Clinical trial NCT03903822: Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
Official title: A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Mild-to-Moderate Atopic Dermatitis
topical
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 292
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
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 multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily \[QD\] vs twice daily \[BID\] application) for the future clinical development of topical PF-06700841.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis for at least 3 months
* Investigator's Global Assessment (IGA) Score of 2 or 3
* Eczema Area Severity Index (EASI) score of 3-21
* Body Surface Area (BSA) of 2-20%
* Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

* Other forms of dermatological diseases (other than atopic dermatitis)
* Fitzpatrick skin type score greater than 5
* Clinically significant abnormal ECG, vital signs, and laboratory values
* Infection with HBV, HCV, herpes zoster or tuberculosis

Primary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation
timeFrame: Baseline, Week 6
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
timeFrame: Baseline, Week 6
measure: Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
timeFrame: Baseline, Weeks 1, 2, 3, 4 and 6
measure: Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
timeFrame: Baseline, Weeks 1, 2, 3, 4 and 6
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
measure: Number of Participants With Pre-defined Criteria For Vital Signs
timeFrame: Baseline up to Week 6
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
measure: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Week 6
measure: Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
timeFrame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
timeFrame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
timeFrame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
timeFrame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
timeFrame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
timeFrame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
timeFrame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
timeFrame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
measure: Change From Baseline in Lipids Profile Values at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
timeFrame: Baseline, Weeks 2 and 6
measure: Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
timeFrame: Baseline, Weeks 2 and 6
measure: Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
timeFrame: Baseline, Weeks 2 and 6
measure: Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
timeFrame: Baseline, Weeks 2 and 6
measure: Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
timeFrame: Baseline, Weeks 2 and 6
measure: Number of Participants With Each Severity Grade in Local Tolerability Assessments
timeFrame: Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery/CCT
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery
state: Arizona
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Long Beach
country: United States
facility: Beach Allergy and Asthma Specialty Group, A Medical Corporation
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Bridgeport
country: United States
facility: New England Associates, LLC
state: Connecticut
city: Shelton
country: United States
facility: Dermatology Physicians of Connecticut
state: Connecticut
city: Washington
country: United States
facility: Yolanda C. Holmes, MD
state: District of Columbia
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites - DeLand Clinical Research Unit
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Precision Imaging
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida d/b/a Ameriderm Research
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, LLC
state: Illinois
city: New Albany
country: United States
facility: DS Research
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Memphis
country: United States
facility: Tanenbaum Dermatology Center
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Cypress
country: United States
facility: studies in Dermatology, LLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, LTD.LLP
state: Texas
city: Hurst
country: United States
facility: Ventavia Research Group LLC
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Franklin
country: United States
facility: Summit Clinical Research, LLC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Dermatology and Skin Cancer Center
state: Virginia
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Sofia
country: Bulgaria
facility: Center for Skin and Venereal Diseases EOOD - Sofia
city: Sofia
country: Bulgaria
facility: DCC Alexandrovska
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Cobourg
country: Canada
facility: SKiN Health
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Berlin
country: Germany
facility: Emovis GmbH
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld gem.GmbH
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: MENSINGDERMA research GmbH
city: Hamburg
country: Germany
facility: MVZ Alstermed GmbH
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
city: Miskolc
country: Hungary
facility: CRU Hungary Kft.
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Sapporo-shi
country: Japan
facility: Kitago Dermatology Clinic
state: Hokkaido
city: Kita-ku, Osaka-shi
country: Japan
facility: Nakatsuhifuka Clinic
state: Osaka
city: Minato-ku
country: Japan
facility: Parkside Hiroo Ladies Clinic
state: Tokyo
city: Ota Ku
country: Japan
facility: Tanpopo Skin Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Shinjuku Minamiguchi Dermatology Skin Clinic
state: Tokyo
city: Tachikawa
country: Japan
facility: Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
state: Tokyo
city: Riga
country: Latvia
facility: Aesthetic dermatology clinic of Prof. J. Kisis
city: Riga
country: Latvia
facility: Health and Aesthetics Ltd
city: Ventspils
country: Latvia
facility: Outpatient Clinic of Ventspils
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Ośrodek Dermatologiczny DERMAL s.c.
city: Torun
country: Poland
facility: NASZ LEKARZ Przychodnie Medyczne
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o
city: Wroclaw
country: Poland
facility: WroMedica I. Bielicka, A. Strzalkowska s.c.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: