Clinical trial NCT05375955: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Plaque Psoriasis
Keywords: Eczema
topical
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 263
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only
timeFrame: Baseline, Week 1, 2, 4, 6, 8, and 10
measure: Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only
timeFrame: Baseline, Week 1, 2, 4, 6, 8, and 10
measure: Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
timeFrame: Week 1, 2, 4, 6, 8, 10 and 12
measure: Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
timeFrame: Week 1, 2, 4, 6, 8, 10 and 12
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only
timeFrame: Week 1, 2, 4, 6, 8, 10 and 12
measure: Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10 and 12
measure: Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis
timeFrame: From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
measure: Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis
timeFrame: From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
measure: Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis
timeFrame: From start of study treatment (Day 1) up to Week 12
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis
timeFrame: From start of study treatment (Day 1) up to Week 12
measure: Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis
timeFrame: From start of study treatment (Day 1) up to Week 12
measure: Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis
timeFrame: From start of study treatment (Day 1) up to Week 12
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Cape Coral
country: United States
facility: Renaissance Research and Medical Group
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, LLC
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Baton Rouge
country: United States
facility: Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Dearborn
country: United States
facility: Wayne Health
state: Michigan
city: Lake Success
country: United States
facility: Northwell Health Clinical Trials Office
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research, Medford
state: Oregon
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Tennessee
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
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: Obihiro
country: Japan
facility: Takagi Dermatological Clinic Branch
state: Hokkaido
city: Obihiro
country: Japan
facility: Takagi Dermatology
state: Hokkaido
city: Kobe
country: Japan
facility: Dermatology Shimizu Clinic
state: Hyogo
city: Sakai City
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Takaoka
country: Japan
facility: Shirasaki dermatology clinic
state: Toyama
city: High Wycombe
country: United Kingdom
facility: Egin Research High Wycombe
state: Buckinghamshire
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Northwood
country: United Kingdom
facility: Accellacare - North London
state: London, CITY OF
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: