Ulcerative ColitisPhase 3ELEVATE UC OLENCT03950232
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing Etrasimod in people with Ulcerative Colitis, run by Pfizer at 472 sites in 39 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Etrasimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 896 participants
- Where
- 472 sitesin 39 countries
- Study dates
- 5 Sep 2019to 19 Jun 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Trial locations and contacts
472 sites in 39 countries.
472 sites in 39 countries
United States133 sites
Cross Timbers Surgery Center(Proctosigmoidoscopy)
Arlington, Texas, 76012
Envision Imaging(Chest X-Ray)
Arlington, Texas, 76012
Texas Clinical Research Institute
Arlington, Texas, 76012
Texas Pulmonary and Critical Care Associates(Pulmonary Function Test)
Arlington, Texas, 76012
Texas Retina Associates(Ophthalmoscopy)
Arlington, Texas, 76012
Emory Pulmonary Function Tedt Lab
Atlanta, Georgia, 30322
Emory Pulmonary Group (PFT only)
Atlanta, Georgia, 30324
Atlanta Gastroenterology Associates (Endoscopy Location)
Atlanta, Georgia, 30342
Atlanta Gastroenterology Associates (endoscopy only)
Atlanta, Georgia, 30342
Atlanta Gastroenterology Associates (Screening and Recruitment)
Atlanta, Georgia, 30342
Atlanta Gastroenterology Associates(IP only)
Atlanta, Georgia, 30342
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Emory Saint Joseph Pulmonary Function Test Lab
Atlanta, Georgia, 30342
Eye Medical Center (OCT location)
Baton Rouge, Louisiana, 70808
Baton Rouge LA Endoscopy
Baton Rouge, Louisiana, 70809
Inquest Clinical Research
Baytown, Texas, 77521
Susquehanna Research Group
Camp Hill, Pennsylvania, 17011
West Shore Endoscopy Center
Camp Hill, Pennsylvania, 17011
Geauga Sleep Center (PFT Only)
Chardon, Ohio, 44024
Chevy Chase Pulmonary Associate (PFT Only)
Chevy Chase, Maryland, 20815
Friendship Heights Endoscopy Center (Endoscopy Facility Only)
Chevy Chase, Maryland, 20815
Retina Group Of Washington (OCT Only)
Chevy Chase, Maryland, 20815
UC Health Hoxworth (OCT only)
Cincinnati, Ohio, 45219
UC Health Physicians Office
Cincinnati, Ohio, 45219
University of Cincinnati Medical Center (PFT and Endoscopy location)
Cincinnati, Ohio, 45219
UC Health (Pulmonary Function Testing)
Cincinnati, Ohio, 45229
Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)
Clearwater, Florida, 33756
West Coast Endoscopy Center (Endoscopy Procedures)
Clearwater, Florida, 33756
Northwood Vision- Optical Coherence Tomography (OCT)
Clearwater, Florida, 33761
Northwood Vision-Optical Coherence Tomography-(OCT)
Clearwater, Florida, 33761
Safety Harbor Surgery (Endoscopy Facility)
Clearwater, Florida, 33761
Gastro Florida (Regulatory & Administrative Duties)
Clearwater, Florida, 33762
Gastro Florida-(Regulatory & Administrative Duties)
Clearwater, Florida, 33762
West Coast Endoscopy Center (Endoscopy Procedures)
Clearwater, Florida, 33765
Front Range Endoscopy Center
Colorado Springs, Colorado, 80903
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80920
Barnes-Jewish West County Hospital (Additional Endoscopy Location)
Creve Coeur, Missouri, 63141
Center for Digestive Health (Colonoscopy Location)
Dothan, Alabama, 36301
Digestive Health Specialists (IP Address)
Dothan, Alabama, 36301
Flowers Hospital (PFT Location)
Dothan, Alabama, 36301
Pulmonary Associates (Secondary PFT Location)
Dothan, Alabama, 36301
Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address)
Dothan, Alabama, 36305
Duke Medical Plaza North Duke Street
Durham, North Carolina, 27704
Duke Eye Center (OCT only)
Durham, North Carolina, 27705
Duke University Medical Center
Durham, North Carolina, 27710
Harman Eye Center (OCT only)
Forest, Virginia, 24551
Texas Retina Associates (OCT Location)
Grapevine, Texas, 76051
Illinois Gastroenterology Group dba GI Alliance (Patients seen; IP Delivered)
Gurnee, Illinois, 60031
Medical Eye Services LTD (Ophthalmoscopy with OCT)
Gurnee, Illinois, 60031
Farrell Ophthalmology (OCT only)
Harrisburg, Pennsylvania, 17110
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110
Harrisburg Eye Associates (OCT only)
Harrisburg, Pennsylvania, 17111
Medical Arts Allergy,PC (PFT Only)
Harrisburg, Pennsylvania, 17111
Plaza Medical Center
Houston, Texas, 77004
East Houston Physicians Group
Houston, Texas, 77029
Baylor College of Medicine- Baylor Medical Center
Houston, Texas, 77030
Cross Eye Center (Optical Coherence Tomography)
Houston, Texas, 77401
Swedish Endoscopy Center - Issaquah
Issaquah, Washington, 98029
Lonestar Endoscopy(Endoscopy Location)
Keller, Texas, 76248
North Shore Endoscopy Center (Endoscopy)
Lake Bluff, Illinois, 60044
Inland Pulmonary Specialists [PFT Only]
Lake Elsinore, California, 92532
A V Pediatrics,Allergy and Family Medicine
Lancaster, California, 93534
Advanced Endoscopy and Pain Center(Colonoscopy)
Lancaster, California, 93534
Antelope Valley Eye Care(Ophthalmologist)
Lancaster, California, 93534
Jatinder S.Pruthi,MD FACG CPI
Lancaster, California, 93534
Om Research LLC
Lancaster, California, 93534
Renaissance Imaging Center(Chest X-Ray only)
Lancaster, California, 93534
Dr Lee Shettle
Largo, Florida, 33771
Florida Center for Gastroenterology
Largo, Florida, 33771
Tampa Bay Regional Surgery Center
Largo, Florida, 33771
Durango Surgical Center
Las Vegas, Nevada, 89113
Abrams Eye Institute (OCT)
Las Vegas, Nevada, 89148
Lung Center of Nevada
Las Vegas, Nevada, 89148
Pulmonary and Critical Care Medicine Associates (PFT only)
Lemoyne, Pennsylvania, 17043
Libertyville Imaging Center (Diagnostic Imaging)
Libertyville, Illinois, 60048
Lynchburg Pulmonary Associates, Inc. (PFT only)
Lynchburg, Virginia, 24501
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Ophthalmic Physicians Incorporated (OCT Only)
Mentor, Ohio, 44060
The Endoscopy Center of Lake County
Mentor, Ohio, 44060
Vitreo Retinal Consultants (OCT only)
Mentor, Ohio, 44060
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
United Surgery Center Murrieta [Endoscopy Only]
Murrieta, California, 92562
United Medical Doctors
Murrieta, California, 92563
Christus Santa Rosa Physicians Ambulatory Surgery Center New Braunfels (Endoscopy)
New Braunfels, Texas, 78130
Tyrus Schroeder (PFT)
New Braunfels, Texas, 78130
NSB Research
New Smyrna Beach, Florida, 32168
Digestive Disease Specialists, Inc. Endoscopy Lab
Oklahoma City, Oklahoma, 73112
Pulmonary Physicians of Oklahoma
Oklahoma City, Oklahoma, 73112
Retina Center of Oklahoma
Oklahoma City, Oklahoma, 73112
Advanced Imaging (Chest X-Ray)
Palmdale, California, 93551
Brier Creek Medical Pavilion
Raleigh, North Carolina, 27617
Central Texas Eye Center (OCT)
San Marcos, Texas, 78666
Christus Santa Rosa Physicians Ambulatory Surgery Center San Marcos (Endoscopy)
San Marcos, Texas, 78666
Thomas Eye Group (OCT only)
Sandy Springs, Georgia, 30328
Pacific Northwest Retina
Seattle, Washington, 98104
Richard Bensinger, MD
Seattle, Washington, 98104
Swedish Gastroenterology
Seattle, Washington, 98104
Swedish Medical Center First Hill Endoscopy Center
Seattle, Washington, 98122
Swedish Medical Center First Hill
Seattle, Washington, 98122
Envision Imaging (Chest X-ray location)
Southlake, Texas, 76092
Lonestar Endoscopy (Endoscopy Location)
Southlake, Texas, 76092
Washington University School of Medicine
St Louis, Missouri, 63108
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Tampa Bay Endoscopy Center (ENDO Only)
Tampa, Florida, 33603
Tampa Bay Endoscopy Center
Tampa, Florida, 33603
Lab - Processing / Storage
Tampa, Florida, 33606
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606
Pulmonary and Sleep of Tampa Bay (PFT Only)
Tampa, Florida, 33607
GCP Clinical Research,LLC
Tampa, Florida, 33609
LoCicero Medical Group (PFT Procedure Only)
Tampa, Florida, 33609
Lyracore Health Alliance (PFT Procedure only)
Tampa, Florida, 33609
Newsome Eye Specialist (OCT Procedures Only)
Tampa, Florida, 33609
USF Health Morsani Center For Advanced Healthcare
Tampa, Florida, 33612
Guardian Angel Research Center, INC
Tampa, Florida, 33614
Perez Eye Center (OCT only)
Tampa, Florida, 33614
California Eye Professionals [OCT Only]
Temecula, California, 92591
United Surgery Center Temecula [Endoscopy Only]
Temecula, California, 92592
Christus Trinity Mother Frances Endosopy Center ( endoscopies only)
Tyler, Texas, 75701
Heaton Eye Associates (OCT only)
Tyler, Texas, 75701
Touchstone Imaging Tyler (chest x-rays only)
Tyler, Texas, 75701
Tyler Internal Medicine (PFT's only)
Tyler, Texas, 75701
UT Health East Texas Physicians (pulmonary functions only)
Tyler, Texas, 75701
Gastro Health & Nutrition
Victoria, Texas, 77904
Lake Pulmonary Associates (PFT only)
Willoughby Hills, Ohio, 44094
Retina Specialist of Ohio (OCT only)
Willoughby Hills, Ohio, 44094
Florida Medical Clinic, LLC (Endoscopy)
Zephyrhills, Florida, 33542
Florida Medical Clinic, LLC (OCT)
Zephyrhills, Florida, 33542
Florida Medical Clinic, LLC (PFT)
Zephyrhills, Florida, 33542
Florida Medical Clinic, LLC
Zephyrhills, Florida, 33542
Wiregrass Ranch special procedure center ( Endoscopy)
Zephyrhills, Florida, 33542
Japan55 sites
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, 070-8610
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
National Hospital Organization Fukuyama Medical Center
Fukuyama, Hiroshima, 720-8520
Nakayama EYE Clinic
Fukuyama-shi, Hiroshima, 720-0822
Gifu University Hospital
Gifu, Gifu, 501-1194
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Matsuda Hospital
Hamamatsu, Shizuoka, 432-8061
Hamamatsu Medical Center
Hamamatsu, Shizuoka, 432-8580
NHO Mito Medical Center
Higashiibaraki-gun, Ibaraki, 311-3193
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Teikyo University Hospital
Itabashi-ku, Tokyo, 173-8606
JA- Kagoshima Koseiren Hospital (PET/DLCO)
Kagoshima, Kagoshima-ken, 890-0062
Jiaikai Idzuro Imamura Hospital
Kagoshima, Kagoshima-ken, 892-0824
Sameshima Eye Clinic (OCT)
Kagoshima, Kagoshima-ken, 892-0825
Sameshima Hospital
Kagoshima, Kagoshima-ken, 892-0846
NHO Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, 277-0871
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka, 816-0864
Takimoto Eye Clinic(OCT)
Kasuga-shi, Fukuoka, 816-0863
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu, Fukuoka, 806-8501
Koyanose Eye Clinic
Kitakyushu-shi, Fukuoka, 807-1266
Showa General Hospital
Kodaira-shi, Tokyo, 187-8510
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520
Our Lady of the Snow St. Mary's Hospital
Kurume, Fukuoka, 830-8543
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
National Hospital Organization Kyoto Medical Center
Kyoto, Kyoto, 612-8555
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, 020-8505
Nagaoka Red Cross Hospital
Nagaoka-shi, Niigata, 940-2085
Ishii Eye Clinic
Nagareyama-shi, Chiba, 270-0116
Kojunkai Daido Clinic
Nagoya, Aichi-ken, 457-8511
Fukuoka Shinmizumaki Hospital
Onga-gun, Fukuoka, 807-0051
NHO Osaka National Hospital
Osaka, Osaka, 540-0006
Japan Community Health care Organization Osaka Hospital
Osaka, Osaka, 553-0003
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585
Saga University Hospital
Saga, Saga-ken, 849-8501
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, 252-5188
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004-0041
JOHAS Tohoku Rosai Hospital
Sendai, Miyagi, 981-8563
Sendai City Hospital
Sendai, Miyagi, 982-8502
JCHO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, 169-0073
Kagawa Prefectural Central Hospital
Takainatsu-shi, Kagawa-ken, 760-8557
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017
Matsumoto Eye Clinic
Toride-shi, Ibaraki, 302-0014
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570
Mie University Hospital
Tsu, Mie-ken, 514-8507
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Hinaga Nishi Ophthalmology Clinic
Yokkaichi- Shi, Mie-ken, 510-0891
Mie Prefectural General Medical Center
Yokkaichi-shi, Mie-ken, 510-8561
Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa, 234-0054
Russia27 sites
LLC "Multidisciplinary Medical Clinic "Anturium"
Barnaul, Altayskiy Kray, 656043
Irkutsk State Medical Academy of Postgraduate Education
Irkutsk, 664049
Professional Education" of MoH of RF
Irkutsk, 664049
LLC "Alliance Biomedical -Ural Group"
Izhevsk, 426061
SAIH "Kemerovo Regional Clinical Hospital"
Kemerovo, 650066
State Budgetary Healthcare Instit. of Nizhniy Novgorod region
Nizhny Novgorod, 603126
LLC "SibNovoMed"
Novosibirsk, 630005
LLC "Novosibirsk GastroCenter"
Novosibirsk, 630007
State Budgetary Healthcare Institution of Novosibirsk region "City clinical hospital # 12"
Novosibirsk, 630084
Medical center "AVITSENNA"
Novosibirsk, 63009
Clinicodiagnostic center "Ultramcd"
Omsk, 644024
State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"
Penza, 440026
LLC "Polyclinic of ultrasonography 4D"
Pyatigorsk, Stavropol Kray, 357500
Federal State Budgetary Ed. Inst. of Higher Education "North-Western Medical University n.a. I.I.
