An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC OLE)

An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

Study Overview

• Status: Active, not recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Etrasimod

• Study Type: Interventional
• Enrollment (Actual): 896
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • Buderim, Australia, 4556
    • Queensland Medical Laboratory (QML) pathology, QML Buderim Laboratory - Healius Pathology Pty Ltd
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
  • Queensland
    • Bowen Hills, Queensland, Australia, 4006
      • Sullivan Nicolaides Pathology
    • Buderim, Queensland, Australia, 4556
      • Buderim Eye Centre( OCT and Ophthalmoscopy Facility)
    • Mackay, Queensland, Australia, 4740
      • Dr Shiran DeSilva Respiratory Clinic
    • Mackay, Queensland, Australia, 4740
      • Queensland X-Ray
    • Mackay, Queensland, Australia, 4740
      • Coral Sea Clinical Research Institute Pty.Ltd
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
• Austria
  • Vienna, Austria, 1090
    • Department of Internal Medicine III, Clinical Division of Gastroenterology and Hepatology
• Belarus
  • Homyel, Belarus, 246027
    • Institution "Gomel Regional Specialized Clinical Hospital"
  • Vitebsk, Belarus, 210009
    • Educational Establishment "Vitebsk State Medical University"
• Belgium
  • Roeselare, Belgium, 8800
    • AZ Delta
  • Roeselare, Belgium, 8800
    • AZ Delta campus Brugsesteenweg
• Bulgaria
  • Sofia, Bulgaria, 1680
    • Diagnostic Consultation Center CONVEX EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski" EAD'
  • Sofia, Bulgaria, 1606
    • "University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov"EAD
  • Veliko Tarnovo, Bulgaria, 5000
    • Medical Centre MEDICA Plus OOD
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u svate Anny v Brne
  • Hradec Králové, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o.
  • Klatovy, Czechia, 339 01
    • GASTRO JeKa, s.r.o.
  • Ostrava-Poruba, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Prague, Czechia, 150 00
    • Axon Clinical, s.r.o.
  • Slaný, Czechia, 274 01
    • Nemocnice Slany
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
  • Tallinn, Estonia, 10120
    • OCT: Eye Clinic Dr. Krista Turman
  • Harju
    • Tallinn, Harju, Estonia, 10117
      • Innomedica OÜ
• France
  • Amiens, France, 80054
    • CHU Amiens Picardie
  • Amiens, France, 80054
    • Pulmonary examination: CHU Amiens-Picardie
  • Amiens, France, 80054
    • Tomography: CHU Amiens-Picardie
  • Grenoble, France, 38043
    • CHU Grenoble Alpes -Hopital Michallon
  • Grenoble, France, 38043
    • Tomography: CHU Grenoble Alpes - Hopital Michallon
  • Nice, France, 06202
    • CHU de Nice - Hopital de l'Archet 2
  • Toulouse, France, 31059
    • Tomography: CHU RANGUEIL
• Georgia
  • Tbilisi, Georgia, 0131
    • LLC Vivamedi
  • Tbilisi, Georgia, 0160
    • LTD Aversi Clinic
  • Tbilisi, Georgia, 0159
    • LTD Institute of Clinical Cardiology
  • Tbilisi, Georgia, 0112
    • Llc Todua Clinic
  • Tbilisi, Georgia, 0159
    • Medical Center CITO LTD
  • Tbilisi, Georgia, 0160
    • LTD Academician Nikoloz Kipshidze Central University Clinic
  • Tbilisi, Georgia, 0160
    • Aversi Clinic, LTD
  • Tbilisi, Georgia, 0119
    • Llc Todua Clinic
• Germany
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede e.V.,
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Charite Mitte Medizinische Klinik m. S. Hepatologie
  • Berlin, Germany, 14163
    • Dr. med Zacharias A. R.Sherif
  • Bonn-Duisdorf, Germany, 53123
    • Schwerpunktpraxis Bonn
  • Neuss, Germany, 41462
    • OCT address: AOZNeuss Dr. Kersten
  • Remscheid, Germany, 42859
    • Praxis Dr. Jorgensen
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem
  • Gyöngyös, Hungary, 3200
    • Gyongyosi Bugat Pal Korhaz
  • Szekszárd, Hungary, 7100
    • Tolna Varmegyei Balassa Janos Korhaz
  • Bekes County
    • Gyula, Bekes County, Hungary, 5700
      • Ophthalmology tests:Bekes Megyei Kozponti Korhaz, Pady Kalman Tagkorhaz, Szemeszeti Osztaly
  • Fejér
    • Székesfehérvár, Fejér, Hungary, 8000
      • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• India
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Sids Hospital & Research Centre
  • Maharashtra
    • Nagpur, Maharashtra, India, 440010
      • Midas Multispeciality Hospital Pvt. Ltd
  • Rajasthan
    • Jaipur, Rajasthan, India, 302001
      • S.R.Kalla Memorial Gastro & General Hospital
• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262000
    • The Chaim Sheba Medical Center
• Italy
  • Catania, Italy, 95100
    • Azienda Ospedalieria Ospedale Cannizzaro
  • Catanzaro, Italy, 88100
    • Azienda Ospedaliero Universitaria Mater Domini
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele UO di Gastroenterologia e Endoscopia Digestiva
  • Roma, Italy, 00157
    • U.O.C. Gastroenterologia ed Endoscopia Digestiva
  • BARI
    • Castellana Grotte, BARI, Italy, 70013
      • I.R.C.C.S "Saverio De Bellis", Gastroenterologia II
  • Reggio Emilia
    • Modena, Reggio Emilia, Italy, 41124
      • A.O.U. Policlinico di Modena
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • Azienda Ospedaliero Universitaria Careggi, U.O. Gastroenterologia 2 (St.19)
  • VR
    • Negrar(vr), VR, Italy, 37024
      • Ospedale Sacro Cuore Don Calabria
• Japan
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Saga, Japan, 849-8501
    • Saga University Hospital
  • Aichi-ken
    • Toyohashi, Aichi-ken, Japan, 441-8570
      • Toyohashi Municipal Hospital
  • Chiba
    • Nagareyama-shi, Chiba, Japan, 270-0116
      • Ishii Eye Clinic
    • Sakura, Chiba, Japan, 285-8741
      • Toho University Sakura Medical Center
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital
    • Kasuga, Fukuoka, Japan, 816-0864
      • Fukuoka Tokushukai Hospital
    • Kurume, Fukuoka, Japan, 830-8543
      • Our Lady of the Snow St. Mary's Hospital
  • Gifu
    • Gifu, Gifu, Japan, 501-1194
      • Gifu University Hospital
  • Gunma
    • Ota-shi, Gunma, Japan, 373-8585
      • SUBARU Health Insurance Society Ota Memorial Hospital
  • Hiroshima
    • Fukuyama-shi, Hiroshima, Japan, 720-0822
      • Nakayama EYE Clinic
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 004-0041
      • Tokushukai Sapporo Tokushukai Hospital
  • Ibaraki
    • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
      • NHO Mito Medical Center
  • Iwate
    • Morioka, Iwate, Japan, 020-8505
      • Iwate Medical University Uchimaru Medical Center
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 892-0846
      • Sameshima Hospital
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-5188
      • Sagamihara Kyodo Hospital
    • Yokohama, Kanagawa, Japan, 234-0054
      • Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
  • Kyoto
    • Kyoto, Kyoto, Japan, 612-8555
      • National Hospital Organization Kyoto Medical Center
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Mie University Hospital
    • Yokkaichi-shi, Mie-ken, Japan, 510-8561
      • Mie Prefectural General Medical Center
  • Miyagi
    • Sendai, Miyagi, Japan, 982-8502
      • Sendai City Hospital
  • Niigata
    • Nagaoka-shi, Niigata, Japan, 940-2085
      • Nagaoka Red Cross Hospital
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital
    • Osaka, Osaka, Japan, 553-0003
      • Japan Community Health care Organization Osaka Hospital
  • Tokyo
    • Kodaira-shi, Tokyo, Japan, 187-8510
      • Showa General Hospital
  • Wakayama
    • Wakayama, Wakayama, Japan, 641-8510
      • Wakayama Medical University Hospital
• Latvia
  • Riga, Latvia, LV-1002
    • P. Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Therapy Center
• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center
• Mexico
  • Chihuahua City, Mexico, 31203
    • Scientia, Investigacion Clinica S.C.
  • Chihuahua City, Mexico, 31207
    • Scientia Investigación Clínica S.C
  • Veracruz, Mexico, 91900
    • Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64660
      • Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.
• Moldova
  • Chisinau, Moldova, 2025
    • IMSP Institutul de Ftiziopneumologie "Chiril Draganiuc"
  • Chisinau, Moldova, 2025
    • IMSP Spitalul Clinic Republican "Timofei Mosneaga"
• Poland
  • Bialystok, Poland, 15-044
    • Centrum Medycyny Oddechowej, Mroz Spolka Jawna (PFT, DLCO)
  • Będzin, Poland, 42-500
    • Centrum Dentystyczno-Lekarskie PROMEDICA Joanna Markiewicz
  • Nowy Targ, Poland, 34-400
    • Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
  • Warsaw, Poland, 00-635
    • Centrum Zdrowia MDM
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 91-495
      • Amicare Sp. z o.o. Sp.k.
• Portugal
  • Guimarães, Portugal, 4835-044
    • Hospital Senhora da Oliveira Guimaraes, E.P.E
• Romania
  • Bucharest, Romania, 014461
    • S.C. Euroclinic Hospital S.A.
• Russia
  • Izhevsk, Russia, 426061
    • LLC "Alliance Biomedical -Ural Group"
  • Novosibirsk, Russia, 630005
    • LLC "SibNovoMed"
  • Novosibirsk, Russia, 63009
    • Medical center "AVITSENNA"
  • Omsk, Russia, 644024
    • Clinicodiagnostic center "Ultramcd"
  • Saint Petersburg, Russia, 191015
    • Federal State Budgetary Ed. Inst. of Higher Education "North-Western Medical University n.a. I.I.
  • Saint Petersburg, Russia, 191015
    • FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF
  • Saint Petersburg, Russia, 194104
    • Spb SBIH "City Mariinskaya Hospital"
  • Saint Petersburg, Russia, 195279
    • LLC "Medi com" (SM-Clinic)
  • Saint Petersburg, Russia, 197022
    • FSBEI of Higher Education "First Saint Petersburg State Medical University n.a. I.P. Pavlov"
  • Samara, Russia, 443093
    • LLC Medical company "Hepatologist"
  • Stavropol, Russia, 355017
    • Autonomous Noncommercial Medical Organizations "Stavropol Regional Clinical Diagnostic Centre''
  • Stavropol, Russia, 355032
    • Autonomous Noncommercial Medical Organizations " Stavropol Regional Clinical Diagnostic Centre ''
  • Stavropol, Russia, 355044
    • City Polyclinic #9
  • Altayskiy Kray
    • Barnaul, Altayskiy Kray, Russia, 656043
      • LLC "Multidisciplinary Medical Clinic "Anturium"
  • Samara Oblast
    • Samara, Samara Oblast, Russia, 443063
      • LLC Medical company "Hepatologist"
  • Stavropol Kray
    • Pyatigorsk, Stavropol Kray, Russia, 357500
      • LLC "Polyclinic of ultrasonography 4D"
• Slovakia
  • Bardejov, Slovakia, 08501
    • GASTROMART s.r.o., Gastroenterologicka ambulancia
  • Levice, Slovakia, 934 01
    • OCULOSANUS, s.r.o., Oftalmologicka ambulancia
  • Lipany, Slovakia, 053 04
    • MUDr. Michal Popovec, s.r.o., Oftalmologicka ambulancia
  • Nitra, Slovakia, 94901
    • KM Management, spol. s r.o .. Gastroenterologicke a hepatologicke centrum
  • Prešov, Slovakia, 080 01
    • PULMO, s.r.o., Plucna ambulancia
• South Africa
  • Centurion, South Africa, 1692
    • Dr Fritz Potgieter, Midstream Medi Clinic
• South Korea
  • Busan, South Korea, 49201
    • Dong-A University Hospital
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital
  • Daegu, South Korea, 41404
    • OCT Facility in Kyungpook National University Chilgok Hospital
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16247
      • OCT Facility in The Catholic University of Korea, St. Vincent's Hospital
    • Suwon, Gyeonggi-do, South Korea, 16427
      • The Catholic University of Korea, St. Vincent'S Hospital
• Spain
  • Valencia
    • Alicante, Valencia, Spain, 03010
      • Hospital General Universitario de Alicante
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe University Medical Faculty
  • Antalya, Turkey (Türkiye), 07030
    • Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76000
    • Communal Non-commercial Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council,
  • Kharkiv, Ukraine, 61022
    • Llc "Ldts-Skaymed"
  • Kharkiv, Ukraine, 61045
    • Llc Medical Center Oftalmika
  • Kharkiv, Ukraine, 61018
    • Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care named alter prof.
  • Kharkiv, Ukraine, 61037
    • Communal Noncommercial Enterprise Prof. O.O.Shalimov City Clinical Hospital #2 of Kharkiv City
  • Kherson, Ukraine, 73000
    • Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City
  • Kherson, Ukraine, 73003
    • LLC "Diagnostic center"
  • Kyiv, Ukraine, 02091
    • Kyiv City Clinical Hosptial #1, Department of Clinical Research at the Special Fund
  • Odesa, Ukraine, 65025
    • LLC GLB Clinik
  • Uzhagorod, Ukraine, 88018
    • Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Gastroenterology
  • Vinnytsia, Ukraine, 21029
    • Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Treatment
  • Vinnytsia, Ukraine, 21036
    • Llc "Optimal M"
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Center for Digestive Health (Colonoscopy Location)
    • Dothan, Alabama, United States, 36305
      • Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address)
    • Dothan, Alabama, United States, 36301
      • Flowers Hospital (PFT Location)
  • California
    • Lake Elsinore, California, United States, 92532
      • Inland Pulmonary Specialists [PFT Only]
    • Lancaster, California, United States, 93534
      • Advanced Endoscopy and Pain Center(Colonoscopy)
    • Lancaster, California, United States, 93534
      • Antelope Valley Eye Care(Ophthalmologist)
    • Lancaster, California, United States, 93534
      • Renaissance Imaging Center(Chest X-Ray only)
    • Palmdale, California, United States, 93551
      • Advanced Imaging (Chest X-Ray)
    • Temecula, California, United States, 92591
      • California Eye Professionals [OCT Only]
  • Florida
    • Clearwater, Florida, United States, 33762
      • Gastro Florida (Regulatory & Administrative Duties)
    • Clearwater, Florida, United States, 33756
      • West Coast Endoscopy Center (Endoscopy Procedures)
    • Clearwater, Florida, United States, 33761
      • Northwood Vision- Optical Coherence Tomography (OCT)
    • Clearwater, Florida, United States, 33761
      • Northwood Vision-Optical Coherence Tomography-(OCT)
    • Clearwater, Florida, United States, 33761
      • Safety Harbor Surgery (Endoscopy Facility)
    • Largo, Florida, United States, 33771
      • Dr Lee Shettle
    • Largo, Florida, United States, 33771
      • Florida Center for Gastroenterology
    • Largo, Florida, United States, 33771
      • Tampa Bay Regional Surgery Center
    • New Smyrna Beach, Florida, United States, 32168
      • NSB Research
    • Tampa, Florida, United States, 33606
      • USF Health South Tampa Center for Advanced Healthcare
    • Tampa, Florida, United States, 33614
      • Guardian Angel Research Center, INC
    • Tampa, Florida, United States, 33609
      • LoCicero Medical Group (PFT Procedure Only)
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, LLC
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, LLC (Endoscopy)
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, LLC (OCT)
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, LLC (PFT)
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Pulmonary Function Tedt Lab
    • Atlanta, Georgia, United States, 30342
      • Emory Saint Joseph Pulmonary Function Test Lab
    • Sandy Springs, Georgia, United States, 30328
      • Thomas Eye Group (OCT only)
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Medical Eye Services LTD (Ophthalmoscopy with OCT)
    • Gurnee, Illinois, United States, 60031
      • Illinois Gastroenterology Group dba GI Alliance (Patients seen; IP Delivered)
    • Libertyville, Illinois, United States, 60048
      • Libertyville Imaging Center (Diagnostic Imaging)
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Retina Group Of Washington (OCT Only)
    • Chevy Chase, Maryland, United States, 20815
      • Friendship Heights Endoscopy Center (Endoscopy Facility Only)
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63108
      • Washington University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Durango Surgical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27705
      • Duke Eye Center (OCT only)
    • Raleigh, North Carolina, United States, 27617
      • Brier Creek Medical Pavilion
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • UC Health Hoxworth (OCT only)
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center (PFT and Endoscopy location)
    • Mentor, Ohio, United States, 44060
      • The Endoscopy Center of Lake County
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists, Inc. Endoscopy Lab
    • Oklahoma City, Oklahoma, United States, 73112
      • Pulmonary Physicians of Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Retina Center of Oklahoma
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Susquehanna Research Group
    • Harrisburg, Pennsylvania, United States, 17110
      • Farrell Ophthalmology (OCT only)
    • Lemoyne, Pennsylvania, United States, 17043
      • Pulmonary and Critical Care Medicine Associates (PFT only)
  • Texas
    • Arlington, Texas, United States, 76012
      • Cross Timbers Surgery Center(Proctosigmoidoscopy)
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research
    • Houston, Texas, United States, 77401
      • Cross Eye Center (Optical Coherence Tomography)
    • Keller, Texas, United States, 76248
      • Lonestar Endoscopy(Endoscopy Location)
    • San Marcos, Texas, United States, 78666
      • Central Texas Eye Center (OCT)
    • Southlake, Texas, United States, 76092
      • Lonestar Endoscopy (Endoscopy Location)
    • Tyler, Texas, United States, 75701
      • Christus Trinity Mother Frances Endosopy Center ( endoscopies only)
    • Tyler, Texas, United States, 75701
      • Touchstone Imaging Tyler (chest x-rays only)
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Gastroenterology
    • Seattle, Washington, United States, 98104
      • Richard Bensinger, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Memorial Lutheran Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:

  1. 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
  2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etrasimod 2 mg	Drug: Etrasimod; Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first; Other Names: APD334

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Severity of Safety Measures	Safety as assessed by the evaluation of adverse events	Up to approximately 8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores		Week 52 and Week 104
Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry		Week 52 and Week 104
Change From Baseline in the Total Mayo Score	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.	Baseline, Week 52, and Week 104
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores		Week 52 and Week 104
Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores		Week 52 and Week 104
Change From Baseline in Partial Mayo Score	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.	Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260

Other Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores	Week 52 and Week 104
Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores	Week 52 and Week 104
Time to Loss of Response Assessed by Mayo Component Sub-scores	Up to Week 260
Proportion of Participants Achieving Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline	Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Arena is a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Estimated): June 19, 2029
• Study Completion (Estimated): June 19, 2029

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Etrasimod; APD334
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; etrasimod
• Other Study ID Numbers: APD334-303; C5041012 (Other Identifier: Alias Study Number); 2024-515156-21-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No