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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04664153




Registration number
NCT04664153
Ethics application status
Date submitted
6/12/2020
Date registered
11/12/2020

Titles & IDs
Public title
Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
Scientific title
A PHASE 2A, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07038124 OINTMENT FOR 6 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS OR PLAQUE PSORIASIS
Secondary ID [1] 0 0
2020-003977-23
Secondary ID [2] 0 0
C3941002
Universal Trial Number (UTN)
Trial acronym
EMPORIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Plaque Psoriasis 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-07038124 ointment
Treatment: Drugs - Vehicle ointment

Experimental: atopic dermatitis - PF-07038124 ointment -

Placebo comparator: atopic dermatitis - vehicle ointment -

Experimental: plaque psoriasis - PF-07038124 ointment -

Experimental: plaque psoriasis - vehicle ointment -


Treatment: Drugs: PF-07038124 ointment
PF-07038124 ointment at 0.01% with QD dosing for 6 weeks

Treatment: Drugs: Vehicle ointment
Vehicle ointment with QD dosing for 6 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants
Timepoint [1] 0 0
Baseline, Week 6
Primary outcome [2] 0 0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants
Timepoint [2] 0 0
Baseline, Week 6
Secondary outcome [1] 0 0
Percentage of AD 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 6
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [2] 0 0
Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS)
Timepoint [2] 0 0
Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Secondary outcome [3] 0 0
Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6
Timepoint [3] 0 0
Baseline, Weeks 1, 2, 4 and 6
Secondary outcome [4] 0 0
Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants
Timepoint [4] 0 0
Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Secondary outcome [5] 0 0
Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS
Timepoint [5] 0 0
Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Secondary outcome [6] 0 0
Percentage of Psoriasis Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) (on a 5-Point Scale) and >=2 Points Improvement From Baseline at Week 6
Timepoint [6] 0 0
Baseline, Week 6
Secondary outcome [7] 0 0
Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS
Timepoint [7] 0 0
Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Secondary outcome [8] 0 0
Percentage of Psoriasis Participants Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS
Timepoint [8] 0 0
Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Secondary outcome [9] 0 0
Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS
Timepoint [9] 0 0
Baseline, Weeks 1, 2, 4 and FUP/EOS (28-35 days post-last dose)
Secondary outcome [10] 0 0
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS
Timepoint [10] 0 0
Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Secondary outcome [11] 0 0
Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS
Timepoint [11] 0 0
Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Secondary outcome [12] 0 0
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS
Timepoint [12] 0 0
Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Secondary outcome [13] 0 0
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [13] 0 0
Day 1 through Week 6
Secondary outcome [14] 0 0
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Timepoint [14] 0 0
Day 1 through Week 6
Secondary outcome [15] 0 0
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria
Timepoint [15] 0 0
Day 1 through Week 6
Secondary outcome [16] 0 0
Number of Participants With Laboratory Test Abnormalities
Timepoint [16] 0 0
Day 1 through Week 6
Secondary outcome [17] 0 0
Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP
Timepoint [17] 0 0
Day 1, Weeks 1, 2, 4, 6, ET and FUP (28-35 days post-last dose)

Eligibility
Key inclusion criteria
* Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.
* Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of skin comorbidities that would interfere with study assessment or response to treatment.
* Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for 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 2
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
21/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2021
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Poland
State/province [11] 0 0
Bialystok
Country [12] 0 0
Poland
State/province [12] 0 0
Grodzisk Mazowiecki
Country [13] 0 0
Poland
State/province [13] 0 0
Katowice
Country [14] 0 0
Poland
State/province [14] 0 0
Lodz
Country [15] 0 0
Poland
State/province [15] 0 0
Ostrowiec Swietokrzyski
Country [16] 0 0
Poland
State/province [16] 0 0
Rzeszow
Country [17] 0 0
Poland
State/province [17] 0 0
Warszawa

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
Email 0 0
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/NCT04664153