AzTrials
AzTrials

Ulcerative ColitisPhase 2GLADIATOR UCNCT04607837

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

A Phase 2 study testing Etrasimod in people with Ulcerative Colitis, run by Pfizer at 288 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Etrasimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
288 sitesin 18 countries
Study dates
12 Apr 2021to 19 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

288 sites in 18 countries.

288 sites in 18 countries

United States132 sites

  • Advantage Diagnostics(X-Ray only)

    Beachwood, Ohio, 44122

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

    Brandon, Florida, 33511

  • West Shore Endoscopy Center

    Camp Hill, Pennsylvania, 17011

  • Geauga Sleep Center(PFT only)

    Chardon, Ohio, 44024

  • Chevy Chase Endoscopy Center (Endoscopy Facility Only)

    Chevy Chase, Maryland, 20815

  • Chevy Chase Pulmonary Associate (PFT Only)

    Chevy Chase, Maryland, 20815

  • Retina Group of Washington (Ophthalmoscopy and OCT Only)

    Chevy Chase, Maryland, 20815

  • UC Health Physicians Office

    Cincinnati, Ohio, 45219

  • UC Health (Pulmonary Function Testing)

    Cincinnati, Ohio, 45229

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45267

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

    Clearwater, Florida, 33756

  • GASTRO FLORIDA (ADMINISTRATIVE DUTIES etc. CRA visits)

    Clearwater, Florida, 33756

  • West Coast Endoscopy (Colonoscopy Procedures)

    Clearwater, Florida, 33756

  • West Coast Endoscopy Center (Endoscopy Procedures)

    Clearwater, Florida, 33756

  • West Coast Radiology (Chest X-ray)

    Clearwater, Florida, 33756

  • Northwood Vision- Optical Coherence Tomography (OCT)

    Clearwater, Florida, 33761

  • Front Range Endoscopy Center

    Colorado Springs, Colorado, 80903

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Colorado Springs Pulmonary Consultants, PC

    Colorado Springs, Colorado, 80909

  • The Wright Eye Center (OCT Facility)

    Colorado Springs, Colorado, 80909

  • Colorado Springs Imaging

    Colorado Springs, Colorado, 80919

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80920

  • Charter Radiology

    Columbia, Maryland, 21044

  • Cascades Endoscopy Center

    Columbia, Maryland, 21045

  • Gastro Center of Maryland, LLC

    Columbia, Maryland, 21045

  • Beraja Medical Institute (OCT)

    Coral Gables, Florida, 33134

  • Juan Barrio, MD (PFT when needed)

    Coral Gables, Florida, 33134

  • Center for Digestive Health (Colonoscopy Location)

    Dothan, Alabama, 36301

  • Digestive Health Specialists

    Dothan, Alabama, 36301

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

    Dothan, Alabama, 36301

  • Pulmonary Associates (Secondary PFT Location)

    Dothan, Alabama, 36301

  • Flowers Hospital (PFT Location)

    Dothan, Alabama, 36305

  • Advanced Radiology Associates (x-Ray only)

    Edinburg, Texas, 78539

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

    El Cajon, California, 92020

  • Harman Eye Center (OCT only)

    Forest, Virginia, 24551

  • Texas Retina Associates (OCT Location)

    Grapevine, Texas, 76051

  • GI Alliance (Patients Seen; IP Delivered)

    Gurnee, Illinois, 60031

  • Medical Eye Services LTD (Ophthalmoscopy with OCT)

    Gurnee, Illinois, 60031

  • Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)

    Hanover, Maryland, 21076

  • Pulmonary and Critical Care Medicine Associates (PFT only)

    Harrisburg, Pennsylvania, 17102

  • Medical Arts Allergy,PC (PFT Only)

    Harrisburg, Pennsylvania, 17109

  • Farrel Opthalmology(OCT only)

    Harrisburg, Pennsylvania, 17110

  • Pinnacle Health Imaging at Tristan (X-Ray only)

    Harrisburg, Pennsylvania, 17110

  • Susquehanna Research Group

    Harrisburg, Pennsylvania, 17110

  • Harrisburg Eye Associates (OCT only)

    Harrisburg, Pennsylvania, 17111

  • Alkek Eye Center Jamail Specialtu Care Center (OCT)

    Houston, Texas, 77030

  • Baylor College of Medicine- Baylor Medical Center

    Houston, Texas, 77030

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

    Houston, Texas, 77030

  • Baylor College of Medicine-Baylor Medical Center (IP Storage)

    Houston, Texas, 77030

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

    Houston, Texas, 77030

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

    Houston, Texas, 77030

  • Center for Clinical Research (CCR)

    Irvine, California, 92697

  • UCI Gavin Herbert Eye Institute

    Irvine, California, 92697

  • UCI Gottschalk Medical Plaza

    Irvine, California, 92697

  • Lonestar Endoscopy

    Keller, Texas, 76248

  • Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only)

    La Mesa, California, 91942

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

    La Mesa, California, 91942

  • North Shore Endoscopy Center (Endoscopy)

    Lake Bluff, Illinois, 60044

  • Advanced Endoscopy and Pain Center (Colonoscopy)

    Lancaster, California, 93534

  • Advanced Imaging Center (Chest X-Ray)

    Lancaster, California, 93534

  • Antelope Valley Eye Care (Ophthalmologist)

    Lancaster, California, 93534

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

    Lancaster, California, 93534

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

    Lancaster, California, 93534

  • OM Research LLC

    Lancaster, California, 93534

  • Lung Center (Pulmonary Function Test only)

    Laurel, Maryland, 20707

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Pulmonary and Critical Care Medicine Associates (PFT only)

    Lemoyne, Pennsylvania, 17043

  • Libertyville Imaging Center (Diagnostic Imaging)

    Libertyville, Illinois, 60048

  • Abraham M. lshaaya MD (X-Ray)

    Los Angeles, California, 90036

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

    Los Angeles, California, 90036

  • Advanced Vision Care (OCT)

    Los Angeles, California, 90067

  • Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist)

    Los Angeles, California, 90067

  • Gastrointestinal Biosciences Clinical Trials, LLC

    Los Angeles, California, 90067

  • Lynchburg Pulmonary Associates, Inc. (PFT only)

    Lynchburg, Virginia, 24501

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Radiology Consultants of Lynchburg (X-ray only)

    Lynchburg, Virginia, 24502

  • Buena Vista Optical ( OCT only)

    McAllen, Texas, 78501

  • Endoscopy Center at Med Point (Endoscopy only)

    McAllen, Texas, 78503

  • Valley Pulmonary Group (PFT only)

    McAllen, Texas, 78503

  • The Endoscopy Center of Lake County

    Mentor, Ohio, 44060

  • The Endoscopy Center (Endoscopy Procedure)

    Miami, Florida, 33134

  • Research Associates of South Florida

    Miami, Florida, 33156

  • Kendall Endoscopy and Surgery Center (Endoscopy)

    Miami, Florida, 33157

  • Clarin Eye Care Center (OCT/Ophthalmoscopy)

    Miami, Florida, 33176

  • United Surgery Center Murrieta [Endoscopy Only]

    Murrieta, California, 92562

  • United Medical Doctors

    Murrieta, California, 92563

  • NSB Research

    New Smyrna Beach, Florida, 32168

  • CCR-ICTS Center for Innovative Patient Care

    Orange, California, 92697

  • UCI Health Eye Care Services (Ophthalmoscopy and OCTs)

    Orange, California, 92868

  • UCI Health H. H. Chao Comprehensive Digestive Disease Center

    Orange, California, 92868

  • UCI Investigational Drug Services (IDSP - Pharmacy)

    Orange, California, 92868

  • UCI Irvine Medical Center - Pulmonology Services - PFTs

    Orange, California, 92868

  • Vitreo Retinal Consultants(OCT only)

    Painesville, Ohio, 44077

  • IMIC Inc

    Palmetto Bay, Florida, 33157

  • Arizona Retina Institute/ Phoenix Retina Associates(OCT)

    Peoria, Arizona, 85381

  • SimonMed Imaging (Imaging)

    Peoria, Arizona, 85381

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • ACRC Studies

    San Diego, California, 92119

  • Pacific Northwest Retina

    Seattle, Washington, 98104

  • Richard Bensinger, MD

    Seattle, Washington, 98104

  • Swedish Medical Center Investigational Drug Services Pharmacy

    Seattle, Washington, 98104

  • Swedish Medical Center First Hill Endoscopy Center

    Seattle, Washington, 98122

  • Swedish Medical Center First Hill

    Seattle, Washington, 98122

  • Larkin Community Hospital (Endoscopy Procedure)

