Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

PHASE2CompletedINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

April 12, 2021

Primary Completion Date

June 19, 2024

Study Completion Date

June 19, 2024

Conditions
Ulcerative Colitis
Interventions
DRUG

Etrasimod

Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment

DRUG

Placebo

Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment

Trial Locations (288)

1025

Ophthalmology tests: Tosho Kft., Budapest

1051

Mediszem Kft., Budapest

1062

Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft., Budapest

Vasutegeszsegugyi Nonprofit Kozhasznu Kft., Budapest

1068

Honvedkorhaz II. telephely, Budapest

Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests), Budapest

1088

Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika, Budapest

1136

Pannonia Maganorvosi Centrum Kft., Budapest

1407

Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD, Sofia

Acibadem City Clinic University Hospital EOOD, Sofia

1431

DCC Alexandrovska, EOOD, Sofia

"UMHAT Aleksandrovska EAD (Colonoscopy/Sigmoidoscopy Facility)", Sofia

UMHAT Aleksandrovska EAD (X-Ray Facility), Sofia

1527

"UMHAT Tsaritsa Yoanna-ISUL EAD", Sofia

"UMHAT ''Tsaritsa Yoanna-lSUL EAD (Colonoscopy/ Sigmoidoscopy Facility)", Sofia

UMHAT Tsaritsa Yoanna - ISUL EAD (X-ray), Sofia

1606

University multiprofile hospital for active treatment and emergency medicine N.l Pirogov EAD, Sofia

1680

Diagnostic Consultation Center CONVEX EOOD, Sofia

1784

Acibadem City Clinic University Hospital Eood, Sofia

2800

DLCO and ophthalmology tests: Szent Borbala Korhaz, Tatabánya

3050

Melbourne Health, Parkville

3084

Austin Health, Heidelberg

3200

Bugat Pal Korhaz, Gyöngyös

4558

Coastal Digestive Helath Pty. Ltd, Maroochydore

4575

Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility ), Birtinya

Sunshine Coast Radiology, Birtinya

Sunshine Coast University Private Hospital, Birtinya

Buderim Eye Centre( OCT and Ophthalmoscopy Facility), Buderim

4740

Coral Sea Clinical Research Institute Pty.Ltd, Mackay

Dr.Shiran DeSilva Respiratory Clinic (PFT), North Mackay

Mater Misericordiae Hospital ( Endoscopy), North Mackay

Queensland X-Ray, North Mackay

Vision Eye Institute Mackay (OCT), North Mackay

5000

Medical Centre MEDICA Plus OOD, Veliko Tarnovo

7002

"UMHAT ,,Kanev AD", Rousse

7100

Clinfan Szolgaltato Kft., Szekszárd

Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz, Szekszárd

8800

AZ Delta, Roeselare

17011

West Shore Endoscopy Center, Camp Hill

17043

Pulmonary and Critical Care Medicine Associates (PFT only), Lemoyne

17102

Pulmonary and Critical Care Medicine Associates (PFT only), Harrisburg

17109

Medical Arts Allergy,PC (PFT Only), Harrisburg

17110

Farrel Opthalmology(OCT only), Harrisburg

Pinnacle Health Imaging at Tristan (X-Ray only), Harrisburg

Susquehanna Research Group, Harrisburg

17111

Harrisburg Eye Associates (OCT only), Harrisburg

20132

IRCCS Ospedale San Raffaele, Unita di Gastroenterologia, Milan

20707

Lung Center (Pulmonary Function Test only), Laurel

20815

Chevy Chase Endoscopy Center (Endoscopy Facility Only), Chevy Chase

Chevy Chase Pulmonary Associate (PFT Only), Chevy Chase

Retina Group of Washington (Ophthalmoscopy and OCT Only), Chevy Chase

21009

Medical Center of LLC Health Clinic, Med Clinical lnvestigational Center, Unit of Gastroenterology,, Vinnytsia

21018

"CNE Vinnytsia Reg Clinical Hosp named after N.I.Pirogov Vinnytsia Regional Council, Reg Specialize", Vinnytsia

