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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04040192




Registration number
NCT04040192
Ethics application status
Date submitted
30/07/2019
Date registered
31/07/2019

Titles & IDs
Public title
A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis
Scientific title
A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment
Secondary ID [1] 0 0
2019-000443-28
Secondary ID [2] 0 0
C3291035
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 - Crisaborole 2%
Treatment: Drugs - Vehicle

Experimental: Crisaborole 2% - Crisaborole 2% ointment applied once daily (QD)

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


Treatment: Drugs: Crisaborole 2%
Crisaborole ointment 2%

Treatment: Drugs: Vehicle
Vehicle ointment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period
Timepoint [1] 0 0
From randomization to first flare or last ISGA assessment (up to 52 weeks)
Primary outcome [2] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Crisaborole 2% BID: From start of study intervention in OL period up to 8 weeks ; Vehicle QD and crisaborole 2% QD: From start of study intervention in DB period up to 28 days after last dose of study intervention (maximum of 56 weeks)
Secondary outcome [1] 0 0
Number of Flare-Free Days During the DB Period
Timepoint [1] 0 0
Up to maximum of 52 weeks
Secondary outcome [2] 0 0
Number of Flares During the DB Period
Timepoint [2] 0 0
Up to maximum of 52 weeks
Secondary outcome [3] 0 0
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS
Timepoint [3] 0 0
From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
Secondary outcome [4] 0 0
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged 6 to <12 Years With Baseline Patient Reported Itch Severity (PRIS) >=2 and >=2 Points Reduction in PRIS
Timepoint [4] 0 0
From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
Secondary outcome [5] 0 0
Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months
Timepoint [5] 0 0
From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
Secondary outcome [6] 0 0
Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period
Timepoint [6] 0 0
From randomization to loss of EASI response or onset of first flare or the last EASI assessment (up to maximum of 52 weeks)
Secondary outcome [7] 0 0
Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period
Timepoint [7] 0 0
From randomization to loss of DLQI response or onset of first flare or the last assessment up to first flare (up to maximum of 52 weeks)
Secondary outcome [8] 0 0
Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period
Timepoint [8] 0 0
From randomization to loss POEM response or onset of first flare or the last assessment up to the first flare (up to maximum of 52 weeks)
Secondary outcome [9] 0 0
Investigator's Static Global Assessment (ISGA) Score for the First Flare Period
Timepoint [9] 0 0
Week 0 (Day 1), Week 4, Week 8 and Week 12
Secondary outcome [10] 0 0
EASI Score for the First Flare Period
Timepoint [10] 0 0
Week 0 (Day 1), Week 4, Week 8 and Week 12
Secondary outcome [11] 0 0
Duration (Days) of Flare Period
Timepoint [11] 0 0
Up to 52 weeks
Secondary outcome [12] 0 0
Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period
Timepoint [12] 0 0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [13] 0 0
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Timepoint [13] 0 0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [14] 0 0
Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period
Timepoint [14] 0 0
Baseline (last observation up to and including the randomization day of DB period),Weeks 0, 4, 8 and 12
Secondary outcome [15] 0 0
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Timepoint [15] 0 0
Baseline (last observation up to and including the randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [16] 0 0
Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period
Timepoint [16] 0 0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [17] 0 0
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Timepoint [17] 0 0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [18] 0 0
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Timepoint [18] 0 0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [19] 0 0
Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period
Timepoint [19] 0 0
Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12
Secondary outcome [20] 0 0
Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period
Timepoint [20] 0 0
Baseline (last observation up to and including the randomization day) Weeks 2, 4, 6 and 8
Secondary outcome [21] 0 0
Change From Baseline in Treatable %BSA: DB Period
Timepoint [21] 0 0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [22] 0 0
Change From Baseline in Treatable %BSA: First Flare Free Period
Timepoint [22] 0 0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [23] 0 0
Change From Baseline in Treatable %BSA: First Flare Period
Timepoint [23] 0 0
Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12
Secondary outcome [24] 0 0
Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period
Timepoint [24] 0 0
Baseline (last observation up to and including the randomization day), Weeks 24 and 52
Secondary outcome [25] 0 0
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Timepoint [25] 0 0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [26] 0 0
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Timepoint [26] 0 0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [27] 0 0
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Timepoint [27] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [28] 0 0
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Timepoint [28] 0 0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [29] 0 0
AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period
Timepoint [29] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [30] 0 0
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Timepoint [30] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [31] 0 0
AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period
Timepoint [31] 0 0
Weeks 0, 4, 8, 12
Secondary outcome [32] 0 0
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Timepoint [32] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [33] 0 0
Patient/Observer Global Impression of Severity Score: OL Run-in Period
Timepoint [33] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [34] 0 0
Patient/Observer Global Impression of Severity Score: DB Period
Timepoint [34] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [35] 0 0
Patient/Observer Global Impression of Severity Score: First Flare Period
Timepoint [35] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [36] 0 0
Patient/Observer Global Impression of Severity Score: First Flare Free Period
Timepoint [36] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [37] 0 0
Patient/Observer Global Impression of Change Score: OL Run-in Period
Timepoint [37] 0 0
Weeks 2, 4, 6 and 8
Secondary outcome [38] 0 0
Patient/Observer Global Impression of Change Score: DB Period
Timepoint [38] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [39] 0 0
Patient/Observer Global Impression of Change Score: First Flare Period
Timepoint [39] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [40] 0 0
Patient/Observer Global Impression of Change Score: First Flare Free Period
Timepoint [40] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [41] 0 0
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Timepoint [41] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [42] 0 0
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Timepoint [42] 0 0
Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [43] 0 0
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Timepoint [43] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [44] 0 0
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Timepoint [44] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [45] 0 0
European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period
Timepoint [45] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [46] 0 0
European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period
Timepoint [46] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [47] 0 0
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Timepoint [47] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [48] 0 0
EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period
Timepoint [48] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [49] 0 0
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period
Timepoint [49] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [50] 0 0
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Timepoint [50] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [51] 0 0
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Timepoint [51] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [52] 0 0
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Timepoint [52] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [53] 0 0
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Timepoint [53] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [54] 0 0
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Timepoint [54] 0 0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [55] 0 0
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Timepoint [55] 0 0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [56] 0 0
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Timepoint [56] 0 0
Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [57] 0 0
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period
Timepoint [57] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [58] 0 0
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period
Timepoint [58] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [59] 0 0
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period
Timepoint [59] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [60] 0 0
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period
Timepoint [60] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [61] 0 0
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period
Timepoint [61] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [62] 0 0
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period
Timepoint [62] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [63] 0 0
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Timepoint [63] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [64] 0 0
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Timepoint [64] 0 0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [65] 0 0
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Timepoint [65] 0 0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [66] 0 0
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Timepoint [66] 0 0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [67] 0 0
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Timepoint [67] 0 0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [68] 0 0
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Timepoint [68] 0 0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [69] 0 0
Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Timepoint [69] 0 0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [70] 0 0
Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Timepoint [70] 0 0
Weeks 0, 2, 4, 6 and 8
Secondary outcome [71] 0 0
Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Timepoint [71] 0 0
Weeks 0, 2, 4, 6 and 8
Secondary outcome [72] 0 0
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Timepoint [72] 0 0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [73] 0 0
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Timepoint [73] 0 0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [74] 0 0
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Timepoint [74] 0 0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [75] 0 0
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Timepoint [75] 0 0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [76] 0 0
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Timepoint [76] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [77] 0 0
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Timepoint [77] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [78] 0 0
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Timepoint [78] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [79] 0 0
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Timepoint [79] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [80] 0 0
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Timepoint [80] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [81] 0 0
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Timepoint [81] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [82] 0 0
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Timepoint [82] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [83] 0 0
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Timepoint [83] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [84] 0 0
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Timepoint [84] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [85] 0 0
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Timepoint [85] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [86] 0 0
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Timepoint [86] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [87] 0 0
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Timepoint [87] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [88] 0 0
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Timepoint [88] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [89] 0 0
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Timepoint [89] 0 0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [90] 0 0
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Timepoint [90] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [91] 0 0
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Timepoint [91] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [92] 0 0
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Timepoint [92] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [93] 0 0
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Timepoint [93] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [94] 0 0
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Timepoint [94] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [95] 0 0
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Timepoint [95] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [96] 0 0
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Timepoint [96] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [97] 0 0
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Timepoint [97] 0 0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Secondary outcome [98] 0 0
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Timepoint [98] 0 0
Baseline (last observation up to and including randomization day), Week 8, 16, 32 and end of treatment [Week 52]
Secondary outcome [99] 0 0
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Timepoint [99] 0 0
Weeks 0, 4, 8 and 12
Secondary outcome [100] 0 0
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Timepoint [100] 0 0
Baseline (last observation up to and including the randomization day of DB period), Weeks 8, 16 and 32

Eligibility
Key inclusion criteria
* Male or female
* 3 months of age and older
* Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
* Minimum of 5% BSA affected by atopic dermatitis
* ISGA score of Mild (2) or Moderate (3)
Minimum age
3 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome).

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 3
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
12/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/01/2022
Sample size
Target
Accrual to date
Final
620
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Saskatchewan
Country [17] 0 0
China
State/province [17] 0 0
Beijing
Country [18] 0 0
China
State/province [18] 0 0
Fujian
Country [19] 0 0
China
State/province [19] 0 0
Guangdong
Country [20] 0 0
China
State/province [20] 0 0
Hubei
Country [21] 0 0
China
State/province [21] 0 0
Jiangxi
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
China
State/province [23] 0 0
Tianjin
Country [24] 0 0
China
State/province [24] 0 0
Yunnan
Country [25] 0 0
China
State/province [25] 0 0
Zhejiang
Country [26] 0 0
Israel
State/province [26] 0 0
Ramat - Gan
Country [27] 0 0
Turkey
State/province [27] 0 0
Istanbul
Country [28] 0 0
Turkey
State/province [28] 0 0
Kayseri

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?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/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?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


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/NCT04040192