Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04607837
Other study ID # APD334-210
Secondary ID C50410112020-003
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date April 12, 2021
Est. completion date July 18, 2024

Study information

Verified date June 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 234
Est. completion date July 18, 2024
Est. primary completion date July 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment

Locations

Country Name City State
Australia Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility ) Birtinya Queensland
Australia Sunshine Coast Radiology Birtinya Queensland
Australia Sunshine Coast University Private Hospital Birtinya Queensland
Australia Buderim Eye Centre( OCT and Ophthalmoscopy Facility) Buderim Queensland
Australia Austin Health Heidelberg Victoria
Australia Coral Sea Clinical Research Institute Pty.Ltd Mackay Queensland
Australia Coastal Digestive Helath Pty. Ltd Maroochydore Queensland
Australia Dr.Shiran DeSilva Respiratory Clinic (PFT) North Mackay Queensland
Australia Mater Misericordiae Hospital ( Endoscopy) North Mackay Queensland
Australia Queensland X-Ray North Mackay Queensland
Australia Vision Eye Institute Mackay (OCT) North Mackay Queensland
Australia Melbourne Health Parkville Victoria
Australia Bankstown-Lidcombe Hospital Sydney New South Wales
Belarus Institution "Gomel Regional Clinical Hospital" Gomel
Belarus Institution "Gomel Regional Specialized Clinical Hospital" Gomel
Belarus Foreign Medical and Pharmaceutical Unitary Enterprise "Medical center "Novoe Zrenie" Grodno
Belarus Health Care Institution "Grodno City Clinical Hospital #4" Grodno
Belarus Health Care Institution "Vitebsk Regional Clinical Specialized Center" Vitebsk
Belarus Vitebsk Regional Clinical Hospital Vitebsk
Belarus Vitebsk Regional Clinical Specialized Center Vitebsk
Belgium AZ Sint-Lucas Gent
Belgium AZ Delta Roeselare
Bulgaria UMHAT ,,Kanev" AD Ruse
Bulgaria Diagnostic-Consultative Center I - Sliven, EOOD Sliven
Bulgaria Acibadem City Clinic University Hospital EOOD Sofia
Bulgaria DCC Alexandrovska, EOOD Sofia
Bulgaria Diagnostic Consultation Center CONVEX EOOD Sofia
Bulgaria UMHAT "Tsaritsa Yoanna-ISUL" EAD Sofia
Bulgaria University multiprofile hospital for active treatment and emergency medicine N.l Pirogov EAD Sofia
Bulgaria Medical Centre MEDICA Plus OOD Veliko Tarnovo
Canada University of Calgary, Department of Medicine - Opthalmology (OCT Only) Calgary Alberta
Canada University of Calgary, Department of Medicine - Respirology (PFT Only) Calgary Alberta
Canada University of Calgary, Heritage Medical Research Clinic Calgary Alberta
Canada London Health Sciences Centre - University Hospital London Ontario
Canada St. Joseph's Hospital (OCT Procedure only) London Ontario
Canada Eye Health MD (OCT) Montreal Quebec
Canada McGill University Health Center- Montreal General Hospital (Electrocardiogram Clinic) Montreal Quebec
Canada McGill University Health Center- Montreal General Hospital (Endoscopy clinic) Montreal Quebec
Canada McGill University Health Center- Montreal General Hospital (IP Address) Montreal Quebec
Canada McGill University Health Center- Montreal General Hospital (Research Site) Montreal Quebec
Canada Montreal General Hospital (MUHC-Radiology) Montreal Quebec
Czechia Gastroenterologicka ambulance Boskovice
Czechia Hepato-Gastroenterologie HK, s.r.o. Hradec Kralove
Czechia VISUS, spol s.r.o. Hradec Kralove
Czechia Gastroenterologicka ordinace MUDr. Pavla Skalova s.r.o., MUDr. Frantisek Sincl s.r.o. Olomouc
Czechia MUDr. Pavlina Kazinotova, s.r.o. Olomouc
Czechia Ocni ordinace Olomouc Olomouc
Czechia PreventaMed s.r.o. Olomouc
Czechia Fakultni nemocnice Ostrava Ostrava-Poruba
Czechia Ocni centrum Praha, a.s. Praha 7
Czechia ISCARE a.s. Praha 9
Czechia Prvni plicni ambulance. s.r.o. Praha 9
Czechia Gastroenterologicka ambulance MUDr. Marcela Vyslouzilova Prerov