Podilskyi tsentr zoru, Vinnytsia

21029

Scientific and Research Institute of lnvalid Rehabilitation (Educational and Scientific, Vinnytsia

21032

"Diagnostic Center Mediscan", Vinnytsia

21036

"Llc Optimal M", Vinnytsia

21044

Charter Radiology, Columbia

21045

Cascades Endoscopy Center, Columbia

Gastro Center of Maryland, LLC, Columbia

21076

Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only), Hanover

24105

OCT: nordBLICK Augenklinik Bellevue, Kiel

Universitatsklinikum Schleswig-Holstein, Campus Kiel, Kiel

24501

Lynchburg Pulmonary Associates, Inc. (PFT only), Lynchburg

24502

Blue Ridge Medical Research, Lynchburg

Radiology Consultants of Lynchburg (X-ray only), Lynchburg

24551

Harman Eye Center (OCT only), Forest

26426

Wonju Severance Christian Hospital, Wŏnju

28046

Hospital Universitario la Paz, Madrid

32127

Advanced Medical Research Center, Port Orange

32168

NSB Research, New Smyrna Beach

33069

SimonMed Imaging, Tampa

33134

Beraja Medical Institute (OCT), Coral Gables

Juan Barrio, MD (PFT when needed), Coral Gables

The Endoscopy Center (Endoscopy Procedure), Miami

33143

Larkin Community Hospital (Endoscopy Procedure), South Miami

33156

Research Associates of South Florida, Miami

33157

Kendall Endoscopy and Surgery Center (Endoscopy), Miami

IMIC Inc, Palmetto Bay

33176

Clarin Eye Care Center (OCT/Ophthalmoscopy), Miami

33511

Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD, Brandon

33573

Absolute Surgical Specialists - Craig Amshel, MD, Sun City Center

33603

Perez Eye Center(OCT & Ophthalmoscopy only), Tampa

Tampa Bay Endoscopy Center(Proctosigmoidoscopy & colonoscopy ONLY), Tampa

Tampa Bay Endoscopy Center, Tampa

33606

Lyracore Health Alliance, Tampa Bay Pulmonology (PFT only), Tampa

33607

Pulmonary and Sleep of Tampa Bay(PFT with DLCO only), Tampa

33609

GCP Clinical Research,LLC, Tampa

LoCicero Medical Group (PFT Procedure Only), Tampa

NewsomEye (OCT only), Tampa

South Tampa Surgery Center, Tampa

33756

Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test), Clearwater

GASTRO FLORIDA (ADMINISTRATIVE DUTIES etc. CRA visits), Clearwater

West Coast Endoscopy (Colonoscopy Procedures), Clearwater

West Coast Endoscopy Center (Endoscopy Procedures), Clearwater

West Coast Radiology (Chest X-ray), Clearwater

33761

Northwood Vision- Optical Coherence Tomography (OCT), Clearwater

36100

Ospedale San Bortolo di Vicenza, Gastroenterologia, Vicenza

36301

Center for Digestive Health (Colonoscopy Location), Dothan

Digestive Health Specialists, Dothan

Dothan Eyecare-Dr. Brent McKinley (OCT Location), Dothan

Pulmonary Associates (Secondary PFT Location), Dothan

36305

Flowers Hospital (PFT Location), Dothan

38043

Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon, Grenoble

40489

Florence-Nightingale-Krankenhaus, Düsseldorf

41944

Endoscopy Facility in kyungpook National University Hospital, Daegu

Kyungpook National University Hospital, Daegu

OCT Facility In kyungpook Natioanl University Hospital, Daegu

PFT Facility in kyungpook Natioanl University Hospital, Daegu

42853

OCT: Augenpraxisklinik REMSCHEID, Remscheid

42859

Magen-Darm-Zentrum Remscheid, Remscheid

44024

Geauga Sleep Center(PFT only), Chardon

44060

The Endoscopy Center of Lake County, Mentor

44077

Vitreo Retinal Consultants(OCT only), Painesville

44093

Centre Hospitalier Universitaire de Nantes - Hotel-Dieu, Nantes

44094

Lake Pulmonary Associates (PFT only), Willoughby

Retina Specialists of Ohio(OCT only), Willoughby Hills

