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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03720470




Registration number
NCT03720470
Ethics application status
Date submitted
24/10/2018
Date registered
25/10/2018

Titles & IDs
Public title
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Scientific title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Secondary ID [1] 0 0
COMPARE
Secondary ID [2] 0 0
B7451029
Universal Trial Number (UTN)
Trial acronym
JADE Compare
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis 0 0
Dermatitis, Atopic 0 0
Eczema 0 0
Skin Diseases 0 0
Skin Diseases, Genetic 0 0
Genetic Diseases, Inborn 0 0
Skin Diseases, Eczematous 0 0
Hypersensitivity 0 0
Hypersensitivity, Immediate 0 0
Immune System Diseases 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-04965842 100 mg
Treatment: Drugs - PF-04965842 200 mg
Treatment: Drugs - Dupilumab
Treatment: Drugs - Oral Placebo
Treatment: Drugs - Injectable Placebo

Experimental: PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg - Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20

Experimental: PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg - Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20

Active comparator: Dupilumab Injection + Oral Placebo followed by Oral Placebo - Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20

Placebo comparator: Oral Placebo + Placebo Inj followed by 100 mg PF-04965842 - Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20

Placebo comparator: Oral Placebo + Placebo Inj followed by 200 mg PF-04965842 - Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20


Treatment: Drugs: PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows:

1. In the arm "PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;
2. In the arm "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" subjects take PF-04965842 100 mg from Week 16 to Week 20.

Treatment: Drugs: PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows:

1. In the arm "PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;
2. In the arm "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842" subjects take PF-04965842 200 mg from Week 16 to Week 20.

Treatment: Drugs: Dupilumab
Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16.

Treatment: Drugs: Oral Placebo
Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows:

1. In the arm "Dupilumab Injection + Oral Placebo followed by Oral Placebo," the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20;
2. In the arms "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" and "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842," subjects, take Oral Placebo from Day 1 until Week 16.

Treatment: Drugs: Injectable Placebo
Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12
Timepoint [1] 0 0
Baseline (the last measurement prior to first dosing on Day 1), Week 12
Primary outcome [2] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16
Timepoint [1] 0 0
Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16
Timepoint [2] 0 0
Baseline, Week 2, 4, 8 and 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16
Timepoint [3] 0 0
Baseline, Week 2, 4, 8 and 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Timepoint [4] 0 0
Baseline, Week 2, 4, 8, 12 and 16
Secondary outcome [5] 0 0
Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Timepoint [5] 0 0
Baseline, Week 2, 4, 8,12 and 16
Secondary outcome [6] 0 0
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Timepoint [6] 0 0
Baseline, Week 2, 4, 8, 12 and 16
Secondary outcome [7] 0 0
Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS
Timepoint [7] 0 0
Baseline up to Week 16
Secondary outcome [8] 0 0
Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16
Timepoint [8] 0 0
Baseline, Week 2, 4, 8, 12 and 16
Secondary outcome [9] 0 0
Percentage BSA at Week 18 and 20
Timepoint [9] 0 0
Week 18 and 20
Secondary outcome [10] 0 0
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16
Timepoint [10] 0 0
Baseline, Week 2, 4, 8, 12 and 16
Secondary outcome [11] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16
Timepoint [11] 0 0
Baseline, Week 2, 12 and 16
Secondary outcome [12] 0 0
DLQI at Week 20
Timepoint [12] 0 0
Week 20
Secondary outcome [13] 0 0
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16
Timepoint [13] 0 0
Baseline, Week 12 and 16
Secondary outcome [14] 0 0
Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16
Timepoint [14] 0 0
Baseline, Week 12 and 16
Secondary outcome [15] 0 0
EQ-5D-5L- Index Value at Week 20
Timepoint [15] 0 0
Week 20
Secondary outcome [16] 0 0
EQ-5D-5L- VAS Score at Week 20
Timepoint [16] 0 0
Week 20
Secondary outcome [17] 0 0
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16
Timepoint [17] 0 0
Baseline, Weeks 12 and 16
Secondary outcome [18] 0 0
Change From Baseline in HADS - Depression Scale at Week 12 and 16
Timepoint [18] 0 0
Baseline, Week 12 and 16
Secondary outcome [19] 0 0
HADS - Anxiety Scale at Week 20
Timepoint [19] 0 0
Week 20
Secondary outcome [20] 0 0
HADS - Depression Scale at Week 20
Timepoint [20] 0 0
Week 20
Secondary outcome [21] 0 0
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16
Timepoint [21] 0 0
Baseline, Week 12 and 16
Secondary outcome [22] 0 0
POEM at Week 20
Timepoint [22] 0 0
Week 20
Secondary outcome [23] 0 0
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16
Timepoint [23] 0 0
Baseline, Week 1 to Week 16
Secondary outcome [24] 0 0
PSAAD Total Score at Week 18 and 20
Timepoint [24] 0 0
Week 18 and 20
Secondary outcome [25] 0 0
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Timepoint [25] 0 0
Baseline, Week 2, 4, 8 12 and 16
Secondary outcome [26] 0 0
Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16
Timepoint [26] 0 0
Baseline, Week 2, 4, 8 12 and 16
Secondary outcome [27] 0 0
Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16
Timepoint [27] 0 0
Baseline, Week 2, 4, 8 12 and 16
Secondary outcome [28] 0 0
SCORAD VAS of Itch and Sleep Loss at Week 18 and 20
Timepoint [28] 0 0
Week 18 and 20
Secondary outcome [29] 0 0
Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16
Timepoint [29] 0 0
Baseline up to Week 16

Eligibility
Key inclusion criteria
* Male or female subjects aged 18 years or older at the time of informed consent
* 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)
* Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.
* Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study
* Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
2. Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
* Female subjects of non-childbearing potential must meet at least 1 of the following criteria:

* Have undergone a documented hysterectomy and/or bilateral oophorectomy;
* Have medically confirmed ovarian failure; or
* Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.

All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.

-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
* 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
* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
* Other active nonAD inflammatory skin diseases or conditions affecting skin
* Prior treatment with JAK inhibitors
* Previous treatment with dupilumab
* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2020
Sample size
Target
Accrual to date
Final
838
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [3] 0 0
The Skin Centre - Benowa
Recruitment hospital [4] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [5] 0 0
North Eastern Health Specialists - Hectorville
Recruitment hospital [6] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
Emeritus Research - Camberwell
Recruitment hospital [8] 0 0
Skin and Cancer Foundation Inc - Carlton
Recruitment hospital [9] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5073 - Hectorville
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
3053 - Carlton
Recruitment postcode(s) [9] 0 0
3002 - East Melbourne
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
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Colorado
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United States of America
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Idaho
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United States of America
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Illinois
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Indiana
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Ohio
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Utah
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Virginia
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Varna
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British Columbia
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Halle
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Daejeon
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Incheon
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Szczecin
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Wroclaw
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Slovakia
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Bratislava
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Kosice-Saca
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Kosice
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Nove Zamky
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Svidnik
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Taiwan
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Taiwan (r.o.c)
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Taiwan
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Taichung City
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
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Berkshire
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Devon
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Essex
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Greater London
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Kent
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Middlesex
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Peterborough
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Warwickshire
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United Kingdom
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WEST Yorkshire
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United Kingdom
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Corby
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United Kingdom
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Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
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Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03720470