Saint Petersburg, 191015
FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF
Saint Petersburg, 191015
Spb SBIH "City Mariinskaya Hospital"
Saint Petersburg, 194104
LLC "Medi com" (SM-Clinic)
Saint Petersburg, 195279
FSBEI of Higher Education "First Saint Petersburg State Medical University n.a. I.P. Pavlov"
Saint Petersburg, 197022
LLC "Gastroenterological centre Expert"
Saint Petersburg, 197110
St.Petersburg State Budgetary Healthcare Institution "City Hospital #40 of Kurortnyi region"
Saint Petersburg, 197706
LLC Medical Company "Hepatologist"
Samara, Samara Oblast, 443063
Private Educational Institution of Higher Education "Medical University "Reaviz", Multifield Clinic
Samara, 443001
LLC Medical company "Hepatologist"
Samara, 443093
Autonomous Noncommercial Medical Organizations "Stavropol Regional Clinical Diagnostic Centre''
Stavropol, 355017
Autonomous Noncommercial Medical Organizations " Stavropol Regional Clinical Diagnostic Centre ''
Stavropol, 355032
City Polyclinic #9
Stavropol, 355044
State Healthcare Institution of Yaroslavl Region "Clinical Hospital No 2"
Yaroslavl, 150030
Poland23 sites
Centrum Dentystyczno-Lekarskie PROMEDICA Joanna Markiewicz
Będzin, 42-500
Centrum Medycyny Oddechowej, Mroz Spolka Jawna (PFT, DLCO)
Bialystok, 15-044
Gastromed Kralisz, Romatowski, Stachurska sp.j.
Bialystok, 15-322
LSSP Eskulap (OCT, Ophthalmoscopy)
Bialystok, 15-453
Dobry Wzrok (OCT)
Gdansk, 80-402
Poradnia Pulmonologiczna
Gdynia, 81-366
Karkonoskie Centrum Badan Klinicznych - Lexmedica Spolka z ograniczona odpowiedzialnoscia
Jelenia Góra, 58-500
Prywatna Praktyka Lekarska lek. med. Mirosław Fic
Jelenia Góra, 58-500
PROMED Centrum Medyczne (OCT, ophthalmoscopy)
Jelenia Góra, 58-506
IP Clinic Sp. z o.o.
Lodz, 90-752
Amicare Sp. z o.o. Sp.k.
Lodz, Łódź Voivodeship, 91-495
Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
Nowy Targ, 34-400
MEDICOME Sp. z o.o.
Oświęcim, 32-600
NSZOZ Termedica - Centrum Badan Klinicznych
Poznan, Greater Poland Voivodeship, 60-681
Centrum Medyczne MEDYK
Rzeszów, 35-326
ENDOSKOPIA Sp. z o.o.
Sopot, 81-756
Kiepury Clinic Malgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno
Sosonowiec, 41-209
DC-MED Sp. z o.o.
Swidnica, 58-100
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434
Centrum Zdrowia MDM
Warsaw, 00-635
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
Warsaw, 02-507
Penta Hospitals Przychodnie
Wroclaw, Other, 54-239
Centrum Medyczne Oporow
Wroclaw, 52-416
Ukraine21 sites
Communal Institution I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital, Department of
Dnipro, 49005
Clinical Diagnostical Center "Simedgroup"
Ivano-Frankivsk, 76000
Communal Non-commercial Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council,
Ivano-Frankivsk, 76000
Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care named alter prof.
Kharkiv, 61018
Llc "Ldts-Skaymed"
Kharkiv, 61022
LLC "EyeQClinic"
Kharkiv, 61024
Communal Noncommercial Enterprise Prof. O.O.Shalimov City Clinical Hospital #2 of Kharkiv City
Kharkiv, 61037
Llc Medical Center Oftalmika
Kharkiv, 61045
Communal Noncommercial Enterprise City Clinical Hospital # 13 of Kharkiv City Council,
Kharkiv, 61124
Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City
Kherson, 73000
LLC "Diagnostic center"
Kherson, 73003
Kyiv City Clinical Hosptial #1, Department of Clinical Research at the Special Fund
Kyiv, 02091
Communal Noncommercial Enterprise Lviv Clinical Emergency Hospital, 1st Department of Therapy
Lviv, 79059
Communal Institution Odesa Regional Clinical Hospital, Regional Center of Gastroenterology,
Odesa, 65025
LLC GLB Clinik
Odesa, 65025
Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Gastroenterology
Uzhagorod, 88018
Transcarpathian Center of Eye Microsurgery
Uzhhorod, 88017
Medical Clinical Investigational Center of Med Center LLC Health Clinic, Unit of Gastroenterology,
Vinnytsia, 21009
Communal Nonprofit Enterprise M.I.Pyrogov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional
Vinnytsia, 21018
Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Treatment
Vinnytsia, 21029
Llc "Optimal M"
Vinnytsia, 21036
France18 sites
CHU Amiens Picardie
Amiens, 80054
Endoscopy: CHU Amiens-Picardie
Amiens, 80054
Pulmonary examination: CHU Amiens-Picardie
Amiens, 80054
Tomography: CHU Amiens-Picardie
Amiens, 80054
CHU Grenoble Alpes -Hopital Michallon
Grenoble, 38043
Endoscopy: CHU Grenoble Alpes- Hopital Michallon
Grenoble, 38043
Pulmonary examination: CHU Grenoble Alpes - Hopital Michallon
Grenoble, 38043
Tomography: CHU Grenoble Alpes - Hopital Michallon
Grenoble, 38043
CHU Montpellier Hopital Saint-Eloi
Montpellier, 34295
Endoscopy: Hopital Saint-Eloi
Montpellier, 34295
Pulmonary examination: Hopital Arnaud de Villeneuve
Montpellier, 34295
Tomography: Hopital Gui de Chauliac
Montpellier, 34295
CHU Hotel Dieu
Nantes, 44093
CHU de Nice - Hopital de l'Archet 2
Nice, 06202
CHU de Toulouse-Hopital Rangueil
Toulouse, 31059
Endoscopy: CHU RANGUEIL
Toulouse, 31059
Pulmonary examination: CHU RANGUEIL
Toulouse, 31059
Tomography: CHU RANGUEIL
Toulouse, 31059
Slovakia16 sites
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica, II. Interna klinika SZU
Banská Bystrica, 97517
ALIAN, s.r.o.
Bardejov, 08501
GASTROMART s.r.o., Gastroenterologicka ambulancia
Bardejov, 08501
3F, s.r.o., Oftalmologicka ambulancia
Košice, 04011
OCULOSANUS, s.r.o., Oftalmologicka ambulancia
Levice, 934 01
MUDr. Michal Popovec, s.r.o., Oftalmologicka ambulancia
Lipany, 053 04
KM Management, spol. s r.o .. Gastroenterologicke a hepatologicke centrum
Nitra, 94901
Fakultna nemocnica Nitra, Oftalmologicka ambulancia
Nitra, 950 01
Fakultna nemocnica Nitra, Pneumologicka ambulancia
Nitra, 950 01
Fakultna nemocnica Nitra
Nitra, 950 01
GASTRO I., s.r.o. Gastroenterologicka ambulancia
Prešov, 080 01
PULMO, s.r.o., Plucna ambulancia
Prešov, 080 01
Accout Center, s.r.o., Gastroenterologicka ambulancia
Šahy, 936 01
COR, s.r.o., Pneumologicko-ftizeologicka ambulancia
Šahy, 936 01
ENDOMED. s.r.o., Gastroenterologicka ambulancia
Vranov nad Topľou, 093 01
PULMOX spol. s r.o., Pneumologicko-ftizeologicka ambulancia
Vranov nad Topľou, 093 01
Australia15 sites
Sunshine Coast University Private Hospital
Birtinya, Queensland, 4575
Sunshine Coast Respiratory and Sleep (PFT Facility)
Birtinya, 4575
Sullivan Nicolaides Pathology
Bowen Hills, Queensland, 4006
Buderim Eye Centre( OCT and Ophthalmoscopy Facility)
Buderim, Queensland, 4556
Queensland Medical Laboratory (QML) pathology, QML Buderim Laboratory - Healius Pathology Pty Ltd
Buderim, 4556
Austin Health
Heidelberg, Victoria, 3084
Liverpool Hospital
Liverpool, New South Wales, 2170
Coral Sea Clinical Research Institute Pty.Ltd
Mackay, Queensland, 4740
Dr Shiran DeSilva Respiratory Clinic
Mackay, Queensland, 4740
Mater Misericordiae Hospital
Mackay, Queensland, 4740
Queensland X-Ray
Mackay, Queensland, 4740
Vision Eye Institute Mackay
Mackay, Queensland, 4740
Coastal Digestive Helath Pty. Ltd
Maroochydore, Queensland, 4558
The Alfred Hospital
Melbourne, Victoria, 3004
Dr Pranav Kumar (PFT Facility)
North Mackey, Queensland, 4740
Hungary14 sites
Endoscopy: Magyar Imre Korhaz
Ajka, Veszprém megye, 8400
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, Veszprém megye, 8230
Pulmonary function tests: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
