An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC OLE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03950232 |
Recruitment Status :
Recruiting
First Posted : May 15, 2019
Last Update Posted : April 22, 2022
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Drug: Etrasimod | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 912 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis |
Actual Study Start Date : | September 20, 2019 |
Estimated Primary Completion Date : | August 2027 |
Estimated Study Completion Date : | August 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: Etrasimod 2 mg |
Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant's country, whichever comes first
Other Name: APD334 |
- Number and Severity of Safety Measures [ Time Frame: Up to approximately 5 years ]Safety as assessed by the evaluation of adverse events
- Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 and Week 104 ]
- Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry [ Time Frame: Week 52 and Week 104 ]
- Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 and Week 104 ]
- Change From Baseline in the Total Mayo Score [ Time Frame: Baseline, Week 52, and Week 104 ]The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 components (endoscopic score, rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.
- Change From Baseline in Partial Mayo Score [ Time Frame: Baseline, Week 52, Week 104, Week 156, and Week 260 ]The partial Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 non-invasive components (rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.
- Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 and Week 104 ]
- Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores [ Time Frame: Week 52 and Week 104 ]
- Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores [ Time Frame: Week 52 and Week 104 ]
- Time to Loss of Response Assessed by Mayo Component Sub-scores [ Time Frame: Up to Week 260 ]
- Proportion of Participants Achieving Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline [ Time Frame: Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies and meet the following additional criteria:
- Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
- Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit
Exclusion Criteria:
- If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
- Experienced an adverse event that led to discontinuation from parent study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950232
Contact: Arena CT.gov Administrator | +1 855-218-9153 | ct.gov@arenapharm.com |


United States, Alabama | |
Digestive Health Specialists of the Southeast | Recruiting |
Dothan, Alabama, United States, 36305 | |
United States, California | |
Downey Medical Center | Withdrawn |
Downey, California, United States, 90242 | |
Valley View Internal Medicine | Withdrawn |
Garden Grove, California, United States, 92845 | |
University of California San Diego Medical Center | Recruiting |
La Jolla, California, United States, 92037 | |
Om Research, LLC | Recruiting |
Lancaster, California, United States, 93534 | |
Entertainment Medical Group, Inc. | Recruiting |
Los Angeles, California, United States, 90036 | |
United Medical Doctors | Recruiting |
Murrieta, California, United States, 92563 | |
Odyssey Clinical Research, LLC | Withdrawn |
Orange, California, United States, 92866 | |
UCI Institute for Clinical Translational Services | Recruiting |
Orange, California, United States, 92868 | |
San Diego Gastroenterology Medical Associates | Withdrawn |
San Diego, California, United States, 92103 | |
Kaiser Permanente - San Diego | Withdrawn |
San Diego, California, United States, 92154 | |
United States, Colorado | |
Peak Gastroenterology Associates | Recruiting |
Colorado Springs, Colorado, United States, 80920 | |
United States, Connecticut | |
Naugatuck Valley Gastroenterology Consultants | Withdrawn |
Prospect, Connecticut, United States, 06712 | |
United States, Florida | |
Xera Med Research | Withdrawn |
Boca Raton, Florida, United States, 33487 | |
Gastro Florida | Recruiting |
Clearwater, Florida, United States, 33761 | |
Gastro Florida | Recruiting |
Clearwater, Florida, United States, 33762 | |
Florida Center for Gastroenterology | Recruiting |
Clearwater, Florida, United States, 33777 | |
UF Health Jacksonville Gastroenterology-Emerson | Withdrawn |
Jacksonville, Florida, United States, 32207 | |
Life Medical Center & Research, INC | Withdrawn |
Miami Lakes, Florida, United States, 33014 | |
Javier Sobrado, MD | Recruiting |
Miami, Florida, United States, 33156 | |
Vista Health Research, LLC | Withdrawn |
Miami, Florida, United States, 33176 | |
Gastroenterology Group of Naples | Recruiting |
Naples, Florida, United States, 34102 | |
Office of Dr Meckstroth | Recruiting |
Naples, Florida, United States, 34110 | |
NSB Research | Recruiting |
New Smyrna Beach, Florida, United States, 32168 | |
Sarkis Clinical Trials | Withdrawn |
Ocala, Florida, United States, 34474 | |
Pediatric & Adult Research Center | Withdrawn |
Orlando, Florida, United States, 32825 | |
IMIC, Inc. | Recruiting |
Palmetto Bay, Florida, United States, 33157 | |
Advanced Medical Research Center | Recruiting |
Port Orange, Florida, United States, 32127 | |
Advanced Research Institute, Inc. | Withdrawn |
Saint Petersburg, Florida, United States, 33710 | |
Lenus Research & Medical Group, LLC | Withdrawn |
Sweetwater, Florida, United States, 33172 | |
USF Deparment of Surgery | Recruiting |
Tampa, Florida, United States, 33606 | |
GCP Clinical Research | Recruiting |
Tampa, Florida, United States, 33609 | |
Guardian Angel Research Center | Recruiting |
Tampa, Florida, United States, 33614 | |
ASCLEPES Research Centers, P.C. | Withdrawn |
Weeki Wachee, Florida, United States, 34607 | |
Florida Medical Clinic, P.A. | Recruiting |
Zephyrhills, Florida, United States, 33542 | |
United States, Georgia | |
Atlanta Gastroenterology Associates LLC | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Atlanta Gastroenterology Associates | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Children's Center for Digestive Health Care, LLC | Withdrawn |
Atlanta, Georgia, United States, 30342 | |
Atlanta Center for Gastroenterology, P.C. | Recruiting |
Decatur, Georgia, United States, 30033 | |
United States, Idaho | |
Treasure Valley Medical Research | Withdrawn |
Boise, Idaho, United States, 83706 | |
United States, Illinois | |
Illinois Gastroenterology Group | Recruiting |
Gurnee, Illinois, United States, 60031 | |
Endoscopy Center of the North Shore - Gen1 Research | Withdrawn |
Wilmette, Illinois, United States, 60091 | |
United States, Iowa | |
The Iowa Clinic | Withdrawn |
West Des Moines, Iowa, United States, 50266 | |
United States, Louisiana | |
Texas Digestive Disease Consultants | Recruiting |
Baton Rouge, Louisiana, United States, 70809 | |
CroNOLA | Withdrawn |
Houma, Louisiana, United States, 70360 | |
Clinical Trials of SW Louisiana, LLC | Withdrawn |
Lake Charles, Louisiana, United States, 70601 | |
Clinical Trials Management, LLC | Withdrawn |
Metairie, Louisiana, United States, 70006 | |
United States, Maryland | |
Chevy Chase Clinical Research | Recruiting |
Chevy Chase, Maryland, United States, 20815 | |
United States, Massachusetts | |
NECCR Primacare Research, LLC | Withdrawn |
Fall River, Massachusetts, United States, 02721 | |
United States, Michigan | |
Flint Clinical Research | Withdrawn |
Flint, Michigan, United States, 48503 | |
Robert Ferguson, MD PC | Withdrawn |
West Bloomfield, Michigan, United States, 48323 | |
United States, Mississippi | |
NDORI - Gen1 Research | Withdrawn |
Biloxi, Mississippi, United States, 39532 | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, Nevada | |
Jubilee Clinical Research, Inc. | Withdrawn |
Las Vegas, Nevada, United States, 89106 | |
Sierra Clinical Research | Withdrawn |
Las Vegas, Nevada, United States, 89106 | |
Las Vegas Medical Research | Recruiting |
Las Vegas, Nevada, United States, 89113 | |
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | Recruiting |
Lebanon, New Hampshire, United States, 03756 | |
United States, New York | |
Oleg Katcher, MD - Gen1 Research | Withdrawn |
Brooklyn, New York, United States, 11229 | |
Lake Success Gastroenterology, a Division of Pro Healthcare | Withdrawn |
Lake Success, New York, United States, 11042 | |
DiGiovanna Institute for Medical Education & Research | Withdrawn |
North Massapequa, New York, United States, 11758 | |
Premier Medical Group of the Hudson Valley, PC | Withdrawn |
Poughkeepsie, New York, United States, 12601 | |
United States, North Carolina | |
Duke University Medical Center GI Clinical Research Unit | Recruiting |
Durham, North Carolina, United States, 27710 | |
Clinical Research of Gastonia | Withdrawn |
Gastonia, North Carolina, United States, 28054 | |
United States, Ohio | |
Great Lakes Medical Research, LLC - Beachwood | Withdrawn |
Beachwood, Ohio, United States, 44122 | |
UC Health Physicians Office | Recruiting |
Cincinnati, Ohio, United States, 45267 | |
Great Lakes Medical Research, LLC - Mentor | Recruiting |
Mentor, Ohio, United States, 44060 | |
Care Access Research | Recruiting |
Poland, Ohio, United States, 44514 | |
Great Lakes Medical Research, LLC - Warren | Withdrawn |
Warren, Ohio, United States, 44483 | |
United States, Oklahoma | |
Digestive Disease Specialists, Inc. | Recruiting |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Pennsylvania | |
St. Luke's University Health Network | Withdrawn |
Bethlehem, Pennsylvania, United States, 18015 | |
Great Lakes Medical Research, LLC - Harrisburg | Recruiting |
Harrisburg, Pennsylvania, United States, 17110 | |
Care Access Research LLC | Withdrawn |
Pottsville, Pennsylvania, United States, 17901 | |
United States, South Carolina | |
Clinical Research of Rock Hill | Withdrawn |
Rock Hill, South Carolina, United States, 29732 | |
United States, Tennessee | |
GI for Kids | Recruiting |
Knoxville, Tennessee, United States, 37916 | |
United States, Texas | |
Texas Clinical Research Institute, LLC | Recruiting |
Arlington, Texas, United States, 76012 | |
Coastal Medical Group | Terminated |
Baytown, Texas, United States, 77521 | |
Texas Gastroenterology Associates, PA | Withdrawn |
Cypress, Texas, United States, 77429 | |
Texas Digestive Disease Consultants - Dallas | Recruiting |
Dallas, Texas, United States, 76092 | |
DHAT Research Institute | Withdrawn |
Garland, Texas, United States, 75044 | |
Spring Gastroenterology | Withdrawn |
Houston, Texas, United States, 77002 | |
CliniCore International | Terminated |
Houston, Texas, United States, 77029 | |
Baylor Gastroenterology Assoc | Recruiting |
Houston, Texas, United States, 77030 | |
Biopharma Informatic, Inc. Research Center | Withdrawn |
Houston, Texas, United States, 77043 | |
Houston Gastroenterology Associates | Withdrawn |
Katy, Texas, United States, 77450 | |
Rio Grande Gastroenterology | Recruiting |
McAllen, Texas, United States, 78503 | |
Digestive System Health Care | Withdrawn |
Pasadena, Texas, United States, 77505 | |
Texas Digestive Disease Consultants - San Marcos | Recruiting |
San Marcos, Texas, United States, 78130 | |
Tyler Research Institute, LLC | Recruiting |
Tyler, Texas, United States, 75701 | |
Victoria Gastroenterology | Recruiting |
Victoria, Texas, United States, 77904 | |
United States, Utah | |
Care Access Research LLC | Recruiting |
Ogden, Utah, United States, 84403 | |
United States, Virginia | |
Gastroenterology Associates of Tidewater | Withdrawn |
Chesapeake, Virginia, United States, 23320 | |
Blue Ridge Medical Research | Recruiting |
Lynchburg, Virginia, United States, 24502 | |
United States, Washington | |
Washington Gastroenterology | Recruiting |
Bellevue, Washington, United States, 98004 | |
Virginia Mason | Withdrawn |
Seattle, Washington, United States, 98101 | |
United States, West Virginia | |
Marshall University Department of Clinical Research | Withdrawn |
Huntington, West Virginia, United States, 25701 | |
United States, Wisconsin | |
Medical College of Wisconsin Clinical Trials Office | Recruiting |
Milwaukee, Wisconsin, United States, 53226-0509 | |
Argentina | |
Centro de Investigacion CICE 9 de Julio | Recruiting |
San Miguel de Tucuman, Tucuman, Argentina, 4000 | |
Australia, New South Wales | |
Bankstown-Lidcombe Hospital | Withdrawn |
Bankstown, New South Wales, Australia, 2200 | |
Liverpool Hospital | Recruiting |
Liverpool, New South Wales, Australia, 2170 | |
Australia, Queensland | |
Coastal Digestive Health | Recruiting |
Maroochydore, Queensland, Australia, 4558 | |
Coral Sea Clinical Research Institute | Recruiting |
North Mackay, Queensland, Australia, 4740 | |
Australia, Victoria | |
Austin Health | Recruiting |
Heidelberg, Victoria, Australia, 3084 | |
Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Royal Melbourne Hospital | Recruiting |
Parkville, Victoria, Australia, 3050 | |
Austria | |
AKH - Medizinische Universität Wien | Recruiting |
Wien, Austria, 1090 | |
Belarus | |
Institution "Gomel Regional Clinical Hospital" | Recruiting |
Gomel, Belarus, 246029 | |
Grodno City Clinical Hospital #4 | Recruiting |
Grodno, Belarus, 230026 | |
Health Care Institution "10th City Clinical Hospital" | Recruiting |
Minsk, Belarus, 220096 | |
Vitebsk Regional Clinical Hospital | Recruiting |
Vitebsk, Belarus, 210037 | |
Vitebsk Regional Clinical Specialized Center | Recruiting |
Vitebsk, Belarus, 210604 | |
Belgium | |
University Hospital Antwerp Gastroenterology and Hepatology Department | Recruiting |
Edegem, Antwerp, Belgium, 2650 | |
Dr. Peter Bossuyt - GI Clinical Research Center | Recruiting |
Bonheiden, Belgium, 2820 | |
AZ Sint-Lucas & Volkskliniek | Recruiting |
