Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
JADE Mono-2
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
3 other identifiers
interventional
391
13 countries
115
Brief Summary
B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2018
Shorter than P25 for phase_3
115 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
June 15, 2018
CompletedStudy Start
First participant enrolled
June 29, 2018
CompletedFirst Posted
Study publicly available on registry
July 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2019
CompletedResults Posted
Study results publicly available
April 21, 2020
CompletedApril 21, 2020
April 1, 2020
1.1 years
June 15, 2018
March 4, 2020
April 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.
Baseline, Week 12
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12
EASI evaluates severity of participants AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\] on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Baseline, Week 12
Secondary Outcomes (17)
Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12
Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12
Baseline, Week 12
Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus
Baseline up to Day 15
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8
Baseline, Weeks 2, 4, and 8
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8
Baseline, Weeks 2, 4, and 8
- +12 more secondary outcomes
Study Arms (3)
PF-04965842 100 mg
EXPERIMENTALPF-04965842 200 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
Eligibility Criteria
You may qualify if:
- years of age or older with a minimum body weight of 40 kg
- Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
- Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control
You may not qualify if:
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Prior treatment with JAK inhibitors
- Other active nonAD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (115)
Emmaus Research Center, Inc.
Anaheim, California, 92804, United States
Advanced Research Center, Inc. - Los Alamitos Site
Los Alamitos, California, 90720, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907, United States
Colorado Springs Dermatology Clinic, PC
Colorado Springs, Colorado, 80910, United States
Olympian Clinical Research
Clearwater, Florida, 33756, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Precision Imaging
Jacksonville, Florida, 32256, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Imaging Center of Idaho
Caldwell, Idaho, 83605, United States
ASR, LLC
Nampa, Idaho, 83687, United States
Meridian Clinical Research
Baton Rouge, Louisiana, 70808, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Sadick Research Group
New York, New York, 10075, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28411, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
The Ohio State University Dermatology East
Gahanna, Ohio, 43230, United States
Tanenbaum Dermatology Center
Memphis, Tennessee, 38117, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Austin Institute for Clinical Research, Inc. - Central
Austin, Texas, 78705, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004, United States
West Houston Dermatology, PA
Houston, Texas, 77082, United States
Summit Clinical Research, LLC
Franklin, Virginia, 23851, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502, United States
Australian Clinical Research Network
Maroubra, New South Wales, 2035, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Skin and Cancer Foundation Inc
Carlton, VIC 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
The Royal Children's Hospital (RCH)
Parkville, Victoria, 3052, Australia
Medical Centre Asklepii OOD
Dupnitsa, 2600, Bulgaria
MHAT Dr. Tota Venkova AD
Gabrovo, 5300, Bulgaria
"Acibadem City Clinic MHAT Tokuda" EAD
Sofia, 1407, Bulgaria
"DCC Aleksandrovska" EOOD
Sofia, 1431, Bulgaria
Diagnostic Consultative Center Fokus-5
Sofia, 1463, Bulgaria
Medical Centre Synexus Sofia EOOD
Sofia, 1784, Bulgaria
University of British Columbia Department of Dermatology and Skin Science
Vancouver, British Columbia, V5Z 4E8, Canada
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
North York Research Inc.
North York, Ontario, M2M 4J5, Canada
Oshawa Clinic Dermatology Trials
Oshawa, Ontario, L1H 1B9, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4C 9M7, Canada
Research Toronto
Toronto, Ontario, M4W 2N2, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
The Second Affiliated Hospital of Army Medical University, PLA
Chongqing, Chongqing Municipality, 400037, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, 518053, China
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, 300052, China
Dermamedica S.R.O.
NĂ¡chod, 547 01, Czechia
Oblastni nemocnice Nachod a.s., Radiodiagnosticke oddeleni
NĂ¡chod, 547 01, Czechia
Lekarna u Stribrneho orla
NĂ¡chod, 54701, Czechia
Sanatorium profesora Arenbergera
Prague, 11000, Czechia
Lekarna U sv. Ignace
Prague, 120 00, Czechia
Dermatologicka Ambulance
Svitavy, 568 02, Czechia
Lekarna na Hranicni
Svitavy, 56802, Czechia
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
ISA GmbH
Berlin, 10789, Germany
Fachärztliche Gemeinschaftspraxis fĂ¼r Dermatologie und Venerologie, Allergologie,
Blankenfelde-Mahlow, 15831, Germany
IKF Pneumologie GmbH & Co KG
Frankfurt, 60596, Germany
Klinische Forschung Hamburg GmbH
Hamburg, 20253, Germany
Universitaet Muenster
MĂ¼nster, 48149, Germany
Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
SE AOK Bor, Nemikortani es Boronkologiai Klinika
Budapest, 1085, Hungary
Budapest FÅ‘vĂ¡ros XIX. KerĂ¼leti Ă–nkormĂ¡nyzat Kispesti EgĂ©szsegĂ¼gyi IntĂ©zete
Budapest, 1195, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
ALLERGO-DERM BAKOS Kft.
Szolnok, 5000, Hungary
Queen's square Medical Facilities Queen's square Dermatology and Allergology
Yokohama, Kanagawa, 220-6208, Japan
Noguchi Dermatology Clinic
Kamimashiki-gun, Kumamoto, 861-3101, Japan
Yoshioka Dermatology Clinic
Neyagawa, Osaka, 572-0838, Japan
Kume Clinic
Sakai, Osaka, 593-8324, Japan
Sumire Dermatology Clinic
Edogawa-ku, Tokyo, 133-0057, Japan
Matsuyama Dermatology Clinic
Nakano-ku, Tokyo, 165-0026, Japan
Hoshikuma Dermatologyăƒ»Allergy Clinic
Fukuoka, 814-0171, Japan
Sanrui Hifuka
Saitama, 330-0854, Japan
Selga Freiberga private practice in dermatovenerology and cosmetology
Jelgava, LV-3001, Latvia
Riga 1st Hospital, Clinic for Dermatology and STD
Riga, LV-1001, Latvia
Aesthetic dermatology clinic of Prof. J. Kisis
Riga, LV-1003, Latvia
Health Centre 4 Ltd. Diagnostics Centre
Riga, LV-1003, Latvia
Health Centre 4 Ltd
Riga, LV-1013, Latvia
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
Bialystok, 15-453, Poland
KLIMED Marek Klimkiewicz
Bialystok, 15-704, Poland
Centrum Badań Klinicznych JCI
Krakow, 30-348, Poland
Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o. o.
Krakow, 31-011, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, 90-242, Poland
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Poznan, 60-848, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Synexus Polska Sp. z o. o. Oddzial w Warszawie
Warsaw, 01-192, Poland
Centrum Medyczne AMED
Warsaw, 01-518, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
Klinika Ambroziak Sp. z o.o.
Warsaw, 02-758, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, 50-381, Poland
Lukasz Matusiak "4HEALTH"
Wroclaw, 50-566, Poland
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584, South Korea
The Catholic University of Korea, Incheon St.Mary's Hospital
Bupyeong-gu, Incheon, 21431, South Korea
Inha University Hospital
Jung-gu, Incheon, 22332, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Severance Hospital, Yonsei Univ. Health System
Seoul, 03722, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Hallym university Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Plymouth Hospitals NHS Trust, Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
MAC Clinical Research
Blackpool, Lancashire, FY2 0JH, United Kingdom
MAC Clinical Research Ltd
Cannock, South Staffordshire, WS11 0BN, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2EP, United Kingdom
University Hospital Bristol NHS Foundation Trust
Bristol, BS2 8HW, United Kingdom
MAC Clinical Research Ltd
Manchester, M13 9NQ, United Kingdom
Related Publications (14)
Paller AS, Eichenfield LF, Irvine AD, Flohr C, Wollenberg A, Barbarot S, Bangert C, Spergel JM, Selfridge A, Biswas P, Fan H, Alderfer J, Watkins M, Koppensteiner H. Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3.
PMID: 40028832DERIVEDSilverberg JI, Thyssen JP, Lazariciu I, Myers DE, Guler E, Chovatiya R. Abrocitinib may improve itch and quality of life in patients with itch-dominant atopic dermatitis. Skin Health Dis. 2024 May 5;4(4):e382. doi: 10.1002/ski2.382. eCollection 2024 Aug.
PMID: 39104653DERIVEDArmstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.
PMID: 38896380DERIVEDSchmid-Grendelmeier P, Gooderham MJ, Hartmann K, Konstantinou GN, Fellmann M, Koulias C, Clibborn C, Biswas P, Brunner PM. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies. Allergy. 2024 Jan;79(1):174-183. doi: 10.1111/all.15952. Epub 2023 Nov 21.
PMID: 37988255DERIVEDAlexis AF, Silverberg JI, Rice ZP, Armstrong AW, Desai SR, Fonacier L, Kabashima K, Biswas P, Cella RR, Chan GL, Levenberg M. Abrocitinib efficacy and safety in moderate-to-severe atopic dermatitis by race, ethnicity, and Fitzpatrick skin type. Ann Allergy Asthma Immunol. 2024 Mar;132(3):383-389.e3. doi: 10.1016/j.anai.2023.11.002. Epub 2023 Nov 10.
PMID: 37949351DERIVEDYosipovitch G, Gooderham MJ, Stander S, Fonacier L, Szepietowski JC, Deleuran M, Girolomoni G, Su JC, Bushmakin AG, Cappelleri JC, Feeney C, Chan G, Thorpe AJ, Valdez H, Biswas P, Rojo R, DiBonaventura M, Myers DE. Interpreting the Relationship Among Itch, Sleep, and Work Productivity in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE MONO-2. Am J Clin Dermatol. 2024 Jan;25(1):127-138. doi: 10.1007/s40257-023-00810-7. Epub 2023 Aug 25.
PMID: 37624488DERIVEDBlauvelt A, Boguniewicz M, Brunner PM, Luna PC, Biswas P, DiBonaventura M, Farooqui SA, Rojo R, Cameron MC. Abrocitinib monotherapy in Investigator's Global Assessment nonresponders: improvement in signs and symptoms of atopic dermatitis and quality of life. J Dermatolog Treat. 2022 Aug;33(5):2605-2613. doi: 10.1080/09546634.2022.2059053. Epub 2022 Jul 6.
PMID: 35763326DERIVEDStander S, Bhatia N, Gooderham MJ, Silverberg JI, Thyssen JP, Biswas P, DiBonaventura M, Romero W, Farooqui SA. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 Aug;36(8):1308-1317. doi: 10.1111/jdv.18170. Epub 2022 May 6.
PMID: 35462428DERIVEDWojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.
PMID: 35342978DERIVEDWojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
PMID: 35061234DERIVEDCork MJ, McMichael A, Teng J, Valdez H, Rojo R, Chan G, Zhang F, Myers DE, DiBonaventura M. Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):422-433. doi: 10.1111/jdv.17792. Epub 2021 Dec 4.
PMID: 34743361DERIVEDSimpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18.
PMID: 34406619DERIVEDSilverberg JI, Thyssen JP, Simpson EL, Yosipovitch G, Stander S, Valdez H, Rojo R, Biswas P, Myers DE, Feeney C, DiBonaventura M. Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes. Am J Clin Dermatol. 2021 Jul;22(4):541-554. doi: 10.1007/s40257-021-00604-9. Epub 2021 May 5.
PMID: 33954933DERIVEDSilverberg JI, Simpson EL, Thyssen JP, Gooderham M, Chan G, Feeney C, Biswas P, Valdez H, DiBonaventura M, Nduaka C, Rojo R. Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Aug 1;156(8):863-873. doi: 10.1001/jamadermatol.2020.1406.
PMID: 32492087DERIVED
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 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2018
First Posted
July 3, 2018
Study Start
June 29, 2018
Primary Completion
August 13, 2019
Study Completion
August 13, 2019
Last Updated
April 21, 2020
Results First Posted
April 21, 2020
Record last verified: 2020-04
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.