Budapest, Budapest, 1062
Ophthalmology tests: Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Budapest, 1068
Semmelweis Egyetem
Budapest, Budapest, 1088
Pannonia Maganorvosi Centrum
Budapest, Budapest, 1136
Gyöngyösi Bugát Pál Kórház
Gyöngyös, 3200
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
Gyula, Bekes County, 5600
Ophthalmology tests:Bekes Megyei Kozponti Korhaz, Pady Kalman Tagkorhaz, Szemeszeti Osztaly
Gyula, Bekes County, 5700
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Fejér, 8000
Clinfan Szolgaltato Kft.
Szekszárd, Tolna County, 7100
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100
Pulmonary function tests, endoscopy: Deak Jeno Korhaz
Tapolca, Veszprém megye, 8300
Ophthalmology tests: RETINASZERVIZ Kft.
Veszprém, 8230
Italy13 sites
Spedali Civili di Brescia, U.O. Gastroenterologia
Brescia, Lombardy, 25123
I.R.C.C.S "Saverio De Bellis", Gastroenterologia II
Castellana Grotte, BARI, 70013
Azienda Ospedalieria Ospedale Cannizzaro
Catania, CATANIA, 95100
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, CATANZARO, 88100
Azienda Ospedaliero Universitaria Careggi, U.O. Gastroenterologia 2 (St.19)
Florence, Tuscany, 50134
IRCCS Ospedale San Raffaele, Oculistica
Milan, Lombardy, 20132
IRCCS Ospedale San Raffaele UO di Gastroenterologia e Endoscopia Digestiva
Milan, Milan, 20132
A.O.U. Policlinico di Modena
Modena, REGGIO EMILIA, 41124
Ospedale Sacro Cuore Don Calabria
Negrar(vr), VR, 37024
ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva
Rho, Milan, 20017
U.O.C. Gastroenterologia ed Endoscopia Digestiva
Roma, ROMA, 00157
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -CEMAD -UOC di Medicina lnterna e Gastro
Roma, ROMA, 00168
I.R.C.C.S Policlinico San Donato
San Donato Milanese, MILANO, 20097
Georgia11 sites
LLC Todua Clinic
Tbilisi, 0112
Israeli-Georgian Medical Research Clinic Healthycore LLC
Tbilisi, 0119
LLC Todua Clinic
Tbilisi, 0119
LLC Vivamedi
Tbilisi, 0131
JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, 0159
LTD Institute of Clinical Cardiology
Tbilisi, 0159
Medical Center CITO LTD
Tbilisi, 0159
Aversi Clinic, LTD
Tbilisi, 0160
LTD Academician Nikoloz Kipshidze Central University Clinic
Tbilisi, 0160
LTD Aversi Clinic
Tbilisi, 0160
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD
Tbilisi
South Korea11 sites
Dong-A University Hospital
Busan, 49201
Endoscopy Facility in Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
OCT Facility in Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
PFT Facility in Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Kyungpook National University Chilgok Hospital
Daegu, 41404
Kyungpook National University Hospital
Daegu, 41944
Endoscopy Facility in The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
OCT Facility in The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
PFT Facility in The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16427
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Bulgaria10 sites
"UMHAT "Kanev"" AD, Ruse
Rousse, Ruse, 7002
Diagnostic-Consultative Center I - Sliven, EOOD
Sliven, Sliven, 8800
Acibadem City Clinic Tokuda Hospital EAD
Sofia, Sofia, 1407
Acibadem City clinic University Hospital EOOD
Sofia, Sofia, 1407
"DCC Alexandrovska", EOOD
Sofia, Sofia, 1431
UMHAT "Sv. Ivan Rilski" EAD'
Sofia, Sofia, 1431
UMHAT "Tsaritsa Yoanna - ISUL" EAD
Sofia, Sofia, 1527
"University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov"EAD
Sofia, Sofia, 1606
Diagnostic Consultation Center CONVEX EOOD
Sofia, Sofia, 1680
Medical Centre MEDICA Plus OOD
Veliko Tarnovo, Veliko Tarnovo, 5000
Belarus9 sites
Foreign Medical and Pharmaceutical Unitary Enterprise "Medical Center" Novoe Zrenie"
Grodno, 230023
Health Care Institution "City Clinical Hospital #4 Grodno"
Grodno, 230026
Healthcare Institution "Grodno University Hospital"
Grodno, 230030
Institution "Gomel Regional Specialized Clinical Hospital"
Homyel, 246027
Institution "Gomel Regional Clinical Hospital
Homyel, 246029
Health care Institution "10th City Clinical Hospital"
Minsk, 220096
Educational Establishment "Vitebsk State Medical University"
Vitebsk, 210009
Health Care Institution "Vitebsk Regional Clinical Hospital"
Vitebsk, 210037
Healthcare Institution: Vitebsk Regional Clinical Specialized Center
Vitebsk, 210604
Czechia9 sites
Fakultni nemocnice u svate Anny v Brne
Brno, 656 91
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12
GASTRO JeKa, s.r.o.
Klatovy, 339 01
PreventaMed s.r.o.
Olomouc, 779 00
Fakultni nemocnice Ostrava
Ostrava-Poruba, 708 52
Axon Clinical, s.r.o.
Prague, 150 00
Nemocnice Na Bulovce
Prague, 180 81
ISCARE a.s.
Prague, 190 00
Nemocnice Slany
Slaný, 274 01
India8 sites
Fortis Memorial Research Institute
Gurgaon, Haryana, 122002
S.R.Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001
Post Graduate Department Of Medicine
Kanpur, Uttar Pradesh, 208002
Midas Multispeciality Hospital Pvt. Ltd
Nagpur, Maharashtra, 440010
Government Medical College & Super Speciality Hospital
Nagpur, 440009
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, 411001
Sids Hospital & Research Centre
Surat, Gujarat, 395002
Surat Institute of Digestive Sciences
Surat, Gujarat, 395002
Germany7 sites
Charite Universitaetsmedizin Berlin - Campus Charite Mitte Medizinische Klinik m. S. Hepatologie
Berlin, 10117
Dr. med Zacharias A. R.Sherif
Berlin, 14163
Krankenhaus Waldfriede e.V.,
Berlin, 14163
Schwerpunktpraxis Bonn
Bonn-Duisdorf, 53123
Johanna-Etienne-Krankenhaus
Neuss, 41462
OCT address: AOZNeuss Dr. Kersten
Neuss, 41462
Praxis Dr. Jorgensen
Remscheid, 42859
Mexico7 sites
Scientia, Investigacion Clinica S.C.
Chihuahua City, Chihuahua, 31203
Scientia Investigación Clínica S.C
Chihuahua City, 31207
Centro de lnvestigacion Medico Biologica y Terapia Avanzada S.C.
Guadalajara, Jalisco, 44130
Invesclinic MX
Irapuato, 36520
Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.
Monterrey, Nuevo León, 64660
FAICIC S. de R.L. de C.V.
Veracruz, Veracruz, 91900
Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.
Veracruz, Veracruz, 91900
Estonia6 sites
Innomedica OÜ
Tallinn, Harju, 10117
OCT: Eye Clinic Dr. Krista Turman
Tallinn, 10120
DLCO: East Tallinn Central Hospital
Tallinn, 10138
West Tallinn Central Hospital
Tallinn, 10617
Endoscopy: North Estonia Medical Centre Foundation
Tallinn, 13149
North Estonia Medical Centre Foundation
Tallinn, 13419
Israel6 sites
Bnai Zion Medical Center
Haifa, 3104802, POB 4940
Shaare Zedek Medical Center
Jerusalem, 9103102
Galilee Medical Center
Nahariya, 2210001
Rabin Medical Center
Petah Tikva, 4941492
The Chaim Sheba Medical Center
Ramat Gan, 5262000
Kaplan Medical Center
Rehovot, 7661041
Lithuania6 sites
Consultancy Polyclinic of Republican Panevezys Hospital
Panevezys, Panevėžys, LT-35144
Republican Panevezys Hospital
Panevezys, Panevėžys, LT-35144
Vilnius University Hospital Santaros Klinikos
Vilnius, Vilnius County, LT-08661
UAB "Northway", Medical and Surgical Centre
Vilnius, 08234
UAB "Inlita", Santaros Clinical Trials Centre
Vilnius, 08406
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
Romania6 sites
S.C. Euroclinic Hospital S.A.
