Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
GLADIATOR UC
A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis
3 other identifiers
interventional
234
17 countries
287
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2021
Typical duration for phase_2
287 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedStudy Start
First participant enrolled
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2024
CompletedResults Posted
Study results publicly available
July 15, 2025
CompletedJuly 15, 2025
July 1, 2025
3.2 years
October 23, 2020
June 13, 2025
July 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS)
MMS is used to assess disease activity in participants with UC and has following components: endoscopic score(ES),rectal bleeding(RB),stool frequency(SF).Each component score ranges from 0 to 3(0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease.ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,scores ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding, ulceration\]).RB reported most severe amount of blood passed per rectum in 24-hour period,scores ranged from 0(no blood seen) to 3(blood alone passes).SF reported number of stools in 24-hour period relative to normal number of stools for that participant in same period,scores ranged from 0(normal number of stools) to 3(5 or more stools than normal).CR per FDA draft guidance defined as:SF=0 or 1 and no greater than baseline, RB=0,ES less than or equal to (\<=)1(excluding friability).Percentage of participants achieving CR at Week 52 was evaluated.
Week 52
Secondary Outcomes (19)
Percentage of Participants Achieving Clinical Remission at Week 12 Using MMS
Week 12
Percentage of Participants Achieving Endoscopic Improvement at Week 52
Week 52
Percentage of Participants Achieving Symptomatic Remission at Week 52
Week 52
Percentage of Participants Achieving Complete Symptomatic Remission at Week 52
Week 52
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 52
Week 52
- +14 more secondary outcomes
Other Outcomes (2)
Number of Participants With Adverse Events (AEs)
From first dose of study treatment up to 4 weeks post last dose of study treatment (up to 56 Weeks)
Number of Participants With AEs Based on Severity
From first dose of study treatment up to 4 weeks post last dose of study treatment (up to 56 Weeks)
Study Arms (2)
Etrasimod 2 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe extensive colitis
- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
- Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Arena is a wholly owned subsidiary of Pfizercollaborator
Study Sites (288)
Center for Digestive Health (Colonoscopy Location)
Dothan, Alabama, 36301, United States
Digestive Health Specialists
Dothan, Alabama, 36301, United States
Dothan Eyecare-Dr. Brent McKinley (OCT Location)
Dothan, Alabama, 36301, United States
Pulmonary Associates (Secondary PFT Location)
Dothan, Alabama, 36301, United States
Flowers Hospital (PFT Location)
Dothan, Alabama, 36305, United States
Arizona Retina Institute/ Phoenix Retina Associates(OCT)
Peoria, Arizona, 85381, United States
SimonMed Imaging (Imaging)
Peoria, Arizona, 85381, United States
Sun City Endoscopy (Endoscopy)
Sun City, Arizona, 85351, United States
Euclid Endoscopy Center-El Cajon (Endoscopy procedure only)
El Cajon, California, 92020, United States
Center for Clinical Research (CCR)
Irvine, California, 92697, United States
UCI Gavin Herbert Eye Institute
Irvine, California, 92697, United States
UCI Gottschalk Medical Plaza
Irvine, California, 92697, United States
Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only)
La Mesa, California, 91942, United States
Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only)
La Mesa, California, 91942, United States
Advanced Endoscopy and Pain Center (Colonoscopy)
Lancaster, California, 93534, United States
Advanced Imaging Center (Chest X-Ray)
Lancaster, California, 93534, United States
Antelope Valley Eye Care (Ophthalmologist)
