Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
3 other identifiers
interventional
319
19 countries
189
Brief Summary
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2017
Typical duration for phase_2
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2016
CompletedFirst Posted
Study publicly available on registry
November 8, 2016
CompletedStudy Start
First participant enrolled
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2021
CompletedResults Posted
Study results publicly available
July 21, 2022
CompletedJuly 21, 2022
June 1, 2022
4.3 years
November 4, 2016
May 9, 2022
June 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Mayo Score at Week 8 (Induction Period)
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score.
Week 8
Secondary Outcomes (34)
Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)
From Week 8 up to Week 32
Number of Participants With Laboratory Test Abnormalities (Chronic Period)
From Week 8 to Week 32
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
From Week 8 to Week 32
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
From Week 8 to Week 32
Number of Participants With Abnormal ECG Findings (Chronic Period)
Week 8 to Week 32
- +29 more secondary outcomes
Other Outcomes (1)
Change From Baseline in Total Mayo Score at Week 32 (Chronic Period)
Week 32
Study Arms (10)
PF-06651600 Drug Dose Level 1
EXPERIMENTALDelivered orally for 8 weeks
PF-06651600 Drug Dose Level 2
EXPERIMENTALDelivered orally for 8 weeks
PF-06651600 Drug Dose Level 3
EXPERIMENTALDelivered orally for 8 weeks.
PF-06651600 Placebo
PLACEBO COMPARATORDelivered orally for 8 weeks.
PF-06700841 Drug Dose Level 1
EXPERIMENTALDelivered orally for 8 weeks
PF-06700841 Drug Dose Level 2
EXPERIMENTALDelivered orally for 8 weeks.
PF-06700841 Drug Dose Level 3
EXPERIMENTALDelivered orally for 8 weeks.
PF-06700841 Placebo
PLACEBO COMPARATORDelivered orally for 8 weeks.
PF-06651600 Drug Dose Level 4
EXPERIMENTALDelivered orally for 24 weeks.
PF-06700841 Drug Dose Level 4
EXPERIMENTALDelivered orally for 24 weeks.
Interventions
Delivered orally for 8 weeks.
Delivered orally for 8 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosis of ulcerative colitis for greater than/equal to 3 months.
- Moderate to severe active ulcerative colitis
- Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
You may not qualify if:
- Pregnant or breastfeeding
- Clinical findings suggestive of Crohn's Disease
- History of bowel surgery within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (189)
Dothan Surgery Center
Dothan, Alabama, 36301, United States
Gut P.C., dba Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Long Beach Clinical Trials Services Inc.
Long Beach, California, 90806, United States
Southern California Research Institute Medical Group/West Gastroenterology Medical Group/Airport En-
Los Angeles, California, 90045, United States
Clinical Application Laboratories, INC.
San Diego, California, 92103, United States
San Diego Endoscopy Center
San Diego, California, 92103, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Front Range Endoscopy Center
Colorado Springs, Colorado, 80903, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Bristol Hospital
Bristol, Connecticut, 06010, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010, United States
Central Connecticut Endoscopy Center
Plainville, Connecticut, 06062, United States
West Coast Endoscopy Center
Clearwater, Florida, 33756, United States
University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Millenia Surgery Center
Orlando, Florida, 32811, United States
HMD Research LLC
Orlando, Florida, 32819, United States
Orlando Gastroenterology, PA
Orlando, Florida, 32835, United States
Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, 20815, United States
Feldman ENT
Chevy Chase, Maryland, 20815, United States
MGG Group Co. Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Cascades Endoscopy Center
Columbia, Maryland, 21045, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
Concorde medical Group, PLLC
New York, New York, 10016, United States
Kips Bay Endoscopy Center
New York, New York, 10016, United States
New York University Langone Medical Center
New York, New York, 10016, United States
NYU Clinical Cancer Center
New York, New York, 10016, United States
NYU Langone Medical Center
New York, New York, 10016, United States
NYU Medical Science Building
New York, New York, 10016, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10021, United States
Weill Cornell Medical College
New York, New York, 10021, United States
New York Presbyterian Hospital-Weill Cornell Medical College
New York, New York, 10065, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10065, United States
Weill Cornell Medical College
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
UNC Hospitals
Chapel Hill, North Carolina, 27514, United States
UNC Hospitals Endoscopy Center at Meadowmont
Chapel Hill, North Carolina, 27517, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7064, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7080, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, 73112, United States
Gastro One
Germantown, Tennessee, 38138, United States
Parkland Health and Hospital System
Dallas, Texas, 75235, United States
UT Southwestern Medical Center - CRU Aston
Dallas, Texas, 75390-8887, United States
UT Southwestern Medical Center-Clements University Hospital
Dallas, Texas, 75390, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine- Baylor Medical Center
Houston, Texas, 77030, United States
Baylor St. Luke's Medical Center Endoscopy-McNair Campus
Houston, Texas, 77030, United States
Gulf Coast Research Group
Houston, Texas, 77098, United States
Lonestar Endoscopy, LLP
Keller, Texas, 76248, United States
Sagact, Pllc.