44122

Advantage Diagnostics(X-Ray only), Beachwood

45219

UC Health Physicians Office, Cincinnati

45229

UC Health (Pulmonary Function Testing), Cincinnati

45267

University of Cincinnati College of Medicine, Cincinnati

47798

OCT: Dr. med. Christopher Kallen, Krefeld

49000

"Limited Liability Company Lookout Medical Center", Dnipro

49005

"Limited Liability Company MDC EXPERT", Dnipro

Municipal Enterprise <<Dnipro Reg Clinical Hosp named after M. I.I. Mechnikov>>, Dnipro

53123

Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling, Bonn

60031

GI Alliance (Patients Seen; IP Delivered), Gurnee

Medical Eye Services LTD (Ophthalmoscopy with OCT), Gurnee

60044

North Shore Endoscopy Center (Endoscopy), Lake Bluff

60048

Libertyville Imaging Center (Diagnostic Imaging), Libertyville

61022

"Llc Ldts-Skaymed", Kharkiv

61037

CNE Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv City Council, Department of Proctology, Kharkiv

61045

Llc Medical Center Oftalmika, Kharkiv

70013

Azienda Ospedaliera Saverio De Bellis, Puglia

75701

Christus Trinity Mother Frances Endoscopy Center, Tyler

Christus Trinity Mother Frances Endosopy Center ( endoscopies only), Tyler

Heaton Eye Associates (OCT only), Tyler

Tyler Open MRI (chest x-ray only), Tyler

UT Health East Texas Physicians (pulmonary functions only), Tyler

76008

"Clinical Diagnostical Center Simedgroup", Ivano-Frankivsk

CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council,Department of Gastroenterology, Ivano-Frankivsk

76051

Texas Retina Associates (OCT Location), Grapevine

76092

Envision Imaging, Southlake

Lonestar Endoscopy, Southlake

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance, Southlake

76248

Lonestar Endoscopy, Keller

77030

Alkek Eye Center Jamail Specialtu Care Center (OCT), Houston

Baylor College of Medicine- Baylor Medical Center, Houston

Baylor College of Medicine-Baylor Medical Center (Chest X-ray location), Houston

Baylor College of Medicine-Baylor Medical Center (IP Storage), Houston

Baylor College of Medicine-Baylor Medical Center (Patients seen address, ECG location, PFT), Houston

Baylor St. Luke's Medical Center Endoscopy- Mc Nair Campus (Endoscopy Location), Houston

77900

Gastroenterologie-interna, SPEA, Olomouc

Vojenska nemocnice Olomouc, Olomouc

77904

Citizen Healthplex (PFT), Victoria

Gastro Health & Nutrition - Victoria, Victoria

Surgery Center (Endoscopy), Victoria

Victoria Eye Center (OCT and Opthalmoscopy), Victoria

78501

Buena Vista Optical ( OCT only), McAllen

78503

Endoscopy Center at Med Point (Endoscopy only), McAllen

Valley Pulmonary Group (PFT only), McAllen

78539

Advanced Radiology Associates (x-Ray only), Edinburg

80903

Front Range Endoscopy Center, Colorado Springs

80907

Peak Gastroenterology Associates, Colorado Springs

80909

Colorado Springs Pulmonary Consultants, PC, Colorado Springs

The Wright Eye Center (OCT Facility), Colorado Springs

80919

Colorado Springs Imaging, Colorado Springs

80920

Peak Gastroenterology Associates, Colorado Springs

85351

Sun City Endoscopy (Endoscopy), Sun City

85381

Arizona Retina Institute/ Phoenix Retina Associates(OCT), Peoria

SimonMed Imaging (Imaging), Peoria

88017

Transcarpathian Center of Eye Microsurgery, Uzhhorod

88018

CNE Andrii Novak Transcarpathian Regional Clinical Hospital of, Uzhhorod

90036

Abraham M. lshaaya MD (X-Ray), Los Angeles

Entertainment Medical Group, Inc (Main Site, Subject Visits, IP Delivery/Storage, Regulatory,, Los Angeles

90067

Advanced Vision Care (OCT), Los Angeles

Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist), Los Angeles

Gastrointestinal Biosciences Clinical Trials, LLC, Los Angeles

91942

Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only), La Mesa

Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only), La Mesa

92020

Euclid Endoscopy Center-El Cajon (Endoscopy procedure only), El Cajon

92119

ACRC Studies, San Diego

92562

United Surgery Center Murrieta [Endoscopy Only], Murrieta

92563

United Medical Doctors, Murrieta

92591

California Eye Professionals [OCT Only], Temecula

92592

United Surgery Center Temecula [Endoscopy Only], Temecula

92697

Center for Clinical Research (CCR), Irvine

UCI Gavin Herbert Eye Institute, Irvine

UCI Gottschalk Medical Plaza, Irvine

CCR-ICTS Center for Innovative Patient Care, Orange

92868

UCI Health Eye Care Services (Ophthalmoscopy and OCTs), Orange

UCI Health H. H. Chao Comprehensive Digestive Disease Center, Orange

UCI Investigational Drug Services (IDSP - Pharmacy), Orange

UCI Irvine Medical Center - Pulmonology Services - PFTs, Orange

93534

Advanced Endoscopy and Pain Center (Colonoscopy), Lancaster

Advanced Imaging Center (Chest X-Ray), Lancaster

Antelope Valley Eye Care (Ophthalmologist), Lancaster

AV Pediatrics, Allergy and Family Medicine (PFT, Physical Exam, ECG Review, Lab Review), Lancaster

Jatinder S. Pruthi, MD FACG CPI (Physical Exam, ECG Review, Lab Review), Lancaster

OM Research LLC, Lancaster

98104

Pacific Northwest Retina, Seattle

Richard Bensinger, MD, Seattle

Swedish Medical Center Investigational Drug Services Pharmacy, Seattle

98122

Swedish Medical Center First Hill Endoscopy Center, Seattle

Swedish Medical Center First Hill, Seattle

191015

"FSBEI of Higher Education North-Western State Medical University n.a. I.I. Mechnikov of MoH RF", Saint Petersburg

197022

"FSBEI of Higher Education I.P.Pavlov First Saint Petersburg State Medical University of MoH of RF", Saint Petersburg

210604

"Health Care Institution Vitebsk Regional Clinical Specialized Center", Vitebsk

214014

"Inter-branch scientific and technical complex Eye microsurgery", Smolensk

214020

"Multidisciplinary Medical center Clinic Park", Smolensk

214031

"Uromed LLC", Smolensk

230023

"Foreign Medical and Pharmaceutical Unitary Enterprise Medical center Novoe Zrenie", Grodno

230026

"Health Care Institution Grodno City Clinical Hospital #4", Grodno

246027

"Institution Gomel Regional Specialized Clinical Hospital", Homyel

246029

"Institution Gomel Regional Clinical Hospital", Homyel

355017

"Autonomous Noncommercial Medical Organization Stavropol Regional Clinical Advisory-Diagnostic", Stavropol

357500

"Clinic Ultrasound 4D LLC", Pyatigorsk

"Platnaya poliklinika LLC", Pyatigorsk

443001

"Private Institution, Educational Organization of Higher Education Medical University Reaviz", Samara

443011

"Private Institution, Educational Organization of Higher Education Medical University Reaviz,", Samara

443029

Clinical Hospital Russian Railways - Medicina, Samara

443045

"Medical Company Hepatolog LLC", Samara

443063

"Medical Company Hepatolog LLC", Samara

443093

Samara Diagnostic center, Samara

443125

Regional Medical center LLC (Branchevsky's clinic), Samara

603126

"SBHI of Nizhniy Novgorod region Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko", Nizhny Novgorod