Czechia Privatni gastroenterologicka ambulance s.r.o. MUDr. Zdenek Vlk Prostejov
Czechia Nemocnice Slany Slany
Czechia Poliklinika Slany, spol. s.r.o. Slany
France Centre Hospitalier Universitaire de Clermont-Ferrand - Hopital Estaing Clermont-Ferrand Cedex 1
France Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon Grenoble
France Centre Hospitalier Universitaire de Nantes - Hotel-Dieu Nantes Cedex 1
France Centre Hospitalier Universitaire de Nice - Hopital de l'Archet 2 Nice Cedex 3
France CHU RENNES - Hopital Pontchaillou Rennes Cedex 09
Georgia JSC Infectious Diseases, AIDS and Clinical Immunology Research Center Tbilisi
Georgia LLC Academic Pridon Todua Medical Center - LLC Research Institute of Clinical Medicine Tbilisi
Georgia LLC Todua Clinic Tbilisi
Georgia LTD Academician Nikoloz Kipshidze Central University Clinic Tbilisi
Georgia LTD Aversi Clinic Tbilisi
Georgia LTD Institute of Clinical Cardiology Tbilisi
Georgia LTD Israeli-Georgian Medical Research Clinic Helsicore Tbilisi
Georgia LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center Tbilisi
Georgia LTD Vivamedi Tbilisi
Georgia Medical Center CITO LTD Tbilisi
Germany Charite - Universitatsmedizin Berlin, Campus Mitte (CCM) Berlin
Germany OCT Charite - Universitatsmedizin Berlin Berlin
Germany PFT Klinik fur Infektiologie & Pneumologie Berlin
Germany Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling Bonn
Germany Florence-Nightingale-Krankenhaus Duesseldorf
Germany OCT: nordBLICK Augenklinik Bellevue Kiel
Germany Universitatsklinikum Schleswig-Holstein, Campus Kiel Kiel
Germany OCT: Dr. med. Christopher Kallen Krefeld
Germany Johanna Etienne Krankenhaus Neuss
Germany OCT: AOZ Neuss Neuss
Germany Magen-Darm-Zentrum Remscheid Remscheid
Germany OCT: Augenpraxisklinik REMSCHEID Remscheid
Hungary Endoexpert EgeszsegUgyi Szolgaltato Kft. Budapest
Hungary Honvedkorhaz II. telephely Budapest
Hungary Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests) Budapest
Hungary Mediszem Kft. Budapest
Hungary Ophthalmology tests: Tosho Kft. Budapest
Hungary Pannonia Maganorvosi Centrum Kft. Budapest
Hungary Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft. Budapest
Hungary Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika Budapest
Hungary Vasutegeszsegugyi Nonprofit Kozhasznu Kft. Budapest
Hungary Vasutegeszsegugyi Nonprofit Kozhasznu Kft. (Pulmonary function) Budapest
Hungary Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Gasztroenterologia Debrecen
Hungary Bugat Pal Korhaz Gyongyos Heves
Hungary Opthalmology tests: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont,Szemeszeti Klinika Szeged
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Belgyogyaszati Klinika Szeged
Hungary Clinfan Szolgaltato Kft. Szekszard Tolna
Hungary Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz Szekszard Tolna
Hungary DLCO and ophthalmology tests: Szent Borbala Korhaz Tatabanya Komarom-esztergom
Israel Edith Wolfson Medical Center Holon
Israel Shaare Zedek Medical Center Jerusalem
Israel Galilee Medical Center Nahariya
Israel Rabin Medical Center Petah Tikva
Israel Kaplan Medical Center Rehovot
Italy ASST Rhodense - Pneumology Unit Garbagnate Milanese Milan
Italy IRCCS Ospedale San Raffaele, Unita di Gastroenterologia Milano Milan
Italy Azienda Ospedaliera Saverio De Bellis Puglia Bari
Italy ASST Rhodense - Ophthalmology Unit Rho Milan
Italy ASST Rhodense - Ophthalmology Unit (For Ophthalmoscopy) Rho Milan
Italy ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva Rho Milan
Italy Fondazione Policlinico Agostino Gemelli IRCCS Roma Rome
Italy Ospedale San Bortolo di Vicenza, Gastroenterologia Vicenza Veneto
Korea, Republic of Endoscopy Facility in Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Endoscopy Facility in kyungpook National University Hospital Daegu
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of OCT Facility In kyungpook Natioanl University Hospital Daegu
Korea, Republic of OCT Facility in Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of PFT Facility in kyungpook Natioanl University Hospital Daegu
Korea, Republic of PFT Facility in Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Endoscopy Facility in Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of OCT(1) Facility in Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of OCT(2) Facility in Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of PFT(1) Facility Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of PFT(2) Facility Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Wonju Severance Christian Hospital Wonju Kang-won-do
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju-si Gangwon-do
Poland Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO) Bystra
Poland Amicare Sp. z o.o. Sp.k. Lodz Lodzkie
Poland Amicare Sp. z o.o. Sp.k. Lodz Lodzkie
Poland Centra Medyczne 'MEDYCEUSZ" (Chest X-Ray) Lodz
Poland Centrum Medyczne Ksiezy Mlyn sp. z o.o. (Ophtalmoscopy, OCT) Lodz
Poland IP Clinic Sp. z o.o. Lodz Lodzkie
Poland Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy) Lodz
Poland Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz
Poland Allmedica Badania Kliniczne Sp. z o.o. Sp. k. Nowy Targ Malopolskie
Poland Medicome Sp. z o.o. Oswiecim Malopolskie
Poland MEDICOME- Oswiecimskie Centrum Medyczne (OCT) Oswiecim
Poland Centrum Medyczne Grunwald Poznan
Poland Centrum Medyczne Grunwald Poznan
Poland Centrum Medyczne Grunwald Poznan Wielkopolskie
Poland NSZOZ Termedica Poznan Wielkopolskie
Poland NSZOZ Termedica - Centrum Badan Klinicznych Poznan Wielkopolskie
Poland Specjalistyczny Okulistyczny Niepubliczny Zaklad Opieki Zdrowotnej OCUSERVICE Poznan Wielkopolskie
Poland Szpital Sw. Wojciecha Poznan Wielkopolskie
Poland Przychodnia EVOMED Pracownia USG i RTG Szczecin Zachodniopomorskie
Poland Spoldzielnia Pracy Lekarzy Specjalistow Medicus (for OCT) Szczecin Zachodniopomorskie
Poland Twoja Przychodnia-Szczecinskie Centrum Medyczne Szczecin Zachodniopomorskie
Poland Centrum Zdrowia MDM Warsaw
Poland Centrum Zdrowia MDM Warszawa
Poland Centrum Zdrowia MDM Warszawa
Poland Centrum Zdrowia MDM Warszawa Mazowieckie
Poland lnstytut Gruzlicy i Chorob Pluc Warszawa Mazowieckie
Poland Centrum Medyczne Oporow Wroclaw Dolnoslaskie
Poland Endomed Wroclaw
Poland EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu Wroclaw Dolnoslaskie
Poland OKOLEK Wroclaw Dolnoslaskie
Portugal Centro Hospitalar Universitario de Sao Joao, E.P.E Porto
Russian Federation SBHI of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko Nizhniy Novgorod
Russian Federation BHI of Omsk region "Clinical oncology dispensary" Omsk
Russian Federation Clinicodiagnostic center "Ultramed" Omsk
Russian Federation Medical center "Intervzglyad" Omsk
Russian Federation "Clinic Ultrasound 4D" LLC Pyatigorsk Stavropol Region
Russian Federation "Platnaya poliklinika" LLC Pyatigorsk Stavropol Region
Russian Federation FSBEI of Higher Education "I.P.Pavlov First Saint Petersburg State Medical University" of MoH of RF Saint Petersburg
Russian Federation Clinical Hospital Russian Railways - Medicina Samara
Russian Federation Medical Company "Hepatolog" LLC Samara
Russian Federation Medical Company "Hepatolog" LLC Samara
Russian Federation Private Institution, Educational Organization of Higher Education "Medical University "Reaviz" Samara
Russian Federation Private Institution, Educational Organization of Higher Education "Medical University "Reaviz", Samara
Russian Federation Regional Medical center LLC (Branchevsky's clinic) Samara
Russian Federation Samara Diagnostic center Samara
Russian Federation "Uromed" LLC Smolensk
Russian Federation Inter-branch scientific and technical complex "Eye microsurgery" Smolensk
Russian Federation Multidisciplinary Medical center "Clinic Park" Smolensk
Russian Federation FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF St. Petersburg
Russian Federation Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical Advisory-Diagnostic Stavropol
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Universitario la Paz Madrid
Ukraine Limited Liability Company "Lookout "Medical Center" Dnipro
Ukraine Limited Liability Company "MDC EXPERT" Dnipro
Ukraine Municipal Enterprise <<Dnipro Reg Clinical Hosp named after M. I.I. Mechnikov>> Dnipro
Ukraine Clinical Diagnostical Center "Simedgroup" Ivano-Frankivsk
Ukraine CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council,Department of Gastroenterology Ivano-Frankivsk
Ukraine CNE Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv City Council, Department of Proctology Kharkiv
Ukraine Llc "Ldts-Skaymed" Kharkiv
Ukraine Llc Medical Center Oftalmika Kharkiv
Ukraine CNE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council (Kyiv City State Kyiv
Ukraine CNE Andrii Novak Transcarpathian Regional Clinical Hospital of Uzhgorod
Ukraine Transcarpathian Center of Eye Microsurgery Uzhgorod
Ukraine CNE "Vinnytsia Reg Clinical Hosp named after N.I.Pirogov Vinnytsia Regional Council", Reg Specialize Vinnytsia
Ukraine Medical Center of LLC Health Clinic, Med Clinical lnvestigational Center, Unit of Gastroenterology, Vinnytsia
Ukraine Podilskyi tsentr zoru Vinnytsia
Ukraine Scientific and Research Institute of lnvalid Rehabilitation (Educational and Scientific Vinnytsia
Ukraine Diagnostic Center "Mediscan" Vinnytsya
Ukraine Llc "Optimal M" Vinnytsya
United States Advantage Diagnostics(X-Ray only) Beachwood Ohio
United States Eastside Endoscopy Center Bellevue Washington
United States Northwest Vision (OCT only) Bellevue Washington
United States Overlake Clinics- Pulmonary Medicine Bellevue Washington
United States Washington Gastroenterology Bellevue Washington
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD Brandon Florida
United States West Shore Endoscopy Center Camp Hill Pennsylvania
United States Geauga Sleep Center(PFT only) Chardon Ohio
United States Chevy Chase Endoscopy Center (Endoscopy Facility Only) Chevy Chase Maryland
United States Chevy Chase Pulmonary Associate (PFT Only) Chevy Chase Maryland
United States Retina Group of Washington (Ophthalmoscopy and OCT Only) Chevy Chase Maryland
United States UC Health (Pulmonary Function Testing) Cincinnati Ohio
United States UC Health Physicians Office Cincinnati Ohio
United States University of Cincinnati College of Medicine Cincinnati Ohio
United States Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test) Clearwater Florida
United States GASTRO FLORIDA (ADMINISTRATIVE DUTIES etc. CRA visits) Clearwater Florida
United States Northwood Vision- Optical Coherence Tomography (OCT) Clearwater Florida
United States West Coast Endoscopy (Colonoscopy Procedures) Clearwater Florida
United States West Coast Endoscopy Center (Endoscopy Procedures) Clearwater Florida
United States West Coast Radiology (Chest X-ray) Clearwater Florida
United States Colorado Springs Imaging Colorado Springs Colorado
United States Colorado Springs Pulmonary Consultants, PC Colorado Springs Colorado
United States Front Range Endoscopy Center Colorado Springs Colorado
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States The Wright Eye Center (OCT Facility) Colorado Springs Colorado
United States Cascades Endoscopy Center Columbia Maryland
United States Charter Radiology Columbia Maryland
United States Gastro Center of Maryland, LLC Columbia Maryland
United States Beraja Medical Institute (OCT) Coral Gables Florida
United States Juan Barrio, MD (PFT when needed) Coral Gables Florida
United States Barnes-Jewish West County Hospital (Additional Endoscopy Location) Creve Coeur Missouri
United States Center for Digestive Health (Colonoscopy Location) Dothan Alabama
United States Digestive Health Specialists Dothan Alabama
United States Dothan Eyecare-Dr. Brent McKinley (OCT Location) Dothan Alabama
United States Flowers Hospital (PFT Location) Dothan Alabama
United States Pulmonary Associates (Secondary PFT Location) Dothan Alabama
United States Advanced Radiology Associates (x-Ray only) Edinburg Texas
United States Euclid Endoscopy Center-El Cajon (Endoscopy procedure only) El Cajon California
United States Harman Eye Center (OCT only) Forest Virginia
United States Retina Consultants of Southwest Florida, PA "OCT" Fort Myers Florida
United States Texas Retina Associates (OCT Location) Grapevine Texas
United States GI Alliance (Patients Seen; IP Delivered) Gurnee Illinois
United States Medical Eye Services LTD (Ophthalmoscopy with OCT) Gurnee Illinois
United States Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only) Hanover Maryland
United States Farrel Opthalmology(OCT only) Harrisburg Pennsylvania
United States Medical Arts Allergy,PC (PFT Only) Harrisburg Pennsylvania
United States Pinnacle Health Imaging at Tristan (X-Ray only) Harrisburg Pennsylvania
United States Susquehanna Research Group Harrisburg Pennsylvania
United States Alkek Eye Center Jamail Specialtu Care Center (OCT) Houston Texas
United States Baylor College of Medicine- Baylor Medical Center Houston Texas
United States Baylor College of Medicine-Baylor Medical Center (Chest X-ray location) Houston Texas
United States Baylor College of Medicine-Baylor Medical Center (IP Storage) Houston Texas
United States Baylor College of Medicine-Baylor Medical Center (Patients seen address, ECG location, PFT) Houston Texas
United States Baylor St. Luke's Medical Center Endoscopy- Mc Nair Campus (Endoscopy Location) Houston Texas
United States Center for Clinical Research (CCR) Irvine California
United States UCI Gavin Herbert Eye Institute Irvine California
United States UCI Gottschalk Medical Plaza Irvine California
United States Lonestar Endoscopy Keller Texas
United States Koman Family Outpatient Pavilion (Endoscopy) La Jolla California
United States Perlman Medical Offices (IBD Clinic) La Jolla California
United States Shiley Eye Institute (OCT) La Jolla California
United States UCSD Clinical and Translational Research Institute (Research Clinic) La Jolla California
United States UCSD Health System (PFT/Endoscopy) La Jolla California
United States UCSD lnvestigational Drug Service Pharmacy La Jolla California
United States Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only) La Mesa California
United States Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only) La Mesa California
United States North Shore Endoscopy Center (Endoscopy) Lake Bluff Illinois
United States Inland Pulmonary Specialists [PFT Only] Lake Elsinore California
United States Advanced Endoscopy and Pain Center (Colonoscopy) Lancaster California
United States Advanced Imaging Center (Chest X-Ray) Lancaster California
United States Antelope Valley Eye Care (Ophthalmologist) Lancaster California
United States AV Pediatrics, Allergy and Family Medicine (PFT, Physical Exam, ECG Review, Lab Review) Lancaster California
United States Jatinder S. Pruthi, MD FACG CPI (Physical Exam, ECG Review, Lab Review) Lancaster California
United States OM Research LLC Lancaster California
United States Lung Center (Pulmonary Function Test only) Laurel Maryland
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Libertyville Imaging Center (Diagnostic Imaging) Libertyville Illinois
United States Abraham M. lshaaya MD (X-Ray) Los Angeles California
United States Advanced Vision Care (OCT) Los Angeles California
United States Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist) Los Angeles California
United States Entertainment Medical Group, Inc (Main Site, Subject Visits, IP Delivery/Storage, Regulatory, Los Angeles California
United States Gastrointestinal Biosciences Clinical Trials, LLC Los Angeles California
United States Blue Ridge Medical Research Lynchburg Virginia
United States Lynchburg Pulmonary Associates, Inc. (PFT only) Lynchburg Virginia
United States Radiology Consultants of Lynchburg (X-ray only) Lynchburg Virginia
United States Buena Vista Optical ( OCT only) McAllen Texas
United States Endoscopy Center at Med Point (Endoscopy only) McAllen Texas
United States Valley Pulmonary Group (PFT only) McAllen Texas
United States The Endoscopy Center of Lake County Mentor Ohio
United States Clarin Eye Care Center (OCT/Ophthalmoscopy) Miami Florida
United States Kendall Endoscopy and Surgery Center (Endoscopy) Miami Florida
United States Research Associates of South Florida Miami Florida
United States The Endoscopy Center (Endoscopy Procedure) Miami Florida
United States Froedtert Memorial Lutheran Hospital Milwaukee Wisconsin
United States United Medical Doctors Murrieta California
United States United Surgery Center Murrieta [Endoscopy Only] Murrieta California
United States Bruce Roy, MD "PFT" Naples Florida
United States Gastroenterology Group of Naples Naples Florida
United States Gulfshore Endoscopy Center Naples Florida
United States Radiology Regional Center "Chest x-ray" Naples Florida
United States Yale New Haven Hospital - Winchester Chest Clinic - PFT New Haven Connecticut
United States Yale Ophtalmology New Haven Connecticut
United States Yale School of Medicine New Haven Connecticut
United States NSB Research New Smyrna Beach Florida
United States Yale New Haven Hospital MEMC- Endoscopy North Haven Connecticut
United States CCR-ICTS Center for Innovative Patient Care Orange California
United States UCI Health Eye Care Services (Ophthalmoscopy and OCTs) Orange California
United States UCI Health H. H. Chao Comprehensive Digestive Disease Center Orange California
United States UCI Investigational Drug Services (IDSP - Pharmacy) Orange California
United States UCI Irvine Medical Center - Pulmonology Services - PFTs Orange California
United States Vitreo Retinal Consultants(OCT only) Painesville Ohio
United States IMIC Inc Palmetto Bay Florida
United States Arizona Retina Institute/ Phoenix Retina Associates(OCT) Peoria Arizona
United States SimonMed Imaging (Imaging) Peoria Arizona
United States Advanced Medical Research Center Port Orange Florida
United States Barnes-Jewish Hospital Saint Louis Missouri
United States Center for Advanced Medicine Saint Louis Missouri
United States Center for Outpatient Health Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States University of Utah Clinic and Endoscopy Suite - Sugarhouse Salt Lake City Utah
United States University of Utah Hospitals and Clinics (PFT) Salt Lake City Utah
United States University of Utah Huntsman Cancer Hospital Endoscopy Salt Lake City Utah
United States University of Utah Moran Eye Center (Opthalmoscopy/OCT) Salt Lake City Utah
United States ACRC Studies San Diego California
United States Swedish Gastroenterology Seattle Washington
United States Swedish Medical Center Seattle Washington
United States Swedish Medical Center Seattle Washington
United States Swedish Medical Center First Hill Endoscopy Center Seattle Washington
United States Larkin Community Hospital (Endoscopy Procedure) South Miami Florida
United States Envision Imaging Southlake Texas
United States Lonestar Endoscopy Southlake Texas
United States Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance Southlake Texas
United States Sun City Endoscopy (Endoscopy) Sun City Arizona
United States Absolute Surgical Specialists - Craig Amshel, MD Sun City Center Florida
United States GCP Clinical Research,LLC Tampa Florida
United States LoCicero Medical Group (PFT Procedure Only) Tampa Florida
United States Lyracore Health Alliance, Tampa Bay Pulmonology (PFT only) Tampa Florida
United States NewsomEye (OCT only) Tampa Florida
United States Perez Eye Center(OCT & Ophthalmoscopy only) Tampa Florida
United States Pulmonary and Sleep of Tampa Bay(PFT with DLCO only) Tampa Florida
United States SimonMed Imaging Tampa Florida
United States South Tampa Surgery Center Tampa Florida
United States Tampa Bay Endoscopy Center(Proctosigmoidoscopy & colonoscopy ONLY) Tampa Florida
United States California Eye Professionals [OCT Only] Temecula California
United States United Surgery Center Temecula [Endoscopy Only] Temecula California
United States Christus Trinity Mother Frances Endoscopy Center Tyler Texas
United States Christus Trinity Mother Frances Endosopy Center ( endoscopies only) Tyler Texas
United States Heaton Eye Associates (OCT only) Tyler Texas
United States Tyler Open MRI (chest x-ray only) Tyler Texas
United States UT Health East Texas Physicians (pulmonary functions only) Tyler Texas
United States Citizen Healthplex (PFT) Victoria Texas
United States Gastro Health & Nutrition - Victoria Victoria Texas
United States Surgery Center (Endoscopy) Victoria Texas
United States Victoria Eye Center (OCT and Opthalmoscopy) Victoria Texas
United States Lake Pulmonary Associates (PFT only) Willoughby Ohio
United States Retina Specialists of Ohio(OCT only) Willoughby Hills Ohio
United States Florida Medical Clinic, LLC Zephyrhills Florida
United States Florida Medical Clinic, LLC (Endoscopy) Zephyrhills Florida
United States Florida Medical Clinic, LLC (OCT) Zephyrhills Florida
United States Florida Medical Clinic, LLC (PFT) Zephyrhills Florida

Sponsors (2)

Lead Sponsor Collaborator
Pfizer Arena is a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belarus,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Georgia,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Poland,  Portugal,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants Achieving Clinical Remission Week 52
Secondary Proportion of Participants Achieving Clinical Remission Week 12
Secondary Proportion of Participants Achieving Endoscopic Improvement Week 52
Secondary Proportion of Participants Achieving Symptomatic Remission Week 52
Secondary Proportion of Participants Achieving Mucosal Healing Week 52
Secondary Proportion of participants achieving clinical remission at both Weeks 12 and 52 Week 12 and Week 52
Secondary Proportion of Participants achieving clinical remission at Week 52 and who had not been receiving corticosteroids for = 12 weeks immediately prior to Week 52 Week 52
Secondary Number and Severity of Adverse Events Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results. Up to approximately 56 weeks (52-Week Treatment Period and 4-Week Follow-Up Period)
See also
  Status Clinical Trial Phase
Recruiting NCT05702879 - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting NCT05953402 - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Recruiting NCT03950232 - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03124121 - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels Phase 4
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Withdrawn NCT04209556 - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis Phase 2
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT04398550 - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis N/A
Recruiting NCT04314375 - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis Phase 4
Active, not recruiting NCT04857112 - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis Phase 2
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting NCT04033445 - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2/Phase 3
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting NCT06221995 - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Completed NCT03760003 - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Phase 2
Not yet recruiting NCT05539625 - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis Phase 2