Lancaster, California, 93534, United States
AV Pediatrics, Allergy and Family Medicine (PFT, Physical Exam, ECG Review, Lab Review)
Lancaster, California, 93534, United States
Jatinder S. Pruthi, MD FACG CPI (Physical Exam, ECG Review, Lab Review)
Lancaster, California, 93534, United States
OM Research LLC
Lancaster, California, 93534, United States
Abraham M. lshaaya MD (X-Ray)
Los Angeles, California, 90036, United States
Entertainment Medical Group, Inc (Main Site, Subject Visits, IP Delivery/Storage, Regulatory,
Los Angeles, California, 90036, United States
Advanced Vision Care (OCT)
Los Angeles, California, 90067, United States
Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist)
Los Angeles, California, 90067, United States
Gastrointestinal Biosciences Clinical Trials, LLC
Los Angeles, California, 90067, United States
United Surgery Center Murrieta [Endoscopy Only]
Murrieta, California, 92562, United States
United Medical Doctors
Murrieta, California, 92563, United States
CCR-ICTS Center for Innovative Patient Care
Orange, California, 92697, United States
UCI Health Eye Care Services (Ophthalmoscopy and OCTs)
Orange, California, 92868, United States
UCI Health H. H. Chao Comprehensive Digestive Disease Center
Orange, California, 92868, United States
UCI Investigational Drug Services (IDSP - Pharmacy)
Orange, California, 92868, United States
UCI Irvine Medical Center - Pulmonology Services - PFTs
Orange, California, 92868, United States
ACRC Studies
San Diego, California, 92119, United States
California Eye Professionals [OCT Only]
Temecula, California, 92591, United States
United Surgery Center Temecula [Endoscopy Only]
Temecula, California, 92592, United States
Front Range Endoscopy Center
Colorado Springs, Colorado, 80903, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Colorado Springs Pulmonary Consultants, PC
Colorado Springs, Colorado, 80909, United States
The Wright Eye Center (OCT Facility)
Colorado Springs, Colorado, 80909, United States
Colorado Springs Imaging
Colorado Springs, Colorado, 80919, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80920, United States
Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
Brandon, Florida, 33511, United States
Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)
Clearwater, Florida, 33756, United States
GASTRO FLORIDA (ADMINISTRATIVE DUTIES etc. CRA visits)
Clearwater, Florida, 33756, United States
West Coast Endoscopy (Colonoscopy Procedures)
Clearwater, Florida, 33756, United States
West Coast Endoscopy Center (Endoscopy Procedures)
Clearwater, Florida, 33756, United States
West Coast Radiology (Chest X-ray)
Clearwater, Florida, 33756, United States
Northwood Vision- Optical Coherence Tomography (OCT)
Clearwater, Florida, 33761, United States
Beraja Medical Institute (OCT)
Coral Gables, Florida, 33134, United States
Juan Barrio, MD (PFT when needed)
Coral Gables, Florida, 33134, United States
The Endoscopy Center (Endoscopy Procedure)
Miami, Florida, 33134, United States
Research Associates of South Florida
Miami, Florida, 33156, United States
Kendall Endoscopy and Surgery Center (Endoscopy)
Miami, Florida, 33157, United States
Clarin Eye Care Center (OCT/Ophthalmoscopy)
Miami, Florida, 33176, United States
NSB Research
New Smyrna Beach, Florida, 32168, United States
IMIC Inc
Palmetto Bay, Florida, 33157, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Larkin Community Hospital (Endoscopy Procedure)
South Miami, Florida, 33143, United States
Absolute Surgical Specialists - Craig Amshel, MD
Sun City Center, Florida, 33573, United States
SimonMed Imaging
Tampa, Florida, 33069, United States
Perez Eye Center(OCT & Ophthalmoscopy only)
Tampa, Florida, 33603, United States
Tampa Bay Endoscopy Center(Proctosigmoidoscopy & colonoscopy ONLY)
Tampa, Florida, 33603, United States
Tampa Bay Endoscopy Center
Tampa, Florida, 33603, United States
Lyracore Health Alliance, Tampa Bay Pulmonology (PFT only)
Tampa, Florida, 33606, United States
Pulmonary and Sleep of Tampa Bay(PFT with DLCO only)
