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Clinical Trial Results:
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

Summary
EudraCT number	2018-003712-45
Trial protocol	DE HU FR PL IT
Global end of trial date	01 Dec 2020

Results information
Results version number	v1(current)
This version publication date	03 Dec 2021
First version publication date	03 Dec 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

INCB 18424-303

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Incyte

Sponsor organisation address

1801 Augustine Cutoff drive, Wilmington, United States, 19803

Public contact

Study Director, Incyte Corporation, +1 8554633463, medinfo@incyte.com

Scientific contact

Study Director, Incyte Corporation, +1 8554633463, medinfo@incyte.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

01 Dec 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

01 Dec 2020

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to assess the efficacy and safety of twice daily ruxolitinib cream in adolescents and adults with Atopic Dermatitis (AD)

Protection of trial subjects

This study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study is being conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

20 Dec 2018

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

11 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 49

Country: Number of subjects enrolled

France: 9

Country: Number of subjects enrolled

Germany: 6

Country: Number of subjects enrolled

Hungary: 17

Country: Number of subjects enrolled

Italy: 6

Country: Number of subjects enrolled

Poland: 153

Country: Number of subjects enrolled

United States: 391

Worldwide total number of subjects

631

EEA total number of subjects

191

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

123

Adults (18-64 years)

450

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

A total of 631 participants took part in the study at 78 sites, 48 in North America and 30 in Europe from December 20, 2018 to December 01, 2020.

Screening details

Participants in Vehicle Control (VC) Period with no safety concerns at week 8 continued in the 44-week Long Term Safety (LTS) Period and equally randomized into 1 of the 2 active treatment groups. Participants who were on active treatment during the VC Period continued with the same treatment regimen in the LTS Period

Period 1 title

Vehicle Control Period (Day 1 to Week 8)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Data analyst

Are arms mutually exclusive

Yes

VC Period: Vehicle Cream BID

Arm description

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.

Arm type

Placebo

Investigational medicinal product name

Vehicle Cream

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Twice a Day

VC Period: Ruxolitinib 0.75% Cream BID

Arm description

Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.

Arm type

Experimental

Investigational medicinal product name

ruxolitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

0.75% cream Twice a Day

VC Period: Ruxolitinib 1.5% Cream BID

Arm description

Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.

Arm type

Experimental

Investigational medicinal product name

ruxolitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

1.5% cream Twice a Day

Number of subjects in period 1	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Started	126	252	253
Completed	95	222	225
Not completed	31	30	28
Physician decision	1	1	-
Consent withdrawn by subject	17	11	19
Adverse event, non-fatal	4	2	1
Reason Not Specified	2	1	-
Pregnancy	1	-	-
Lost to follow-up	5	12	8
Lack of efficacy	1	-	-
Protocol deviation	-	3	-

Period 2 title

Long-Term Safety Period (Weeks 8 to 52)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID

Arm description

Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period.

Arm type

Experimental

Investigational medicinal product name

ruxolitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

0.75% Cream Twice a day

LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID

Arm description

Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period.

Arm type

Experimental

Investigational medicinal product name

ruxolitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

1.5% Cream Twice a day

LTS Period: Ruxolitinib 0.75% Cream

Arm description

Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period.

Arm type

Experimental

Investigational medicinal product name

ruxolitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

0.75% Cream Twice a day

LTS Period: Ruxolitinib 1.5% Cream

Arm description

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 52 during the LTS Period.

Arm type

Experimental

Investigational medicinal product name

ruxolitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

1.5% Cream Twice a day

Number of subjects in period 2	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Started	48	47	222	225
Completed	37	38	176	174
Not completed	11	9	46	51
Consent withdrawn by subject	7	3	17	21
Physician decision	-	1	3	-
Adverse event, non-fatal	-	-	6	1
Reason Not Specified	-	-	4	3
Lost to follow-up	3	5	13	24
Lack of efficacy	1	-	2	2
Protocol deviation	-	-	1	-

Baseline characteristics

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Reporting group title

VC Period: Vehicle Cream BID

Reporting group description

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.

Reporting group title

VC Period: Ruxolitinib 0.75% Cream BID

Reporting group description

Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.

Reporting group title

VC Period: Ruxolitinib 1.5% Cream BID

Reporting group description

Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.

Reporting group values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID	Total
Number of subjects	126	252	253	631
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	23	53	47	123
Adults (18-64 years)	92	171	187	450
From 65-84 years	11	27	19	57
85 years and over	0	1	0	1
Age Continuous
Units: years
arithmetic mean (standard deviation)	35.2 ( 18.11 )	36.8 ( 19.06 )	33.7 ( 17.15 )	-
Sex: Female, Male
Units: participants
Female	79	154	158	391
Male	47	98	95	240
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	21	30	37	88
Not Hispanic or Latino	104	218	212	534
Unknown or Not Reported	1	4	4	9
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	2	0	2
Asian	8	10	14	32
Native Hawaiian or Other Pacific Islander	0	3	0	3
Black or African American	29	55	56	140
White	85	173	177	435
More than one race	0	0	0	0
Unknown or Not Reported	4	9	6	19
Body Mass Index (BMI)
Units: Kilograms per square metre (kg/m^2)
arithmetic mean (standard deviation)	26.92 ( 6.245 )	27.33 ( 6.745 )	27.47 ( 8.077 )	-

End points

Top of page

Reporting group title

VC Period: Vehicle Cream BID

Reporting group description

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.

Reporting group title

VC Period: Ruxolitinib 0.75% Cream BID

Reporting group description

Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.

Reporting group title

VC Period: Ruxolitinib 1.5% Cream BID

Reporting group description

Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period.

Reporting group title

LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID

Reporting group description

Reporting group title

LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID

Reporting group description

Reporting group title

LTS Period: Ruxolitinib 0.75% Cream

Reporting group description

Reporting group title

LTS Period: Ruxolitinib 1.5% Cream

Reporting group description

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 52 during the LTS Period.

Primary: Percentage of Participants Who Achieved Investigator’s Global Assessment - Treatment Success (IGA-TS) at Week 8

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End point title

Percentage of Participants Who Achieved Investigator’s Global Assessment - Treatment Success (IGA-TS) at Week 8

End point description

The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.

End point type

Primary

End point timeframe

Baseline to Week 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (confidence interval 95%)	15.1 (9.3 to 22.5)	50.0 (43.7 to 56.3)	53.8 (47.4 to 60.0)

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[1]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

7.5

Confidence interval

level

95%

sides

2-sided

lower limit

4.178

upper limit

14.04

Notes
[1] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[2]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

6.38

Confidence interval

level

95%

sides

2-sided

lower limit

3.556

upper limit

11.923

Notes
[2] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Secondary: VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75)

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End point title

VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75)

End point description

EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.

End point type

Secondary

End point timeframe

Baseline to Week 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (confidence interval 95%)	24.6 (17.4 to 33.1)	56.0 (49.6 to 62.2)	62.1 (55.8 to 68.1)

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[3]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

4.04

Confidence interval

level

95%

sides

2-sided

lower limit

2.441

upper limit

6.808

Notes
[3] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[4]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

5.22

Confidence interval

level

95%

sides

2-sided

lower limit

3.145

upper limit

8.831

Notes
[4] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Secondary: VC Period: Percentage of Participants with a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score

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End point title

VC Period: Percentage of Participants with a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score

End point description

The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants were asked to rate the itching severity because of their AD in the daily diary by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.

End point type

Secondary

End point timeframe

Baseline to Week 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	78	156	161
Units: percentage of participants
number (not applicable)	15.4	40.4	52.2

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

239

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[5]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

6.01

Confidence interval

level

95%

sides

2-sided

lower limit

2.931

upper limit

13.22

Notes
[5] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0002 ^[6]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

3.66

Confidence interval

level

95%

sides

2-sided

lower limit

1.773

upper limit

8.083

Notes
[6] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Secondary: VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form – Sleep Disturbance (8b – 24-Hour Recall) Score

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End point title

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form – Sleep Disturbance (8b – 24-Hour Recall) Score

End point description

The PROMIS Short Form – Sleep Disturbance (8b) questionnaire assesses participant’s self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. Each item asks the participant to rate the severity of the participant's sleep disturbance.

End point type

Secondary

End point timeframe

Baseline to Week 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	116	233	238
Units: percentage of participants
number (not applicable)	9.5	21.0	22.3

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

354

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0039 ^[7]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

2.74

Confidence interval

level

95%

sides

2-sided

lower limit

1.334

upper limit

6.083

Notes
[7] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

349

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0081 ^[8]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

2.56

Confidence interval

level

95%

sides

2-sided

lower limit

1.242

upper limit

5.723

Notes
[8] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Secondary: VC Period: Percentage of Participants with a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep-Related Impairment (8a – 24-Hour Recall)

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End point title

VC Period: Percentage of Participants with a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep-Related Impairment (8a – 24-Hour Recall)

End point description

The 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 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. Each item asks the participant to rate the severity of the participant's sleep impairment.

End point type

Secondary

End point timeframe

Baseline to Week 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	114	233	245
Units: percentage of participants
number (not applicable)	13.2	20.2	21.6

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

347

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1421 ^[9]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

1.67

Confidence interval

level

95%

sides

2-sided

lower limit

0.862

upper limit

3.391

Notes
[9] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Exact Logistic Regression

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

359

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0746 ^[10]

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

1.82

Confidence interval

level

95%

sides

2-sided

lower limit

0.949

upper limit

3.665

Notes
[10] - The unadjusted p-values between each treatment group and vehicle were calculated based on Conditional Exact test .

Secondary: VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)

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End point title

VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)

End point description

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.

End point type

Secondary

End point timeframe

From first dose up to Week 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (not applicable)
TEAE	34.9	29.0	29.2
Treatment Emergent SAE	1.6	0.4	0.8

No statistical analyses for this end point

Secondary: LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE

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End point title

LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE

End point description

End point type

Secondary

End point timeframe

Week 8 until last follow-up visit (up to 52 weeks)

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	48	47	222	225
Units: percentage of participants
number (not applicable)
TEAE	47.9	48.9	54.5	53.3
Treatment Emergent SAE	6.3	2.1	2.3	1.3

No statistical analyses for this end point

Secondary: VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4

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End point title

VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4

End point description

The IGA is an overall eczema severity rating on a 0 (clear skin) to 4 (severe disease) scale. The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.

End point type

Secondary

End point timeframe

Baseline to Weeks 2 and 4

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (not applicable)
Week 2	3.2	22.2	27.3
Week 4	6.3	42.5	46.6

No statistical analyses for this end point

Secondary: VC Period: Percentage of Participants Achieving IGA Scores of 0 or 1

Top of page

End point title

VC Period: Percentage of Participants Achieving IGA Scores of 0 or 1

End point description

The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. IGA score signifies 0 (clear skin) and 1 (almost clear skin).

End point type

Secondary

End point timeframe

Weeks 2, 4 and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (not applicable)
Week 2	6.3	32.5	34.8
Week 4	15.1	53.2	54.9
Week 8	23.8	58.7	62.8

No statistical analyses for this end point

Secondary: LTS Period: Percentage of Participants Achieving IGA Scores of 0 or 1

Top of page

End point title

LTS Period: Percentage of Participants Achieving IGA Scores of 0 or 1

End point description

End point type

Secondary

End point timeframe

Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	48	47	222	225
Units: percentage of participants
number (not applicable)
Week 8	18.8	38.3	65.3	68.4
Week 12	55.6	65.2	62.7	66.5
Week 16	60.5	62.2	66.5	68.9
Week 20	63.6	67.4	62.4	73.5
Week 24	71.4	78.6	67.0	76.7
Week 28	64.9	74.4	67.3	77.3
Week 32	77.1	81.4	71.5	75.9
Week 36	73.5	82.1	74.5	71.7
Week 40	81.3	79.5	73.5	75.5
Week 44	84.8	86.5	74.3	76.2
Week 48	72.2	76.3	74.3	73.8
Week 52	76.3	73.7	76.9	75.4

No statistical analyses for this end point

Secondary: VC Period: Percentage of Participants with a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4

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End point title

VC Period: Percentage of Participants with a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4

End point description

The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.

End point type

Secondary

End point timeframe

Baseline to Weeks 2 and 4

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	78	156	161
Units: percentage of participants
number (not applicable)
Week 2	5.1	26.3	33.5
Week 4	11.5	38.5	51.6

No statistical analyses for this end point

Secondary: VC period: Percentage of Participants Achieving EASI50

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End point title

VC period: Percentage of Participants Achieving EASI50

End point description

EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI50 responder was defined as a participant achieving 50% or greater improvement from Baseline in EASI score.

End point type

Secondary

End point timeframe

Weeks 2, 4 and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (not applicable)
Week 2	19.8	53.2	62.5
Week 4	27.8	68.7	75.5
Week 8	43.7	69.4	77.9

No statistical analyses for this end point

Secondary: VC Period: Percentage of Participants Achieving EASI75

Top of page

End point title

VC Period: Percentage of Participants Achieving EASI75

End point description

End point type

Secondary

End point timeframe

Weeks 2 and 4

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (not applicable)
Week 2	5.6	30.2	36.0
Week 4	14.3	51.6	58.5

No statistical analyses for this end point

Secondary: VC Period: Percentage of Participants Achieving EASI90

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End point title

VC Period: Percentage of Participants Achieving EASI90

End point description

EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI90 responder was defined as a participant achieving 90% or greater improvement from Baseline in EASI score.

End point type

Secondary

End point timeframe

Weeks 2, 4 and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (not applicable)
Week 2	2.4	12.7	19.8
Week 4	4.0	30.6	36.4
Week 8	9.5	38.1	44.3

No statistical analyses for this end point

Secondary: VC Period: Percent Change From Baseline in EASI Score

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End point title

VC Period: Percent Change From Baseline in EASI Score

End point description

EASI scoring system examines 4 areas of the body and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) for an average degree of severity of each sign in each region. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. A negative change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4 and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percent change
least squares mean (standard error)
Percent Change From Baseline at Week 2	-16.34 ( 3.42 )	-51.82 ( 2.36 )	-56.62 ( 2.35 )
Percent Change From Baseline at Week 4	-23.03 ( 3.90 )	-68.04 ( 2.66 )	-71.08 ( 2.64 )
Percent Change From Baseline at Week 8	-37.88 ( 3.72 )	-71.01 ( 2.52 )	-77.40 ( 2.49 )

Mixed Model

Statistical analysis description

Percent change from Baseline in EASI score at Week 2

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-35.48

Confidence interval

level

95%

sides

2-sided

lower limit

-43.64

upper limit

-27.32

Variability estimate

Standard error of the mean

Dispersion value

4.16

Mixed Model

Statistical analysis description

Percent change from Baseline in EASI score at Week 2

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Method of Mean Difference]

Point estimate

-40.29

Confidence interval

level

95%

sides

2-sided

lower limit

-48.44

upper limit

-32.13

Variability estimate

Standard error of the mean

Dispersion value

4.15

Mixed Model

Statistical analysis description

Percent change from Baseline in EASI score at Week 4

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-45.01

Confidence interval

level

95%

sides

2-sided

lower limit

-54.28

upper limit

-35.74

Variability estimate

Standard error of the mean

Dispersion value

4.72

Mixed Model

Statistical analysis description

Percent change from Baseline in EASI score at Week 4

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-48.05

Confidence interval

level

95%

sides

2-sided

lower limit

-57.3

upper limit

-38.79

Variability estimate

Standard error of the mean

Dispersion value

4.71

Mixed Model

Statistical analysis description

Percent change from Baseline in EASI score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[11]

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-33.13

Confidence interval

level

95%

sides

2-sided

lower limit

-41.95

upper limit

-24.3

Variability estimate

Standard error of the mean

Dispersion value

4.49

Notes
[11] - The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.

Mixed Model

Statistical analysis description

Percent change from Baseline in EASI score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-39.52

Confidence interval

level

95%

sides

2-sided

lower limit

-48.32

upper limit

-30.72

Variability estimate

Standard error of the mean

Dispersion value

4.48

Secondary: VC Period: Percent Change From Baseline In SCORing Atopic Dermatitis (SCORAD) Score

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End point title

VC Period: Percent Change From Baseline In SCORing Atopic Dermatitis (SCORAD) Score

End point description

The SCORAD is a tool to assess extent and severity of eczema. To determine the extent, the rule of nines or handprint method is used to assess eczema affected area (A). To determine disease severity (B) it evaluates 6 clinical characteristics: 1. redness, 2. swelling, 3. oozing/crusting, 4. scratch marks, 5. lichenification, and 6. dryness on a 4-point scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), added to give B with maximum score of 18. Subjective symptoms (C) of itch and sleeplessness are assessed using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), added to give C with maximum score of 20. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combined using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. A negative change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4 and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percent change
arithmetic mean (standard deviation)
Percent Change From Baseline at Week 2	-16.67 ( 34.152 )	-43.96 ( 28.548 )	-49.32 ( 31.878 )
Percent Change From Baseline at Week 4	-27.68 ( 34.518 )	-57.80 ( 28.635 )	-61.33 ( 30.113 )
Percent Change From Baseline at Week 8	-37.00 ( 36.392 )	-62.14 ( 31.108 )	-67.24 ( 28.711 )

ANCOVA

Statistical analysis description

Percent change from Baseline in SCORAD score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-30.4

Confidence interval

level

95%

sides

2-sided

lower limit

-37.68

upper limit

-23.06

Variability estimate

Standard error of the mean

Dispersion value

3.72

ANCOVA

Statistical analysis description

Percent change from Baseline in SCORAD score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-25.3

Confidence interval

level

95%

sides

2-sided

lower limit

-32.62

upper limit

-17.95

Variability estimate

Standard error of the mean

Dispersion value

3.74

Secondary: VC Period: Change From Baseline in Itch NRS Score

Top of page

End point title

VC Period: Change From Baseline in Itch NRS Score

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: score on a scale
least squares mean (standard error)
Change From Baseline at Week 2	-0.89 ( 0.20 )	-2.28 ( 0.14 )	-2.53 ( 0.13 )
Change From Baseline at Week 4	-1.08 ( 0.23 )	-2.79 ( 0.16 )	-3.16 ( 0.15 )
Change From Baseline at Week 8	-1.54 ( 0.25 )	-3.14 ( 0.17 )	-3.53 ( 0.16 )

Mixed Model

Statistical analysis description

Change from Baseline in Itch NRS score at Week 2

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.39

Confidence interval

level

95%

sides

2-sided

lower limit

-1.87

upper limit

-0.91

Variability estimate

Standard error of the mean

Dispersion value

0.24

Mixed Model

Statistical analysis description

Change from Baseline in Itch NRS score at Week 2

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.64

Confidence interval

level

95%

sides

2-sided

lower limit

-2.11

upper limit

-1.16

Variability estimate

Standard error of the mean

Dispersion value

0.24

Mixed Model

Statistical analysis description

Change from Baseline in Itch NRS score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

-1.01

Variability estimate

Standard error of the mean

Dispersion value

0.3

Mixed Model

Statistical analysis description

Change from Baseline in Itch NRS score at Week 4

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.25

upper limit

-1.15

Variability estimate

Standard error of the mean

Dispersion value

0.28

Mixed Model

Statistical analysis description

Change from Baseline in Itch NRS score at Week 4

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-2.08

Confidence interval

level

95%

sides

2-sided

lower limit

-2.63

upper limit

-1.53

Variability estimate

Standard error of the mean

Dispersion value

0.28

Mixed Model

Statistical analysis description

Change from Baseline in Itch NRS score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.99

Confidence interval

level

95%

sides

2-sided

lower limit

-2.58

upper limit

-1.4

Variability estimate

Standard error of the mean

Dispersion value

0.3

Secondary: VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points

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End point title

VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points

End point description

The Itch NRS is a daily participant-reported measure (24-hour recall), using a diary, of the worst level of itch intensity. Participants were asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.

End point type

Secondary

End point timeframe

Up to Week 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: days
median (confidence interval 95%)
≥ 2-Point Improvement in Itch NRS Score	15.0 (10.0 to 22.0)	4.0 (3.0 to 5.0)	3.0 (3.0 to 4.0)
≥ 3-Point Improvement in Itch NRS Score	27.0 (13.0 to 69.0)	8.0 (7.0 to 11.0)	6.0 (5.0 to 9.0)
≥ 4-Point Improvement in Itch NRS Score	99999 (9.9999 to 999999)	14.0 (9.0 to 19.0)	13.0 (9.0 to 15.0)

No statistical analyses for this end point

Secondary: VC Period: Change From Baseline in Skin Pain NRS Score

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End point title

VC Period: Change From Baseline in Skin Pain NRS Score

End point description

The Skin Pain NRS is a daily patient-reported measure (24-hour recall), using a ediary, of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked, “Rate the pain severity from your atopic dermatitis skin changes by selecting a number that best describes your worst level of pain in the past 24 hours.” A negative change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-0.70 ( 1.746 )	-1.90 ( 1.950 )	-2.07 ( 2.164 )
Change From Baseline at Week 4	-0.84 ( 2.307 )	-2.36 ( 2.217 )	-2.72 ( 2.513 )
Change From Baseline at Week 8	-1.16 ( 2.610 )	-2.55 ( 2.360 )	-2.84 ( 2.743 )

ANCOVA

Statistical analysis description

Change from Baseline in Skin Pain NRS score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-2.11

upper limit

-1.13

Variability estimate

Standard error of the mean

Dispersion value

0.25

ANCOVA

Statistical analysis description

Change from Baseline in Skin Pain NRS score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.74

upper limit

-0.74

Variability estimate

Standard error of the mean

Dispersion value

0.25

Secondary: VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

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End point title

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

End point description

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.

End point type

Secondary

End point timeframe

Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	116	233	238
Units: percentage of participants
number (not applicable)
Week 2	5.2	13.7	14.7
Week 4	6.9	19.3	21.0
Week 8	9.5	21.0	22.3

No statistical analyses for this end point

Secondary: VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

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End point title

VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

End point description

The 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.

End point type

Secondary

End point timeframe

Weeks 2, 4 and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	114	233	245
Units: percentage of participants
number (not applicable)
Week 2	8.8	16.3	13.5
Week 4	13.2	20.6	19.2
Week 8	13.2	20.2	21.6

No statistical analyses for this end point

Secondary: VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

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End point title

VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

End point description

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.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: score on a scale
least squares mean (standard error)
Change From Baseline at Week 2	-0.18 ( 0.45 )	-1.72 ( 0.31 )	-2.49 ( 0.30 )
Change From Baseline at Week 4	-0.25 ( 0.50 )	-2.58 ( 0.34 )	-3.10 ( 0.33 )
Change From Baseline at Week 8	-0.43 ( 0.59 )	-2.97 ( 0.39 )	-3.62 ( 0.39 )

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form–Sleep Disturbance (8b) 24-hour recall score at Week 2

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0049

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.53

Confidence interval

level

95%

sides

2-sided

lower limit

-2.6

upper limit

-0.47

Variability estimate

Standard error of the mean

Dispersion value

0.54

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form–Sleep Disturbance (8b) 24-hour recall score at Week 2

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-2.31

Confidence interval

level

95%

sides

2-sided

lower limit

-3.37

upper limit

-1.25

Variability estimate

Standard error of the mean

Dispersion value

0.54

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form–Sleep Disturbance (8b) 24-hour recall score at Week 4

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-2.33

Confidence interval

level

95%

sides

2-sided

lower limit

-3.52

upper limit

-1.15

Variability estimate

Standard error of the mean

Dispersion value

0.6

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form–Sleep Disturbance (8b) 24-hour recall score at Week 4

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-2.85

Confidence interval

level

95%

sides

2-sided

lower limit

-4.03

upper limit

-1.67

Variability estimate

Standard error of the mean

Dispersion value

0.6

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form–Sleep Disturbance (8b) 24-hour recall score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0004

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-2.54

Confidence interval

level

95%

sides

2-sided

lower limit

-3.93

upper limit

-1.14

Variability estimate

Standard error of the mean

Dispersion value

0.71

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form–Sleep Disturbance (8b) 24-hour recall score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-3.18

Confidence interval

level

95%

sides

2-sided

lower limit

-4.57

upper limit

-1.79

Variability estimate

Standard error of the mean

Dispersion value

0.71

Secondary: VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

Top of page

End point title

VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

End point description

The 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.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: score on a scale
least squares mean (standard error)
Change From Baseline at Week 2	-0.58 ( 0.49 )	-1.76 ( 0.33 )	-2.25 ( 0.33 )
Change From Baseline at Week 4	-1.06 ( 0.55 )	-2.71 ( 0.37 )	-2.97 ( 0.36 )
Change From Baseline at Week 8	-1.22 ( 0.62 )	-3.34 ( 0.41 )	-3.52 ( 0.40 )

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form – Sleep-Related Impairment (8a) 24-hour recall score at Week 2

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0487

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.18

Confidence interval

level

95%

sides

2-sided

lower limit

-2.35

upper limit

-0.01

Variability estimate

Standard error of the mean

Dispersion value

0.6

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form – Sleep-Related Impairment (8a) 24-hour recall score at Week 2

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0049

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.68

Confidence interval

level

95%

sides

2-sided

lower limit

-2.84

upper limit

-0.51

Variability estimate

Standard error of the mean

Dispersion value

0.59

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form – Sleep-Related Impairment (8a) 24-hour recall score at Week 4

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0128

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.64

Confidence interval

level

95%

sides

2-sided

lower limit

-2.94

upper limit

-0.35

Variability estimate

Standard error of the mean

Dispersion value

0.66

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form – Sleep-Related Impairment (8a) 24-hour recall score at Week 4

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0037

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.91

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

-0.62

Variability estimate

Standard error of the mean

Dispersion value

0.66

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form – Sleep-Related Impairment (8a) 24-hour recall score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0048

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-2.11

Confidence interval

level

95%

sides

2-sided

lower limit

-3.58

upper limit

-0.65

Variability estimate

Standard error of the mean

Dispersion value

0.75

Mixed Model

Statistical analysis description

Change from Baseline in PROMIS Short Form – Sleep-Related Impairment (8a) 24-hour recall score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

= 0.002

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-3.75

upper limit

-0.84

Variability estimate

Standard error of the mean

Dispersion value

0.74

Secondary: LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score

Top of page

End point title

LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score

End point description

The 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.

End point type

Secondary

End point timeframe

Baseline, Weeks 12, 24, and 52

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	48	47	222	225
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-1.51 ( 4.739 )	-2.22 ( 7.305 )	-0.39 ( 3.984 )	-0.39 ( 3.907 )
Change From Baseline at Week 24	-0.54 ( 5.211 )	-2.66 ( 7.268 )	0.11 ( 4.929 )	0.02 ( 5.584 )
Change From Baseline at Week 52	-0.97 ( 5.085 )	-2.81 ( 7.005 )	-0.37 ( 5.775 )	-0.54 ( 5.511 )

No statistical analyses for this end point

Secondary: LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score

Top of page

End point title

LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score

End point description

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.

End point type

Secondary

End point timeframe

Baseline, Weeks 12, 24, and 52

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	48	47	222	225
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-1.93 ( 5.284 )	-2.67 ( 7.160 )	-0.67 ( 4.575 )	-0.66 ( 3.865 )
Change From Baseline at Week 24	-1.22 ( 5.681 )	-3.15 ( 8.242 )	0.02 ( 5.536 )	0.51 ( 5.563 )
Change From Baseline at Week 52	-1.95 ( 4.876 )	-3.31 ( 7.082 )	-0.27 ( 6.506 )	-0.07 ( 5.918 )

No statistical analyses for this end point

Secondary: VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)

Top of page

End point title

VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)

End point description

Body surface area affected by AD was assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Used the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSA head and neck + 0.3*BSA trunk + 0.2* BSA upper limbs + 0.4*BSA lower limbs. A negative change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4 and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: % BSA
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-0.43 ( 5.559 )	-3.69 ( 4.230 )	-3.76 ( 4.238 )
Change From Baseline at Week 4	-1.56 ( 4.088 )	-5.29 ( 4.969 )	-5.25 ( 5.190 )
Change From Baseline at Week 8	-2.51 ( 4.722 )	-6.30 ( 5.378 )	-6.54 ( 4.967 )

ANCOVA

Statistical analysis description

Change from Baseline in %BSA at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4.67

upper limit

-2.79

Variability estimate

Standard error of the mean

Dispersion value

0.48

ANCOVA

Statistical analysis description

Change from Baseline in %BSA at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3.1

Confidence interval

level

95%

sides

2-sided

lower limit

-4.07

upper limit

-2.18

Variability estimate

Standard error of the mean

Dispersion value

0.48

Secondary: LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA

Top of page

End point title

LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	48	47	222	225
Units: % BSA
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-4.23 ( 4.849 )	-2.84 ( 4.907 )	-6.84 ( 4.852 )	-6.96 ( 4.989 )
Change From Baseline at Week 16	-4.96 ( 5.194 )	-2.98 ( 5.429 )	-7.36 ( 4.875 )	-7.26 ( 5.080 )
Change From Baseline at Week 20	-4.78 ( 5.095 )	-3.75 ( 5.321 )	-7.69 ( 4.901 )	-7.49 ( 5.012 )
Change From Baseline at Week 24	-5.32 ( 4.964 )	-3.85 ( 5.223 )	-7.64 ( 4.998 )	-7.64 ( 4.737 )
Change From Baseline at Week 28	-4.56 ( 5.486 )	-4.43 ( 4.995 )	-7.66 ( 5.029 )	-7.62 ( 4.913 )
Change From Baseline at Week 32	-5.17 ( 4.472 )	-4.53 ( 5.399 )	-7.80 ( 5.011 )	-7.61 ( 5.261 )
Change From Baseline at Week 36	-5.21 ( 4.972 )	-4.39 ( 5.509 )	-8.18 ( 5.111 )	-7.97 ( 5.010 )
Change From Baseline at Week 40	-4.67 ( 5.519 )	-4.75 ( 5.337 )	-8.07 ( 4.899 )	-8.11 ( 4.997 )
Change From Baseline at Week 44	-5.28 ( 5.173 )	-4.56 ( 5.609 )	-8.14 ( 4.789 )	-8.02 ( 4.939 )
Change From Baseline at Week 48	-5.65 ( 5.128 )	-4.58 ( 5.696 )	-8.39 ( 5.023 )	-7.96 ( 4.993 )
Change From Baseline at Week 52	-5.72 ( 5.481 )	-4.93 ( 5.771 )	-8.58 ( 5.013 )	-8.14 ( 4.906 )

No statistical analyses for this end point

Secondary: VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score

Top of page

End point title

VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score

End point description

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. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-2.25 ( 5.779 )	-9.47 ( 7.212 )	-10.60 ( 6.670 )
Change From Baseline at Week 4	-3.38 ( 6.685 )	-10.12 ( 7.380 )	-11.53 ( 6.891 )
Change From Baseline at Week 8	-4.30 ( 7.044 )	-10.60 ( 7.262 )	-11.82 ( 6.931 )

ANCOVA

Statistical analysis description

Change from Baseline in POEM score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-5.1

Confidence interval

level

95%

sides

2-sided

lower limit

-6.43

upper limit

-3.8

Variability estimate

Standard error of the mean

Dispersion value

0.67

ANCOVA

Statistical analysis description

Change from Baseline in POEM score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-6.3

Confidence interval

level

95%

sides

2-sided

lower limit

-7.62

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

0.67

Secondary: LTS Period: Change From Baseline in POEM Score

Top of page

End point title

LTS Period: Change From Baseline in POEM Score

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 12, 24, and 52

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	41	46	206	206
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-5.95 ( 6.607 )	-6.89 ( 9.730 )	-10.74 ( 6.653 )	-11.38 ( 6.710 )
Change From Baseline at Week 24	-4.46 ( 6.185 )	-7.26 ( 9.189 )	-10.46 ( 6.655 )	-11.44 ( 6.689 )
Change From Baseline at Week 52	-4.61 ( 6.868 )	-7.00 ( 8.752 )	-10.51 ( 7.396 )	-10.61 ( 7.057 )

No statistical analyses for this end point

Secondary: VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

Top of page

End point title

VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

End point description

The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 (”no impact on participant’s life”) to 30 (”extremely large effect on participant’s life”), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant’s life.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	107	215	223
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-1.54 ( 4.618 )	-6.18 ( 5.740 )	-6.90 ( 5.980 )
Change From Baseline at Week 4	-2.50 ( 6.101 )	-6.88 ( 5.867 )	-7.15 ( 6.565 )
Change From Baseline at Week 8	-2.83 ( 6.722 )	-7.28 ( 5.907 )	-7.72 ( 6.152 )

ANCOVA

Statistical analysis description

Change from Baseline in total DLQI score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

322

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3.8

Confidence interval

level

95%

sides

2-sided

lower limit

-4.85

upper limit

-2.68

Variability estimate

Standard error of the mean

Dispersion value

0.55

ANCOVA

Statistical analysis description

Change from Baseline in total DLQI score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

330

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-4.5

Confidence interval

level

95%

sides

2-sided

lower limit

-5.56

upper limit

-3.42

Variability estimate

Standard error of the mean

Dispersion value

0.55

Secondary: LTS Period: Change From Baseline in DLQI Score

Top of page

End point title

LTS Period: Change From Baseline in DLQI Score

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 12, 24, and 52

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	40	38	189	200
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-3.65 ( 5.602 )	-4.53 ( 6.246 )	-7.67 ( 5.855 )	-7.79 ( 6.240 )
Change From Baseline at Week 24	-3.21 ( 4.814 )	-5.32 ( 6.304 )	-7.87 ( 6.080 )	-7.75 ( 6.277 )
Change From Baseline at Week 52	-3.35 ( 5.438 )	-4.81 ( 6.720 )	-7.95 ( 6.589 )	-7.70 ( 6.443 )

No statistical analyses for this end point

Secondary: VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score

Top of page

End point title

VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score

End point description

CDLQI is the youth/children’s version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant’s life) and a minimum score of 0 (no impact on participant’s life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant’s life.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	19	37	30
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-1.06 ( 3.733 )	-5.06 ( 6.937 )	-6.76 ( 6.306 )
Change From Baseline at Week 4	-2.47 ( 6.530 )	-4.35 ( 8.683 )	-6.90 ( 5.101 )
Change From Baseline at Week 8	-2.31 ( 5.618 )	-5.88 ( 7.524 )	-7.61 ( 6.142 )

ANCOVA

Statistical analysis description

Change from Baseline in total CDLQI score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0018

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3.3

Confidence interval

level

95%

sides

2-sided

lower limit

-5.29

upper limit

-1.26

Variability estimate

Standard error of the mean

Dispersion value

1.01

ANCOVA

Statistical analysis description

Change from Baseline in total CDLQI score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0378

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-4.43

upper limit

-0.13

Variability estimate

Standard error of the mean

Dispersion value

1.08

Secondary: LTS Period: Change From Baseline in CDLQI Score

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End point title

LTS Period: Change From Baseline in CDLQI Score

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 12, 24, and 52

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	8	9	33	25
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-4.00 ( 5.477 )	-1.13 ( 8.907 )	-5.83 ( 7.661 )	-8.86 ( 5.532 )
Change From Baseline at Week 24	-2.71 ( 5.155 )	-2.00 ( 3.780 )	-6.72 ( 7.640 )	-9.42 ( 7.214 )
Change From Baseline at Week 52	-4.33 ( 8.359 )	-0.43 ( 4.928 )	-6.70 ( 7.766 )	-9.71 ( 6.262 )

No statistical analyses for this end point

Secondary: VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8

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End point title

VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8

End point description

The PGIC is a participants’ self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions 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. The lower score indicates improvement.

