A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

PHASE2CompletedINTERVENTIONAL
Enrollment

246

Participants

Timeline

Start Date

December 19, 2019

Primary Completion Date

October 25, 2022

Study Completion Date

October 25, 2022

Conditions
Moderate to Severe Ulcerative Colitis
Interventions
DRUG

Induction- PF-06480605 50 mg SC Q4W

PF-06480605

DRUG

Induction- PF-06480605 150 mg SC Q4W

PF-06480605

DRUG

Induction- PF-06480605 450 mg SC Q4W

PF-06480605

OTHER

Induction- Placebo SC Q4W

0 mg Placebo

DRUG

Chronic- PF-06480605 50 mg SC Q4W

PF-06480605

DRUG

Chronic- PF-06480605 150 mg SC Q4W

PF-06480605

DRUG

Chronic- PF-06480605 450 mg SC Q4W

PF-06480605

Trial Locations (167)

1619

Arwyp Medical Centre, Kempton Park

Clinresco Centres (Pty) Ltd, Kempton Park

1784

"ACIBADEM City Clinic Diagnostic-Consultative Center EOOD", Sofia

1827

Ahmed Kathrada Private Hospital, Johannesburg

Lenasia Clinical Trial Centre, Johannesburg

2139

Concord Repatriation General Hospital, Concord

3000

University Hospitals Leuven/Department of Gastroenterology, Leuven

4101

Mater Misericordiae Ltd., South Brisbane

5000

Royal Adelaide Hospital, Adelaide

7100

Clinfan Kft., Szekszárd

8000

Life Egészségcentrum, Székesfehérvár

8200

Szofia Private Clinic, Veszprém

8230

DRC Gyogyszervizsgalo Kozpont Kft., Balatonfüred

8300

Deák Jenő Kórház, Tapolca

8400

Magyar Imre Kórház, Ajka

9301

Dr van Dyk & Partners Inc, Bloemfontein

IATROS International, Bloemfontein

Universitas Private Hospital, Bloemfontein

10021

Weill Cornell Medical College - New York Presbyterian Hospital, New York

Weill Cornell Medical College, New York

10065

New York Presbyterian Hospital - Weill Cornell Medical Center, New York

Weill Cornell Medical College - New York Presbyterian Hospital, New York

Weill Cornell Medical College- New York Presbyterian Hospital, New York

10330

King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, Pathum Wan

10400

Phramongkutklao Hospital, Bangkok

14050

Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH, Berlin

19104

Investigational Drug Services, Philadelphia

Perelman Center for Advanced Medicine, Philadelphia

20089

Istituto Clinico Humanitas Centro per le Malattie Infiammatorie Croniche dell'Intestino - IBD Cent, Rozzano

21009

"Medical center of Limited Liability Company Health Clinic, medical clinical research center", Vinnytsia

22031

Gastroenterology Associates of Northern VA, Fairfax

Gastroenterology Associates of Northern Virginia, Fairfax

Verity Research, Inc., Fairfax

23000

"Opsta Bolnica Djordje Joanovic, Odeljenje Interno, Odsek Gastroenterologija", Zrenjanin

24000

Opsta Bolnica Subotica, Subotica

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

29607

Gastroenterology Associates, PA of Greenville, Greenville

30076

Gastroenterology Consultants P.C., Roswell

33110

Mersin Universitesi Tip Fakultesi Hastanesi, Mersin

33603

Akumin, Tampa

Tampa Bay Endoscopy Center, Tampa

33615

Alliance Clinical Research of Tampa, Tampa

33761

Safety Harbor Surgery, Clearwater

33762

Trident Care, Clearwater

34000

Klinicki Centar Kragujevac, Kragujevac

34093

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi, Istanbul

Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul

34613

Medycal Research Inc., Brooksville

34677

Tower Radiology Center, Oldsmar

35128

Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia, Padua

36301

Digestive Health Specialists, Dothan

Dothan Surgery Center, Dothan

36305

Flowers Hospital, Dothan

37024

"UO Malattie retto-Intestinali Ospedale Sacro Cuore-don Calabria", Negrar

37204

Vanderbilt GI Endoscopy Lab at One Hundred Oaks, Nashville

Vanderbilt Heart One Hundred Oaks, Nashville

Vanderbilt Inflammatory Bowel Disease Clinic, Nashville

Vanderbilt Laboratory Services North One Hundred Oaks, Nashville

Vanderbilt One Hundred Oaks Imaging, Nashville

37212

Vanderbilt University Medical Center, Nashville

37232

Vanderbilt University Medical Center- Heart Station (ECG), Nashville

Vanderbilt University Medical Center, Nashville

41380

Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali, Kocaeli

44093

CHU Hôtel-Dieu, Nantes

44600

BRCR Global Mexico, Guadalajara

48334

Michigan Endoscopy Center, Farmington Hills

52242

University of Iowa Hospitals and Clinics, Iowa City

53222

Medical Diagnostic Imaging, Wauwatosa

53226

Allegiance Internal Medicine and Allegiance Research Specialists, Wauwatosa

GI Associates, Wauwatosa

59037

Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC, Lille

Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez, Lille

Centre Hospitalier Regional Universitaire (CHU) de Lille, Lille

60637

The University of Chicago Medical Center (clinic address), Chicago

The University of Chicago Medical Center, Chicago

61024

"Municipal non-profit enterprise of Kharkiv regional council Regional clinical hospital", Kharkiv

61037

"Municipal non-profit enterprise City clinical hospital #2 named after O.O.Shalimov", Kharkiv

67600

Bulent Ecevit Universitesi Tip Fakultesi, Zonguldak

69076

"Medical Centre DIACENTER LLC", Zaporizhzhia

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

Centre Hospitalier Universitaire de Lyon Sud, Pierre-Bénite

70013

"IRCCS Saverio de Bellis, UOC Gastroenterologia", Castellana Grotte

72204

Lynn Institute of the Ozarks, Little Rock

76070

Smiq S. de R.L. de C.V., Querétaro

77024

PrimeCare Medical Group, Houston

78230

Gastroenterology Consultants of San Antonio, PA, San Antonio

VIP Trials, San Antonio

78258

South Texas Radiology Imaging Centers, San Antonio

80054

CHU d'Amiens-Picardie - SITE SUD, Amiens

80138

"A.O.U. dell'Università degli Studi della Campania Luigi Vanvitelli", Napoli

89102

Valley View Surgery Center, Las Vegas

89106

Sierra Clinical Research, Las Vegas

90110

Songklanagarind Hospital, Prince of Songkla University, Hat Yai

92660

Surinder Saini, M.D., Inc., Newport Beach

97130

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion, Mérida

115419

"KDC Evromedservis, OJSC", Moscow

150062

"SBHI YaR Regional Clinical Hospital", Yaroslavl

170004

Asociacion IPS Medicos Internistas de Caldas, Manizales

214019

Research Institute of Antimicrobial Chemotherapy, Smolensk

302001

S.R. Kalla Memorial Gastro & General Hospital, Jaipur

302004

S.M.S. Medical College & Hospital, Jaipur

357500

Pyatigorsk City Clinical Hospital, Pyatigorsk

360005

Shree Giriraj Multispeciality Hospital, Rajkot

395002

Surat Institute of Digestive Sciences, Surat

395009

Gujarat Hospital Gastro and Vascular Centre, Opp. Shree Ram Petrol Pump, Surat

410054

Clinical Hospital named after S.R. Mirotvortsev, Saratov

411001

Grant Medical Foundation, Ruby Hall Clinic, Pune

443029

"Private Healthcare Institution Clinical Hospital Russian Railways-Medicine Samara city", Samara

560054

M.S. Ramaiah Medical College and Hospitals,, Bangalore

M.S. Ramaiah Medical College and Hospitals, Bangalore

614109

Perm Clinical Centre of the Federal Medical-Biological Agency, Perm

625007

"City Hospital JSC Medical centre", Tyumen

630005

"Limited Liability Company Medicinsky Center SibNovoMed", Novosibirsk

630007

LLC Novosibirskiy Gastrocenter, Novosibirsk

634063

Tomsk Regional Clinical Hospital, Tomsk

644050

Clinic of OSMU, Omsk

06437

Endoscopy Center of Connecticut, LLC, Guilford

06518

Endoscopy Center of Connecticut, LLC, Hamden

Medical Research Center Of Connecticut, LLC, Hamden

PACT Gastroenterology Center, Hamden

Whitney Imaging, Hamden

02115

Brigham & Women's Hospital, Boston

Brigham and Women's Hospital - Office, Boston

Brigham and Women's Hospital, Boston

37212-1610

Vanderbilt University Medical Center - GI Research Office, Nashville

37232-5543

Vanderbilt University Med. Center, Nashville

06108

Studiengesellschaft BSF UG (haftungsbeschränkt), Halle

Studiengesellschaft BSF Unternehmergesellschaft, Halle

H-1033

Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest

H-2800

Clinexpert Tatabanya, Szent Borbala Hospital, Tatabánya

00128

Policlinico Universitario Campus Bio-Medico di Roma, Roma

480-1195

Aichi Medical University Hospital, Nagakute

285-8741

Toho University Sakura Medical Center, Sakura

830-0011

Kurume University Hospital, Kurume

060-8543

Sapporo Medical University Hospital, Sapporo

983-8520

National Hospital Organization Sendai Medical Center, Sendai

113-8519

Tokyo Medical And Dental University Hospital, Bunkyo-ku

160-8582

Keio University Hospital, Shinjuku-ku

814-0180

Fukuoka University Hospital, Fukuoka

01120

Karla Adriana Espinosa Bautista, Mexico City

15-704

KLIMED Marek Klimkiewicz, Bialystok

44-190

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla, Knurów

MZ Badania Slowik Zymla Sp. j., Knurów

81-756

ENDOSKOPIA Sp. z o. o., Sopot

71-434

Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin

00-728

WIP Warsaw IBD Point Profesor Kierkus, Warsaw

03-580

NZOZ Vivamed Jadwiga Miecz, Warsaw

50-449

Centrum Medyczne Melita Medical, Wroclaw

010719

Medlife S.A., Bucharest

020125

Spitalul Clinic Colentina, Bucharest

949 01

KM Management spol. s.r.o., Nitra

080 01

Gastro LM s.r.o, Prešov

093 01

ENDOMED, s.r.o., Vranov nad Topľou

0002

Emmed Research, Pretoria

Radiology24 Jakaranda Hospital, Pretoria

0048

Mediclinic Kloof Hospital, Pretoria

01023

Medical Centre Medical Clinic Blagomed LLC, Kyiv

02091

"Municipal Non-profit Enterprise Kyiv City Clinical Hospital #1", Kyiv

04078

"Municipal Non-profit enterprise of Kyiv Regional Council Kyiv regional hospital", Kyiv

04107

"Municipal non-profit enterprise of Kyiv regional council Kyiv regional clinical hospital", Kyiv

B74 3UP

Endoscopy Facility - Spire Little Aston Hospital, Sutton Coldfield

HA6 2RN

MeDiNova North London Quality Research Site, Northwood

NN18 9EZ

MeDiNova Northamptonshire Quality Research Site, Corby

HP11 2QW

Egin Research Ltd, High Wycombe

HA6 2JW

Chest X-ray Facility - BMI Bishops Wood Hospital, Northwood

NG12 4GA

Spire Nottingham Hospital, Nottingham

BR5 3TW

Endoscopy Facility - Orpington Endoscopy Centre, Orpington

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY

NCT04090411 - A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis | Biotech Hunter | Biotech Hunter