Tampa, Florida, 33607, United States
GCP Clinical Research,LLC
Tampa, Florida, 33609, United States
LoCicero Medical Group (PFT Procedure Only)
Tampa, Florida, 33609, United States
NewsomEye (OCT only)
Tampa, Florida, 33609, United States
South Tampa Surgery Center
Tampa, Florida, 33609, United States
GI Alliance (Patients Seen; IP Delivered)
Gurnee, Illinois, 60031, United States
Medical Eye Services LTD (Ophthalmoscopy with OCT)
Gurnee, Illinois, 60031, United States
North Shore Endoscopy Center (Endoscopy)
Lake Bluff, Illinois, 60044, United States
Libertyville Imaging Center (Diagnostic Imaging)
Libertyville, Illinois, 60048, United States
Chevy Chase Endoscopy Center (Endoscopy Facility Only)
Chevy Chase, Maryland, 20815, United States
Chevy Chase Pulmonary Associate (PFT Only)
Chevy Chase, Maryland, 20815, United States
Retina Group of Washington (Ophthalmoscopy and OCT Only)
Chevy Chase, Maryland, 20815, United States
Charter Radiology
Columbia, Maryland, 21044, United States
Cascades Endoscopy Center
Columbia, Maryland, 21045, United States
Gastro Center of Maryland, LLC
Columbia, Maryland, 21045, United States
Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
Hanover, Maryland, 21076, United States
Lung Center (Pulmonary Function Test only)
Laurel, Maryland, 20707, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Advantage Diagnostics(X-Ray only)
Beachwood, Ohio, 44122, United States
Geauga Sleep Center(PFT only)
Chardon, Ohio, 44024, United States
UC Health Physicians Office
Cincinnati, Ohio, 45219, United States
UC Health (Pulmonary Function Testing)
Cincinnati, Ohio, 45229, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
The Endoscopy Center of Lake County
Mentor, Ohio, 44060, United States
Vitreo Retinal Consultants(OCT only)
Painesville, Ohio, 44077, United States
Lake Pulmonary Associates (PFT only)
Willoughby, Ohio, 44094, United States
Retina Specialists of Ohio(OCT only)
Willoughby Hills, Ohio, 44094, United States
West Shore Endoscopy Center
Camp Hill, Pennsylvania, 17011, United States
Pulmonary and Critical Care Medicine Associates (PFT only)
Harrisburg, Pennsylvania, 17102, United States
Medical Arts Allergy,PC (PFT Only)
Harrisburg, Pennsylvania, 17109, United States
Farrel Opthalmology(OCT only)
Harrisburg, Pennsylvania, 17110, United States
Pinnacle Health Imaging at Tristan (X-Ray only)
Harrisburg, Pennsylvania, 17110, United States
Susquehanna Research Group
Harrisburg, Pennsylvania, 17110, United States
Harrisburg Eye Associates (OCT only)
Harrisburg, Pennsylvania, 17111, United States
Pulmonary and Critical Care Medicine Associates (PFT only)
Lemoyne, Pennsylvania, 17043, United States
Advanced Radiology Associates (x-Ray only)
Edinburg, Texas, 78539, United States
Texas Retina Associates (OCT Location)
Grapevine, Texas, 76051, United States
Alkek Eye Center Jamail Specialtu Care Center (OCT)
Houston, Texas, 77030, United States
Baylor College of Medicine- Baylor Medical Center
Houston, Texas, 77030, United States
Baylor College of Medicine-Baylor Medical Center (Chest X-ray location)
Houston, Texas, 77030, United States
Baylor College of Medicine-Baylor Medical Center (IP Storage)
Houston, Texas, 77030, United States
Baylor College of Medicine-Baylor Medical Center (Patients seen address, ECG location, PFT)
Houston, Texas, 77030, United States
Baylor St. Luke's Medical Center Endoscopy- Mc Nair Campus (Endoscopy Location)
Houston, Texas, 77030, United States
Lonestar Endoscopy
Keller, Texas, 76248, United States
Buena Vista Optical ( OCT only)
McAllen, Texas, 78501, United States
Endoscopy Center at Med Point (Endoscopy only)
McAllen, Texas, 78503, United States
Valley Pulmonary Group (PFT only)
McAllen, Texas, 78503, United States
Envision Imaging
Southlake, Texas, 76092, United States
Lonestar Endoscopy
Southlake, Texas, 76092, United States
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
Southlake, Texas, 76092, United States
Christus Trinity Mother Frances Endoscopy Center
Tyler, Texas, 75701, United States
Christus Trinity Mother Frances Endosopy Center ( endoscopies only)
Tyler, Texas, 75701, United States
Heaton Eye Associates (OCT only)
Tyler, Texas, 75701, United States
Tyler Open MRI (chest x-ray only)
Tyler, Texas, 75701, United States
UT Health East Texas Physicians (pulmonary functions only)
Tyler, Texas, 75701, United States
Citizen Healthplex (PFT)
Victoria, Texas, 77904, United States
Gastro Health & Nutrition - Victoria
Victoria, Texas, 77904, United States
Surgery Center (Endoscopy)
Victoria, Texas, 77904, United States
Victoria Eye Center (OCT and Opthalmoscopy)
Victoria, Texas, 77904, United States
Harman Eye Center (OCT only)
Forest, Virginia, 24551, United States
Lynchburg Pulmonary Associates, Inc. (PFT only)
Lynchburg, Virginia, 24501, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Radiology Consultants of Lynchburg (X-ray only)
Lynchburg, Virginia, 24502, United States
Pacific Northwest Retina
Seattle, Washington, 98104, United States
Richard Bensinger, MD
Seattle, Washington, 98104, United States
Swedish Medical Center Investigational Drug Services Pharmacy
Seattle, Washington, 98104, United States
Swedish Medical Center First Hill Endoscopy Center
Seattle, Washington, 98122, United States
Swedish Medical Center First Hill
Seattle, Washington, 98122, United States
Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )
Birtinya, Queensland, 4575, Australia
Sunshine Coast Radiology
Birtinya, Queensland, 4575, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, 4575, Australia
Buderim Eye Centre( OCT and Ophthalmoscopy Facility)
Buderim, Queensland, 4575, Australia
Coral Sea Clinical Research Institute Pty.Ltd
Mackay, Queensland, 4740, Australia
Coastal Digestive Helath Pty. Ltd
Maroochydore, Queensland, 4558, Australia
Dr.Shiran DeSilva Respiratory Clinic (PFT)
North Mackay, Queensland, 4740, Australia
Mater Misericordiae Hospital ( Endoscopy)
North Mackay, Queensland, 4740, Australia
Queensland X-Ray
North Mackay, Queensland, 4740, Australia
Vision Eye Institute Mackay (OCT)
North Mackay, Queensland, 4740, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Melbourne Health
Parkville, Victoria, 3050, Australia
Foreign Medical and Pharmaceutical Unitary Enterprise "Medical center "Novoe Zrenie"
Grodno, 230023, Belarus
Health Care Institution "Grodno City Clinical Hospital #4"
Grodno, 230026, Belarus
Institution "Gomel Regional Specialized Clinical Hospital"
Homyel, 246027, Belarus
Institution "Gomel Regional Clinical Hospital"
Homyel, 246029, Belarus
Health Care Institution "Vitebsk Regional Clinical Specialized Center"
Vitebsk, 210604, Belarus
Vitebsk Regional Clinical Specialized Center
Vitebsk, Belarus
AZ Delta
Roeselare, 8800, Belgium
UMHAT ,,Kanev" AD
Rousse, 7002, Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407, Bulgaria
Acibadem City Clinic University Hospital EOOD
Sofia, 1407, Bulgaria
DCC Alexandrovska, EOOD
Sofia, 1431, Bulgaria
UMHAT "Aleksandrovska" EAD (Colonoscopy/Sigmoidoscopy Facility)
Sofia, 1431, Bulgaria
UMHAT Aleksandrovska EAD (X-Ray Facility)
Sofia, 1431, Bulgaria
UMHAT "Tsaritsa Yoanna-ISUL" EAD
Sofia, 1527, Bulgaria
UMHAT ''Tsaritsa Yoanna-lSUL" EAD (Colonoscopy/ Sigmoidoscopy Facility)
Sofia, 1527, Bulgaria
UMHAT Tsaritsa Yoanna - ISUL EAD (X-ray)
Sofia, 1527, Bulgaria
University multiprofile hospital for active treatment and emergency medicine N.l Pirogov EAD
Sofia, 1606, Bulgaria
Diagnostic Consultation Center CONVEX EOOD
Sofia, 1680, Bulgaria
Acibadem City Clinic University Hospital Eood
Sofia, 1784, Bulgaria
Medical Centre MEDICA Plus OOD
Veliko Tarnovo, 5000, Bulgaria
Gastroenterologicka ambulance
Boskovice, 680 01, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
VISUS, spol s.r.o.
Hradec Králové, 500 12, Czechia
Gastroenterologicka ordinace MUDr. Pavla Skalova s.r.o., MUDr. Frantisek Sincl s.r.o.
Olomouc, 779 00, Czechia
MUDr. Pavlina Kazinotova, s.r.o.
Olomouc, 779 00, Czechia
PreventaMed s.r.o.
Olomouc, 779 00, Czechia
Gastroenterologie-interna, SPEA
Olomouc, 77900, Czechia
Vojenska nemocnice Olomouc
Olomouc, 77900, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, 708 52, Czechia
Privatni gastroenterologicka ambulance s.r.o. MUDr. Zdenek Vlk
Prostějov, 796 01, Czechia
Gastroenterologicka ambulance MUDr. Marcela Vyslouzilova
Přerov, 750 02, Czechia
Nemocnice Slany
Slaný, 274 01, Czechia
Poliklinika Slany, spol. s.r.o.
Slaný, 274 01, Czechia
Gatronell s.r.o
Vsetín, 755 01, Czechia
Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon
Grenoble, 38043, France
Centre Hospitalier Universitaire de Nantes - Hotel-Dieu
Nantes, 44093, France
Centre Hospitalier Universitaire de Nice - Hopital de l'Archet 2
Nice, 06202, France
LLC Academic Pridon Todua Medical Center - LLC Research Institute of Clinical Medicine
Tbilisi, 0112, Georgia
LLC Todua Clinic
Tbilisi, 0112, Georgia
LTD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112, Georgia
LTD Vivamedi
Tbilisi, 0131, Georgia
LTD Institute of Clinical Cardiology
Tbilisi, 0159, Georgia
Medical Center CITO LTD
Tbilisi, 0159, Georgia
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, 0160, Georgia
LTD Academician Nikoloz Kipshidze Central University Clinic
Tbilisi, 0160, Georgia
LTD Aversi Clinic
Tbilisi, 0160, Georgia
LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
Tbilisi, 0172, Georgia
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Bonn, 53123, Germany
Florence-Nightingale-Krankenhaus
Düsseldorf, 40489, Germany
OCT: nordBLICK Augenklinik Bellevue
Kiel, 24105, Germany
Universitatsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
OCT: Dr. med. Christopher Kallen
Krefeld, 47798, Germany
OCT: Augenpraxisklinik REMSCHEID
Remscheid, 42853, Germany
Magen-Darm-Zentrum Remscheid
Remscheid, 42859, Germany
Bugat Pal Korhaz
Gyöngyös, Heves County, 3200, Hungary
DLCO and ophthalmology tests: Szent Borbala Korhaz
Tatabánya, Komárom-Esztergom, 2800, Hungary
Clinfan Szolgaltato Kft.
Szekszárd, Tolna County, 7100, Hungary
Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz
Szekszárd, Tolna County, 7100, Hungary
Ophthalmology tests: Tosho Kft.
Budapest, 1025, Hungary
Mediszem Kft.
Budapest, 1051, Hungary
Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
Budapest, 1062, Hungary
Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
Budapest, 1062, Hungary
Honvedkorhaz II. telephely
Budapest, 1068, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests)
Budapest, 1068, Hungary
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest, 1088, Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, 1136, Hungary
Edith Wolfson Medical Center
Holon, 5822012, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Azienda Ospedaliera Saverio De Bellis
Puglia, BARI, 70013, Italy
IRCCS Ospedale San Raffaele, Unita di Gastroenterologia
Milan, Milan, 20132, Italy
Fondazione Policlinico Agostino Gemelli IRCCS
Roma, ROME, 00168, Italy
Ospedale San Bortolo di Vicenza, Gastroenterologia
Vicenza, Veneto, 36100, Italy
NSZOZ Termedica - Centrum Badan Klinicznych
Poznan, Greater Poland Voivodeship, 60-681, Poland
Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
Nowy Targ, Lesser Poland Voivodeship, 34-400, Poland
Medicome Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
Centrum Medyczne Oporow
Wroclaw, Lower Silesian Voivodeship, 52-416, Poland
OKOLEK
Wroclaw, Lower Silesian Voivodeship, 53-162, Poland
EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 54-144, Poland
lnstytut Gruzlicy i Chorob Pluc
Warsaw, Masovian Voivodeship, 01-138, Poland
Spoldzielnia Pracy Lekarzy Specjalistow Medicus (for OCT)
Szczecin, West Pomeranian Voivodeship, 70-233, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Przychodnia EVOMED Pracownia USG i RTG
Szczecin, West Pomeranian Voivodeship, 71-610, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
Bystra, 43-360, Poland
Centrum Medyczne Ksiezy Mlyn sp. z o.o. (Ophtalmoscopy, OCT)
Lodz, 90-338, Poland
Centra Medyczne 'MEDYCEUSZ" (Chest X-Ray)
Lodz, 91-053, Poland
Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy)
Lodz, 91-347, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, 93-513, Poland
MEDICOME- Oswiecimskie Centrum Medyczne (OCT)
Oświęcim, 32-600, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
Endomed
Wroclaw, 53-661, Poland
Amicare Sp. z o.o. Sp.k.
Lodz, Łódź Voivodeship, 90-644, Poland
IP Clinic Sp. z o.o.
Lodz, Łódź Voivodeship, 90-752, Poland
Amicare Sp. z o.o. Sp.k.
Lodz, Łódź Voivodeship, 91-495, Poland
Centro Hospitalar Universitario de Sao Joao, E.P.E
Porto, 4200-319, Portugal
"Clinic Ultrasound 4D" LLC
Pyatigorsk, Stavropol Kray, 357500, Russia
"Platnaya poliklinika" LLC
Pyatigorsk, Stavropol Kray, 357500, Russia
SBHI of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, 603126, Russia
BHI of Omsk region "Clinical oncology dispensary"
Omsk, 644013, Russia
Clinicodiagnostic center "Ultramed"
Omsk, 644024, Russia
Medical center "Intervzglyad"
Omsk, 644070, Russia
FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF
Saint Petersburg, 191015, Russia
FSBEI of Higher Education "I.P.Pavlov First Saint Petersburg State Medical University" of MoH of RF
Saint Petersburg, 197022, Russia
Private Institution, Educational Organization of Higher Education "Medical University "Reaviz"
Samara, 443001, Russia
Private Institution, Educational Organization of Higher Education "Medical University "Reaviz",
Samara, 443011, Russia
Clinical Hospital Russian Railways - Medicina
Samara, 443029, Russia
Medical Company "Hepatolog" LLC
Samara, 443045, Russia
Medical Company "Hepatolog" LLC
Samara, 443063, Russia
Samara Diagnostic center
Samara, 443093, Russia
Regional Medical center LLC (Branchevsky's clinic)
Samara, 443125, Russia
Inter-branch scientific and technical complex "Eye microsurgery"
Smolensk, 214014, Russia
Multidisciplinary Medical center "Clinic Park"
Smolensk, 214020, Russia
"Uromed" LLC
Smolensk, 214031, Russia
Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical Advisory-Diagnostic
Stavropol, 355017, Russia
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Endoscopy Facility in kyungpook National University Hospital
Daegu, 41944, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
OCT Facility In kyungpook Natioanl University Hospital
Daegu, 41944, South Korea
PFT Facility in kyungpook Natioanl University Hospital
Daegu, 41944, South Korea
Endoscopy Facility in Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
OCT(1) Facility in Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
OCT(2) Facility in Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
PFT(1) Facility Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
PFT(2) Facility Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Hospital Universitario la Paz
Madrid, 28046, Spain
Limited Liability Company "Lookout "Medical Center"
Dnipro, 49000, Ukraine
Limited Liability Company "MDC EXPERT"
Dnipro, 49005, Ukraine
Municipal Enterprise <<Dnipro Reg Clinical Hosp named after M. I.I. Mechnikov>>
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Clinical Diagnostical Center "Simedgroup"
Ivano-Frankivsk, 76008, Ukraine
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Ivano-Frankivsk, 76008, Ukraine
Llc "Ldts-Skaymed"
Kharkiv, 61022, Ukraine
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Llc Medical Center Oftalmika
Kharkiv, 61045, Ukraine
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Kyiv, 02091, Ukraine
Transcarpathian Center of Eye Microsurgery
Uzhhorod, 88017, Ukraine
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Vinnytsia, 21009, Ukraine
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Vinnytsia, 21018, Ukraine
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Vinnytsia, 21018, Ukraine
Scientific and Research Institute of lnvalid Rehabilitation (Educational and Scientific
Vinnytsia, 21029, Ukraine
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Vinnytsia, 21032, Ukraine
Llc "Optimal M"
Vinnytsia, 21036, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 23, 2020
First Posted
October 29, 2020
Study Start
April 12, 2021
Primary Completion
June 19, 2024
Study Completion
June 19, 2024
Last Updated
July 15, 2025
Results First Posted
July 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
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.