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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03903822




Registration number
NCT03903822
Ethics application status
Date submitted
20/03/2019
Date registered
4/04/2019

Titles & IDs
Public title
Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
2018-003050-24
Secondary ID [2] 0 0
B7931022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 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-06700841
Treatment: Drugs - Vehicle (Placebo)

Experimental: PF-06700841 0.1% cream QD - PF-06700841 0.1% cream applied once daily (QD)

Experimental: PF-06700841 0.3% cream QD - PF-06700841 0.3% cream applied once daily (QD)

Experimental: PF-06700841 1% cream QD - PF-06700841 1% cream applied once daily (QD)

Experimental: PF-06700841 3% cream QD - PF-06700841 3% cream applied once daily (QD)

Experimental: PF-06700841 0.3% cream BID - PF-06700841 0.3% cream applied twice daily (BID)

Experimental: PF-06700841 1% cream BID - PF-06700841 1% cream applied twice daily (BID)

Placebo comparator: Vehicle cream QD - Vehicle cream applied once daily (QD)

Placebo comparator: Vehicle cream BID - Vehicle cream applied twice daily (BID)


Treatment: Drugs: PF-06700841
PF-06700841 topical cream

Treatment: Drugs: Vehicle (Placebo)
Vehicle topical cream
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: Multiple Imputation
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [2] 0 0
Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
Timepoint [2] 0 0
Baseline, Week 6
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline, Weeks 1, 2, 3, 4 and 6
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [5] 0 0
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
Timepoint [5] 0 0
Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline, Weeks 1, 2, 3, 4 and 6
Secondary outcome [7] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [7] 0 0
Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Secondary outcome [8] 0 0
Number of Participants With Pre-defined Criteria For Vital Signs
Timepoint [8] 0 0
Baseline up to Week 6
Secondary outcome [9] 0 0
Number of Participants With Laboratory Abnormalities
Timepoint [9] 0 0
Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Secondary outcome [10] 0 0
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Timepoint [10] 0 0
Baseline up to Week 6
Secondary outcome [11] 0 0
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Timepoint [11] 0 0
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [12] 0 0
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Timepoint [12] 0 0
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [13] 0 0
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Timepoint [13] 0 0
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [14] 0 0
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Timepoint [14] 0 0
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [15] 0 0
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Timepoint [15] 0 0
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [17] 0 0
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Timepoint [17] 0 0
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Secondary outcome [19] 0 0
Change From Baseline in Lipids Profile Values at Week 6
Timepoint [19] 0 0
Baseline, Week 6
Secondary outcome [20] 0 0
Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6
Timepoint [20] 0 0
Baseline, Week 6
Secondary outcome [21] 0 0
Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
Timepoint [21] 0 0
Baseline, Weeks 2 and 6
Secondary outcome [22] 0 0
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
Timepoint [22] 0 0
Baseline, Weeks 2 and 6
Secondary outcome [23] 0 0
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Timepoint [23] 0 0
Baseline, Weeks 2 and 6
Secondary outcome [24] 0 0
Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
Timepoint [24] 0 0
Baseline, Weeks 2 and 6
Secondary outcome [25] 0 0
Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
Timepoint [25] 0 0
Baseline, Weeks 2 and 6
Secondary outcome [26] 0 0
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Timepoint [26] 0 0
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)

Eligibility
Key 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
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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
13/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2020
Sample size
Target
Accrual to date
Final
292
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 hospital [3] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [4] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
South Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Canada
State/province [20] 0 0
Manitoba
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Denmark
State/province [23] 0 0
Hellerup
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Bielefeld
Country [26] 0 0
Germany
State/province [26] 0 0
Bonn
Country [27] 0 0
Germany
State/province [27] 0 0
Frankfurt
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Mahlow
Country [30] 0 0
Germany
State/province [30] 0 0
Schwerin
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Debrecen
Country [33] 0 0
Hungary
State/province [33] 0 0
Kecskemet
Country [34] 0 0
Hungary
State/province [34] 0 0
Miskolc
Country [35] 0 0
Hungary
State/province [35] 0 0
Szeged
Country [36] 0 0
Japan
State/province [36] 0 0
Hokkaido
Country [37] 0 0
Japan
State/province [37] 0 0
Osaka
Country [38] 0 0
Japan
State/province [38] 0 0
Tokyo
Country [39] 0 0
Latvia
State/province [39] 0 0
Riga
Country [40] 0 0
Latvia
State/province [40] 0 0
Ventspils
Country [41] 0 0
Poland
State/province [41] 0 0
Bialystok
Country [42] 0 0
Poland
State/province [42] 0 0
Torun
Country [43] 0 0
Poland
State/province [43] 0 0
Warszawa
Country [44] 0 0
Poland
State/province [44] 0 0
Wroclaw

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?
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/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?


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/NCT03903822