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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02780167
Registration number
NCT02780167
Ethics application status
Date submitted
11/04/2016
Date registered
23/05/2016
Date last updated
2/05/2019
Titles & IDs
Public title
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
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Scientific title
A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER, DOSE-RANGING, STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-04965842 IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
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Secondary ID [1]
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0
2015-005513-72
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Secondary ID [2]
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B7451006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF-04965842
Treatment: Drugs - PF-04965842
Treatment: Drugs - PF-04965842
Treatment: Drugs - PF-04965842
Treatment: Drugs - Placebo
Experimental: Cohort 1 - 10 mg of PF-04965842 QD
Experimental: Cohort 2 - 30 mg of PF-04965842 QD
Experimental: Cohort 3 - 100 mg of PF-04965842 QD
Experimental: Cohort 4 - 200 mg of PF-04965842 QD
Placebo Comparator: Cohort 5 - placebo QD
Treatment: Drugs: PF-04965842
10 mg of PF-04965842 QD for 12 weeks
Treatment: Drugs: PF-04965842
30 mg of PF-04965842 QD for 12 weeks
Treatment: Drugs: PF-04965842
100 mg of PF-04965842 QD for 12 weeks
Treatment: Drugs: PF-04965842
200 mg of PF-04965842 QD for 12 weeks
Treatment: Drugs: Placebo
Placebo QD for 12 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12
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Assessment method [1]
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The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [1]
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Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12
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Assessment method [1]
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The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
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Assessment method [2]
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The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
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Timepoint [2]
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Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.
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Secondary outcome [3]
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Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
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Assessment method [3]
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The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
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Timepoint [3]
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Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
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Secondary outcome [4]
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Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
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Assessment method [4]
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The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
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Timepoint [4]
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Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16
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Secondary outcome [5]
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Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
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Assessment method [5]
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The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).
The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
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Timepoint [5]
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Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
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Secondary outcome [6]
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Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
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Assessment method [6]
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The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).
The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
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Timepoint [6]
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Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
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Secondary outcome [7]
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Time to Achieving >=3 Points Improvement in NRS
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Assessment method [7]
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The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).
The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
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Timepoint [7]
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Baseline till Week 16
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Secondary outcome [8]
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Time to Achieving >=4 Points Improvement in NRS
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Assessment method [8]
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The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).
The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
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Timepoint [8]
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Baseline till Week 16
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Secondary outcome [9]
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Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
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Assessment method [9]
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The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).
The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
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Timepoint [9]
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Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
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Secondary outcome [10]
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Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
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Assessment method [10]
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The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).
The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).
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Timepoint [10]
0
0
Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
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Secondary outcome [11]
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Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
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Assessment method [11]
0
0
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
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Timepoint [11]
0
0
All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
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Secondary outcome [12]
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Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
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Assessment method [12]
0
0
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
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Timepoint [12]
0
0
All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
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Secondary outcome [13]
0
0
Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
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Assessment method [13]
0
0
The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.
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Timepoint [13]
0
0
All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
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Secondary outcome [14]
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Change From Baseline in Affected BSA at All Scheduled Time Points
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Assessment method [14]
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BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%.
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Timepoint [14]
0
0
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
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Secondary outcome [15]
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Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
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Assessment method [15]
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0
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
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Timepoint [15]
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0
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
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Secondary outcome [16]
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Percent Change From Baseline in SCORAD at All Scheduled Time Points
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Assessment method [16]
0
0
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
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Timepoint [16]
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Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
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Secondary outcome [17]
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Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
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Assessment method [17]
0
0
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
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Timepoint [17]
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0
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
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Secondary outcome [18]
0
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Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
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Assessment method [18]
0
0
SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
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Timepoint [18]
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0
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
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Secondary outcome [19]
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Number of Participants With Treatment-emergent Adverse Events (AEs)
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Assessment method [19]
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An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state.
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Timepoint [19]
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Baseline till Week 16
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Secondary outcome [20]
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0
Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
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Assessment method [20]
0
0
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Timepoint [20]
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0
Baseline up to Week 16
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Secondary outcome [21]
0
0
Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
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Assessment method [21]
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0
The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
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Timepoint [21]
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0
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
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Secondary outcome [22]
0
0
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
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Assessment method [22]
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0
The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality.
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Timepoint [22]
0
0
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
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Secondary outcome [23]
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Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
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Assessment method [23]
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The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.
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Timepoint [23]
0
0
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
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Secondary outcome [24]
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0
Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
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Assessment method [24]
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0
The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
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Timepoint [24]
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0
Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
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Eligibility
Key inclusion criteria
- Male or female subjects between 18 75 years of age, inclusive, at time of informed
consent.
- Must have the following atopic dermatitis criteria:
1. Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic
eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis
(Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
2. Have inadequate response to treatment with topical medications given for at least
4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg,
because of important side effects or safety risks) within 12 months of the first
dose of study drug.
3. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the
screening and baseline visits).
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
- Infected with hepatitis B or hepatitis C viruses.
- Have evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)
- Have received any of the following treatment regiments specified in the timeframes
outlined below:
Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of
first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks
of first dose of study drug: Participation in other studies involving investigational
drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or
attenuated live vaccine.
Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy
(NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning
booth/parlor.
Within 1 week of first dose of study drug: Topical treatments that could affect atopic
dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2017
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Sample size
Target
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Accrual to date
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Final
269
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
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Recruitment hospital [1]
0
0
Woden Dermatology - Phillip
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Recruitment hospital [2]
0
0
Australian Clinical Research Network - Sydney
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Recruitment hospital [3]
0
0
The Skin Centre - Benowa
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Recruitment hospital [4]
0
0
Veracity Clinical Research - Woolloongabba
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Recruitment hospital [5]
0
0
Sinclair Dermatology - East Melbourne
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Recruitment hospital [6]
0
0
Royal Melbourne Hospital - Parkville
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Recruitment hospital [7]
0
0
Fremantle Dermatology - Fremantle
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Recruitment hospital [8]
0
0
North Eastern Health Specialists - Hectorville, South Australia
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Recruitment postcode(s) [1]
0
0
2606 - Phillip
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Recruitment postcode(s) [2]
0
0
2035 - Sydney
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Recruitment postcode(s) [3]
0
0
4217 - Benowa
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Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
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Recruitment postcode(s) [5]
0
0
3002 - East Melbourne
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Recruitment postcode(s) [6]
0
0
3050 - Parkville
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Recruitment postcode(s) [7]
0
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6160 - Fremantle
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Recruitment postcode(s) [8]
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5073 - Hectorville, South Australia
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Michigan
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Missouri
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Nevada
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New Jersey
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New York
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Oklahoma
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Pennsylvania
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Rhode Island
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South Dakota
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Texas
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Virginia
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Germany
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Berlin
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Germany
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Luebeck
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Germany
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Muenster
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Germany
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Tuebingen
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Hungary
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Kecskemet
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Hungary
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Miskolc
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Hungary
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Szeged
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Hungary
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Szolnok
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
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Summary
Brief summary
Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily
(QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the
efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of
the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease
severity in patients with moderate to severe AD as measured by the Investigator's Global
Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support
further clinical development of PF 04965842.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02780167
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02780167
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