November 15, 2018
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November 19, 2018
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November 19, 2020
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December 20, 2018
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November 18, 2019 (Final data collection date for primary outcome measure)
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Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS) [ Time Frame: From baseline up to 8 weeks ] Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2 grade improvement from baseline.
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Same as current
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- Proportion of participants who achieve EASI75 [ Time Frame: Up to 8 weeks ]
Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.
- Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score [ Time Frame: Up to 8 weeks ]
- Proportion of participants with a clinically meaningful improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep Disturbance (8b) 24-hour recall score [ Time Frame: Up to 8 weeks ]
- Participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 52 weeks ]
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
- Proportion of participants achieving an IGA-TS [ Time Frame: From baseline up to 4 weeks ]
Defined as IGA score of 0 or 1 with ≥ 2 grade improvement from baseline.
- Proportion of participants achieving an IGA of 0 or 1 at each visit [ Time Frame: Up to 8 weeks ]
- Proportion of participants with a ≥ 4-point improvement in Itch NRS score [ Time Frame: Up to 4 weeks ]
- Proportion of participants who achieve EASI50 at each visit during the VC period. [ Time Frame: Up to 8 weeks ]
Defined as ≥ 50% improvement in EASI score.
- Proportion of participants who achieve EASI75 [ Time Frame: Up to 4 weeks ]
Defined as ≥ 75% improvement in EASI score.
- Proportion of participants who achieve EASI90 at each visit during the VC period [ Time Frame: Up to 8 weeks ]
≥ 90% improvement in EASI score.
- Mean percentage change from baseline in EASI score at each visit during the VC period [ Time Frame: From baseline up to 8 weeks ]
- Mean percentage change from baseline in SCORAD score at each visit during the VC period [ Time Frame: From baseline up to 8 weeks ]
SCORing Atopic Dermatitis - tool used to assess extent and severity (intensity) of eczema.
- Change from baseline in Itch NRS score at each visit during the VC period [ Time Frame: From baseline up to 8 weeks ]
The Itch NRS is a daily patient-reported measure of the worst level of itch intensity. Participants will be asked to rate the itching severity by selecting a number from 0 (no itch) to 10 (worst imaginable itch).
- Time to achieve Itch NRS score improvement of at least 2, 3, or 4 points [ Time Frame: Up to 8 weeks ]
- Change from baseline in Skin Pain NRS score at each visit during the VC period [ Time Frame: From baseline up to 8 weeks ]
The Skin Pain NRS is a daily patient-reported measure of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain).
- Proportion of participants with a clinically meaningful improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score [ Time Frame: Up to 8 weeks ]
- Change from baseline in PROMIS Short Form - Sleep Related Impairment (8a) 24-hour recall and Short Form - Sleep Disturbance (8b) 24-hour recall score [ Time Frame: From baseline up to 8 weeks ]
- PROMIS Short Form - Sleep-Related Impairment (8a) 7-day recall and Short Form - Sleep Disturbance (8b) 7-day recall score [ Time Frame: Up to 52 weeks ]
- Change from baseline in AD afflicted percentage of body surface area (%BSA) at every visit [ Time Frame: From baseline up to 52 weeks ]
- Change from baseline in Patient-Oriented Eczema Measure (POEM) score at each visit [ Time Frame: From baseline up to 52 weeks ]
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.
- Change from baseline in Dermatology Life Quality Index (DLQI) score [ Time Frame: From baseline up to 52 weeks ]
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.
- Mean Patient Global Impression of Change (PGIC) score [ Time Frame: Up to 8 weeks ]
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
- Proportion of participants with each score on the PGIC [ Time Frame: Up to 8 weeks ]
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
- Proportion of participants with a score of either 1 or 2 on the PGIC [ Time Frame: Up to 8 weeks ]
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
- Change from baseline in EQ-5D-5L score during the VC period [ Time Frame: From baseline up to 8 weeks ]
EQ-5D is a validated, self-administered, generic, utility questionnaire wherein participants will rate their current health state based on the following criteria: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The 5L indicates that for each dimension, there are 5 levels, which are as follows: no problems, slight problems, moderate problems, severe problems, and extreme problems.
The digits for the 5 dimensions can be combined into a 5-digit number that describes the participant's health state.
- Change from baseline in WPAI-SHP v2.0 [ Time Frame: From baseline up to 52 weeks ]
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Version 2.0.
The WPAI:SHP v2.0 questionnaire is a validated 6-item instrument, completed that measures the effect of overall health and specific symptoms on productivity at work and regular activities outside of work.
- Trough plasma concentrations of ruxolitinib at all study visits [ Time Frame: Up to 52 weeks ]
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- Proportion of participants who achieve EASI75 [ Time Frame: Up to 8 weeks ]
Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.
- Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score [ Time Frame: Up to 8 weeks ]
- Proportion of participants with a clinically meaningful improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep Disturbance (8b - 24-hour recall) score [ Time Frame: Up to 8 weeks ]
- Participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 52 weeks ]
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
- Proportion of participants achieving an IGA-TS [ Time Frame: From baseline up to 4 weeks ]
Defined as IGA score of 0 or 1 with ≥ 2 grade improvement from baseline.
- Proportion of participants achieving an IGA of 0 or 1 at each visit [ Time Frame: Up to 8 weeks ]
- Proportion of participants with a ≥ 4-point improvement in Itch NRS score [ Time Frame: Up to 4 weeks ]
- Proportion of participants who achieve EASI50 at each visit during the vehicle-controlled (VC) period. [ Time Frame: Up to 8 weeks ]
Defined as ≥ 50% improvement in EASI score.
- Proportion of participants who achieve EASI75 [ Time Frame: Up to 4 weeks ]
Defined as ≥ 75% improvement in EASI score.
- Proportion of participants who achieve EASI90 at each visit during the VC period [ Time Frame: Up to 8 weeks ]
≥ 90% improvement in EASI score.
- Mean percentage change from baseline in EASI score at each visit during the VC period [ Time Frame: From baseline up to 8 weeks ]
- Mean percentage change from baseline in SCORAD score at each visit during the VC period [ Time Frame: From baseline up to 8 weeks ]
SCORing Atopic Dermatitis - tool used to assess extent and severity (intensity) of eczema.
- Change from baseline in Itch NRS score at each visit during the VC period [ Time Frame: From baseline up to 8 weeks ]
- Time to achieve Itch NRS score improvement of at least 2, 3, or 4 points [ Time Frame: Up to 8 weeks ]
- Change from baseline in Skin Pain NRS score at each visit during the VC period [ Time Frame: From baseline up to 8 weeks ]
- Proportion of participants with a clinically meaningful improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score [ Time Frame: Up to 8 weeks ]
- Change from baseline in PROMIS Short Form - Sleep Related Impairment (8a) 24-hour recall and Short Form - Sleep Disturbance (8b) 24-hour recall score [ Time Frame: From baseline up to 8 weeks ]
- PROMIS Short Form - Sleep-Related Impairment (8a) 7-day recall and Short Form - Sleep Disturbance (8b) 7-day recall score [ Time Frame: Up to 52 weeks ]
- Change from baseline in AD afflicted percentage of body surface area (%BSA) at every visit [ Time Frame: From baseline up to 52 weeks ]
- Change from baseline in Patient-Oriented Eczema Measure (POEM) score at each visit [ Time Frame: From baseline up to 52 weeks ]
- Change from baseline in Dermatology Life Quality Index (DLQI) score [ Time Frame: From baseline up to 52 weeks ]
- Mean Patient Global Impression of Change (PGIC) score [ Time Frame: Up to 8 weeks ]
- Proportion of participants with each score on the PGIC [ Time Frame: Up to 8 weeks ]
- Proportion of participants with a score of either 1 or 2 on the PGIC [ Time Frame: Up to 8 weeks ]
- Change from baseline in EQ-5D-5L score during the VC period [ Time Frame: From baseline up to 8 weeks ]
EQ-5D is a validated, self-administered, generic, utility questionnaire wherein participants will rate their current health state based on the following criteria: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
- Change from baseline in WPAI-SHP v2.0 [ Time Frame: From baseline up to 52 weeks ]
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Version 2.0.
- Trough plasma concentrations of ruxolitinib at all study visits [ Time Frame: Up to 52 weeks ]
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Not Provided
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Not Provided
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TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
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Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2 (TRuE AD2) - A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis
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The purpose of this study is to assess the efficacy and safety of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).
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Not Provided
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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Atopic Dermatitis
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- Drug: Ruxolitinib cream
Ruxolitinib cream 1.5% or 0.75% applied as a thin film twice daily (BID) (vehicle-controlled (VC) and long-term safety extension periods).
Other Name: INCB018424 phosphate cream
- Drug: Vehicle cream
Matching vehicle cream applied as a thin film BID (VC period only).
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Not Provided
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Completed
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618
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600
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November 9, 2020
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November 18, 2019 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥ 18 years.
- Participants diagnosed with AD as defined by the Hanifin and Rajka criteria.
- AD duration of at least 2 years.
- Participants with an IGA score of 2 to 3 at screening and baseline (VC period) and 0 to 4 at Week 8 (long-term safety period).
- Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline (VC period) and 0% to 20% at Week 8 (long-term safety period)
- Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
- Participants who have at least 1 "target lesion" that measures approximately 10 cm^2 or more at screening and baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia.
- Willingness to avoid pregnancy or fathering of children
Exclusion Criteria:
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Sexes Eligible for Study: |
All |
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12 Years and older (Child, Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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Bulgaria, Canada, Czechia, Germany, Poland, Spain, United States
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NCT03745651
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INCB 18424-304
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No
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Incyte Corporation
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Incyte Corporation
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Not Provided
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Study Director: |
Michael E. Kuligowski, MD, PhD, MBA |
Incyte Corporation |
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Incyte Corporation
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November 2020
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