod | 603126 | Russia |
| LLC Medicine Center SibNovoMed | Novosibirsk | 630005 | Russia |
| CDC "Ultramed" | Omsk | 644024 | Russia |
| State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko" | Penza | 440026 | Russia |
| Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University" | Saint Petersburg | 195067 | Russia |
| FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov | Saint Petersburg | 197022 | Russia |
| LLC "Gastroenterological centre Expert" | Saint Petersburg | 197110 | Russia |
| LLC SM-Clinic | Saint-Peterburg | 195279 | Russia |
| Irkutsk State Medical Academy of Continuing Education | Samara | 443011 | Russia |
| Private Educational Institution of Higher Education "Medical University "REAVIZ" | Samara | 443011 | Russia |
| LLC Medical Company "Hepatologist" | Samara | 443093 | Russia |
| SPb SBIH "City Hospital # 40 of Kurortnyi region" | Sestroretsk | 197706 | Russia |
| LLC Uromed | Smolensk | 214031 | Russia |
| Stavropol Regional Clinical Diagnostic Centre | Stavropol | 355017 | Russia |
| LLC "Polyclinic of ultrasonography 4D" | Stavropol | 357000 | Russia |
| City Clinical Hospital #8 | Yaroslavl | 150030 | Russia |
| Clinical Center " Dr Dragisa Misovic Dedinje" | Belgrade | 11000 | Serbia |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Clinical Health Center Zvezdara | Belgrade | 11000 | Serbia |
| Clinical Center Bezanijska Kosa | Belgrade | 11080 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| General Hospital Sremska Mitrovica | Sremska Mitrovica | 22000 | Serbia |
| Endomed, S.R.O | Vranov nad Topľou | Presov | 093 01 | Slovakia |
| Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banská Bystrica | 975 17 | Slovakia |
| Alian S.R.O | Bardejov | 085 01 | Slovakia |
| KM Management spol. s r.o. | Nitra | 949 01 | Slovakia |
| Fakultna nemocnica Nitra | Nitra | 950 01 | Slovakia |
| Gastro I, s.r.o. | Prešov | 080 01 | Slovakia |
| Accout Center s.r.o. | Šahy | 936 01 | Slovakia |
| BeneDig s.r.o. | Žilina | 010 08 | Slovakia |
| Johese Clinical Research: Unitas | Lyttelton | Centurion | 0157 | South Africa |
| Johese Clinical Research | Midstream | Centurion | 1692 | South Africa |
| Lenasia Clinical Trial Centre | Lenasia | Gauteng | 1827 | South Africa |
| Dr JP Wright Practice | Cape Town | Western Cape | 7708 | South Africa |
| Kyungpook National University Hospital | Junggu | Daegu | 41944 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea |
| The Catholic University of Korea St. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Seodaemun-gu | 03722 | South Korea |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Centro Médico Teknon | Barcelona | 08022 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas | 35010 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Kantonsspital Baden | Baden | 5404 | Switzerland |
| Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum | Bern | 3010 | Switzerland |
| Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner | Bern | 3012 | Switzerland |
| Siriraj Hospital | Bangkoknoi | Bangkok | 10700 | Thailand |
| King Chulalongkorn Memorial Hospital | Pathum Wan | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital | Ratchathewi | Bangkok | 10400 | Thailand |
| Uludag University Medical Faculty | Beşevler | Yenimahalle/Ankara | 16059 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Gazi University Medical Faculty | Ankara | 06500 | Turkey (Türkiye) |
| Antalya Training and Research Hospital | Antalya | 07030 | Turkey (Türkiye) |
| Kocaeli University Research and Training Hospital | Kocaeli | 41380 | Turkey (Türkiye) |
| Karadeniz Tecnical Uni. Med. Fac. | Trabzon | 61100 | Turkey (Türkiye) |
| I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital | Dnipro | 49005 | Ukraine |
| Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University | Ivano-Frankivsk | 76018 | Ukraine |
| Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Ga | Ivano-Frankivsk | 76018 | Ukraine |
| CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC | Kharkiv | 61037 | Ukraine |
| Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | 61058 | Ukraine |
| Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council | Kharkiv | 61124 | Ukraine |
| Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City | Kherson | 73000 | Ukraine |
| Kremenchuk first city hospital n.a. O.T. Bohaievskyi | Kremenchuk | 39617 | Ukraine |
| Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU | Kyiv | 01030 | Ukraine |
| Kyiv City Clinical Hospital N 1 | Kyiv | 02091 | Ukraine |
| Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care | Lviv | 79059 | Ukraine |
| Odesa regional clinical hospital, regional center of gastroenterology, surgical department | Odesa | 65025 | Ukraine |
| A. Novak Transcarpathian Regional Clinical Hospital | Uzhhorod | 88000 | Ukraine |
| Medical Clinical Investigational Center of Medical Center Health Clinic LLC | Vinnytsia | 21009 | Ukraine |
| M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU | Vinnytsia | 21018 | Ukraine |
| SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU | Vinnytsia | 21029 | Ukraine |
| Whipps Cross University Hospital | London | Greater London | E11 1NR | United Kingdom |
| Guy's and Saint Thomas NHS Foundation Trust | London | Greater London | SE1 9RT | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | Norfolk | NR4 7UQ | United Kingdom |
| Yeovil District Hospital | Yeovil | Somerset | BA21 4AT | United Kingdom |
| Derived |
| Dubinsky MC, Chaparro M, Irving PM, Hur P, Sidhu S, Woolcott JC, Wang W, Goetsch M, Torres J, Panaccione R. Rapid symptomatic improvement with etrasimod in ulcerative colitis: a post-hoc analysis of the ELEVATE UC program. Inflamm Bowel Dis. 2026 Jun 1;32(6):1075-1085. doi: 10.1093/ibd/izaf333. |
| 40889900 | Derived | Chaparro M, Panaccione R, Sands BE, Irving PM, Goetsch M, Kunina E, Wang W, Wu J, Woolcott JC, Bartolome L, Cognata C, Wosik K, Dubinsky MC. Etrasimod for the symptomatic relief of ulcerative colitis: a post-hoc analysis from the ELEVATE UC clinical programme. BMJ Open Gastroenterol. 2025 Aug 31;12(1):e001838. doi: 10.1136/bmjgast-2025-001838. |
| 40618942 | Derived | Yarur AJ, Reinisch W, Chang S, Gecse KB, Green J, Abbatemarco AM, Wu J, Goetsch M, Lazin K, Pradeep G, Sands BE. Efficacy of Etrasimod in Ulcerative Colitis: Analysis of ELEVATE UC 52 and ELEVATE UC 12 by Baseline Endoscopic Severity. Clin Gastroenterol Hepatol. 2026 Jan;24(1):210-220.e3. doi: 10.1016/j.cgh.2025.06.020. Epub 2025 Jul 4. |
| 40184206 | Derived | Lichtenstein GR, Allegretti JR, Loftus EV Jr, Irving PM, Banerjee R, Charabaty A, Kuehbacher T, Bananis E, Woolcott JC, Dalam AB, Lazin K, Keating M, McDonnell A, Danese S. Assessment and Impact of Age on the Safety and Efficacy of Etrasimod in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From the ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Sep 1;31(9):2352-2362. doi: 10.1093/ibd/izae308. |
| 40036804 | Derived | Sands BE, Dubinsky MC, Kotze PG, Vermeire S, Panaccione R, Long MD, Woolcott JC, Wu J, McDonnell A, Goetsch M, Bananis E, Yarur AJ. Efficacy and Safety of Etrasimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Baseline Modified Mayo Score: A Post Hoc Analysis From the Phase 3 ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Oct 1;31(10):2681-2692. doi: 10.1093/ibd/izaf036. |
| 39891572 | Derived | Afzali A, Regueiro M, Yarur AJ, Zabana Y, Ng SC, Menon S, McDonnell A, Lazin K, Keating M, Bhattacharjee A, Branquinho D, Bananis E, Peyrin-Biroulet L. Concomitant Use of Etrasimod With Opioids or Antidepressants in Patients With Ulcerative Colitis-A Safety Analysis. United European Gastroenterol J. 2025 Jun;13(5):719-727. doi: 10.1002/ueg2.12745. Epub 2025 Feb 1. |
| 39878434 | Derived | Yarur AJ, Long MD, Torres J, Nandi N, Cross RK, Abbatemarco AM, Blanco D, Niezychowski W, Crosby C, Wu J, Pradeep G, Goetsch M, Panaccione R. Body Mass Index Did Not Affect Efficacy and Safety of Etrasimod: A Post Hoc Analysis of the ELEVATE Ulcerative Colitis Clinical Program. Am J Gastroenterol. 2025 Nov 1;120(11):2611-2622. doi: 10.14309/ajg.0000000000003330. Epub 2025 Jan 29. |
| 39778975 | Derived | Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516. |
| 39671695 | Derived | Yarur AJ, Chiorean MV, Allegretti JR, Cross RK, Ha C, Goetsch M, McDonnell A, Dalam AB, Wu J, Blanco DA, Abbatemarco AM, Panes J. Etrasimod as a Monotherapy or With Concomitant Use of Corticosteroids and/or Aminosalicylates: Results From the ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Aug 1;31(8):2144-2153. doi: 10.1093/ibd/izae288. |
| 39526078 | Derived | Lees CW, Torres J, Leung Y, Vermeire S, Fellmann M, Modesto I, McDonnell A, Lazin K, Keating M, Goetsch M, Wu J, Loftus EV Jr. Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials. Ther Adv Gastroenterol. 2024 Nov 7;17:17562848241293643. doi: 10.1177/17562848241293643. eCollection 2024. |
| 39326009 | Derived | Armuzzi A, Rubin DT, Schreiber S, Panes J, Fellmann M, Bartolome L, Gruben D, Goetsch M, Bhattacharjee A, Chaparro M, Dubinsky MC. Health-Related Quality of Life Outcomes With Etrasimod Treatment in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From ELEVATE UC 52 and ELEVATE UC 12. Inflamm Bowel Dis. 2025 Jun 13;31(6):1583-1594. doi: 10.1093/ibd/izae229. |
| 39306680 | Derived | Sands BE, Leung Y, Rubin DT, Gecse KB, Panes J, Goetsch M, Wang W, Woolcott JC, Smith CC, Wosik K, Schreiber S. Etrasimod Corticosteroid-Free Efficacy, Impact of Concomitant Corticosteroids on Efficacy and Safety, and Corticosteroid-Sparing Effect in Ulcerative Colitis: Analyses of the ELEVATE UC Clinical Program. J Crohns Colitis. 2025 Mar 5;19(3):jjae150. doi: 10.1093/ecco-jcc/jjae150. |
| 39089519 | Derived | Magro F, Peyrin-Biroulet L, Sands BE, Danese S, Jairath V, Goetsch M, Bhattacharjee A, Wu J, Branquinho D, Modesto I, Feagan BG. Endoscopic, Histologic, and Composite Endpoints in Patients With Ulcerative Colitis Treated With Etrasimod. Clin Gastroenterol Hepatol. 2025 Feb;23(2):341-350.e6. doi: 10.1016/j.cgh.2024.07.010. Epub 2024 Jul 31. |
| 38877972 | Derived | Vermeire S, Sands BE, Peyrin-Biroulet L, D'Haens GR, Panes J, Yarur AJ, Wolf DC, Ritter T, Schreiber S, Woolcott JC, Modesto I, Keating M, Shan K, Wu J, Chiorean MV, Baert F, Dubinsky MC, Goetsch M, Danese S, Feagan BG. Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials. J Crohns Colitis. 2024 Nov 4;18(11):1780-1794. doi: 10.1093/ecco-jcc/jjae079. |
| 38700040 | Derived | Regueiro M, Siegmund B, Yarur AJ, Steinwurz F, Gecse KB, Goetsch M, Bhattacharjee A, Wu J, Green J, McDonnell A, Crosby C, Lazin K, Branquinho D, Modesto I, Abreu MT. Etrasimod for the Treatment of Ulcerative Colitis: Analysis of Infection Events from the ELEVATE UC Clinical Programme. J Crohns Colitis. 2024 Oct 15;18(10):1596-1605. doi: 10.1093/ecco-jcc/jjae060. |
| 38613425 | Derived | Peyrin-Biroulet L, Dubinsky MC, Sands BE, Panes J, Schreiber S, Reinisch W, Feagan BG, Danese S, Yarur AJ, D'Haens GR, Goetsch M, Wosik K, Keating M, Lazin K, Wu J, Modesto I, McDonnell A, Bartolome L, Vermeire S. Efficacy and Safety of Etrasimod in Patients with Moderately to Severely Active Isolated Proctitis: Results From the Phase 3 ELEVATE UC Clinical Programme. J Crohns Colitis. 2024 Aug 14;18(8):1270-1282. doi: 10.1093/ecco-jcc/jjae038. |
| 36871574 | Derived | Sandborn WJ, Vermeire S, Peyrin-Biroulet L, Dubinsky MC, Panes J, Yarur A, Ritter T, Baert F, Schreiber S, Sloan S, Cataldi F, Shan K, Rabbat CJ, Chiorean M, Wolf DC, Sands BE, D'Haens G, Danese S, Goetsch M, Feagan BG. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet. 2023 Apr 8;401(10383):1159-1171. doi: 10.1016/S0140-6736(23)00061-2. Epub 2023 Mar 2. |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set: All randomized participants who received at least 1 dose of study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etrasimod 2 mg | Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks. |
| BG001 | Placebo | Participants were administered one tablet of placebo orally QD for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Clinical Remission | Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | Full Analysis Set Population (All randomized participants who received at least 1 dose of study intervention), with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving Endoscopic Improvement | Endoscopic improvement was defined as an ES <= 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease. | Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving Symptomatic Remission | Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease. | Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants With Mucosal Healing | Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. | Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Clinical Response | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a >= 2-point and >= 30 percent (%) decrease from Baseline MMS, and a >= 1-point decrease from Baseline in RB sub-score or an absolute RB sub-score <= 1. Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Endoscopic Normalization | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease); higher score indicated more severe disease. | Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8 | Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease. | Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Weeks 2, 4 and 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Complete Symptomatic Remission | Complete symptomatic remission was defined as an SF sub-score = 0 and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease. | Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Weeks 2, 4, 8 and 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Non-invasive Clinical Response | Non-invasive clinical response was defined as a >= 30% decrease from Baseline in composite RB and SF sub-scores, and a >= 1 point decrease from Baseline in RB sub-score or RB sub-score <= 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. | Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Weeks 2, 4, 8 and 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Symptomatic Response | Symptomatic response was defined as a >= 30% decrease from Baseline in composite RB and SF score. The SF sub-score ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. | Full Analysis Set Population with actual Baseline MMS 5 to 9. Only those participants with data available at the specified time points were analyzed. | Posted | Number | Percentage of participants | Weeks 2, 4, 8 and 12 |
|
|
All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention.
Safety set population included all randomized participants who received at least 1 dose of study intervention.
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 | Etrasimod 2 mg | Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks. | 0 | 238 | 6 | 238 | 112 | 238 |
| EG001 | Placebo | Participants were administered one tablet of placebo orally QD for 12 weeks. | 0 | 116 | 2 | 116 | 54 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatobiliary procedural complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anal eczema | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrointestinal hypermotility | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperaesthesia teeth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lip blister | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Genitourinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Enterocolitis bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| FEV1/FVC ratio decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lung diffusion test decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Drug withdrawal headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Underweight | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eyelid margin crusting | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Meibomian gland dysfunction | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pigment dispersion syndrome | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Metamorphopsia | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Visual snow syndrome | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chorioretinopathy | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Exudative retinopathy | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nail bed bleeding | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arena CT.gov Administrator | Arena Pharmaceuticals, Inc. | +1 855-218-9153 | ct.gov@arenapharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2022 | Nov 3, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656249 | etrasimod |
Not provided
Not provided
Not provided
| 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 |
|
|
|
|
|
| Participants |
|
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|
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