End point type

Secondary

End point timeframe

Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: score on a scale
arithmetic mean (standard deviation)
Week 2	3.53 ( 1.500 )	2.06 ( 0.937 )	1.94 ( 0.911 )
Week 4	3.30 ( 1.434 )	1.78 ( 0.903 )	1.68 ( 0.843 )
Week 8	3.08 ( 1.489 )	1.76 ( 0.913 )	1.61 ( 0.914 )

No statistical analyses for this end point

Secondary: VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8

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End point title

VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8

End point description

End point type

Secondary

End point timeframe

Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (not applicable)
Week 2 - Very Much Improved: 1	5.3	31.4	36.7
Week 2 - Much Improved: 2	18.6	38.6	40.1
Week 2 - Minimally Improved: 3	37.2	25.0	16.9
Week 2 - No Change: 4	13.3	4.2	5.5
Week 2 - Minimally Worse: 5	11.5	0.4	0.8
Week 2 - Much Worse: 6	10.6	0.0	0.0
Week 2 - Very Much Worse: 7	3.5	0.4	0.0
Week 4 - Very Much Improved: 1	6.7	48.5	51.7
Week 4 - Much Improved: 2	22.9	29.5	32.1
Week 4 - Minimally Improved: 3	38.1	18.1	13.3
Week 4 - No Change: 4	11.4	3.0	2.1
Week 4 - Minimally Worse: 5	11.4	0.8	0.8
Week 4 - Much Worse: 6	6.7	0.0	0.0
Week 4 - Very Much Worse: 7	2.9	0.0	0.0
Week 8 - Very Much Improved: 1	11.0	48.4	59.8
Week 8 - Much Improved: 2	30.0	33.2	25.8
Week 8 - Minimally Improved: 3	29.0	14.8	10.0
Week 8 - No Change: 4	12.0	1.3	2.2
Week 8 - Minimally Worse: 5	7.0	2.2	2.2
Week 8 - Much Worse: 6	10.0	0.0	0.0
Week 8 - Very Much Worse: 7	1.0	0.0	0.0

No statistical analyses for this end point

Secondary: VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8

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End point title

VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8

End point description

End point type

Secondary

End point timeframe

Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: percentage of participants
number (confidence interval 95%)
Week 2	23.9 (16.4 to 32.8)	69.9 (63.6 to 75.7)	76.8 (70.9 to 82.0)
Week 4	29.5 (21.0 to 39.2)	78.1 (72.2 to 83.2)	83.8 (78.5 to 88.2)
Week 8	41.0 (31.3 to 51.3)	81.6 (75.9 to 86.5)	85.6 (80.4 to 89.9)

Exact Logistic Regression

Statistical analysis description

Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

8.39

Confidence interval

level

95%

sides

2-sided

lower limit

4.755

upper limit

15.083

Exact Logistic Regression

Statistical analysis description

Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Conditional Exact test

Parameter type

Odds ratio (OR)

Point estimate

6.28

Confidence interval

level

95%

sides

2-sided

lower limit

3.632

upper limit

11.018

Secondary: VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score

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End point title

VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score

End point description

EQ-5D-5L questionnaire has 2 parts: EQ-5D-5L descriptive system & EQ-VAS. EQ-5D is a validated, self-administered, generic utility questionnaire wherein participants rate their current health state based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 5L indicates that for each dimension, there are 5 levels:1=no problems,2=slight problems,3=moderate problems,4=severe problems, and 5=extreme problems. EQ-5D-5L score is assessed using VAS that ranges from 0 to 100 millimetres (mm), where 0 indicates “worst health you can imagine” and 100 indicates “best health you can imagine”. The participant was asked to indicate his/her health state over past 7 days in each of the 5 dimensions. Digits for the 5 dimensions can be combined into a 5-digit number that describes the participant’s health. In the EQ-VAS, participants had to record their health state on a scale ranging from 0 to 100. A positive change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: score on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-0.94 ( 14.046 )	6.93 ( 17.690 )	8.21 ( 15.770 )
Change From Baseline at Week 4	1.76 ( 11.618 )	8.73 ( 17.494 )	7.10 ( 16.697 )
Change From Baseline at Week 8	1.74 ( 14.376 )	9.12 ( 17.871 )	7.98 ( 16.813 )

ANCOVA

Statistical analysis description

Change from Baseline in EQ VAS score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0037

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

4.9

Confidence interval

level

95%

sides

2-sided

lower limit

1.59

upper limit

8.15

Variability estimate

Standard error of the mean

Dispersion value

1.67

ANCOVA

Statistical analysis description

Change from Baseline in EQ VAS score at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0006

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

5.7

Confidence interval

level

95%

sides

2-sided

lower limit

2.45

upper limit

8.96

Variability estimate

Standard error of the mean

Dispersion value

1.66

Secondary: VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0)

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End point title

VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0)

End point description

The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, and 8

End point values	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	126	252	253
Units: score on a scale
arithmetic mean (standard deviation)
Percent Work : Change From Baseline at Week 2	4.45 ( 19.542 )	-3.89 ( 24.223 )	1.19 ( 14.954 )
Percent Work : Change From Baseline at Week 4	14.09 ( 30.660 )	1.22 ( 23.898 )	3.43 ( 17.242 )
Percent Work : Change From Baseline at Week 8	5.07 ( 23.253 )	-0.26 ( 23.891 )	6.23 ( 22.211 )
Percent Impairment : From Baseline at Week 2	-7.36 ( 22.630 )	-15.00 ( 22.494 )	-16.75 ( 20.951 )
Percent Impairment : From Baseline at Week 4	-9.56 ( 25.580 )	-16.86 ( 22.417 )	-19.43 ( 20.933 )
Percent Impairment : From Baseline at Week 8	-13.54 ( 28.019 )	-19.43 ( 24.878 )	-21.61 ( 22.071 )
% Overall Impairment: From Baseline at Week 2	-5.27 ( 21.539 )	-15.04 ( 27.812 )	-15.49 ( 23.785 )
% Overall Impairment: From Baseline at Week 4	-2.35 ( 27.602 )	-13.82 ( 26.207 )	-15.82 ( 25.545 )
% Overall Impairment: From Baseline at Week 8	-9.01 ( 31.735 )	-18.09 ( 27.718 )	-15.54 ( 27.119 )
% Activity Impairment: From Baseline at Week 2	-6.32 ( 23.434 )	-16.58 ( 24.696 )	-21.56 ( 24.695 )
% Activity Impairment: From Baseline at Week 4	-10.09 ( 26.349 )	-20.80 ( 24.107 )	-23.53 ( 25.422 )
% Activity Impairment: From Baseline at Week 8	-11.70 ( 28.992 )	-21.30 ( 24.653 )	-24.06 ( 26.682 )

