Atopic Dermatitis
Conditions
Brief summary
The binary response status of EASI75 at VC Week 8. (EASI75 response is defined as achieving ≥ 75% improvement in EASI score from baseline.)
Detailed description
The binary response status of IGA-TS at VC Week 8. (IGA-TS response is defined as achieving an IGA score of 0 or 1 with ≥ 2-grade improvement from baseline.), The binary response status of ITCH4 at VC Week 8. (ITCH4 response is defined as achieving ≥ 4-point improvement in Itch NRS [participants aged 12 to < 18 years] or WI NRS [participants aged 6 to < 12 years] score from baseline.), Time to first 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.), The type, frequency, and severity of AEs and changes in vital signs, height, weight, and laboratory data for hematology and serum chemistry., The binary response status of EASI75 at each postbaseline visit except VC Week 8., The binary response status of IGA-TS at each postbaseline visit except VC Week 8., The binary response status of ITCH4 at Days 2, 3, and 7 and VC Weeks 2 and 4., Time to achieve ITCH4 during the VC period., The binary response status of both EASI75 and IGA-TS at each postbaseline visit in the VC period., The binary response status of DLQI-4 (or CDLQI-4) at VC Weeks 2, 4, and 8 (DLQI-4 (or CDLQI-4) is defined as achieving ≥ 4-point improvement in DLQI (or CDLQI) from baseline.), Change from baseline at each postbaseline visit in the VC period and DC period for the following: − DLQI (or CDLQI) score − POEM score, Acceptability and tolerability assessment (exit interview/questionnaire), Number of DEs during the DC period., Amount of ruxolitinib cream used during the DC period., Plasma concentrations of ruxolitinib and PK parameters (Ctrough,ss) at VC Week 2 and VC Week 8 assessed in at least 10 evaluable ruxolitinib-treated participants in each of the 12 to < 18 year old and 6 to < 12 years old age groups.
Interventions
DRUGVehicle cream: same formulation of cream as the test product but without active substance and phosphoric acid
Sponsors
Incyte Corp.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The binary response status of EASI75 at VC Week 8. (EASI75 response is defined as achieving ≥ 75% improvement in EASI score from baseline.) | — |
Secondary
| Measure | Time frame |
|---|---|
| The binary response status of IGA-TS at VC Week 8. (IGA-TS response is defined as achieving an IGA score of 0 or 1 with ≥ 2-grade improvement from baseline.), The binary response status of ITCH4 at VC Week 8. (ITCH4 response is defined as achieving ≥ 4-point improvement in Itch NRS [participants aged 12 to < 18 years] or WI NRS [participants aged 6 to < 12 years] score from baseline.), Time to first 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.), The type, frequency, and severity of AEs and changes in vital signs, height, weight, and laboratory data for hematology and serum chemistry., The binary response status of EASI75 at each postbaseline visit except VC Week 8., The binary response status of IGA-TS at each postbaseline visit except VC Week 8., The binary response status of ITCH4 at Days 2, 3, and 7 and VC Weeks 2 and 4., Time to achiev | — |
Countries
Belgium, France, Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed