An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified April 2026 by Pfizer
Sponsor
Pfizer
Information Provided by (Responsible Party)
Pfizer
Clinicaltrials.gov Identifier
NCT03950232
Other Study ID Numbers:
APD334-303
First Submitted
May 12, 2019
First Posted
May 14, 2019
Last Update Posted
May 10, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Ulcerative Colitis
Drug: Etrasimod

Study Design

Study TypeInterventional
Actual Enrollment896 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Study Start DateSeptember 4, 2019
Actual Primary Completion Date2yrs 11mos from now
Actual Study Completion Date2yrs 11mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures
  1. Number and Severity of Safety Measures
    Safety as assessed by the evaluation of adverse events
Secondary Outcome Measures
  1. Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
  2. Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry
  3. 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.
  4. 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.
  5. Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
  6. Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

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