San Antonio, Texas, 78229, United States
Sagact, Pllc
San Antonio, Texas, 78229, United States
Lonestar Endoscopy, LLP
Southlake, Texas, 76092, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
Verity Research
Fairfax, Virginia, 22031, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
University of Washington
Seattle, Washington, 98195, United States
AKH Wien Universitaetsklinik fuer Innere Medizin III
Vienna, 1090, Austria
"Medical Center-1- Sevlievo" EOOD
Sevlievo, Gabrovo, 5400, Bulgaria
"MHAT-Blagoevgrad" AD
Blagoevgrad, 2700, Bulgaria
MHAT Dobrich AD
Dobrich, 9300, Bulgaria
MC Hipocrat-2000 OOD
Haskovo, 6300, Bulgaria
MHAT Prof. Dr. Paraskev Stoyanov AD
Lovech, 5500, Bulgaria
Medical Center Vitadar Consult OOD
Rousse, 7000, Bulgaria
SHATPPD dr. Dimitar Gramatikov - Ruse EOOD
Rousse, 7002, Bulgaria
"MC Asklepion - researches in human medicine"" EOOD
Sofia, 1303, Bulgaria
"Acibadem City Clinic UMHAT" EOOD
Sofia, 1784, Bulgaria
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Nemocnice Slany, p.o.
Slaný, 274 01, Czechia
Nemocnice Strakonice, a.s., interni oddeleni
Strakonice, 386 01, Czechia
Nordsjaellands Hospital Frederikssund
Frederikssund, 3600, Denmark
Nordsjaellands Hospital Hilleroed
Hilleroed, 3400, Denmark
Amager og Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Research institute of Clinical Medicine
Tbilisi, 0112, Georgia
The First University Clinic of TSMU
Tbilisi, 0141, Georgia
Paian MED Research GmbH
Berlin, 10318, Germany
Gastrostudien GbR
Berlin, 10825, Germany
Krankenhaus Waldfriede e.V.
Berlin, 14163, Germany
MVZ Dachau - Patientenzentrum
Dachau, 85221, Germany
MVZ Dachau
Dachau, 85221, Germany
Asklepios Westklinikum Hamburg
Hamburg, 22559, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Eugastro GmbH
Leipzig, 04103, Germany
Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz
Békéscsaba, 5600, Hungary
Semmelweis Egyetem, II. Belgyogyaszati Klinika
Budapest, 1088, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I. Belgyogyaszati Gasztroenterologiai Osztaly
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Javorszky Odon Korhaz, Gasztroenterologia
Vác, 2600, Hungary
Clalit Health Services
Bat Yam, 5962025, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Diabetes and Endocrinology Unit
Tel Aviv, 6203854, Israel
Migdal Hamea Clinic
Tel Aviv, 6203854, Israel
IRCCS Saverio De Bellis
Castellana Grotte, BARI, 70013, Italy
AOU Sant'Orsola-Malpighi
Bologna, BO, 40138, Italy
A.O.U. Policlinico G. Martino
Messina, ME, 98125, Italy
Istituto Clinico Humanitas
Rozzano, Milan (MI), 20089, Italy
ASST Rhodense - Ospedale di Circolo di Rho
Rho, Milano (MI), 20017, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, PI, 56124, Italy
Policlinico Universitario Campus Biomedico
Roma, RM, 00128, Italy
AOU Policlinico di Modena
Modena, 41124, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Azienda Sanitaria Universitaria Integrata Udine
Udine, 33100, Italy
SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego w Bialymstoku
Bialystok, 15-950, Poland
ETG Kielce
Kielce, 25-355, Poland
Gastromed Sp. z o.o.
Lublin, 20-582, Poland
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, 61-113, Poland
KO-MED Centra Kliniczne Pulawy
Puławy, 24-100, Poland
ENDOSKOPIA Sp. z o. o.
Sopot, 81-756, Poland
H-T. Centrum Medyczne
Tychy, 43-100, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
Melita Medical Sp z o.o.
Wroclaw, 50-449, Poland
Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
Wroclaw, 51-162, Poland
Lexmedica
Wroclaw, 53-114, Poland
EMC Instytut Medyczny S.A., Szpital Specjalistyczny EuroMediCare z Przychodnia
Wroclaw, 54-144, Poland
Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.
Włocławek, 87-800, Poland
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Bucuresti
Bucharest, Sector 1,, 010825, Romania
S.C. Cabinet Particular Policlinic Algomed SRL
Timișoara, Timiș County, 300002, Romania
Spitalul Clinic Colentina, Sectia de Gastroenterologie
Bucharest, 020125, Romania
LLC "Olla-Med"
Moscow, 105554, Russia
FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University)
Moscow, 119435, Russia
Limited Liability Company "Medicinsky Center SibNovoMed"
Novosibirsk, 630005, Russia
LLC Novosibirskiy Gastrocentr
Novosibirsk, 630007, Russia
Novosibirskiy Gastrocenter
Novosibirsk, 630007, Russia
Federal State Budgetary Scientific Institution
Novosibirsk, 630117, Russia
FGBOU VO OmGMU Minzdrava Rossii
Omsk, 644050, Russia
FSBEI HE "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation
Rostov-on-Don, 344022, Russia
State Budgetary Institution of Ryazan Region "Regional Clinical Hospital"
Ryazan, 390039, Russia
RIAT Limited Liability Company (RIAT LLC)
Saint Petersburg, 195220, Russia
Saint-Petersburg State Budgetary Healthcare Institution
Saint Petersburg, 195257, Russia
Medical University REAVIZ
Samara, 443011, Russia
Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara"
Samara, 443029, Russia
LLC Medical Company Hepatolog
Samara, 443063, Russia
LLC Medical Company Hepatolog
Samara, 443076, Russia
State Budgetary Institution of Healthcare Yaroslavl Regional Clinical Hospital
Yaroslavl, 150062, Russia
Clinical Hospital Centre Zvezdara Clinic for Internal Diseases
Belgrade, 11000, Serbia
Clinical Hospital Centre Bezanijska Kosa Clinic for Internal Medicine
Belgrade, 11080, Serbia
Clinical Centre of Kragujevac
Kragujevac, 34000, Serbia
Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology
Niš, 18000, Serbia
General Hospital Subotica
Subotica, 24000, Serbia
Clinical Hospital Center Zemun
Zemun, Belgrade, 11080, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, 23000, Serbia
Abawi spol. s r.o
Bratislava, 82107, Slovakia
KM Management spol. s.r.o.
Nitra, 949 01, Slovakia
MUDr. Frantisek Horvath Gastroenterologia
Šahy, 936 01, Slovakia
ENDOMED, s.r.o.
Vranov nad Topľou, 093 01, Slovakia
Kyungpook National University Hospital
Daegu, 41944, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi, Ic Hastaliklari Anabilim Dali,
Ankara, 06100, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi, Ibn-i-Sina Hastanesi
Ankara, 06100, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, 06590, Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tıp Fakultesi
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, 38039, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Bulent Ecevit Universitesi Tip Fakultesi
Kozlu Zonguldak, 67600, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33110, Turkey (Türkiye)
Bulent Ecevit Universitesi Tip Fakultesi
Zonguldak, 67600, Turkey (Türkiye)
Regional Consultative Polyclinic
Chernivtsi, 58000, Ukraine
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", gastroenterology department,
Chernivtsi, 58001, Ukraine
MNCECCH No.2 n.a. PROF O.O. SHALIMOV of KHARKIV CITY COUNCIL
Kharkiv, 61037, Ukraine
Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olga Tropiny"
Kherson, 73000, Ukraine
Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center
Kropyvnytskyi, 25006, Ukraine
Kyiv Municipal Clinical Hospital #18, Proctology Department
Kyiv, 01030, Ukraine
Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center
Kyiv, 03680, Ukraine
Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway
Lviv, 79007, Ukraine
Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital"
Lviv, 79059, Ukraine
Municipal Institution "Odesa Regional Clinical Hospital"
Odesa, 65025, Ukraine
Municipal Institution of Ternopil regional council Ternopil University Hospital
Ternopil, 46002, Ukraine
Municipal Institution "Uzhgorod Regional Hospital"
Uzhhorod, 88009, Ukraine
Zakarpattia Regional Clinical Hospital n.a. A. Novak,
Uzhhorod, 88018, Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
Vinnytsia, 21018, Ukraine
Related Publications (4)
Hassan-Zahraee M, Ye Z, Xi L, Dushin E, Lee J, Romatowski J, Leszczyszyn J, Danese S, Sandborn WJ, Banfield C, Gale JD, Peeva E, Longman RS, Hyde CL, Hung KE. Baseline Serum and Stool Microbiome Biomarkers Predict Clinical Efficacy and Tissue Molecular Response After Ritlecitinib Induction Therapy in Ulcerative Colitis. J Crohns Colitis. 2024 Sep 3;18(9):1361-1370. doi: 10.1093/ecco-jcc/jjad213.
PMID: 38141256DERIVEDWojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
PMID: 37917289DERIVEDSandborn WJ, Danese S, Leszczyszyn J, Romatowski J, Altintas E, Peeva E, Hassan-Zahraee M, Vincent MS, Reddy PS, Banfield C, Salganik M, Banerjee A, Gale JD, Hung KE. Oral Ritlecitinib and Brepocitinib for Moderate-to-Severe Ulcerative Colitis: Results From a Randomized, Phase 2b Study. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2616-2628.e7. doi: 10.1016/j.cgh.2022.12.029. Epub 2023 Jan 6.
PMID: 36623678DERIVEDFensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.
PMID: 30113844DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2016
First Posted
November 8, 2016
Study Start
February 3, 2017
Primary Completion
May 10, 2021
Study Completion
May 10, 2021
Last Updated
July 21, 2022
Results First Posted
July 21, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.