Back to resultsA Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
Primary Purpose
Atopic Dermatitis, Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-07038124 ointment 0.01%
Vehicle ointment
PF-07038124 ointment 0.03%
PF-07038124 ointment 0.06%
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema, topical
Eligibility Criteria
Inclusion Criteria for AD population:
- Diagnosis of Atopic Dermatitis (AD) for at least 3 months
- Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate)
- AD covering 5% and up to 40% of Body Surface Area (BSA)
- A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2
Inclusion Criteria for Plaque Psoriasis
- Diagnosis of Plaque Psoriasis (PsO) for at least 6 months
- Physician Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe)
- PsO covering 2% to 20% (inclusive) of BSA
Exclusion Criteria:
- Presence of skin comorbidities that would interfere with study assessment or response to treatment
- Psychiatric condition including recent or active suicidal ideation or behavior
- Current or recent history of severe, progressive, or uncontrolled disease
- A history of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy, or is judged clinically significant.
- Recent, significant trauma or major surgery
- History of cancer or have undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence.
- History of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products.
- Use of any prohibited concomitant medication(s)
- Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- Participants with an estimated glomerular filtration rate (eGFR) of <40 mL/min/1.73m2 calculated using the serum creatinine-based Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for adults and serum creatinine >1.5 x upper limit of normal (ULN) in adolescents (12-18 years old)
- Participants with total bilirubin ≥2x ULN (≥3 x ULN for Gilbert's disease), aspartate aminotransferase (AST) ≥2.5 x ULN, ALT ≥2.5 x ULN.
- Clinically relevant abnormal baseline standard 12-lead electrocardiogram (ECG) including, but not limited to QTC corrected using Fridericia's Formula (QTcF) interval >450 msec and QRS > 120 msec
- A recent history of alcohol or substance abuse
Sites / Locations
- California Dermatology & Clinical Research Institute
- USC/Norris Comprehensive Cancer Center
- Renaissance Research and Medical Group
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
- ForCare Clinical Research
- Skin Care Physicians of Georgia
- Sneeze, Wheeze & Itch Associates, LLC
- Dawes Fretzin Clinical Research Group, LLC
- Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
- University of Michigan
- Wayne Health
- Northwell Health Clinical Trials Office
- Icahn School of Medicine at Mount Sinai
- Icahn School of Medicine at Mount Sinai
- Vital Prospects Clinical Research Institute, PC
- Velocity Clinical Research, Medford
- Health Concepts
- Clinical Neuroscience Solutions Inc.
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
- Dermatology Treatment and Research Center
- Progressive Clinical Research
- Texas Dermatology and Laser Specialists
- Virginia Clinical Research, Inc.
- Dermatology Research Institute
- Wiseman Dermatology Research Inc.
- Lynderm Research Inc.
- DermEdge Research
- SKiN Centre for Dermatology
- Innovaderm Research Inc.
- Centre de Recherche Dermatologique du Quebec metropolitain
- Takagi Dermatological Clinic Branch
- Takagi Dermatology
- Dermatology Shimizu Clinic
- Dermatology and Ophthalmology Kume Clinic
- Shirasaki dermatology clinic
- Egin Research High Wycombe
- Southampton General Hospital
- Accellacare - North London
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Atopic Dermatitis PF-07038124 0.01% ointment
Atopic Dermatitis Vehicle ointment
Atopic Dermatitis PF-07038124 0.03% ointment
Plaque Psoriasis PF-07038124 0.01% ointment
Plaque Psoriasis PF-07038124 0.03% ointment
Plaque Psoriasis PF-07038124 0.06% ointment
Plaque Psoriasis Vehicle ointment
Arm Description
Atopic Dermatitis
Atopic Dermatitis
Atopic Dermatitis
Plaque Psoriasis
Plaque Psoriasis
Plaque Psoriasis
Plaque Psoriasis
Outcomes
Primary Outcome Measures
Proportion of participants achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12
Atopic Dermatitis population only
Proportion of participants achieving Patient Global Assessment (PGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12
Plaque Psoriasis population only
Secondary Outcome Measures
Proportion of participants achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline
Atopic Dermatitis population only
Proportion of participants achieving >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline
Plaque Psoriasis population only
Proportion of participants achieving IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points
Atopic Dermatitis population only
Proportion of participants achieving PGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points
Plaque Psoriasis population only
Proportion of Participants Achieving IGA Score of Clear (0) or Almost Clear (1)
Atopic Dermatitis population only
Proportion of Participants Achieving PGA Score of Clear (0) or Almost Clear (1)
Plaque Psoriasis population only
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) total score
Atopic Dermatitis population only
Change From Baseline in Psoriasis Area and Severity Index (PASI) total score
Plaque Psoriasis population only
Proportion of participants having ≥4 points of reduction from baseline in weekly averages of PP-NRS
Atopic Dermatitis population only
Proportion of adult (18-75 years old) participants having ≥4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS)
Plaque Psoriasis population only
Percent CFB in Affected Body Surface Area (BSA)
Atopic Dermatitis and Plaque Psoriasis population
Incidence of Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Atopic Dermatitis and Plaque Psoriasis population
Number of Participants With Clinically Significant Changes in Vital Signs
Atopic Dermatitis and Plaque Psoriasis population
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Atopic Dermatitis and Plaque Psoriasis population
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities
Atopic Dermatitis and Plaque Psoriasis population
Incidence of Increase in Local Tolerability Severity Grades
Atopic Dermatitis and Plaque Psoriasis population
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05375955
Brief Title
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
Official Title
A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (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
No
5. Study Description
Brief Summary
The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form.
This study is seeking participants who
If they have Atopic Dermatitis (AD):
Have a diagnosis for at least 3 months
Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA)
Have percent Body Surface Area (%BSA) covering 5% up to 40%
A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period
If they have plaque psoriasis (PsO):
Have a diagnosis for at least 6 months
Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA)
Have percent Body Surface Area (%BSA) covering 2% up to 20%
All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group.
PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective.
Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Plaque Psoriasis
Keywords
Eczema, topical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atopic Dermatitis PF-07038124 0.01% ointment
Arm Type
Experimental
Arm Description
Atopic Dermatitis
Arm Title
Atopic Dermatitis Vehicle ointment
Arm Type
Placebo Comparator
Arm Description
Atopic Dermatitis
Arm Title
Atopic Dermatitis PF-07038124 0.03% ointment
Arm Type
Experimental
Arm Description
Atopic Dermatitis
Arm Title
Plaque Psoriasis PF-07038124 0.01% ointment
Arm Type
Experimental
Arm Description
Plaque Psoriasis
Arm Title
Plaque Psoriasis PF-07038124 0.03% ointment
Arm Type
Experimental
Arm Description
Plaque Psoriasis
Arm Title
Plaque Psoriasis PF-07038124 0.06% ointment
Arm Type
Experimental
Arm Description
Plaque Psoriasis
Arm Title
Plaque Psoriasis Vehicle ointment
Arm Type
Placebo Comparator
Arm Description
Plaque Psoriasis
Intervention Type
Drug
Intervention Name(s)
PF-07038124 ointment 0.01%
Intervention Description
Atopic Dermatitis and Plaque Psoriasis
Intervention Type
Drug
Intervention Name(s)
Vehicle ointment
Intervention Description
Atopic Dermatitis and Plaque Psoriasis
Intervention Type
Drug
Intervention Name(s)
PF-07038124 ointment 0.03%
Intervention Description
Atopic Dermatitis and Plaque Psoriasis
Intervention Type
Drug
Intervention Name(s)
PF-07038124 ointment 0.06%
Intervention Description
PF-07038124 ointment 0.06% (Plaque Psoriasis only)
Primary Outcome Measure Information:
Title
Proportion of participants achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12
Description
Atopic Dermatitis population only
Time Frame
Week 12
Title
Proportion of participants achieving Patient Global Assessment (PGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12
Description
Plaque Psoriasis population only
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of participants achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline
Description
Atopic Dermatitis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Proportion of participants achieving >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline
Description
Plaque Psoriasis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Proportion of participants achieving IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points
Description
Atopic Dermatitis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, and Follow-up
Title
Proportion of participants achieving PGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points
Description
Plaque Psoriasis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, and Follow-up
Title
Proportion of Participants Achieving IGA Score of Clear (0) or Almost Clear (1)
Description
Atopic Dermatitis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Proportion of Participants Achieving PGA Score of Clear (0) or Almost Clear (1)
Description
Plaque Psoriasis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) total score
Description
Atopic Dermatitis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) total score
Description
Plaque Psoriasis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Proportion of participants having ≥4 points of reduction from baseline in weekly averages of PP-NRS
Description
Atopic Dermatitis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Proportion of adult (18-75 years old) participants having ≥4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS)
Description
Plaque Psoriasis population only
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Percent CFB in Affected Body Surface Area (BSA)
Description
Atopic Dermatitis and Plaque Psoriasis population
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Incidence of Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Atopic Dermatitis and Plaque Psoriasis population
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Number of Participants With Clinically Significant Changes in Vital Signs
Description
Atopic Dermatitis and Plaque Psoriasis population
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Description
Atopic Dermatitis and Plaque Psoriasis population
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities
Description
Atopic Dermatitis and Plaque Psoriasis population
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
Title
Incidence of Increase in Local Tolerability Severity Grades
Description
Atopic Dermatitis and Plaque Psoriasis population
Time Frame
Week 1, 2, 4, 6, 8, 10, 12, and Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for AD population:
Diagnosis of Atopic Dermatitis (AD) for at least 3 months
Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate)
AD covering 5% and up to 40% of Body Surface Area (BSA)
A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2
Inclusion Criteria for Plaque Psoriasis
Diagnosis of Plaque Psoriasis (PsO) for at least 6 months
Physician Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe)
PsO covering 2% to 20% (inclusive) of BSA
Exclusion Criteria:
Presence of skin comorbidities that would interfere with study assessment or response to treatment
Psychiatric condition including recent or active suicidal ideation or behavior
Current or recent history of severe, progressive, or uncontrolled disease
A history of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy, or is judged clinically significant.
Recent, significant trauma or major surgery
History of cancer or have undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence.
History of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products.
Use of any prohibited concomitant medication(s)
Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
Participants with an estimated glomerular filtration rate (eGFR) of <40 mL/min/1.73m2 calculated using the serum creatinine-based Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for adults and serum creatinine >1.5 x upper limit of normal (ULN) in adolescents (12-18 years old)
Participants with total bilirubin ≥2x ULN (≥3 x ULN for Gilbert's disease), aspartate aminotransferase (AST) ≥2.5 x ULN, ALT ≥2.5 x ULN.
Clinically relevant abnormal baseline standard 12-lead electrocardiogram (ECG) including, but not limited to QTC corrected using Fridericia's Formula (QTcF) interval >450 msec and QRS > 120 msec
A recent history of alcohol or substance abuse
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
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Renaissance Research and Medical Group
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33991
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Skin Care Physicians of Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Sneeze, Wheeze & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne Health
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Northwell Health Clinical Trials Office
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10028
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
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Velocity Clinical Research, Medford
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Dermatology Treatment and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
DermEdge Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec metropolitain
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Takagi Dermatological Clinic Branch
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Takagi Dermatology
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Dermatology Shimizu Clinic
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
657-0846
Country
Japan
Facility Name
Dermatology and Ophthalmology Kume Clinic
City
Sakai City
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Shirasaki dermatology clinic
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-0871
Country
Japan
Facility Name
Egin Research High Wycombe
City
High Wycombe
State/Province
Buckinghamshire
ZIP/Postal Code
HP11 2QW
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Accellacare - North London
City
Northwood
State/Province
London, CITY OF
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
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=C3941005
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
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