Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis (JADE MOA)

January 17, 2023 updated by: Pfizer

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE MECHANISM OF ACTION OF ABROCITINIB MONOTHERAPY IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • Beacon Dermatology
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research, Inc.
  • United States
    • California
      • Encinitas, California, United States, 92024
        • California Dermatology & Clinical Research Institute
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of USC - IDS Pharmacy
    • Florida
      • Largo, Florida, United States, 33770
        • Olympian Clinical Research
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC - Dermatology Research
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Wayne Health - Wayne State Dermatology
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Texas
      • Dallas, Texas, United States, 75246
        • Menter Dermatology Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of chronic moderate-to-severe atopic dermatitis (AD) for at least 1 year
  • Recent history of inadequate response to medicated topical therapy for AD or required systemic therapy to control disease
  • Moderate-to-severe AD defined as affected BSA at least 10%, IGA at least 3, EASI at least 16, Peak Pruritus NRS at least 4

Exclusion Criteria:

  • A current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction
  • Currently have active forms of other inflammatory skin diseases, i.e. not AD, or have evidence of skin conditions (e.g. psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of AD or response to treatment
  • Participants who have received prior treatment with any systemic JAK inhibitors
  • Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication within specified time frames prior to the first dose of study medication, including topical treatments that could affect AD
  • Pregnant or breastfeeding women or sexually-active women of childbearing potential who are unwilling to use contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo administered as two tablets to be taken orally once daily for 12 weeks
EXPERIMENTAL: PF-04965842 100 mg
Drug: PF-04965842 100 mg
PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks
EXPERIMENTAL: PF-04965842 200 mg
Drug: PF-04965842 200 mg
PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12
Time Frame: Baseline, Week 12
Mean fold-changes from baseline at Week 12 in the biomarkers for general inflammation (Matrix Metallopeptidase [MMP]12), hyperplasia (Keratin [KRT]16), Th2 immune response (C-C motif chemokine ligand [CCL]17, CCL18, CCL26), and Th22 immune response (S100 calcium binding protein A [S100A]8, S100A9, S100A12), in lesional (LS) and non-lesional (NL) skin tissues, respectively. Expression levels from RT-PCR are normalized to the housekeeping gene RPLP0 by negatively transforming the Ct values to -dCt.
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12
Time Frame: Baseline, Week 12
Mean fold-changes from baseline in immunohistochemistry analysis in lesional skin endpoints at Week 12 are presented. Fold-changes are computed by obtaining the antilog of log2 fold-changes, retaining the sign for log2 fold-change.
Baseline, Week 12
Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12
Time Frame: Baseline, Week 12
Mean fold-changes from baseline in hyperplasia markers in skin biopsies at Week 12 are presented. Fold-changes are computed by obtaining the antilog of log2 fold-changes, retaining the sign for log2 fold-change.
Baseline, Week 12
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12
Time Frame: Baseline, Week 12
OLINK Proteomics Microassay was used to analyze biomarkers in serum to assess the effect of abrocitinib on the blood biomarkers. Mean fold-changes at Week 12 from baseline are listed. Baseline is defined as the last observation on or prior to day of first dose (Day 1).
Baseline, Week 12
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12
Time Frame: Baseline, Week 12
Mean percent changes from baseline at Week 12 in T-cell lymphocyte subset populations (CD3+ T cells, CD4+ T cells, CD8+ T cells, NK cells, B cells) are presented. Baseline is defined as the last observation on or prior to day of first dose (Day 1).
Baseline, Week 12
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin
Time Frame: Baseline, Week 12
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. Spearman correlation coefficient was calculated to assess the relationship between PP-NRS CFB and fold CFB of IHC and gene expression biomarkers.
Baseline, Week 12
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline at Week 2, 4, 8 and 12
Time Frame: Baseline, Weeks 2, 4, 8, and 12
The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Baseline, Weeks 2, 4, 8, and 12
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12
Time Frame: Baseline, Week 2, 4, 8, and 12
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Baseline, Week 2, 4, 8, and 12
Percentage of Participants With >=4 Points at Baseline and Achieving >=4 Points Improvement From Baseline in Numeric Rating Scale for Severity of Pruritus (PP-NRS) at Weeks 2, 4, 8 and 12
Time Frame: Baseline, Week 2, 4, 8, 12
PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Higher scores indicated worse itch. Participants who withdrew from the study were counted as non-responder.
Baseline, Week 2, 4, 8, 12
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12
Time Frame: Baseline to Week 2, 4, 8 and 12
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Baseline to Week 2, 4, 8 and 12
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12
Time Frame: Baseline to Week 2, 4, 8 and 12
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Baseline to Week 2, 4, 8 and 12
Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12
Time Frame: Baseline and Week 2, 4, 8 and 12
BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Baseline and Week 2, 4, 8 and 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline to 16 weeks
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Baseline to 16 weeks
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Baseline to 16 weeks
A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Baseline to 16 weeks
Number of Participants Who Discontinued From the Study Due to TEAEs
Time Frame: Baseline to 16 weeks
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Baseline to 16 weeks
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time Frame: Baseline to 16 weeks
Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.
Baseline to 16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12
Time Frame: Baseline and Week 2, 4, 8 and 12
Clinical laboratory tests including red blood cell (erythrocytes) were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.
Baseline and Week 2, 4, 8 and 12
Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12
Time Frame: Baseline and Week 2, 4, 8 and 12
Clinical laboratory tests including reticulocytes were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.
Baseline and Week 2, 4, 8 and 12
Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12
Time Frame: Baseline and Week 2, 4, 8 and 12
Clinical laboratory tests including platelet counts were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.
Baseline and Week 2, 4, 8 and 12
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12
Time Frame: Baseline and Week 2, 4, 8 and 12
Clinical laboratory tests including hs-CRP were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.
Baseline and Week 2, 4, 8 and 12
Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12
Time Frame: Baseline and Week 2, 4, 8 and 12
Clinical laboratory tests including interleukin were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.
Baseline and Week 2, 4, 8 and 12
Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12
Time Frame: Baseline and Week 2, 4, 8 and 12
Clinical laboratory tests including erythropoietin were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.
Baseline and Week 2, 4, 8 and 12
Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12
Time Frame: Baseline and Week 2, 4, 8 and 12
Clinical laboratory tests including thrombopoietin were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.
Baseline and Week 2, 4, 8 and 12
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12
Time Frame: Baseline and Week 2, 4, 8 and 12
The severity and frequency of itch (pruritus) during the night due to AD was assessed using the Night Time Itch Scale Score. Participants assessed their worst itching due to AD during their most recent night's sleep on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Higher scores indicated worse itch. The frequency of itch was assessed using a 5-point qualitative scale, with responses including "Never", "Rarely", "Sometimes", "Often" and "Almost Always".
Baseline and Week 2, 4, 8 and 12
Plasma PF-04965842 Concentration
Time Frame: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
Pharmacokinetic (PK) samples were collected at Week 4 and 12 for measurement of plasma concentration of PF-04965842.
Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
Plasma PF-06471658 (M1) Concentration
Time Frame: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-06471658 (M1).
Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
Plasma PF-07055087 (M2) Concentration
Time Frame: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-07055087 (M2).
Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
Plasma PF-07054874 (M4) Concentration
Time Frame: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolites PF-07054874 (M4).
Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7451037
  • JADE MOA (OTHER: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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