Bucharest, 014461
Spitalul de Oncologie Monza
Bucharest, 13823
Oculens Med S.R.L.
Cluj-Napoca, Cluj, 400501
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, JUD. CLUJ, 400006
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca
Cluj-Napoca, 400371
SC Pelican lmpex SRL
Oradea, Bihor County, 410469
Turkey (Türkiye)6 sites
Hacettepe University Medical Faculty
Ankara, 06100
Gazi University Medical Faculty
Ankara, 06500
Gazi University Medical Faculty
Ankara, 06560
Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi
Antalya, 07030
Uludag University Medical Faculty
Bursa, 16059
Kocaeli University Medical Faculty
Kocaeli, 41380
South Africa5 sites
Dr John Philip Wright
Cape Town, Western Cape, 7708
Johese Clinical Research: Midstream
Centurion, Gauteng, 0157
Johese Clinical Research:Unitas
Centurion, Gauteng, 0157
Unitas Hospital
Centurion, Gauteng, 0157
Dr Fritz Potgieter, Midstream Medi Clinic
Centurion, 1692
Portugal4 sites
Unidade Local de Saude de Coimbra, E.P.E
Coimbra, Coimbra District, 3004-561
Hospital Senhora da Oliveira Guimaraes, E.P.E
Guimarães, 4835-044
Centro Hospitalar Universitario de Sao Joao, E.P.E
Porto, 4200-319
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Vila Nova de Gaia, Porto District, 4434-502
Belgium3 sites
Hospital AZ Sint-Lucas
Ghent, 9000
AZ Delta campus Brugsesteenweg
Roeselare, 8800
AZ Delta
Roeselare, 8800
Moldova3 sites
IMSP Institutul de Ftiziopneumologie "Chiril Draganiuc"
Chisinau, 2025
IMSP Spitalul Clinic Republican "Timofei Mosneaga"
Chisinau, 2025
Spitalul Polivalent Novamed
Chisinau, 2038
Serbia3 sites
Clinical Center " Dr Dragisa Misovic-Dedinje"
Belgrade, 11000
Clinical Center Zvezdara
Belgrade, 11000
General Hospital Sremska Mitrovica
Sremska Mitrovica, 22000
United Kingdom3 sites
Barts Health NHS Trust - Whipps Cross University Hospital
London, London, E11 1NR
Guy's and St Thomas' NHS Foundation Trust
London, London, SE1 9RT
Yeovil District Hospital NHS Foundation Trust
Yeovil, SOMERSET, BA21 4AT
Croatia2 sites
General Hospital Zadar
Zadar, 23000
University Hospital Center Zagreb
Zagreb, 10000
Denmark2 sites
Aalborg University Hospital, department of medical gastroenterology,
Aalborg, 9000
Herlev Hospital, Stomach, -Bowel and Liver disease, Clinic 1
Herlev, 2730
Spain2 sites
HOSPITAL GENERAL UNIVERSITARIO de Alicante
Alicante, Valencia, 03010
Hospital Universitario la Paz
Madrid, 28046
Thailand2 sites
Chulalongkorn University, King Chulalongkorn Memorial Hospital
Bangkok, 10330
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
Argentina1 site
Centro de lnvestigation C.I .C.E. 9 de Julio
San Miguel de Tucumán, Tucumán Province, 4000
Austria1 site
Department of Internal Medicine III, Clinical Division of Gastroenterology and Hepatology
Vienna, 1090
Latvia1 site
P. Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Therapy Center
Riga, LV-1002
About this study
Official title: 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]).
- Conditions
- Ulcerative Colitis
- Being tested
- Etrasimod
- Keywords
- Ulcerative Colitis, Etrasimod, APD334
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtrasimodDrug
Also called APD334
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
| Study group | Role | What they receive |
|---|---|---|
| Etrasimod 2 mg | Experimental | Not described Receives: Drug: Etrasimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Safety Measures
Safety as assessed by the evaluation of adverse events
Measured: Up to approximately 8 years
Secondary outcomes (6)
Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
Measured: Week 52 and Week 104
Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry
Measured: 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.
Measured: Baseline, 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.
Measured: Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
Measured: Week 52 and Week 104
Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores
Measured: Week 52 and Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start5 Sep 2019
- Primary completion19 Jun 2029 (estimated)
- Study completion19 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arena is a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950232
- Sponsor's protocol ID
- APD334-303
- Other IDs
- C5041012, 2024-515156-21-00
- Acronym
- ELEVATE UC OLE
- Status last verified
- Oct 2026
- First submitted
- 13 May 2019
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
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.
PubMed 39778975