644013

"BHI of Omsk region Clinical oncology dispensary", Omsk

644024

"Clinicodiagnostic center Ultramed", Omsk

644070

"Medical center Intervzglyad", Omsk

2210001

Galilee Medical Center, Nahariya

4941492

Rabin Medical Center, Petah Tikva

5822012

Edith Wolfson Medical Center, Holon

9103102

Shaare Zedek Medical Center, Jerusalem

03756

Dartmouth-Hitchcock Medical Center, Lebanon

Unknown

Vitebsk Regional Clinical Specialized Center, Vitebsk

680 01

Gastroenterologicka ambulance, Boskovice

500 12

Hepato-Gastroenterologie HK, s.r.o., Hradec Králové

VISUS, spol s.r.o., Hradec Králové

779 00

Gastroenterologicka ordinace MUDr. Pavla Skalova s.r.o., MUDr. Frantisek Sincl s.r.o., Olomouc

MUDr. Pavlina Kazinotova, s.r.o., Olomouc

PreventaMed s.r.o., Olomouc

708 52

Fakultni nemocnice Ostrava, Ostrava-Poruba

796 01

Privatni gastroenterologicka ambulance s.r.o. MUDr. Zdenek Vlk, Prostějov

750 02

Gastroenterologicka ambulance MUDr. Marcela Vyslouzilova, Přerov

274 01

Nemocnice Slany, Slaný

Poliklinika Slany, spol. s.r.o., Slaný

755 01

Gatronell s.r.o, Vsetín

06202

Centre Hospitalier Universitaire de Nice - Hopital de l'Archet 2, Nice

0112

LLC Academic Pridon Todua Medical Center - LLC Research Institute of Clinical Medicine, Tbilisi

LLC Todua Clinic, Tbilisi

LTD Israeli-Georgian Medical Research Clinic Helsicore, Tbilisi

0131

LTD Vivamedi, Tbilisi

0159

LTD Institute of Clinical Cardiology, Tbilisi

Medical Center CITO LTD, Tbilisi

0160

JSC Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi

LTD Academician Nikoloz Kipshidze Central University Clinic, Tbilisi

LTD Aversi Clinic, Tbilisi

0172

LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, Tbilisi

00168

Fondazione Policlinico Agostino Gemelli IRCCS, Roma

60-681

NSZOZ Termedica - Centrum Badan Klinicznych, Poznan

34-400

Allmedica Badania Kliniczne Sp. z o.o. Sp. k., Nowy Targ

32-600

Medicome Sp. z o.o., Oświęcim

MEDICOME- Oswiecimskie Centrum Medyczne (OCT), Oświęcim

52-416

Centrum Medyczne Oporow, Wroclaw

53-162

OKOLEK, Wroclaw

54-144

EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu, Wroclaw

01-138

lnstytut Gruzlicy i Chorob Pluc, Warsaw

70-233

Spoldzielnia Pracy Lekarzy Specjalistow Medicus (for OCT), Szczecin

71-434

Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin

71-610

Przychodnia EVOMED Pracownia USG i RTG, Szczecin

43-360

Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO), Bystra

90-338

Centrum Medyczne Ksiezy Mlyn sp. z o.o. (Ophtalmoscopy, OCT), Lodz

91-053

"Centra Medyczne 'MEDYCEUSZ (Chest X-Ray)", Lodz

91-347

Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy), Lodz

93-513

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz

00-635

Centrum Zdrowia MDM, Warsaw

53-661

Endomed, Wroclaw

90-644

Amicare Sp. z o.o. Sp.k., Lodz

90-752

IP Clinic Sp. z o.o., Lodz

91-495

Amicare Sp. z o.o. Sp.k., Lodz

4200-319

Centro Hospitalar Universitario de Sao Joao, E.P.E, Porto

03722

Endoscopy Facility in Severance Hospital, Yonsei University Health System, Seoul

OCT(1) Facility in Severance Hospital, Yonsei University Health System, Seoul

OCT(2) Facility in Severance Hospital, Yonsei University Health System, Seoul

PFT(1) Facility Severance Hospital, Yonsei University Health System, Seoul

PFT(2) Facility Severance Hospital, Yonsei University Health System, Seoul

Severance Hospital, Yonsei University Health System, Seoul

02091

CNE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council (Kyiv City State, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Arena is a wholly owned subsidiary of Pfizer

INDUSTRY

lead

Pfizer

INDUSTRY

NCT04607837 - Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | Biotech Hunter | Biotech Hunter