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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04965842 200 mg
PF-04965842 100 mg
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, atopic eczema, eczema, JAK, janus kinase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 pat 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

Sites / Locations

  • California Dermatology & Clinical Research Institute
  • Keck School of Medicine of USC - IDS Pharmacy
  • USC/Norris Comprehensive Cancer Center
  • Olympian Clinical Research
  • ForCare Clinical Research
  • The Indiana Clinical Trials Center, PC - Dermatology Research
  • Wayne Health - Wayne State Dermatology
  • Icahn School of Medicine at Mount Sinai
  • Menter Dermatology Research Institute
  • Beacon Dermatology
  • Innovaderm Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

PF-04965842 200 mg

PF-04965842 100 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at 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.

Secondary Outcome Measures

Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at 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.
Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at 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.
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at 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).
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at 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).
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
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.
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
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.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From 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.
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
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.
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at 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.
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at 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.
Percent Change From Baseline in Percentage Body Surface Area (BSA) at 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Number of Participants With Serious Adverse Events (SAEs)
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.
Number of Participants Who Discontinued From the Study Due to TEAEs
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.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
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.

Full Information

First Posted
March 22, 2019
Last Updated
January 17, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03915496
Brief Title
Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
Acronym
JADE MOA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
November 16, 2021 (Actual)
Study Completion Date
November 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, atopic eczema, eczema, JAK, janus kinase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-04965842 200 mg
Arm Type
Experimental
Arm Title
PF-04965842 100 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04965842 200 mg
Intervention Description
PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04965842 100 mg
Intervention Description
PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered as two tablets to be taken orally once daily for 12 weeks
Primary Outcome Measure Information:
Title
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
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
Description
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.
Time Frame
Baseline, Week 12
Title
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
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, and 12
Title
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline, Week 2, 4, 8, and 12
Title
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
Description
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.
Time Frame
Baseline, Week 2, 4, 8, 12
Title
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline to Week 2, 4, 8 and 12
Title
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline to Week 2, 4, 8 and 12
Title
Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline and Week 2, 4, 8 and 12
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Baseline to 16 weeks
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline to 16 weeks
Title
Number of Participants Who Discontinued From the Study Due to TEAEs
Description
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.
Time Frame
Baseline to 16 weeks
Title
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Description
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.
Time Frame
Baseline to 16 weeks
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline and Week 2, 4, 8 and 12
Title
Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline and Week 2, 4, 8 and 12
Title
Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline and Week 2, 4, 8 and 12
Title
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline and Week 2, 4, 8 and 12
Title
Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline and Week 2, 4, 8 and 12
Title
Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline and Week 2, 4, 8 and 12
Title
Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12
Description
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.
Time Frame
Baseline and Week 2, 4, 8 and 12
Title
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12
Description
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".
Time Frame
Baseline and Week 2, 4, 8 and 12
Title
Plasma PF-04965842 Concentration
Description
Pharmacokinetic (PK) samples were collected at Week 4 and 12 for measurement of plasma concentration of PF-04965842.
Time Frame
Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
Title
Plasma PF-06471658 (M1) Concentration
Description
PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-06471658 (M1).
Time Frame
Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
Title
Plasma PF-07055087 (M2) Concentration
Description
PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-07055087 (M2).
Time Frame
Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose
Title
Plasma PF-07054874 (M4) Concentration
Description
PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolites PF-07054874 (M4).
Time Frame
Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Keck School of Medicine of USC - IDS Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Olympian Clinical Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC - Dermatology Research
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Wayne Health - Wayne State Dermatology
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Menter Dermatology Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Beacon Dermatology
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
Innovaderm Research, Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7451037
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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