Clinical trial NCT04664153: Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Plaque Psoriasis
Keywords: atopic dermatitis, plaque psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants
timeFrame: Baseline, Week 6
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: 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
timeFrame: Baseline, Week 6
measure: 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)
timeFrame: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
measure: 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
timeFrame: Baseline, Weeks 1, 2, 4 and 6
measure: Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants
timeFrame: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
measure: Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS
timeFrame: Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
measure: 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
timeFrame: Baseline, Week 6
measure: Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS
timeFrame: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
measure: 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
timeFrame: Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
measure: Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS
timeFrame: Baseline, Weeks 1, 2, 4 and FUP/EOS (28-35 days post-last dose)
measure: Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS
timeFrame: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
measure: Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS
timeFrame: Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
measure: Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS
timeFrame: Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
measure: Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 through Week 6
measure: Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
timeFrame: Day 1 through Week 6
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria
timeFrame: Day 1 through Week 6
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Day 1 through Week 6
measure: Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP
timeFrame: Day 1, Weeks 1, 2, 4, 6, ET and FUP (28-35 days post-last dose)
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Cape Coral
country: United States
facility: Renaissance Research and Medical Group
state: Florida
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Doral
country: United States
facility: Moonshine Research Center, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Tampa
country: United States
facility: Center for Clinical Studies
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Medical Center, New Center One
state: Michigan
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Tennessee
city: Cypress
country: United States
facility: studies in Dermatology, LLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Hamilton
country: Canada
facility: Dermatrials Research Inc.
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
city: Grodzisk Mazowiecki
country: Poland
facility: Mazowieckie Centrum Badań Klinicznych
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie
city: Warszawa
country: Poland
facility: ETG Warszawa
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: