The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
159
The study cream will be applied topically as defined in the protocol for each period.
Matching vehicle cream will be applied topically as defined in the protocol for each period.
VC Period: Binary response status of Eczema Area and Severity Index 75 (EASI75)
Defined as achieving ≥ 75% improvement in Eczema Area and Severity Index (EASI) score from baseline.
Time frame: VC Week 8
VC Period: Binary response status of Investigator's Global Assessment Treatment Success (IGA-TS)
Defined as achieving Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2-grade improvement from baseline.
Time frame: VC Week 8
VC Period: Binary response status of ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
Defined as achieving ≥ 4-point improvement in Itch NRS \[participants aged 12 to \< 18 years\] or Worst Itch Numerical Rating Scale (WI NRS) \[participants aged 6 to \< 12 years\] score from baseline.
Time frame: VC Week 8
DC Period: Time to first disease exacerbation, defined as Investigator's Global Assessment score of ≥ 2 (DE) in the DC period
Defined as responders \[IGA score \< 2\] from the VC period or the OLE period rerandomized to proactive treatment, time to first DE, where DE is defined as IGA score of ≥ 2.)
Time frame: Up to 44 Weeks
Number of Treatment Emergent Adverse Events (TEAEs)
Defined as any AE reported for the first time or worsening of a pre-existing event after the first application of study cream.
Time frame: From Baseline up to 70 weeks
Binary response status of Eczema Area and Severity Index 75 (EASI75) at each postbaseline visit except Week 8
Defined as achieving ≥ 75% improvement in Eczema Area and Severity Index (EASI) score from baseline.
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Saguaro Dermatology
Phoenix, Arizona, United States
National Jewish Health
Denver, Colorado, United States
Encore Medical Research, Llc Hollywood
Hollywood, Florida, United States
Lane Dermatology and Dermatologic Surgery
Columbus, Georgia, United States
Cleaver Medical Group
Cumming, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Sneeze Wheeze and Itch Associates Llc
Normal, Illinois, United States
Endeavor Health Medical Group
Skokie, Illinois, United States
Raven Clinical Research
Marriottsville, Maryland, United States
...and 83 more locations
Time frame: Up to 44 weeks
Binary response status of Investigator's Global Assessment Treatment Success (IGA-TS) at each postbaeline visit except Week 8
Defined as achieving Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2-grade improvement from baseline.
Time frame: Up to 44 weeks
Binary response status of ≥ 4-point improvement in Itch Numeric Rating Scale (NRS) score (ITCH4)
Defined as achieving ≥ 4-point improvement in Itch NRS \[participants aged 12 to \< 18 years\] or Worst Itch Numerical Rating Scale (WI NRS) \[participants aged 6 to \< 12 years\] score from baseline.
Time frame: Days 2, 3, and 7 and VC Weeks 2 and 4
VC Period: Time to achieve ITCH4
Defined as time to achieve ≥ 4-point improvement in Itch NRS \[participants aged 12 to \< 18 years\] or Worst Itch Numerical Rating Scale (WI NRS) \[participants aged 6 to \< 12 years\] score from baseline.
Time frame: Up to 8 weeks
VC Period: Binary response status of both EASI75 and IGA-TS at each postbaseline visit in the VC period
Time frame: Up to 44 weeks
VC Period: The binary response status of DLQI-4/CDLQI-4 at VC Weeks 2, 4, and 8
Dermatology Life Quality Index (DLQI)-4/ Children's Dermatology Life Quality Index (CDLQI)-4 is defined as achieving ≥ 4-point improvement in DLQI/CDLQI from baseline.
Time frame: Weeks 2, 4 and 8
VC Period and DC Period: Change from baseline in the CDLQI (or DLQI) score at each postbaseline visit
The DLQI will be administered to participants aged 16 and 17 years. The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The CDLQI will be administered to participants aged 6 to 15 years. The CDLQI is a simple validated questionnaire to measure how much the skin problem has affected the participant over the past week (7-day recall). The higher the score, the more quality of life is impaired.
Time frame: Up to 52 weeks
VC Period and DC Period: Change from baseline in the Patient-Oriented Eczema Measure (POEM) score at each postbaseline visit
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.
Time frame: Up to 52 weeks
VC Period and DC Period: Acceptability and tolerability assessment (exit interview/questionnaire)
The overall impression of the acceptability and tolerability of study cream will be assessed quantitatively using the Pediatric Impression of Cream Acceptability and Tolerability questionnaire. This is a structured questionnaire with 2 questions: one for assessing overall impression of acceptability and one for assessing tolerability. Each question has 4 possible response options, with a corresponding score from 1 to 4. The total score will range from 2 (most acceptable and tolerable) to 8 (least acceptable and tolerable).
Time frame: VC Period Week 8 and DC Period Week 44
DC Period: Number of disease exacerbations (DEs)
Defined as Investigator's Global Assessment score of ≥ 2.
Time frame: Up to 44 weeks
DC Period: Amount of ruxolitinib cream used
Time frame: Up to 44 weeks
VC Period: Plasma concentrations of ruxolitinib and PK parameters (Ctrough,ss)
Trough and steady-state concentrations for ruxolitinib in plasma will be determined.
Time frame: VC Week 2 and VC Week 8