AzTrials
AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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

Other trials in United States

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

Other trials in Japan

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

Other trials in Russia

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

Other trials in Poland

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

Other trials in Ukraine

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

Other trials in France

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

Other trials in Slovakia

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

Other trials in Australia

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

Other trials in Hungary

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

Other trials in Italy

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

Other trials in Georgia

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

Other trials in South Korea

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

Other trials in Bulgaria

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

Other trials in Belarus

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

Other trials in Czechia

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

Other trials in India

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

Other trials in Germany

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

Other trials in Mexico

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

Other trials in Estonia

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

Other trials in Israel

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

Other trials in Lithuania

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

Other trials in Romania

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

Other trials in Turkey (Türkiye)

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

Other trials in South Africa

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

Other trials in Portugal

Belgium3 sites
  • Hospital AZ Sint-Lucas

    Ghent, 9000

  • AZ Delta campus Brugsesteenweg

    Roeselare, 8800

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Moldova3 sites
  • IMSP Institutul de Ftiziopneumologie "Chiril Draganiuc"

    Chisinau, 2025

  • IMSP Spitalul Clinic Republican "Timofei Mosneaga"

    Chisinau, 2025

  • Spitalul Polivalent Novamed

    Chisinau, 2038

Other trials in Moldova

Serbia3 sites
  • Clinical Center " Dr Dragisa Misovic-Dedinje"

    Belgrade, 11000

  • Clinical Center Zvezdara

    Belgrade, 11000

  • General Hospital Sremska Mitrovica

    Sremska Mitrovica, 22000

Other trials in Serbia

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

Other trials in United Kingdom

Croatia2 sites
  • General Hospital Zadar

    Zadar, 23000

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

Denmark2 sites
  • Aalborg University Hospital, department of medical gastroenterology,

    Aalborg, 9000

  • Herlev Hospital, Stomach, -Bowel and Liver disease, Clinic 1

    Herlev, 2730

Other trials in Denmark

Spain2 sites
  • HOSPITAL GENERAL UNIVERSITARIO de Alicante

    Alicante, Valencia, 03010

  • Hospital Universitario la Paz

    Madrid, 28046

Other trials in Spain

Thailand2 sites
  • Chulalongkorn University, King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Siriraj Hospital, Mahidol University

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

Argentina1 site
  • Centro de lnvestigation C.I .C.E. 9 de Julio

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Austria1 site
  • Department of Internal Medicine III, Clinical Division of Gastroenterology and Hepatology

    Vienna, 1090

Other trials in Austria

Canada1 site
  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

Other trials in Canada

Chile1 site
  • Clinical Research Chile

    Valdivia, Los Ríos Region

Other trials in Chile

Latvia1 site
  • P. Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Therapy Center

    Riga, LV-1002

Other trials in Latvia

Lebanon1 site
  • American University of Beirut Medical Center

    Beirut

Other trials in Lebanon

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]).

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 groups in NCT03950232
Study groupRoleWhat they receive
Etrasimod 2 mgExperimentalNot described
Receives: Drug: Etrasimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Severity of Safety Measures

    Safety as assessed by the evaluation of adverse events

    Measured: Up to approximately 8 years

Secondary outcomes (6)
  1. Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores

    Measured: Week 52 and Week 104

  2. 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

  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.

    Measured: Baseline, Week 52, and Week 104

  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.

    Measured: Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260

  5. Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores

    Measured: Week 52 and Week 104

  6. 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.

  1. First posted15 May 2019
  2. Study start5 Sep 2019
  3. Primary completion19 Jun 2029 (estimated)
  4. Study completion19 Jun 2029 (estimated)

Resources

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)
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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in