A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis
Who is this study for? Adults with moderately active ulcerative colitis
What treatments are being studied? Etrasimod
Status: Completed
Location: See all (274) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
• Active UC confirmed by endoscopy
• Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1
• Received a surveillance colonoscopy within 12 months before baseline
Locations
United States
Alabama
Center for Digestive Health (Colonoscopy Location)
Dothan
Digestive Health Specialists
Dothan
Dothan Eyecare-Dr. Brent McKinley (OCT Location)
Dothan
Flowers Hospital (PFT Location)
Dothan
Pulmonary Associates (Secondary PFT Location)
Dothan
Arizona
Arizona Retina Institute/ Phoenix Retina Associates(OCT)
Peoria
SimonMed Imaging (Imaging)
Peoria
Sun City Endoscopy (Endoscopy)
Sun City
California
Euclid Endoscopy Center-El Cajon (Endoscopy procedure only)
El Cajon
Center for Clinical Research (CCR)
Irvine
UCI Gavin Herbert Eye Institute
Irvine
UCI Gottschalk Medical Plaza
Irvine
Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only)
La Mesa
Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only)
La Mesa
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
Abraham M. lshaaya MD (X-Ray)
Los Angeles
Advanced Vision Care (OCT)
Los Angeles
Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist)
Los Angeles
Entertainment Medical Group, Inc (Main Site, Subject Visits, IP Delivery/Storage, Regulatory,
Los Angeles
Gastrointestinal Biosciences Clinical Trials, LLC
Los Angeles
United Medical Doctors
Murrieta
United Surgery Center Murrieta [Endoscopy Only]
Murrieta
CCR-ICTS Center for Innovative Patient Care
Orange
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
ACRC Studies
San Diego
California Eye Professionals [OCT Only]
Temecula
United Surgery Center Temecula [Endoscopy Only]
Temecula
Colorado
Colorado Springs Imaging
Colorado Springs
Colorado Springs Pulmonary Consultants, PC
Colorado Springs
Front Range Endoscopy Center
Colorado Springs
Peak Gastroenterology Associates
Colorado Springs
Peak Gastroenterology Associates
Colorado Springs
The Wright Eye Center (OCT Facility)
Colorado Springs
Florida
Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
Brandon
Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)
Clearwater
GASTRO FLORIDA (ADMINISTRATIVE DUTIES etc. CRA visits)
Clearwater
Northwood Vision- Optical Coherence Tomography (OCT)
Clearwater
West Coast Endoscopy (Colonoscopy Procedures)
Clearwater
West Coast Endoscopy Center (Endoscopy Procedures)
Clearwater
West Coast Radiology (Chest X-ray)
Clearwater
Beraja Medical Institute (OCT)
Coral Gables
Juan Barrio, MD (PFT when needed)
Coral Gables
Clarin Eye Care Center (OCT/Ophthalmoscopy)
Miami
Kendall Endoscopy and Surgery Center (Endoscopy)
Miami
Research Associates of South Florida
Miami
The Endoscopy Center (Endoscopy Procedure)
Miami
NSB Research
New Smyrna Beach
IMIC Inc
Palmetto Bay
Advanced Medical Research Center
Port Orange
Larkin Community Hospital (Endoscopy Procedure)
South Miami
Absolute Surgical Specialists - Craig Amshel, MD
Sun City Center
GCP Clinical Research,LLC
Tampa
LoCicero Medical Group (PFT Procedure Only)
Tampa
Lyracore Health Alliance, Tampa Bay Pulmonology (PFT only)
Tampa
NewsomEye (OCT only)
Tampa
Perez Eye Center(OCT & Ophthalmoscopy only)
Tampa
Pulmonary and Sleep of Tampa Bay(PFT with DLCO only)
Tampa
SimonMed Imaging
Tampa
South Tampa Surgery Center
Tampa
Tampa Bay Endoscopy Center
Tampa
Tampa Bay Endoscopy Center(Proctosigmoidoscopy & colonoscopy ONLY)
Tampa
Illinois
GI Alliance (Patients Seen; IP Delivered)
Gurnee
Medical Eye Services LTD (Ophthalmoscopy with OCT)
Gurnee
North Shore Endoscopy Center (Endoscopy)
Lake Bluff
Libertyville Imaging Center (Diagnostic Imaging)
Libertyville
Maryland
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
Cascades Endoscopy Center
Columbia
Charter Radiology
Columbia
Gastro Center of Maryland, LLC
Columbia
Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
Hanover
Lung Center (Pulmonary Function Test only)
Laurel
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
Ohio
Advantage Diagnostics(X-Ray only)
Beachwood
Geauga Sleep Center(PFT only)
Chardon
UC Health (Pulmonary Function Testing)
Cincinnati
UC Health Physicians Office
Cincinnati
University of Cincinnati College of Medicine
Cincinnati
The Endoscopy Center of Lake County
Mentor
Vitreo Retinal Consultants(OCT only)
Painesville
Lake Pulmonary Associates (PFT only)
Willoughby
Retina Specialists of Ohio(OCT only)
Willoughby Hills
Pennsylvania
West Shore Endoscopy Center
Camp Hill
Farrel Opthalmology(OCT only)
Harrisburg
Harrisburg Eye Associates (OCT only)
Harrisburg
Medical Arts Allergy,PC (PFT Only)
Harrisburg
Pinnacle Health Imaging at Tristan (X-Ray only)
Harrisburg
Pulmonary and Critical Care Medicine Associates (PFT only)
Harrisburg
Susquehanna Research Group
Harrisburg
Pulmonary and Critical Care Medicine Associates (PFT only)
Lemoyne
Texas
Advanced Radiology Associates (x-Ray only)
Edinburg
Texas Retina Associates (OCT Location)
Grapevine
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
Lonestar Endoscopy
Keller
Buena Vista Optical ( OCT only)
Mcallen
Endoscopy Center at Med Point (Endoscopy only)
Mcallen
Valley Pulmonary Group (PFT only)
Mcallen
Envision Imaging
Southlake
Lonestar Endoscopy
Southlake
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
Southlake
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
Citizen Healthplex (PFT)
Victoria
Gastro Health & Nutrition - Victoria
Victoria
Surgery Center (Endoscopy)
Victoria
Victoria Eye Center (OCT and Opthalmoscopy)
Victoria
Virginia
Harman Eye Center (OCT only)
Forest
Blue Ridge Medical Research
Lynchburg
Lynchburg Pulmonary Associates, Inc. (PFT only)
Lynchburg
Radiology Consultants of Lynchburg (X-ray only)
Lynchburg
Washington
Pacific Northwest Retina
Seattle
Richard Bensinger, MD
Seattle
Swedish Medical Center First Hill
Seattle
Swedish Medical Center First Hill Endoscopy Center
Seattle
Swedish Medical Center Investigational Drug Services Pharmacy
Seattle
Other Locations
Australia
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
Austin Health
Heidelberg
Coral Sea Clinical Research Institute Pty.Ltd
Mackay
Coastal Digestive Helath Pty. Ltd
Maroochydore
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
Melbourne Health
Parkville
Belarus
Foreign Medical and Pharmaceutical Unitary Enterprise Medical center Novoe Zrenie
Grodno
Health Care Institution Grodno City Clinical Hospital #4
Grodno
Institution Gomel Regional Clinical Hospital
Homyel
Institution Gomel Regional Specialized Clinical Hospital
Homyel
Health Care Institution Vitebsk Regional Clinical Specialized Center
Vitebsk
Vitebsk Regional Clinical Specialized Center
Vitebsk
Belgium
AZ Delta
Roeselare
Bulgaria
UMHAT ,,Kanev AD
Rousse
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia
Acibadem City Clinic University Hospital Eood
Sofia
Acibadem City Clinic University Hospital EOOD
Sofia
DCC Alexandrovska, EOOD
Sofia
Diagnostic Consultation Center CONVEX EOOD
Sofia
UMHAT ''Tsaritsa Yoanna-lSUL EAD (Colonoscopy/ Sigmoidoscopy Facility)
Sofia
UMHAT Aleksandrovska EAD (Colonoscopy/Sigmoidoscopy Facility)
Sofia
UMHAT Aleksandrovska EAD (X-Ray Facility)
Sofia
UMHAT Tsaritsa Yoanna - ISUL EAD (X-ray)
Sofia
UMHAT Tsaritsa Yoanna-ISUL EAD
Sofia
University multiprofile hospital for active treatment and emergency medicine N.l Pirogov EAD
Sofia
Medical Centre MEDICA Plus OOD
Veliko Tarnovo
France
Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon
Grenoble
Centre Hospitalier Universitaire de Nantes - Hotel-Dieu
Nantes
Centre Hospitalier Universitaire de Nice - Hopital de l'Archet 2
Nice
Georgia
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi
LLC Academic Pridon Todua Medical Center - LLC Research Institute of Clinical Medicine
Tbilisi
LLC Todua Clinic
Tbilisi
LTD Academician Nikoloz Kipshidze Central University Clinic
Tbilisi
LTD Aversi Clinic
Tbilisi
LTD Institute of Clinical Cardiology
Tbilisi
LTD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi
LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
Tbilisi
LTD Vivamedi
Tbilisi
Medical Center CITO LTD
Tbilisi
Germany
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Bonn
Florence-Nightingale-Krankenhaus
Düsseldorf
OCT: nordBLICK Augenklinik Bellevue
Kiel
Universitatsklinikum Schleswig-Holstein, Campus Kiel
Kiel
OCT: Dr. med. Christopher Kallen
Krefeld
Magen-Darm-Zentrum Remscheid
Remscheid
OCT: Augenpraxisklinik REMSCHEID
Remscheid
Hungary
Honvedkorhaz II. telephely
Budapest
Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests)
Budapest
Mediszem Kft.
Budapest
Ophthalmology tests: Tosho Kft.
Budapest
Pannonia Maganorvosi Centrum Kft.
Budapest
Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
Budapest
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest
Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
Budapest
Bugat Pal Korhaz
Gyöngyös
Clinfan Szolgaltato Kft.
Szekszárd
Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz
Szekszárd
DLCO and ophthalmology tests: Szent Borbala Korhaz
Tatabánya
Israel
Edith Wolfson Medical Center
Holon
Shaare Zedek Medical Center
Jerusalem
Galilee Medical Center
Nahariya
Rabin Medical Center
Petah Tikva
Italy
IRCCS Ospedale San Raffaele, Unita di Gastroenterologia
Milan
Azienda Ospedaliera Saverio De Bellis
Puglia
Fondazione Policlinico Agostino Gemelli IRCCS
Roma
Ospedale San Bortolo di Vicenza, Gastroenterologia
Vicenza
Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
Bystra
Amicare Sp. z o.o. Sp.k.
Lodz
Amicare Sp. z o.o. Sp.k.
Lodz
Centra Medyczne 'MEDYCEUSZ (Chest X-Ray)
Lodz
Centrum Medyczne Ksiezy Mlyn sp. z o.o. (Ophtalmoscopy, OCT)
Lodz
IP Clinic Sp. z o.o.
Lodz
Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy)
Lodz
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz
Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
Nowy Targ
Medicome Sp. z o.o.
Oświęcim
MEDICOME- Oswiecimskie Centrum Medyczne (OCT)
Oświęcim
NSZOZ Termedica - Centrum Badan Klinicznych
Poznan
Przychodnia EVOMED Pracownia USG i RTG
Szczecin
Spoldzielnia Pracy Lekarzy Specjalistow Medicus (for OCT)
Szczecin
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin
Centrum Zdrowia MDM
Warsaw
lnstytut Gruzlicy i Chorob Pluc
Warsaw
Centrum Medyczne Oporow
Wroclaw
Endomed
Wroclaw
EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
Wroclaw
OKOLEK
Wroclaw
Portugal
Centro Hospitalar Universitario de Sao Joao, E.P.E
Porto
Republic of Korea
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
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
Wonju Severance Christian Hospital
Wŏnju
Russian Federation
SBHI of Nizhniy Novgorod region Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod
BHI of Omsk region Clinical oncology dispensary
Omsk
Clinicodiagnostic center Ultramed
Omsk
Medical center Intervzglyad
Omsk
Clinic Ultrasound 4D LLC
Pyatigorsk
Platnaya poliklinika LLC
Pyatigorsk
FSBEI of Higher Education I.P.Pavlov First Saint Petersburg State Medical University of MoH of RF
Saint Petersburg
FSBEI of Higher Education North-Western State Medical University n.a. I.I. Mechnikov of MoH RF
Saint Petersburg
Clinical Hospital Russian Railways - Medicina
Samara
Medical Company Hepatolog LLC
Samara
Medical Company Hepatolog LLC
Samara
Private Institution, Educational Organization of Higher Education Medical University Reaviz
Samara
Private Institution, Educational Organization of Higher Education Medical University Reaviz,
Samara
Regional Medical center LLC (Branchevsky's clinic)
Samara
Samara Diagnostic center
Samara
Inter-branch scientific and technical complex Eye microsurgery
Smolensk
Multidisciplinary Medical center Clinic Park
Smolensk
Uromed LLC
Smolensk
Autonomous Noncommercial Medical Organization Stavropol Regional Clinical Advisory-Diagnostic
Stavropol
Spain
Hospital Universitario la Paz
Madrid
Ukraine
Limited Liability Company Lookout Medical Center
Dnipro
Limited Liability Company MDC EXPERT
Dnipro
Municipal Enterprise <<Dnipro Reg Clinical Hosp named after M. I.I. Mechnikov>>
Dnipro
Clinical Diagnostical Center Simedgroup
Ivano-frankivsk
CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council,Department of Gastroenterology
Ivano-frankivsk
CNE Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv City Council, Department of Proctology
Kharkiv
Llc Ldts-Skaymed
Kharkiv
Llc Medical Center Oftalmika
Kharkiv
CNE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council (Kyiv City State
Kyiv
CNE Andrii Novak Transcarpathian Regional Clinical Hospital of
Uzhhorod
Transcarpathian Center of Eye Microsurgery
Uzhhorod
CNE Vinnytsia Reg Clinical Hosp named after N.I.Pirogov Vinnytsia Regional Council, Reg Specialize
Vinnytsia
Diagnostic Center Mediscan
Vinnytsia
Llc Optimal M
Vinnytsia
Medical Center of LLC Health Clinic, Med Clinical lnvestigational Center, Unit of Gastroenterology,
Vinnytsia
Podilskyi tsentr zoru
Vinnytsia
Scientific and Research Institute of lnvalid Rehabilitation (Educational and Scientific
Vinnytsia
Time Frame
Start Date: 2021-04-12
Completion Date: 2024-06-19
Participants
Target number of participants: 234
Treatments
Experimental: Etrasimod 2 mg
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: Arena is a wholly owned subsidiary of Pfizer
Leads: Pfizer