Gent, Belgium, 9000 | |
UZ Gent- Gastroenterology | Recruiting |
Gent, Belgium, 9000 | |
UZ Leuven Campus Gasthuisberg | Recruiting |
Leuven, Belgium, 3000 | |
ZNA Jan Palfijn | Recruiting |
Merksem, Belgium, 2170 | |
AZ Delta | Recruiting |
Roeselare, Belgium | |
Bulgaria | |
Medical center Medconsult Pleven OOD | Withdrawn |
Pleven, Bulgaria, 5800 | |
UMHAT "Sv. Georgi", EAD | Withdrawn |
Plovdiv, Bulgaria, 4002 | |
UMHAT Kanev AD Ruse | Recruiting |
Ruse, Bulgaria, 7002 | |
Diagnostic-Consultative Center I - Sliven, EOOD | Recruiting |
Sliven, Bulgaria, 8800 | |
Acibadem City Clinic Tokuda Hospital Ead | Recruiting |
Sofia, Bulgaria, 1407 | |
DCC "Alexandrovska", EOOD | Recruiting |
Sofia, Bulgaria, 1431 | |
UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology | Recruiting |
Sofia, Bulgaria, 1431 | |
UMHAT 'Tsaritsa Yoanna - ISUL', EAD | Terminated |
Sofia, Bulgaria, 1527 | |
Diagnostic Consultation Center CONVEX EOOD | Recruiting |
Sofia, Bulgaria, 1606 | |
UMHATEM 'N.I. Pirogov', EAD | Recruiting |
Sofia, Bulgaria, 1606 | |
Acibadem City Clinic University Hospital EOOD | Terminated |
Sofia, Bulgaria, 1784 | |
MC "Nov Rehabilitatsionen Tsentar"EOOD | Recruiting |
Stara Zagora, Bulgaria, 6000 | |
MC Medica Plus | Recruiting |
Veliko Tarnovo, Bulgaria, 5000 | |
Canada, Alberta | |
Heritage Medical Research Clinic | Recruiting |
Calgary, Alberta, Canada, T2N 4Z6 | |
Canada, Ontario | |
Mount Sinai Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 1X5 | |
Chile | |
Enroll SpA | Withdrawn |
Santiago, Chile, 7500588 | |
Centro de Investigación del Maule SPA | Withdrawn |
Talca, Chile, 3465586 | |
Clinical Research Chile SpA | Recruiting |
Valdivia, Chile, 5090000 | |
Croatia | |
General Hospital "Dr.Tomislav Bardek" Koprivnica | Recruiting |
Koprivnica, Croatia, 48000 | |
General Hospital Zadar | Recruiting |
Zadar, Croatia, 23000 | |
University hospital centre Zagreb | Recruiting |
Zagreb, Croatia, 10000 | |
Czechia | |
Fakultni nemocnice u svate Anny v Brne | Recruiting |
Brno, Czechia, 656 91 | |
Hepato-Gastroenterologie HK, s.r.o., | Recruiting |
Hradec Kralove, Czechia, 500 12 | |
GASTRO JeKa, s.r.o. | Recruiting |
Klatovy, Czechia, 339 01 | |
PreventaMed s.r.o. | Recruiting |
Olomouc, Czechia, 779 00 | |
Fakultni nemocnice Ostrava | Recruiting |
Ostrava-Poruba, Czechia, 708 52 | |
Axon Clinical s.r.o. | Recruiting |
Praha, Czechia, 150 00 | |
ISCARE I.V.F. a.s. | Recruiting |
Praha, Czechia, 170 04 | |
Nemocnice Na Bulovce | Recruiting |
Praha, Czechia, 180 81 | |
Nemocnice Slany | Recruiting |
Slany, Czechia, 274 01 | |
Denmark | |
Aalborg University Hospital, department of medical gastroenterology | Recruiting |
Aalborg, Nordjylland, Denmark, 9000 | |
Herlev Hospital, Gastroenheden, 54Q2 | Recruiting |
Herlev, Denmark, 2730 | |
Estonia | |
Ou Innomedica | Recruiting |
Tallinn, Estonia, 10117 | |
West Tallinn Central Hospital | Recruiting |
Tallinn, Estonia, 10617 | |
North Estonia Medical Centre Foundation | Recruiting |
Tallinn, Estonia, 13419 | |
Tartu University Hospital | Recruiting |
Tartu, Estonia, 50406 | |
France | |
CHU Nice - Hôpital de l'Archet 2 | Recruiting |
Nice Cedex 3, Alpes Maritimes, France, 06202 | |
CHU de Toulouse - Hopital Rangueil | Recruiting |
Toulouse cedex 9, Haute Garonne, France, 31059 | |
CHU Nantes Hôtel-Dieu | Recruiting |
Nantes, Loire Atlantique, France, 44000 | |
CHU Amiens Picardie Sit Sud | Recruiting |
AMIENS cedex 1, Somme, France, 80054 | |
CHU Grenoble Alpes - Hôpital Michallon | Recruiting |
Grenoble, France, 38043 | |
CHU Montpellier - Hopital Saint Eloi | Recruiting |
Montpellier cedex 5, France, 34295 | |
Georgia | |
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine | Recruiting |
Tbilisi, Georgia, 0112 | |
LTD Israeli-Georgian Medical Research clinic Helsicore | Recruiting |
Tbilisi, Georgia, 0112 | |
LLC Vivamedi | Recruiting |
Tbilisi, Georgia, 0131 | |
LTD Institute of Clinical Cardiology | Recruiting |
Tbilisi, Georgia, 0159 | |
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center | Recruiting |
Tbilisi, Georgia, 0160 | |
LTD Aversi Clinic | Recruiting |
Tbilisi, Georgia, 0160 | |
LTD Central University Clinic After Academic N. Kipshidze | Recruiting |
Tbilisi, Georgia, 0160 | |
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center | Recruiting |
Tbilisi, Georgia, 0172 | |
Germany | |
Praxis Dr. Joergensen | Recruiting |
Remscheid, Nordrhein Westfalen, Germany, 42859 | |
Schwerpunktpraxis Bonn | Recruiting |
Bonn, Rheinland Pfalz, Germany, 53123 | |
Charité Universitätsmedizin Berlin - Campus Charité Mitte | Recruiting |
Berlin, Germany, 10117 | |
Krankenhaus Waldfriede e. V. | Recruiting |
Berlin, Germany, 14163 | |
Johanna Etienne Krankenhaus | Recruiting |
Neuss, Germany, 41462 | |
Klinische Forschung Schwerin GmbH | Recruiting |
Schwerin, Germany, 19055 | |
Hungary | |
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia | Recruiting |
Debrecen, Hajdu-Bihar, Hungary, 4032 | |
DRC Gyogyszervizsgalo Kozpont Kft. | Recruiting |
Balatonfured, Hungary, 8230 | |
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz | Recruiting |
Bekescsaba, Hungary, 5600 | |
Semmelweis Egyetem | Recruiting |
Budapest, Hungary, 1088 | |
Pannonia Maganorvosi Centrum | Recruiting |
Budapest, Hungary, 1136 | |
Bugat Pal Korhaz | Recruiting |
Gyongyos, Hungary, 3200 | |
Somogy Megyei Kaposi Mor Oktato Korhaz | Recruiting |
Kaposvar, Hungary, 7400 | |
Clinfan Szolgaltato Kft. | Recruiting |
Szekszard, Hungary, 7100 | |
Dept of Gastroenterology, Szent Gyorgy Hospital | Recruiting |
Székesfehérvár, Hungary, 8000 | |
Szent Borbala Korhaz | Recruiting |
Tatabanya, Hungary, 2800 | |
India | |
Nirmal Hospitals Pvt Ltd | Recruiting |
Surat, Gujarat, India, 395002 | |
Surat Institute of Digestive Sciences | Recruiting |
Surat, Gujarat, India, 395002 | |
Fortis Memorial Research Institute | Recruiting |
Gurgaon, Haryana, India, 122002 | |
Aster Medcity, Aster DM healthcare Ltd | Recruiting |
Kochi, Kerala, India, 682027 | |
Government Medical College and Super Speciality Hospital | Recruiting |
Nagpur, Maharashtra, India, 440009 | |
Midas Multispeciality Hospital Pvt.Ltd. | Recruiting |
Nagpur, Maharashtra, India, 440010 | |
Ruby Hall Clinic | Recruiting |
Pune, Maharashtra, India, 411001 | |
Shweta Paliwal/Vipin Kumar Jain | Recruiting |
Jaipur, Rajasthan, India, 302001 | |
Postgraduate department of Medicine, GSVM Medical college | Recruiting |
Kanpur, Uttar Pradesh, India, 208002 | |
Israel | |
HaEmek Medical Center | Recruiting |
Afula, Israel, 1834111 | |
Bnei Zion Medical Center | Recruiting |
Haifa, Israel, 3339419 | |
Wolfson Medical Center | Recruiting |
Holon, Israel, 5810001 | |
Shaare Zedek Medical Center | Recruiting |
Jerusalem, Israel, 9103102 | |
Hadassah University Hospital - Ein Kerem | Recruiting |
Jerusalem, Israel, 9112001 | |
Galilee Medical Center | Recruiting |
Nahariya, Israel, 2210001 | |
Rabin Medical Center-Beilinson Campus | Recruiting |
Petach Tikva, Israel, 4941492 | |
Chaim Sheba Medical Center | Recruiting |
Ramat Gan, Israel, 5262000 | |
Kaplan Medical Center | Recruiting |
Rehovot, Israel, 7610001 | |
Italy | |
Azienda Ospedaliera Saverio De Bellis | Recruiting |
Castellana Grotte, Bari, Italy, 70013 | |
Ospedale di Circolo | Recruiting |
Rho, Milano, Italy, 20017 | |
I.R.C.C.S Policlinico San Donato | Recruiting |
San Donato Milanese, Milano, Italy, 20097 | |
Azienda Ospedaliera Universitaria Careggi | Recruiting |
Firenze, Toscana, Italy, 50134 | |
Ospedale Sacro Cuore Don Calabria | Recruiting |
Negrar, Verona, Italy, 37024 | |
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Recruiting |
Brescia, Italy, 25123 | |
Azienda Ospedaliera Ospedale Cannizzaro | Recruiting |
Catania, Italy, 95126 | |
Azienda Ospedaliero Universitaria Mater Domini | Recruiting |
Catanzaro, Italy, 88100 | |
A.O.U. Policlinico di Modena | Recruiting |
Modena, Italy, 41124 | |
Ospedale Sandro Pertini | Recruiting |
Roma, Italy, 00157 | |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD | Recruiting |
Roma, Italy, 00168 | |
Ospedale San Bortolo di Vicenza | Recruiting |
Vicenza, Italy, 36100 | |
Japan | |
Nagoya City University Hospital | Recruiting |
Nagoya-shi, Aichi, Japan, 467-8602 | |
Koujunkai Daido Clinic | Recruiting |
Nagoya, Aichi, Japan, 457-8511 | |
Toyohashi Municipal Hospital | Recruiting |
Toyohashi-shi, Aichi, Japan, 441-8570 | |
Tsujinaka Hospital Kashiwanoha | Recruiting |
Kashiwa-city, Chiba, Japan, 277-0871 | |
Fukuoka University Hospital | Recruiting |
Fukuoka-shi, Fukuoka, Japan, 814-0180 | |
Fukuoka Tokushukai Hospital | Recruiting |
Kasuga, Fukuoka, Japan, 816-0864 | |
Gifu University Hospital | Recruiting |
Gifu-shi, Gifu, Japan, 501-1194 | |
SUBARU Health Insurance Society Ota Memorial Hospital | Recruiting |
Ota-shi, Gunma, Japan, 373-8585 | |
Hiroshima University Hospital | Recruiting |
Hiroshima-shi, Hiroshima, Japan, 734-8551 | |
Asahikawa City Hospital | Recruiting |
Asahikawa-shi, Hokkaido, Japan, 070-8610 | |
NHO Mito Medical Center | Recruiting |
Higashi, Ibaraki, Japan, 311-3193 | |
NHO Kanazawa Medical Center | Recruiting |
Kanazawa, Ishikawa, Japan, 920-8650 | |
Iwate Medical University Uchimaru Medical Center | Recruiting |
Morioka-shi, Iwate, Japan, 020-8505 | |
Takamatsu Red Cross Hospital | Recruiting |
Takamatsu-shi, Kagawa, Japan, 760-0017 | |
Kagawa Prefectural Central Hospital | Recruiting |
Takamatsu-shi, Kagawa, Japan, 760-8557 | |
Jiaikai Izuro Imamura Hospital | Recruiting |
Kagoshima-shi, Kagoshima, Japan, 892-0824 | |
Sameshima Hospital | Recruiting |
Kagoshima-shi, Kagoshima, Japan, 892-0846 | |
Japanese Red Cross Kumamoto Hospital | Recruiting |
Kumamoto-shi, Kumamoto, Japan, 862-8520 | |
NHO Kyoto Medical Center | Recruiting |
Kyoto-shi, Kyoto, Japan, 612-8555 | |
Mie University Hospital | Recruiting |
Tsu-shi, Mie-Ken, Japan, 514-8507 | |
Mie Prefectural General Medical Center | Recruiting |
Yokkaichi-shi, Mie-Ken, Japan, 510-8561 | |
JOHAS Tohoku Rosai Hospital | Recruiting |
Sendai-shi, Miyagi, Japan, 981-8563 | |
Sendai City Hospital | Recruiting |
Sendai-shi, Miyagi, Japan, 982-8502 | |
Japan Community Health care Organization Osaka Hospital | Recruiting |
Osaka-shi, Osaka, Japan, 553-0003 | |
Saga University Hospital | Recruiting |
Saga-shi, Saga-ken, Japan, 849-8501 | |
St. Luke's International Hospital | Recruiting |
Chuo-ku, Tokyo, Japan, 104-8560 | |
Showa General Hospital | Recruiting |
Kodaira-shi, Tokyo, Japan, 187-8510 | |
Kitasato University Kitasato Institute Hospital | Recruiting |
Minato-ku, Tokyo, Japan, 108-8642 | |
JCHO Tokyo Yamate Medical Center | Recruiting |
Shinjuku-ku, Tokyo, Japan, 169-0073 | |
Wakayama Medical University Hospital | Recruiting |
Wakayama-shi, Wakayama-ken, Japan, 641-8510 | |
Korea, Republic of | |
Kyungpook National University Hospital | Recruiting |
Junggu, Daegu, Korea, Republic of, 41944 | |
Wonju Severance Christian Hospital | Recruiting |
Wonju, Gangwon-do, Korea, Republic of, 26426 | |
The Catholic University of Korea St. Vincent's Hospital | Recruiting |
Suwon-si, Gyeonggi-do, Korea, Republic of, 16247 | |
Dong-A University Hospital | Recruiting |
Busan, Korea, Republic of, 49201 | |
Kyungpook National University Chilgok Hospital | Recruiting |
Daegu, Korea, Republic of, 41404 | |
Latvia | |
P. Stradins Clinical University Hospital | Terminated |
Riga, Latvia, LV-1002 | |
Lebanon | |
American University of Beirut Medical Center | Recruiting |
Beirut, Lebanon, 1107 2020 | |
Lithuania | |
Republican Panevezys Hospital, Department of Gastroenterology | Recruiting |
Panevezys, Lithuania, LT-35144 | |
UAB "Inlita", Santaros Clinical Trials Centre | Recruiting |
Vilnius, Lithuania, 08406 | |
Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology | Recruiting |
Vilnius, Lithuania, LT-08661 | |
Mexico | |
Consultorio Medico, InvesclinicMX | Recruiting |
Irapuato, Guanajuato, Mexico, 36650 | |
Centro de Investigacion Medico Biologica y Terapia Avanzada s.c. | Recruiting |
Guadalajara, Jalisco, Mexico, 44130 | |
InspirePharma S. de R. L. de C.V. | Recruiting |
Monterrey, Nuevo León, Mexico, 64660 | |
Scientia Investigación Clínica S.C. | Recruiting |
Chihuahua, Mexico, 31203 | |
Faicic S. de R.L. de Cv | Recruiting |
Veracruz, Mexico, 91900 | |
Moldova, Republic of | |
Clinical Hospital of the Ministry of Health, Labor and Social Protection | Recruiting |
Chisinau, Moldova, Republic of, 2005 | |
Rtl Sm Srl | Recruiting |
Chisinau, Moldova, Republic of, 2025 | |
Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology | Recruiting |
Chisinau, Moldova, Republic of, 2025 | |
Netherlands | |
Radboudumc | Recruiting |
Nijmegen, Netherlands, 6525 GA | |
Zuyderland Medisch Centrum - Sittard-Geleen | Recruiting |
Sittard-Geleen, Netherlands, 6162 BG | |
ETZ Elisabeth | Recruiting |
Tilburg, Netherlands, 5022 GC | |
Poland | |
Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz | Recruiting |
Bedzin, Poland, 42-500 | |
Gastromed Kralisz, Romatowski, Stachurska sp.j | Recruiting |
Bialystok, Poland, 15-322 | |
Centrum Medyczne Pratia Czestochowa | Recruiting |
Czestochowa, Poland, 42-200 | |
Karkonoskie Centrum Badan Klinicznych - Lexmedica | Recruiting |
Jelenia Gora, Poland, 58-500 | |
ETG Kielce Zagorska | Recruiting |
Kielce, Poland, 25-355 | |
Centrum Medyczne Plejady | Recruiting |
Kraków, Poland, 30-363 | |
Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna | Recruiting |
Kraków, Poland, 31-506 | |
AmiCare Sp. z O.O. Sp.K. | Recruiting |
Lodz, Poland, 90-644 | |
IP Clinic | Recruiting |
Lodz, Poland, 90-752 | |
Allmedica Badania Kliniczne Sp. z o.o. Sp.k. | Recruiting |
Nowy Targ, Poland, 34-400 | |
Medicenter Nowy Targ | Recruiting |
Nowy Targ, Poland, 34-400 | |
Medicome Sp.Zo.O. | Recruiting |
Oswiecim, Poland, 32-600 | |
Centrum Medyczne Grunwald | Recruiting |
Poznan, Poland, 60-369 | |
SOLUMED Centrum Medyczne | Recruiting |
Poznan, Poland, 60-529 | |
Korczowski Bartosz, Gabinet Lekarski | Recruiting |
Rzeszow, Poland, 35-302 | |
Centrum Medyczne Medyk | Recruiting |
Rzeszow, Poland, 35-326 | |
ENDOSKOPIA Sp.zo.o | Recruiting |
Sopot, Poland, 81-756 | |
DC-MED | Recruiting |
Swidnica, Poland, 58-100 | |
Twoja Przychodnia-Szczecinskie Centrum Medyczne | Recruiting |
Szczecin, Poland, 71-434 | |
Centrum Zdrowia MDM | Recruiting |
Warsaw, Poland, 00-635 | |
Centralny Szpital Kliniczny MSW w Warszawie | Recruiting |
Warsaw, Poland, 02-507 | |
EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia | Recruiting |
Wroclaw, Poland, 144-148 | |
Centrum Medyczne Oporow | Recruiting |
Wroclaw, Poland, 52-416 | |
LexMedica Osrodek Badan Klinicznych | Recruiting |
Wroclaw, Poland, 53-114 | |
Portugal | |
Centro Hospitalar e Universitário de Coimbra E.P.E | Recruiting |
Coimbra, Portugal, 3000-075 | |
Hospital da Senhora da Oliveira Guimarães | Recruiting |
Guimarães, Portugal, 4835-044 | |
Centro Hospitalar de São João, EPE | Recruiting |
Porto, Portugal, 4200-319 | |
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E | Recruiting |
Vila Nova de Gaia, Portugal, 4434-502 | |
Romania | |
S.C MedLife S.A | Recruiting |
Bucuresti, Romania, 010719 | |
S.C Euroclinic Hospital S.A | Recruiting |
Bucuresti, Romania, 014461 | |
Spitalul Clinic Colentina | Recruiting |
Bucuresti, Romania, 020125 | |
Institutul Clinic Fundeni | Recruiting |
Bucuresti, Romania, 022328 | |
Hifu Terramed Conformal SRL | Recruiting |
Bucuresti, Romania, 031864 | |
Spitalul Clinic Judetean de Urgenta Cluj Napoca | Recruiting |
Cluj-Napoca, Romania, 400006 | |
Spitalul Clinic Judetean de Urgenta | Recruiting |
Craiova, Romania, 200640 | |
S.C Pelican Impex S.R.L | Recruiting |
Oradea, Romania, 410469 | |
Russian Federation | |
Clinic of Plastic and Laser Surgery "Anturium" LLC | Recruiting |
Barnaul, Russian Federation, 656043 | |
LLC "Alyans Biomedical- Ural Group" | Recruiting |
Izhevsk, Russian Federation, 664049 | |
Kazan State Medical University | Recruiting |
Kazan, Russian Federation, 420012 | |
SAIH "Kemerovo Regional Clinical Hospital | Recruiting |
Kemerovo, Russian Federation, 650066 | |
SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko" | Recruiting |
Nizhniy Novgorod, Russian Federation, 603126 | |
LLC "Medicine Center SibNovoMed | Recruiting |
Novosibirsk, Russian Federation, 630005 | |
CDC Ultramed | Recruiting |
Omsk, Russian Federation, 644024 | |
State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko" | Recruiting |
Penza, Russian Federation, 440026 | |
Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University" | Recruiting |
Saint Petersburg, Russian Federation, 195067 | |
LLC SM-Clinic | Recruiting |
Saint Petersburg, Russian Federation, 195279 | |
FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov | Recruiting |
Saint Petersburg, Russian Federation, 197022 | |
LLC "Gastroenterological centre Expert", | Recruiting |
Saint Petersburg, Russian Federation, 197110 | |
Irkutsk State Medical Academy of Continuing Education | Recruiting |
Samara, Russian Federation, 443011 | |
Private Educational Institution of Higher Education "Medical University "REAVIZ" | Recruiting |
Samara, Russian Federation, 443011 | |
LLC Medical Company "Hepatologist" | Recruiting |
Samara, Russian Federation, 443093 | |
SPb SBIH "City Hospital # 40 of Kurortnyi region" | Recruiting |
Sestroretsk, Russian Federation, 197706 | |
LLC "Uromed" | Recruiting |
Smolensk, Russian Federation, 214031 | |
Stavropol Regional Clinical Diagnostic Centre | Recruiting |
Stavropol, Russian Federation, 355017 | |
LLC "Polyclinic of ultrasonography 4D", | Recruiting |
Stavropol, Russian Federation, 357000 | |
City Clinical Hospital #8 | Recruiting |
Yaroslavl, Russian Federation, 150030 | |
Serbia | |
Clinical Center " Dr Dragisa Misovic Dedinje" | Recruiting |
Belgrade, Serbia, 11000 | |
Clinical Center of Serbia | Recruiting |
Belgrade, Serbia, 11000 | |
Clinical Health Centre Zvezdara | Recruiting |
Belgrade, Serbia, 11000 | |
Clinical Center Kragujevac | Recruiting |
Kragujevac, Serbia, 34000 | |
General Hospital Sremska Mitrovica | Recruiting |
Sremska Mitrovica, Serbia, 22000 | |
Slovakia | |
ENDOMED, s.r.o. | Recruiting |
Vranov nad Toplou, Presov, Slovakia, 093 01 | |
Fakultna nemocnica s poliklinikou F.D. Roosevelta | Recruiting |
Banska Bystrica, Slovakia, 975 17 | |
Alian S.R.O. | Recruiting |
Bardejov, Slovakia, 085 01 | |
KM Management spol. s r.o. | Recruiting |
Nitra, Slovakia, 949 01 | |
Fakultna nemocnica Nitra | Recruiting |
Nitra, Slovakia, 950 01 | |
GASTROENTEROLOG, s.r.o. | Recruiting |
Nove Zamky, Slovakia, 940 01 | |
Gastromedic, s.r.o. | Withdrawn |
Nove Zamky, Slovakia, 940 02 | |
Gastro I, s.r.o. | Recruiting |
Presov, Slovakia, 080 01 | |
Accout Center s.r.o. | Recruiting |
Sahy, Slovakia, 936 01 | |
BeneDig s.r.o. | Withdrawn |
Zilina, Slovakia, 010 08 | |
South Africa | |
Johese Clinical Research: Unitas | Recruiting |
Lyttelton, Centurion, South Africa, 0157 | |
Johese Clinical Research | Recruiting |
Midstream, Centurion, South Africa, 1692 | |
Lenasia Clinical Trial Centre | Recruiting |
Johannesburg, Gauteng, South Africa, 1827 | |
Dr JP Wright Practice | Recruiting |
Cape Town, Western Cape, South Africa, 7708 | |
Spain | |
Hospital General Universitario de Alicante | Recruiting |
Alicante, Spain, 03010 | |
Hospital Universitario La Paz | Recruiting |
Madrid, Spain, 28046 | |
Thailand | |
Siriraj Hospital | Recruiting |
Bangkok noi, Bangkok, Thailand, 10700 | |
King Chulalongkorn Memorial Hospital | Recruiting |
Pathum wan, Bangkok, Thailand, 10330 | |
Phramongkutklao Hospital | Recruiting |
Ratchathewi, Bangkok, Thailand, 10400 | |
Piyapath Boonsamrej | Recruiting |
Watthana, Bangkok, Thailand, 10110 | |
Maharaj Nakorn Chiang Mai Hospital | Withdrawn |
Chiang Mai, Thailand, 50200 | |
Turkey | |
Uludag University Medical Faculty | Recruiting |
Besevler, Yenimahalle/ANKARA, Turkey, 16059 | |
Hacettepe University Medical Faculty | Recruiting |
Ankara, Turkey, 06100 | |
Gazi University Medical Faculty | Recruiting |
Ankara, Turkey, 06500 | |
Antalya Training and Research Hospital | Recruiting |
Antalya, Turkey, 07030 | |
Kocaeli University Research and Training Hospital | Recruiting |
Kocaeli, Turkey, 41380 | |
Karadeniz Tecnical Uni. Med. Fac. | Recruiting |
Trabzon, Turkey, 61100 | |
Ukraine | |
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital | Recruiting |
Dnipro, Ukraine, 49005 | |
Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University | Recruiting |
Ivano-Frankivsk, Ukraine, 76018 | |
Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council | Recruiting |
Ivano-Frankivsk, Ukraine, 76018 | |
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC | Recruiting |
Kharkiv, Ukraine, 61037 | |
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Recruiting |
Kharkiv, Ukraine, 61058 | |
Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council | Recruiting |
Kharkiv, Ukraine, 61124 | |
Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City | Recruiting |
Kherson, Ukraine, 73000 | |
Kremenchuk first city hospital n.a. O.T. Bohaievskyi | Recruiting |
Kremenchuk, Ukraine, 39617 | |
National Military Medical Clinical Center Main Military Clinical Hospital | Withdrawn |
Kyiv, Ukraine, 01133 | |
Kyiv City Clinical Hospital N 1 | Recruiting |
Kyiv, Ukraine, 02091 | |
Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care | Recruiting |
Lviv, Ukraine, 79059 | |
Odesa regional clinical hospital, regional center of gastroenterology, surgical department | Recruiting |
Odesa, Ukraine, 65025 | |
A. Novak Transcarpathian Regional Clinical Hospital | Recruiting |
Uzhgorod, Ukraine, 88000 | |
Medical Clinical Investigational Center Medical Center LLC Health Clinic | Recruiting |
Vinnytsia, Ukraine, 21009 | |
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU | Recruiting |
Vinnytsia, Ukraine, 21018 | |
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU | Recruiting |
Vinnytsia, Ukraine, 21029 | |
CI City Clinical Hospital #6 Dept of Gastroenterology | Recruiting |
Zaporizhzhia, Ukraine, 69035 | |
United Kingdom | |
Barts Health NHS Trust - Whipps Cross University Hospital | Recruiting |
London, Greater London, United Kingdom, E11 1NR | |
Guy's and St Thomas NHS Foundation Trust | Recruiting |
London, Greater London, United Kingdom, SE1 9RT | |
Norfolk and Norwich University Hospital | Recruiting |
Norwich, Norfolk, United Kingdom, NR4 7UQ | |
Yeovil District Hospital | Recruiting |
Yeovil, Somerset, United Kingdom, BA21 4AT | |
Queen's Hospital | Withdrawn |
Burton, United Kingdom, DE13 0RB |
Study Director: | Arena CT.gov Administrator | Arena Pharmaceuticals |
Responsible Party: | Arena Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03950232 |
Other Study ID Numbers: |
APD334-303 |
First Posted: | May 15, 2019 Key Record Dates |
Last Update Posted: | April 22, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Ulcerative Colitis Etrasimod APD334 |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |