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A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
Sponsor: Hoffmann-La Roche
Summary
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
Official title: A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate The Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants With Moderate To Severe Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
246
Start Date
2019-12-19
Completion Date
2022-10-25
Last Updated
2026-07-17
Healthy Volunteers
No
Conditions
Interventions
Induction- PF-06480605 50 mg SC Q4W
PF-06480605
Induction- PF-06480605 150 mg SC Q4W
PF-06480605
Induction- PF-06480605 450 mg SC Q4W
PF-06480605
Induction- Placebo SC Q4W
0 mg Placebo
Chronic- PF-06480605 50 mg SC Q4W
PF-06480605
Chronic- PF-06480605 150 mg SC Q4W
PF-06480605
Chronic- PF-06480605 450 mg SC Q4W
PF-06480605
Locations (166)
Digestive Health Specialists
Dothan, Alabama, United States
Dothan Surgery Center
Dothan, Alabama, United States
Flowers Hospital
Dothan, Alabama, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Surinder Saini, M.D., Inc.
Newport Beach, California, United States
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, United States
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, United States
Medical Research Center Of Connecticut, LLC
Hamden, Connecticut, United States
PACT Gastroenterology Center
Hamden, Connecticut, United States
Whitney Imaging
Hamden, Connecticut, United States
Medycal Research Inc.
Brooksville, Florida, United States
Safety Harbor Surgery
Clearwater, Florida, United States
Trident Care
Clearwater, Florida, United States
Tower Radiology Center
Oldsmar, Florida, United States
Akumin
Tampa, Florida, United States
Tampa Bay Endoscopy Center
Tampa, Florida, United States
Alliance Clinical Research of Tampa
Tampa, Florida, United States
Gastroenterology Consultants P.C.
Roswell, Georgia, United States
The University of Chicago Medical Center (clinic address)
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital - Office
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Michigan Endoscopy Center
Farmington Hills, Michigan, United States
Valley View Surgery Center
Las Vegas, Nevada, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
New York Presbyterian Hospital - Weill Cornell Medical Center
New York, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
Weill Cornell Medical College- New York Presbyterian Hospital
New York, New York, United States
Investigational Drug Services
Philadelphia, Pennsylvania, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Gastroenterology Associates, PA of Greenville
Greenville, South Carolina, United States
Vanderbilt GI Endoscopy Lab at One Hundred Oaks
Nashville, Tennessee, United States
Vanderbilt Heart One Hundred Oaks
Nashville, Tennessee, United States
Vanderbilt Inflammatory Bowel Disease Clinic
Nashville, Tennessee, United States
Vanderbilt Laboratory Services North One Hundred Oaks
Nashville, Tennessee, United States
Vanderbilt One Hundred Oaks Imaging
Nashville, Tennessee, United States
Vanderbilt University Medical Center - GI Research Office
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Vanderbilt University Med. Center
Nashville, Tennessee, United States
Vanderbilt University Medical Center- Heart Station (ECG)
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
PrimeCare Medical Group
Houston, Texas, United States
Gastroenterology Consultants of San Antonio, PA
San Antonio, Texas, United States
VIP Trials
San Antonio, Texas, United States
South Texas Radiology Imaging Centers
San Antonio, Texas, United States
Gastroenterology Associates of Northern VA
Fairfax, Virginia, United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States
Verity Research, Inc.
Fairfax, Virginia, United States
Medical Diagnostic Imaging
Wauwatosa, Wisconsin, United States
Allegiance Internal Medicine and Allegiance Research Specialists
Wauwatosa, Wisconsin, United States
GI Associates
Wauwatosa, Wisconsin, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Mater Misericordiae Ltd.
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
University Hospitals Leuven/Department of Gastroenterology
Leuven, Belgium
"ACIBADEM City Clinic Diagnostic-Consultative Center" EOOD
Sofia, Bulgaria
Asociacion IPS Medicos Internistas de Caldas
Manizales, Caldas Department, Colombia
CHU d'Amiens-Picardie - SITE SUD
Amiens, France
Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC
Lille, France
Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez
Lille, France
Centre Hospitalier Regional Universitaire (CHU) de Lille
Lille, France
CHU Hôtel-Dieu
Nantes, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Hospitalier Universitaire de Lyon Sud
Pierre-Bénite, France
Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH
Berlin, Germany
Studiengesellschaft BSF UG (haftungsbeschränkt)
Halle, Germany
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Germany
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, Veszprém megye, Hungary
Magyar Imre Kórház
Ajka, Hungary
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, Hungary
Clinfan Kft.
Szekszárd, Hungary
Life Egészségcentrum
Székesfehérvár, Hungary
Deák Jenő Kórház
Tapolca, Hungary
Clinexpert Tatabanya, Szent Borbala Hospital
Tatabánya, Hungary
Szofia Private Clinic
Veszprém, Hungary
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, India
Surat Institute of Digestive Sciences
Surat, Gujarat, India
Gujarat Hospital Gastro and Vascular Centre, Opp. Shree Ram Petrol Pump
Surat, Gujarat, India
M.S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India
Grant Medical Foundation, Ruby Hall Clinic
Pune, Maharashtra, India
S.R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
S.M.S. Medical College & Hospital
Jaipur, Rajasthan, India
IRCCS "Saverio de Bellis", UOC Gastroenterologia
Castellana Grotte, BARI, Italy
Istituto Clinico Humanitas Centro per le Malattie Infiammatorie Croniche dell'Intestino - IBD Cent
Rozzano, Milan, Italy
A.O.U. dell'Università degli Studi della Campania "Luigi Vanvitelli"
Naples, Naples, Italy
Policlinico Universitario Campus Bio-Medico di Roma
Roma, RM, Italy
UO Malattie retto-Intestinali Ospedale "Sacro Cuore-don Calabria"
Negrar, Verona, Italy
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
Padova, Italy
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Fukuoka University Hospital
Fukuoka, Japan