ANCOVA

Statistical analysis description

Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1417

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-4.9

Confidence interval

level

95%

sides

2-sided

lower limit

-11.49

upper limit

1.65

Variability estimate

Standard error of the mean

Dispersion value

3.34

ANCOVA

Statistical analysis description

Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

= 0.6037

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-8.19

upper limit

4.77

Variability estimate

Standard error of the mean

Dispersion value

3.29

ANCOVA

Statistical analysis description

Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0003

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-11

Confidence interval

level

95%

sides

2-sided

lower limit

-16.89

upper limit

-5.12

Variability estimate

Standard error of the mean

Dispersion value

2.99

ANCOVA

Statistical analysis description

Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-12.2

Confidence interval

level

95%

sides

2-sided

lower limit

-17.98

upper limit

-6.47

Variability estimate

Standard error of the mean

Dispersion value

2.93

ANCOVA

Statistical analysis description

Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-15.4

Confidence interval

level

95%

sides

2-sided

lower limit

-22.95

upper limit

-7.81

Variability estimate

Standard error of the mean

Dispersion value

3.85

ANCOVA

Statistical analysis description

Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0011

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-12.4

Confidence interval

level

95%

sides

2-sided

lower limit

-19.85

upper limit

-5.01

Variability estimate

Standard error of the mean

Dispersion value

3.77

ANCOVA

Statistical analysis description

Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 0.75% Cream BID

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-10.5

Confidence interval

level

95%

sides

2-sided

lower limit

-14.64

upper limit

-6.29

Variability estimate

Standard error of the mean

Dispersion value

2.13

ANCOVA

Statistical analysis description

Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8

Comparison groups

VC Period: Vehicle Cream BID v VC Period: Ruxolitinib 1.5% Cream BID

Number of subjects included in analysis

379

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-12.4

Confidence interval

level

95%

sides

2-sided

lower limit

-16.6

upper limit

-8.29

Variability estimate

Standard error of the mean

Dispersion value

2.12

Secondary: LTS Period: Change From Baseline in WPAI-SHP v2.0

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End point title

LTS Period: Change From Baseline in WPAI-SHP v2.0

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 12, 24, 36, and 52

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	20	22	98	110
Units: score on a scale
arithmetic mean (standard deviation)
% Work Missed : Change From Baseline at Week 12	-4.78 ( 18.023 )	-2.02 ( 4.902 )	-0.26 ( 27.118 )	7.72 ( 22.067 )
% Work Missed : Change From Baseline at Week 24	-0.39 ( 21.466 )	4.77 ( 16.899 )	-1.00 ( 28.511 )	4.96 ( 18.942 )
% Work Missed : Change From Baseline at Week 36	-3.92 ( 23.687 )	-3.12 ( 6.143 )	-0.32 ( 27.115 )	8.93 ( 21.916 )
% Work Missed : Change From Baseline at Week 52	-8.11 ( 18.718 )	3.23 ( 26.008 )	1.81 ( 26.094 )	2.38 ( 16.245 )
% Impairment Change From Baseline in at Week 12	-11.50 ( 23.458 )	-18.64 ( 28.668 )	-20.21 ( 24.925 )	-20.65 ( 21.844 )
% Impairment Change From Baseline in at Week 24	-8.42 ( 16.754 )	-16.67 ( 28.697 )	-23.51 ( 25.067 )	-23.66 ( 24.396 )
% Impairment Change From Baseline in at Week 36	-3.13 ( 20.887 )	-8.46 ( 33.378 )	-23.15 ( 25.813 )	-22.72 ( 23.185 )
% Impairment Change From Baseline in at Week 52	-10.00 ( 25.166 )	-20.00 ( 27.634 )	-23.42 ( 26.597 )	-22.77 ( 24.109 )
% Overall Impairment: From Baseline at Week 12	-12.18 ( 24.763 )	-19.64 ( 28.842 )	-18.21 ( 28.345 )	-14.99 ( 28.777 )
% Overall Impairment: From Baseline at Week 24	-7.46 ( 16.254 )	-12.96 ( 34.336 )	-20.26 ( 31.191 )	-18.60 ( 28.284 )
% Overall Impairment: From Baseline at Week 36	-5.70 ( 23.040 )	-10.43 ( 33.034 )	-20.52 ( 31.307 )	-14.86 ( 29.482 )
% Overall Impairment: From Baseline at Week 52	-16.36 ( 29.721 )	-16.67 ( 40.350 )	-19.42 ( 29.878 )	-20.50 ( 26.949 )
% Activity Impairment: From Baseline at Week 12	-12.20 ( 21.273 )	-8.48 ( 26.244 )	-21.50 ( 26.470 )	-25.19 ( 26.314 )
% Activity Impairment: From Baseline at Week 24	-11.46 ( 16.517 )	-7.14 ( 25.113 )	-22.83 ( 27.440 )	-27.47 ( 25.943 )
% Activity Impairment: From Baseline at Week 36	-6.39 ( 18.997 )	-1.25 ( 27.845 )	-24.48 ( 26.203 )	-26.84 ( 27.493 )
% Activity Impairment: From Baseline at Week 52	-11.05 ( 24.910 )	-13.42 ( 25.392 )	-22.91 ( 27.669 )	-26.92 ( 28.042 )

No statistical analyses for this end point

Secondary: VC Period: Trough Plasma Concentrations of Ruxolitinib

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End point title

VC Period: Trough Plasma Concentrations of Ruxolitinib ^[12]

End point description

End point type

Secondary

End point timeframe

Weeks 2, 4 and 8

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Since VC group is a placebo no Trough plasma concentrations were measured.

End point values	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	236	241
Units: nanomole per liter (nM)
arithmetic mean (standard deviation)
Week 2	26.8 ( 51.2 )	33.4 ( 49.9 )
Week 4	25.1 ( 42.7 )	34.7 ( 43.3 )
Week 8	24.0 ( 39.7 )	33.3 ( 49.5 )

No statistical analyses for this end point

Secondary: LTS Period: Trough Plasma Concentrations of Ruxolitinib

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End point title

LTS Period: Trough Plasma Concentrations of Ruxolitinib

End point description

End point type

Secondary

End point timeframe

Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream	LTS Period: Ruxolitinib 1.5% Cream
Number of subjects analysed	48	47	210	213
Units: nM
arithmetic mean (standard deviation)
Week 12	13.8 ( 21.3 )	21.9 ( 34.4 )	16.5 ( 28.1 )	24.9 ( 45.4 )
Week 16	11.9 ( 18.8 )	18.1 ( 34.6 )	19.7 ( 58.8 )	24.6 ( 51.0 )
Week 20	13.0 ( 22.2 )	15.4 ( 32.0 )	16.1 ( 31.2 )	24.2 ( 46.1 )
Week 24	13.0 ( 22.1 )	18.7 ( 31.6 )	18.8 ( 42.4 )	24.6 ( 51.8 )
Week 28	18.5 ( 36.9 )	15.5 ( 24.6 )	16.2 ( 31.2 )	23.7 ( 45.3 )
Week 32	17.8 ( 27.3 )	17.7 ( 33.3 )	21.4 ( 59.8 )	21.0 ( 35.3 )
Week 36	21.1 ( 54.8 )	29.5 ( 84.0 )	15.7 ( 30.5 )	26.6 ( 51.2 )
Week 40	14.9 ( 25.3 )	16.5 ( 31.0 )	14.7 ( 27.6 )	23.2 ( 64.1 )
Week 44	14.3 ( 23.7 )	15.7 ( 32.6 )	17.3 ( 33.5 )	26.8 ( 58.6 )
Week 48	15.6 ( 26.8 )	17.9 ( 56.0 )	15.3 ( 30.3 )	24.8 ( 55.3 )
Week 52	11.0 ( 17.9 )	14.2 ( 27.5 )	11.9 ( 20.5 )	21.0 ( 55.7 )

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

60 weeks

Adverse event reporting additional description

AE additional description

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

VC and LTS Period: Vehicle Cream BID

Reporting group description

Participants received vehicle cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants from Vehicle cream arm were crossed over to 0.75 or 1.5mg rux BID

Reporting group title

VC and LTS Period: Ruxolitinib 0.75% Cream BID

Reporting group description

Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants from Vehicle cream arm were crossed over to 0.75 rux BID.

Reporting group title

VC and LTS Period: Ruxolitinib 1.5% Cream BID

Reporting group description

Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants from Vehicle cream arm were crossed over to 1.5 rux BID.

Serious adverse events	VC and LTS Period: Vehicle Cream BID	VC and LTS Period: Ruxolitinib 0.75% Cream BID	VC and LTS Period: Ruxolitinib 1.5% Cream BID
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 126 (1.59%)	9 / 300 (3.00%)	6 / 300 (2.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal sinus cancer
subjects affected / exposed	1 / 126 (0.79%)	0 / 300 (0.00%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Anaemia postoperative
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Central nervous system lesion
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Serositis
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Acute abdomen
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholangitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	1 / 126 (0.79%)	0 / 300 (0.00%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Substance-induced psychotic disorder
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 126 (0.00%)	2 / 300 (0.67%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypovolaemia
subjects affected / exposed	0 / 126 (0.00%)	0 / 300 (0.00%)	1 / 300 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	0 / 126 (0.00%)	1 / 300 (0.33%)	0 / 300 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	VC and LTS Period: Vehicle Cream BID	VC and LTS Period: Ruxolitinib 0.75% Cream BID	VC and LTS Period: Ruxolitinib 1.5% Cream BID
Total subjects affected by non serious adverse events
subjects affected / exposed	10 / 126 (7.94%)	52 / 300 (17.33%)	70 / 300 (23.33%)
Nervous system disorders
Headache
subjects affected / exposed	5 / 126 (3.97%)	11 / 300 (3.67%)	16 / 300 (5.33%)
occurrences all number	6	15	22
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	4 / 126 (3.17%)	27 / 300 (9.00%)	36 / 300 (12.00%)
occurrences all number	4	36	41
Nasopharyngitis
subjects affected / exposed	2 / 126 (1.59%)	18 / 300 (6.00%)	31 / 300 (10.33%)
occurrences all number	2	22	43

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: 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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Who Achieved Investigator’s Global Assessment - Treatment Success (IGA-TS) at Week 8

Primary: Percentage of Participants Who Achieved Investigator’s Global Assessment - Treatment Success (IGA-TS) at Week 8

Secondary: VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75)

Secondary: VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75)

Secondary: VC Period: Percentage of Participants with a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score

Secondary: VC Period: Percentage of Participants with a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score

Secondary: VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form – Sleep Disturbance (8b – 24-Hour Recall) Score

Secondary: VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form – Sleep Disturbance (8b – 24-Hour Recall) Score

Secondary: VC Period: Percentage of Participants with a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep-Related Impairment (8a – 24-Hour Recall)

Secondary: VC Period: Percentage of Participants with a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep-Related Impairment (8a – 24-Hour Recall)

Secondary: VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)

Secondary: VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)

Secondary: LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE

Secondary: LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE

Secondary: VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4

Secondary: VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4

Secondary: VC Period: Percentage of Participants Achieving IGA Scores of 0 or 1

Secondary: VC Period: Percentage of Participants Achieving IGA Scores of 0 or 1

Secondary: LTS Period: Percentage of Participants Achieving IGA Scores of 0 or 1

Secondary: LTS Period: Percentage of Participants Achieving IGA Scores of 0 or 1

Secondary: VC Period: Percentage of Participants with a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4

Secondary: VC Period: Percentage of Participants with a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4

Secondary: VC period: Percentage of Participants Achieving EASI50

Secondary: VC period: Percentage of Participants Achieving EASI50

Secondary: VC Period: Percentage of Participants Achieving EASI75

Secondary: VC Period: Percentage of Participants Achieving EASI75

Secondary: VC Period: Percentage of Participants Achieving EASI90

Secondary: VC Period: Percentage of Participants Achieving EASI90

Secondary: VC Period: Percent Change From Baseline in EASI Score

Secondary: VC Period: Percent Change From Baseline in EASI Score

Secondary: VC Period: Percent Change From Baseline In SCORing Atopic Dermatitis (SCORAD) Score

Secondary: VC Period: Percent Change From Baseline In SCORing Atopic Dermatitis (SCORAD) Score

Secondary: VC Period: Change From Baseline in Itch NRS Score

Secondary: VC Period: Change From Baseline in Itch NRS Score

Secondary: VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points

Secondary: VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points

Secondary: VC Period: Change From Baseline in Skin Pain NRS Score

Secondary: VC Period: Change From Baseline in Skin Pain NRS Score

Secondary: VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

Secondary: VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

Secondary: VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

Secondary: VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

Secondary: VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

Secondary: VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score

Secondary: VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

Secondary: VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score

Secondary: LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score

Secondary: LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score

Secondary: LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score

Secondary: LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score

Secondary: VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)

Secondary: VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)

Secondary: LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA

Secondary: LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA

Secondary: VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score

Secondary: VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score

Secondary: LTS Period: Change From Baseline in POEM Score

Secondary: LTS Period: Change From Baseline in POEM Score

Secondary: VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

Secondary: VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

Secondary: LTS Period: Change From Baseline in DLQI Score

Secondary: LTS Period: Change From Baseline in DLQI Score

Secondary: VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score

Secondary: VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score

Secondary: LTS Period: Change From Baseline in CDLQI Score

Secondary: LTS Period: Change From Baseline in CDLQI Score

Secondary: VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8

Secondary: VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8

Secondary: VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8

Secondary: VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8

Clinical Trial Results:
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