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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06238817
Registration number
NCT06238817
Ethics application status
Date submitted
25/01/2024
Date registered
2/02/2024
Titles & IDs
Public title
A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
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Scientific title
A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
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Secondary ID [1]
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2023-505433-27-00
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Secondary ID [2]
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INCB18424-326
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Universal Trial Number (UTN)
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Trial acronym
TRuE-AD4
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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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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 - Ruxolitinib Cream
Treatment: Drugs - Vehicle Cream
Experimental: VC Period: Ruxolitinib 1.5% Cream BID - Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Placebo comparator: VC Period: Vehicle Cream BID - Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Experimental: VC Extension Period/Escape Arm: Ruxolitinib 1.5% Cream BID - Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 24 during the Vehicle Control Extension (VCE) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Placebo comparator: VC Extension Period/Escape Arm: Vehicle Cream BID - Participants who applied vehicle cream during the VC Period, continued applying vehicle cream as a thin film twice daily (BID) from Weeks 8 to 24 during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants will be eligible to enter the ruxolitinib 1.5% cream open-label escape arm as defined in the protocol.
Experimental: VC Extension Period: Ruxolitinib 1.5% cream open-label escape arm - Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Treatment: Drugs: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Treatment: Drugs: Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
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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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VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)
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Assessment method [1]
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Defined as = 75% improvement in Eczema Area and Severity Index (EASI) score.
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Timepoint [1]
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Baseline to Week 8
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Primary outcome [2]
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VC Period: Proportion of participants who achieved Investigator's Global Assessment Treatment Success (IGA-TS)
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Assessment method [2]
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Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with = 2 grade improvement from baseline.
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Timepoint [2]
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Baseline to Week 8
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Secondary outcome [1]
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VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
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Assessment method [1]
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ITCH4 is defined as achieving = 4-point improvement in Itch NRS score.
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Timepoint [1]
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Baseline to Week 8
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Secondary outcome [2]
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VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
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Assessment method [2]
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ITCH4 is defined as achieving = 4-point improvement in Itch NRS score.
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Timepoint [2]
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Baseline to Day 7
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Secondary outcome [3]
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VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
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Assessment method [3]
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ITCH4 is defined as achieving = 4-point improvement in Itch NRS score.
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Timepoint [3]
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Baseline to Day 3
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Secondary outcome [4]
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VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
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Assessment method [4]
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ITCH4 is defined as achieving = 4-point improvement in Itch NRS score.
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Timepoint [4]
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Baseline to Day 2
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Secondary outcome [5]
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VC Period: Number of Treatment Emergent Adverse Events (TEAEs)
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Assessment method [5]
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An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.
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Timepoint [5]
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Up to Week 24, followed by 30 days follow-up
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Secondary outcome [6]
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VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)
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Assessment method [6]
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Defined as = 75% improvement in Eczema Area and Severity Index (EASI) score.
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Timepoint [6]
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Baseline to Weeks 2 and 4
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Secondary outcome [7]
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VC Period: Proportion of participants who achieved Investigator's Global Assessment - Treatment Success (IGA-TS)
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Assessment method [7]
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Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with = 2 grade improvement from baseline.
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Timepoint [7]
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Baseline to Weeks 2 and 4
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Secondary outcome [8]
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VC Period: Proportion of participants with a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
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Assessment method [8]
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ITCH4 is defined as achieving = 4-point improvement in Itch NRS score.
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Timepoint [8]
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Baseline to Weeks 2 and 4
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Secondary outcome [9]
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VC Period: Time to achieve a = 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
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Assessment method [9]
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ITCH4 is defined as achieving = 4-point improvement in Itch NRS score.
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Timepoint [9]
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Baseline to Week 8
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Secondary outcome [10]
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VC Period: Time to achieve = 2-point improvement from in Itch Numeric Rating Scale (NRS) score (ITCH2)
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Assessment method [10]
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ITCH2 is defined as achieving = 2-point improvement from baseline in Itch NRS score.
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Timepoint [10]
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Baseline to Week 8
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Secondary outcome [11]
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VC Period: Change from baseline (pre-study cream application) in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.
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Assessment method [11]
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Timepoint [11]
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Baseline to Day 1
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Secondary outcome [12]
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VC Period: Proportion of participants achieving at least a 2-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.
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Assessment method [12]
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Timepoint [12]
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Baseline to Day 1
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Secondary outcome [13]
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VC Period: Proportion of participants achieving at least a 4-point decrease from baseline in current Itch NRS score at 5, 15, 30, 45, and 60 minutes and 2, 4, and 6 hours post-initial dose on Day 1.
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Assessment method [13]
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Timepoint [13]
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Baseline to Day 1
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Secondary outcome [14]
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VC and VCE Periods: Proportion of participants who achieved EASI50
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Assessment method [14]
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Defined as = 50% improvement in Eczema Area and Severity Index (EASI) score.
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Timepoint [14]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [15]
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VC and VCE Periods: Proportion of participants who achieved EASI90
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Assessment method [15]
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Defined as = 90% improvement in Eczema Area and Severity Index (EASI) score.
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Timepoint [15]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [16]
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VC and VCE Periods: Proportion of participants achieving both EASI75 and IGA-TS
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Assessment method [16]
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Defined as = 75% improvement in Eczema Area and Severity Index (EASI) score and IGA score of 0 or 1 with = 2 grade improvement from baseline.
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Timepoint [16]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [17]
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VC and VCE Periods: Change from Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)
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Assessment method [17]
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A negative change from Baseline indicates improvement.
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Timepoint [17]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [18]
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VC and VCE Periods: Change from baseline in EASI score
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Assessment method [18]
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A negative change from Baseline indicates improvement.
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Timepoint [18]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [19]
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VC and VCE Periods: Change from baseline in SCORAD score
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Assessment method [19]
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SCORing Atopic Dermatitis - tool used to assess extent and severity (intensity) of eczema.
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Timepoint [19]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [20]
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VC and VCE Periods: Change from baseline in Itch NRS score
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Assessment method [20]
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The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
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Timepoint [20]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [21]
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VC and VCE Periods: Change from baseline in Skin Pain NRS score
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Assessment method [21]
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The Skin Pain NRS is a daily participant-reported measure (24-hour or 7-day recall) of the worst level of pain intensity from 0 (no pain) to 10 (worst pain imaginable.
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Timepoint [21]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [22]
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VCE Period: Time to open-label escape arm
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Assessment method [22]
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Defined as not achieving 50% improvement in EASI score from baseline at 2 consecutive visits at least 1 week apart.
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Timepoint [22]
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Baseline to Week 24
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Secondary outcome [23]
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VC and VCE Periods: Proportion of participants concurrently meeting all of the following criteria: IGA score = 3, EASI score = 16, Itch NRS score = 4, BSA = 10%, and DLQI score > 10
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Assessment method [23]
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Timepoint [23]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [24]
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VC and VCE Periods: Time to concurrently meeting all of the following criteria: IGA score = 3, EASI score = 16, Itch NRS score = 4, BSA = 10%, and DLQI score > 10
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Assessment method [24]
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Timepoint [24]
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Baseline to Week 24
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Secondary outcome [25]
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VC Period: Proportion of participants who experience a relapse after study treatment discontinuation
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Assessment method [25]
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Defined as proportion of participants among EASI75 responders who are on study treatment at Week 24 who meet relapse criteria \[loss of EASI50 from baseline\] at the safety follow-up visit.
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Timepoint [25]
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Week 24 to Follow-up (30 days)
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Secondary outcome [26]
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VCE period: Time to first re-treatment
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Assessment method [26]
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Timepoint [26]
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Week 8 to Week 24
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Secondary outcome [27]
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VCE Period: Proportion of time off study treatment due to lesion clearance
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Assessment method [27]
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Timepoint [27]
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Week 8 to Week 24
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Secondary outcome [28]
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VCE period: Proportion of time on study treatment
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Assessment method [28]
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Timepoint [28]
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Week 8 to Week 24
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Secondary outcome [29]
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VC and VCE Periods: Proportion of participants who achieve = 4-point improvement in DLQI from baseline
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Assessment method [29]
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The DLQI is a 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The participant will answer the questionnaire with either (1) very much, (2) a lot, (3) a little, or (4) not at all. A negative change from Baseline indicates less impact of the skin problem on participant's life.
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Timepoint [29]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [30]
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VC and VCE Periods: Change From Baseline in Dermatology Life Quality Index (DLQI) Score
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Assessment method [30]
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The DLQI is a 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The participant will answer the questionnaire with either (1) very much, (2) a lot, (3) a little, or (4) not at all. A negative change from Baseline indicates less impact of the skin problem on participant's life.
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Timepoint [30]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [31]
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VC and VCE Periods: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score
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Assessment method [31]
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The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. A negative change from Baseline indicates improvement.
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Timepoint [31]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [32]
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VC and VCE Periods: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score
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Assessment method [32]
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he EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1 = no problems, Level 2 = slight problems, Level 3 = moderate problems, Level 4 = severe problems, and Level 5 = extreme problems.
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Timepoint [32]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [33]
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VC and VCE Periods: Change from baseline in the HADS scores
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Assessment method [33]
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The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire to be completed by tablet; the questionnaire assesses the levels of anxiety and depression a person is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3). Separate scores are calculated for anxiety and depression. The recall period will be the past 7 days for both the VC and VCE periods.
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Timepoint [33]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [34]
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VC and VCE Periods: Change from baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score
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Assessment method [34]
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The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.
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Timepoint [34]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [35]
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VC and VCE Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score
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Assessment method [35]
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The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement.
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Timepoint [35]
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [36]
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VC and VCE Periods: Change from baseline score in Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD)
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Assessment method [36]
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The WPAI-AD questionnaire is a validated 6-item instrument that measures the effect of overall health and specific symptoms on productivity at work and regular activities outside of it during the past 7 days.
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Timepoint [36]
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Baseline to Week 8 and Week 24
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Eligibility
Key inclusion criteria
* Adults aged = 18 years at screening (Note: Legal adult age for Korea is = 19 years).
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
* AD duration of at least 2 years.
* IGA score of 3 at screening and Day 1.
* EASI score > 7 at screening and Day 1.
* Itch NRS score = 4 at Day 1, defined as the average of the 7 days directly before Day 1, with Itch NRS values available for at least 4 of the 7 days.
* %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20% at screening and Day 1.
* DLQI score > 10 at screening and Day 1.
* Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs.
* Agree to discontinue all agents used to treat AD from screening through the final follow up visit, except as outlined in the protocol.
* Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.
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Minimum age
18
Years
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Maximum age
No limit
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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
* Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
* Concurrent conditions and history of other diseases as follows:
* Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
* Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day 1.
* Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before Day 1.
* Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
* Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.
* Other types of eczema within the 6 months prior to screening. Note: Seborrheic dermatitis on the scalp is allowed, as the scalp will not be treated with study cream.
* Current or history of hepatitis B or C virus infection.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Any of the following clinical laboratory test results at screening:
* Hemoglobin < 10 g/dL.
* Liver function tests:
* AST or ALT = 2 × ULN.
* Alkaline phosphatase > 1.5 × ULN.
* Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) with the exception of Gilbert's disease.
* Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation).
* Positive serology test results for HIV antibody.
* Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
* Use of any of the following treatments within the indicated washout period before Day 1:
* 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor.
* 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating agents (eg, mycophenolate or tacrolimus).
* 2 weeks or 5 half-lives, whichever is longer - strong systemic CYP3A4 inhibitors.
* 2 weeks: immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted).
Note: COVID-19 vaccination is allowed.
• 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno creams, ointments, sprays, soap substitutes), such as antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap.
Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
* History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) for AD or any other inflammatory condition.
* Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study that is thought by the investigator to potentially impact the participant's AD.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug protocol.
* In the opinion of the investigator, are unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance).
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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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 administering 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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
26/04/2024
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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
30/10/2025
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Actual
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Sample size
Target
225
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Premier Specialists Pty Ltd - Kogarah
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Recruitment hospital [2]
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Australian Clinical Research Network - Maroubra
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Recruitment hospital [3]
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Veracity Clinical Research - Woolloongabba
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Recruitment hospital [4]
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Clinical Trials Sa - Campbelltown
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Recruitment hospital [5]
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Skin Health Institute Inc. - Carlton
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Recruitment hospital [6]
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Paratus Clinical Research, Woden - Phillip
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Recruitment postcode(s) [1]
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02217 - Kogarah
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Recruitment postcode(s) [2]
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02035 - Maroubra
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Recruitment postcode(s) [3]
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04102 - Woolloongabba
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Recruitment postcode(s) [4]
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05074 - Campbelltown
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Recruitment postcode(s) [5]
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03053 - Carlton
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Recruitment postcode(s) [6]
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02606 - Phillip
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Recruitment outside Australia
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United States of America
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Arkansas
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California
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Illinois
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Ohio
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Texas
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Washington
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Loverval
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Bulgaria
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Gabrovo
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Bulgaria
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Haskovo
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Alberta
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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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New Brunswick
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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France
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Le Mans Cedex
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France
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Lille Cedex
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France
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Nantes
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France
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Pierre Bénite Cedex
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France
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Rouen
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France
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Saint Etienne Cedex 2
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Germany
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Augsburg
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Germany
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Bad Bentheim
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Germany
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Berlin
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Germany
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Heidelberg
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Germany
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Muenster
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Germany
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Potsdam
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Italy
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Bari
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Italy
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Milano
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Italy
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Naples
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Italy
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Napoli
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Italy
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Rome
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Italy
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Rozzano
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Korea, Republic of
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Bucheon
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Korea, Republic of
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Seoul
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Netherlands
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Bergen Op Zoom
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Netherlands
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Breda
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Netherlands
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Groningen
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Ostrowiec
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Manises
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Spain
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Villajoyosa
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Buochs
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Switzerland
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Zuerich
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United Kingdom
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Bristol
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United Kingdom
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Isleworth
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United Kingdom
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London
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United Kingdom
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Northampton
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United Kingdom
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Plymouth
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United Kingdom
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Walsall
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Incyte Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.
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Trial website
https://clinicaltrials.gov/study/NCT06238817
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Incyte Medical Monitor
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Address
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Incyte Corporation
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Incyte Corporation Call Center (US)
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Address
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Country
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Phone
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0
1.855.463.3463
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications
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Available to whom?
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06238817