    South Miami, Florida, 33143

  • Envision Imaging

    Southlake, Texas, 76092

  • Lonestar Endoscopy

    Southlake, Texas, 76092

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

    Southlake, Texas, 76092

  • Sun City Endoscopy (Endoscopy)

    Sun City, Arizona, 85351

  • Absolute Surgical Specialists - Craig Amshel, MD

    Sun City Center, Florida, 33573

  • SimonMed Imaging

    Tampa, Florida, 33069

  • Perez Eye Center(OCT & Ophthalmoscopy only)

    Tampa, Florida, 33603

  • Tampa Bay Endoscopy Center(Proctosigmoidoscopy & colonoscopy ONLY)

    Tampa, Florida, 33603

  • Tampa Bay Endoscopy Center

    Tampa, Florida, 33603

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

    Tampa, Florida, 33606

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

    Tampa, Florida, 33607

  • GCP Clinical Research,LLC

    Tampa, Florida, 33609

  • LoCicero Medical Group (PFT Procedure Only)

    Tampa, Florida, 33609

  • NewsomEye (OCT only)

    Tampa, Florida, 33609

  • South Tampa Surgery Center

    Tampa, Florida, 33609

  • California Eye Professionals [OCT Only]

    Temecula, California, 92591

  • United Surgery Center Temecula [Endoscopy Only]

    Temecula, California, 92592

  • Christus Trinity Mother Frances Endoscopy Center

    Tyler, Texas, 75701

  • Christus Trinity Mother Frances Endosopy Center ( endoscopies only)

    Tyler, Texas, 75701

  • Heaton Eye Associates (OCT only)

    Tyler, Texas, 75701

  • Tyler Open MRI (chest x-ray only)

    Tyler, Texas, 75701

  • UT Health East Texas Physicians (pulmonary functions only)

    Tyler, Texas, 75701

  • Citizen Healthplex (PFT)

    Victoria, Texas, 77904

  • Gastro Health & Nutrition - Victoria

    Victoria, Texas, 77904

  • Surgery Center (Endoscopy)

    Victoria, Texas, 77904

  • Victoria Eye Center (OCT and Opthalmoscopy)

    Victoria, Texas, 77904

  • Lake Pulmonary Associates (PFT only)

    Willoughby, Ohio, 44094

  • Retina Specialists of Ohio(OCT only)

    Willoughby Hills, Ohio, 44094

Other trials in United States

Poland21 sites

  • Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)

    Bystra, 43-360

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

    Lodz, 90-338

  • Centra Medyczne 'MEDYCEUSZ" (Chest X-Ray)

    Lodz, 91-053

  • Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy)

    Lodz, 91-347

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

    Lodz, 93-513

  • Amicare Sp. z o.o. Sp.k.

    Lodz, Łódź Voivodeship, 90-644

  • IP Clinic Sp. z o.o.

    Lodz, Łódź Voivodeship, 90-752

  • Amicare Sp. z o.o. Sp.k.

    Lodz, Łódź Voivodeship, 91-495

  • Allmedica Badania Kliniczne Sp. z o.o. Sp. k.

    Nowy Targ, Lesser Poland Voivodeship, 34-400

  • Medicome Sp. z o.o.

    Oświęcim, Lesser Poland Voivodeship, 32-600

  • MEDICOME- Oswiecimskie Centrum Medyczne (OCT)

    Oświęcim, 32-600

  • NSZOZ Termedica - Centrum Badan Klinicznych

    Poznan, Greater Poland Voivodeship, 60-681

  • Spoldzielnia Pracy Lekarzy Specjalistow Medicus (for OCT)

    Szczecin, West Pomeranian Voivodeship, 70-233

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Przychodnia EVOMED Pracownia USG i RTG

    Szczecin, West Pomeranian Voivodeship, 71-610

  • lnstytut Gruzlicy i Chorob Pluc

    Warsaw, Masovian Voivodeship, 01-138

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • Centrum Medyczne Oporow

    Wroclaw, Lower Silesian Voivodeship, 52-416

  • OKOLEK

    Wroclaw, Lower Silesian Voivodeship, 53-162

  • EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship, 54-144

  • Endomed

    Wroclaw, 53-661

Other trials in Poland

Russia19 sites

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

    Nizhny Novgorod, 603126

  • BHI of Omsk region "Clinical oncology dispensary"

    Omsk, 644013

  • Clinicodiagnostic center "Ultramed"

    Omsk, 644024

  • Medical center "Intervzglyad"

    Omsk, 644070

  • "Clinic Ultrasound 4D" LLC

    Pyatigorsk, Stavropol Kray, 357500

  • "Platnaya poliklinika" LLC

    Pyatigorsk, Stavropol Kray, 357500

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

    Saint Petersburg, 191015

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

    Saint Petersburg, 197022

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

    Samara, 443001

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

    Samara, 443011

  • Clinical Hospital Russian Railways - Medicina

    Samara, 443029

  • Medical Company "Hepatolog" LLC

    Samara, 443045

  • Medical Company "Hepatolog" LLC

    Samara, 443063

  • Samara Diagnostic center

    Samara, 443093

  • Regional Medical center LLC (Branchevsky's clinic)

    Samara, 443125

  • Inter-branch scientific and technical complex "Eye microsurgery"

    Smolensk, 214014

  • Multidisciplinary Medical center "Clinic Park"

    Smolensk, 214020

  • "Uromed" LLC

    Smolensk, 214031

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

    Stavropol, 355017

Other trials in Russia

Ukraine17 sites

  • Limited Liability Company "Lookout "Medical Center"

    Dnipro, 49000

  • Limited Liability Company "MDC EXPERT"

    Dnipro, 49005

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

    Dnipro, 49005

  • Clinical Diagnostical Center "Simedgroup"

    Ivano-Frankivsk, 76008

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

    Ivano-Frankivsk, 76008

  • Llc "Ldts-Skaymed"

    Kharkiv, 61022

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

    Kharkiv, 61037

  • Llc Medical Center Oftalmika

    Kharkiv, 61045

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

    Kyiv, 02091

  • Transcarpathian Center of Eye Microsurgery

    Uzhhorod, 88017

  • CNE Andrii Novak Transcarpathian Regional Clinical Hospital of

    Uzhhorod, 88018

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

    Vinnytsia, 21009

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

    Vinnytsia, 21018

  • Podilskyi tsentr zoru

    Vinnytsia, 21018

  • Scientific and Research Institute of lnvalid Rehabilitation (Educational and Scientific

    Vinnytsia, 21029

  • Diagnostic Center "Mediscan"

    Vinnytsia, 21032

  • Llc "Optimal M"

    Vinnytsia, 21036

Other trials in Ukraine

Czechia14 sites

  • Gastroenterologicka ambulance

    Boskovice, 680 01

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • VISUS, spol s.r.o.

    Hradec Králové, 500 12

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

    Olomouc, 779 00

  • MUDr. Pavlina Kazinotova, s.r.o.

    Olomouc, 779 00

  • PreventaMed s.r.o.

    Olomouc, 779 00

  • Gastroenterologie-interna, SPEA

    Olomouc, 77900

  • Vojenska nemocnice Olomouc

    Olomouc, 77900

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • Gastroenterologicka ambulance MUDr. Marcela Vyslouzilova

    Přerov, 750 02

  • Privatni gastroenterologicka ambulance s.r.o. MUDr. Zdenek Vlk

    Prostějov, 796 01

  • Nemocnice Slany

    Slaný, 274 01

  • Poliklinika Slany, spol. s.r.o.

    Slaný, 274 01

  • Gatronell s.r.o

    Vsetín, 755 01

Other trials in Czechia

Bulgaria13 sites

  • UMHAT ,,Kanev" AD

    Rousse, 7002

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia, 1407

  • Acibadem City Clinic University Hospital EOOD

    Sofia, 1407

  • DCC Alexandrovska, EOOD

    Sofia, 1431

  • UMHAT "Aleksandrovska" EAD (Colonoscopy/Sigmoidoscopy Facility)

    Sofia, 1431

  • UMHAT Aleksandrovska EAD (X-Ray Facility)

    Sofia, 1431

  • UMHAT "Tsaritsa Yoanna-ISUL" EAD

    Sofia, 1527

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

    Sofia, 1527

  • UMHAT Tsaritsa Yoanna - ISUL EAD (X-ray)

    Sofia, 1527

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

    Sofia, 1606

  • Diagnostic Consultation Center CONVEX EOOD

    Sofia, 1680

  • Acibadem City Clinic University Hospital Eood

    Sofia, 1784

  • Medical Centre MEDICA Plus OOD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Australia12 sites

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

    Birtinya, Queensland, 4575

  • Sunshine Coast Radiology

    Birtinya, Queensland, 4575

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, 4575

  • Buderim Eye Centre( OCT and Ophthalmoscopy Facility)

    Buderim, Queensland, 4575

  • Austin Health

    Heidelberg, Victoria, 3084

  • Coral Sea Clinical Research Institute Pty.Ltd

    Mackay, Queensland, 4740

  • Coastal Digestive Helath Pty. Ltd

    Maroochydore, Queensland, 4558

  • Dr.Shiran DeSilva Respiratory Clinic (PFT)

    North Mackay, Queensland, 4740

  • Mater Misericordiae Hospital ( Endoscopy)

    North Mackay, Queensland, 4740

  • Queensland X-Ray

    North Mackay, Queensland, 4740

  • Vision Eye Institute Mackay (OCT)

    North Mackay, Queensland, 4740

  • Melbourne Health

    Parkville, Victoria, 3050

Other trials in Australia

Hungary12 sites

  • Ophthalmology tests: Tosho Kft.

    Budapest, 1025

  • Mediszem Kft.

    Budapest, 1051

  • Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.

    Budapest, 1062

  • Vasutegeszsegugyi Nonprofit Kozhasznu Kft.

    Budapest, 1062

  • Honvedkorhaz II. telephely

    Budapest, 1068

  • Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests)

    Budapest, 1068

  • Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika

    Budapest, 1088

  • Pannonia Maganorvosi Centrum Kft.

    Budapest, 1136

  • Bugat Pal Korhaz

    Gyöngyös, Heves County, 3200

  • Clinfan Szolgaltato Kft.

    Szekszárd, Tolna County, 7100

  • Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz

    Szekszárd, Tolna County, 7100

  • DLCO and ophthalmology tests: Szent Borbala Korhaz

    Tatabánya, Komárom-Esztergom, 2800

Other trials in Hungary

South Korea11 sites

  • Endoscopy Facility in kyungpook National University Hospital

    Daegu, 41944

  • Kyungpook National University Hospital

    Daegu, 41944

  • OCT Facility In kyungpook Natioanl University Hospital

    Daegu, 41944

  • PFT Facility in kyungpook Natioanl University Hospital

    Daegu, 41944

  • Endoscopy Facility in Severance Hospital, Yonsei University Health System

    Seoul, 03722

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

    Seoul, 03722

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

    Seoul, 03722

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

    Seoul, 03722

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

    Seoul, 03722

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Georgia10 sites

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

    Tbilisi, 0112

  • LLC Todua Clinic

    Tbilisi, 0112

  • LTD Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112

  • LTD Vivamedi

    Tbilisi, 0131

  • LTD Institute of Clinical Cardiology

    Tbilisi, 0159

  • Medical Center CITO LTD

    Tbilisi, 0159

  • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

    Tbilisi, 0160

  • LTD Academician Nikoloz Kipshidze Central University Clinic

    Tbilisi, 0160

  • LTD Aversi Clinic

    Tbilisi, 0160

  • LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

    Tbilisi, 0172

Other trials in Georgia

Germany7 sites

  • Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling

    Bonn, 53123

  • Florence-Nightingale-Krankenhaus

    Düsseldorf, 40489

  • OCT: nordBLICK Augenklinik Bellevue

    Kiel, 24105

  • Universitatsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • OCT: Dr. med. Christopher Kallen

    Krefeld, 47798

  • OCT: Augenpraxisklinik REMSCHEID

    Remscheid, 42853

  • Magen-Darm-Zentrum Remscheid

    Remscheid, 42859

Other trials in Germany

Belarus6 sites

  • Foreign Medical and Pharmaceutical Unitary Enterprise "Medical center "Novoe Zrenie"

    Grodno, 230023

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

    Grodno, 230026

  • Institution "Gomel Regional Specialized Clinical Hospital"

    Homyel, 246027

  • Institution "Gomel Regional Clinical Hospital"

    Homyel, 246029

  • Health Care Institution "Vitebsk Regional Clinical Specialized Center"

    Vitebsk, 210604

  • Vitebsk Regional Clinical Specialized Center

    Vitebsk

Other trials in Belarus

Israel4 sites

  • Edith Wolfson Medical Center

    Holon, 5822012

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Galilee Medical Center

    Nahariya, 2210001

  • Rabin Medical Center

    Petah Tikva, 4941492

Other trials in Israel

Italy4 sites

  • IRCCS Ospedale San Raffaele, Unita di Gastroenterologia

    Milan, Milan, 20132

  • Azienda Ospedaliera Saverio De Bellis

    Puglia, BARI, 70013

  • Fondazione Policlinico Agostino Gemelli IRCCS

    Roma, ROME, 00168

  • Ospedale San Bortolo di Vicenza, Gastroenterologia

    Vicenza, Veneto, 36100

Other trials in Italy

France3 sites

  • Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon

    Grenoble, 38043

  • Centre Hospitalier Universitaire de Nantes - Hotel-Dieu

    Nantes, 44093

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

    Nice, 06202

Other trials in France

Belgium1 site

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Portugal1 site

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

    Porto, 4200-319

Other trials in Portugal

Spain1 site

  • Hospital Universitario la Paz

    Madrid, 28046

Other trials in Spain

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis

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.

Being tested
Etrasimod, Placebo
Keywords
Ulcerative colitis, Etrasimod, APD334, UC
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrasimodDrug

    Also called APD334

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

  • PlaceboDrug

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

Study groups in NCT04607837
Study groupRoleWhat they receive
Etrasimod 2 mgExperimentalNot described
Receives: Drug: Etrasimod
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  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.

    Measured: Week 52

Secondary outcomes (19)

  1. Percentage of Participants Achieving Clinical Remission at Week 12 Using MMS

    MMS is used to assess disease activity in participants with UC and has following components: ES, RB and 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 the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes). SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance was defined as: SF=0 or =1 and no greater than baseline, RB=0, and ES <=1 (excluding friability). Percentage of participants achieving CR at Week 12 was evaluated in this endpoint.

    Measured: Week 12

  2. Percentage of Participants Achieving Endoscopic Improvement at Week 52

    Endoscopic improvement was defined as ES <=1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. Percentage of participants achieving endoscopic improvement at Week 52 was evaluated in this endpoint.

    Measured: Week 52

  3. Percentage of Participants Achieving Symptomatic Remission at Week 52

    Symptomatic remission was defined as SF =0 (or = 1 with a >= 1 point decrease from baseline) and RB =0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving symptomatic remission at Week 52 was evaluated in this endpoint.

    Measured: Week 52

  4. Percentage of Participants Achieving Complete Symptomatic Remission at Week 52

    Complete symptomatic remission was defined as participants with RB = 0 and SF = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving complete symptomatic remission at Week 52 was evaluated in this endpoint.

    Measured: Week 52

  5. Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 52

    Histologic-endoscopic mucosal improvement was defined as ES <=1 (excluding friability) with Geboes score <2.0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. The Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving mucosal improvement at Week 52 was evaluated in this endpoint.

    Measured: Week 52

  6. Percentage of Participants Achieving Clinical Remission at Both Weeks 12 and 52 [Combined] Using MMS

    MMS is used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); higher scores = more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease). RB: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes). SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). Clinical remission per FDA draft guidance: SF =0 or =1 and no greater than baseline, RB =0, and ES <=1 (excluding friability). Percentage of participants who achieved clinical remission at both the time points Week 12 and Week 52 [Combined] are reported.

    Measured: Weeks 12 and 52 [Combined]

  7. Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS

    MMS has following components:ES, RB and SF. Each component score ranges from 0 to 3(0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease. ES:worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease)to 3(severe disease). RB:most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen)to 3(blood alone passes). SF:number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools)to 3(5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 12-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=12 weeks immediately prior to Week 52. The baseline was balanced between treatment groups and representative of participants with mildly to moderately active UC.

    Measured: Week 52

  8. Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS

    MMS has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 12-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=12 weeks immediately prior to Week 52.

    Measured: Week 52

  9. Percentage of Participants Achieving 4-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS

    MMS has following components: ES, RB and SF; each ranged as 0=normal,1=mild,2=moderate,3=severe; total MMS score 0-9; higher scores=more severe disease. ES:worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease)to 3(severe disease). RB:most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3(blood alone passes). SF:number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools)to 3(5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 4-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=4 weeks immediately prior to Week 52. The baseline was balanced between treatment groups and representative of participants with mildly to moderately active UC.

    Measured: Week 52

  10. Percentage of Participants With 4-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS

    MMS has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal,1=mild,2=moderate,3=severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 4-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=4 weeks immediately prior to Week 52.

    Measured: Week 52

  11. Percentage of Participants Achieving Clinical Response at Week 12 Using MMS

    Clinical response was defined as a >=2-point and >=30 percentage (%) decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore <=1 and is as per FDA draft guidance. MMS was used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]). Percentage of participants achieving clinical response at Week 12 was evaluated in this endpoint.

    Measured: Week 12

  12. Percentage of Participants Achieving Clinical Response at Week 52 Using MMS

    Clinical response was defined as a >=2-point and >=30 % decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore <=1 and is as per FDA draft guidance. MMS is used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component scores ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); where total score is sum of three components giving total MMS score as 0 to 9; 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]). Percentage of participants achieving clinical response at Week 52 was evaluated in this endpoint.

    Measured: Week 52

  13. Percentage of Participants Achieving Endoscopic Improvement at Week 12

    Endoscopic improvement was defined as ES <=1 (excluding friability). 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]), higher scores = more severity. Percentage of participants achieving endoscopic improvement at Week 12 was evaluated in this endpoint.

    Measured: Week 12

  14. Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 12

    Histologic-endoscopic mucosal improvement was defined as ES <=1 (excluding friability) with Geboes score <2.0. 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]), higher scores = more severity. The Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving mucosal improvement at Week 12 was evaluated in this endpoint.

    Measured: Week 12

  15. Percentage of Participants Achieving Symptomatic Remission at Week 12

    Symptomatic remission was defined as SF =0 (or = 1 with a >= 1 point decrease from baseline) and RB =0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving symptomatic remission at Week 12 was evaluated in this endpoint.

    Measured: Week 12

  16. Percentage of Participants Achieving Complete Symptomatic Remission at Week 12

    Complete symptomatic remission was defined as participants with RB = 0 and SF = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving complete symptomatic remission at Week 12 was evaluated in this endpoint.

    Measured: Week 12

  17. Percentage of Participants Achieving Change From Baseline in Both ES and RB or in Both ES and SF at Week 12

    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]), higher scores = more severity. RB: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. Percentage of participants with reduction from baseline in both ES and RB or in both ES and SF at Week 12 was evaluated in this endpoint. The baseline primary analysis set was balanced between treatment groups and representative of participants with mildly to moderately active UC.

    Measured: Baseline to Week 12

  18. Percentage of Participants Achieving Histologic Response Based on the Geboes Grading System at Week 12

    Histologic response based on the Geboes grading system was defined as Geboes score <=3.1. The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving histologic response based on the Geboes grading system at week 12 was evaluated in this endpoint.

    Measured: Week 12

  19. Percentage of Participants Achieving Histologic Response Based on Robarts Histopathology Index (RHI) at Week 12

    RHI is an evaluative index, derived from the Geboes score, that is designed to be reproducible and responsive to clinically meaningful change in disease activity over time. Histologic response based on RHI was defined as decrease in RHI of >=7 points from baseline. Total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity), higher score = more severity. Percentage of participants achieving histologic response based on RHI at Week 12 was evaluated in this endpoint.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start12 Apr 2021
  3. Primary completion19 Jun 2024
  4. Study completion19 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607837
Sponsor's protocol ID
APD334-210
Other IDs
2020-003507-34, C5041011
Acronym
GLADIATOR UC
Status last verified
Jul 2025
First submitted
23 Oct 2020
Last updated
15 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Expanded access
Available

Publications

  • Danese S, Goetsch M, Peyrin-Biroulet L, Yarur AJ, Dubinsky M, Rubin DT, Feagan BG, D'Haens G, Baert F, Lazin K, Gu G, Yu J, Lawendy N, Zang C, Wang W, Menon S, Law EH, Modesto I, Wosik K, Sidhu S, Niezychowski W, Vermeire S. The Efficacy and Safety of Etrasimod in Mildly to Moderately Active Ulcerative Colitis: Results From the Phase II GLADIATOR Trial. Clin Gastroenterol Hepatol. 2026 Jun 4:S1542-3565(26)00405-2. doi: 10.1016/j.cgh.2026.05.024. Online ahead of print.

    PubMed 42248437

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etrasimod in people with Ulcerative Colitis, run by Pfizer at 288 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 288 sites in United States, Poland, Russia, Ukraine, Czechia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS) (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607837, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in