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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	2018-003713-18
Trial protocol	CZ DE BG PL ES
Global end of trial date	09 Nov 2020

Results information
Results version number	v1(current)
This version publication date	04 Dec 2021
First version publication date	04 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 18424-304

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Incyte Corporation

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

09 Nov 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

09 Nov 2020

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to assess the efficacy of 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

Bulgaria: 35

Country: Number of subjects enrolled

Canada: 6

Country: Number of subjects enrolled

Czechia: 88

Country: Number of subjects enrolled

Germany: 9

Country: Number of subjects enrolled

Poland: 63

Country: Number of subjects enrolled

Spain: 8

Country: Number of subjects enrolled

United States: 409

Worldwide total number of subjects

618

EEA total number of subjects

203

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)

122

Adults (18-64 years)

439

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

A total of 618 participants were enrolled at 65 investigative sites in North America and Europe from December 20, 2018 to November 09, 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

Investigator, Carer, Subject, Assessor

Are arms mutually exclusive

Yes

VC Period: Vehicle Cream BID

Arm description

Ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8.

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 Daily

VC Period: Ruxolitinib 0.75% Cream BID

Arm description

Ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8.

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 Daily

VC Period: Ruxolitinib 1.5% Cream BID

Arm description

Ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8.

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 Daily

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	124	248	246
Completed	105	209	224
Not completed	19	39	22
Physician decision	3	-	1
Consent withdrawn by subject	11	21	15
Adverse event, non-fatal	1	1	-
Lost to follow-up	3	13	4
Reason not Specified	1	2	2
Protocol deviation	-	2	-

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, Data analyst

Are arms mutually exclusive

Yes

LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID

Arm description

Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 9 up to Week 52.

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 daily

LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID

Arm description

Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 9 up to Week 52.

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 daily

LTS Period: Ruxolitinib 0.75% Cream BID

Arm description

Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 9 up to Week 52.

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 daily

LTS Period: Ruxolitinib 1.5% Cream BID

Arm description

Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 9 up to Week 52.

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 daily

Number of subjects in period 2 ^[1]	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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Started	53	52	204	221
Completed	33	41	151	170
Not completed	20	11	53	51
Physician decision	1	-	4	2
Consent withdrawn by subject	12	8	26	34
Adverse event, non-fatal	-	-	4	-
Pregnancy	1	-	-	1
Lost to follow-up	4	2	13	10
Reason not Specified	1	1	1	-
Lack of efficacy	1	-	4	4
Protocol deviation	-	-	1	-

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: As per disposition table some subjects discontinued the study after vehicle period, and the participants from vehicle period are randomly assigned to one of the treatment groups in LTS period.

Baseline characteristics

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Reporting group title

VC Period: Vehicle Cream BID

Reporting group description

Ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8.

Reporting group title

VC Period: Ruxolitinib 0.75% Cream BID

Reporting group description

Ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8.

Reporting group title

VC Period: Ruxolitinib 1.5% Cream BID

Reporting group description

Ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8.

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	124	248	246	618
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)	22	55	45	122
Adults (18-64 years)	87	171	181	439
From 65-84 years	15	22	19	56
85 years and over	0	0	1	1
Age Continuous
Units: years
arithmetic mean (standard deviation)	38.9 ( 18.90 )	35.8 ( 18.45 )	35.9 ( 18.01 )	-
Sex: Female, Male
Units: participants
Female	80	150	150	380
Male	44	98	96	238
Race/Ethnicity, Customized
Units: Subjects
Hispanic or Latino	17	31	30	78
Not Hispanic or Latino	107	217	216	540
Race/Ethnicity, Customized
Units: Subjects
White/Caucasian	85	174	178	437
Black/African-American	32	63	57	152
Asian	2	6	6	14
American-Indian/Alaska Native	0	0	1	1
Native Hawaiian/Pacific Islander	2	0	0	2
Other	3	5	4	12
Body Mass Index
Units: Kilograms per square metre (kg/m^2)
arithmetic mean (standard deviation)	27.75 ( 6.737 )	27.60 ( 7.091 )	28.01 ( 7.495 )	-

End points

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Reporting group title

VC Period: Vehicle Cream BID

Reporting group description

Ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8.

Reporting group title

VC Period: Ruxolitinib 0.75% Cream BID

Reporting group description

Ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8.

Reporting group title

VC Period: Ruxolitinib 1.5% Cream BID

Reporting group description

Ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8.

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 BID

Reporting group description

Reporting group title

LTS Period: Ruxolitinib 1.5% Cream BID

Reporting group description

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	118	231	228
Units: percentage of participants
number (confidence interval 95%)	7.6 (3.5 to 14.0)	39.0 (32.6 to 45.6)	51.3 (44.6 to 58.0)

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

< 0.0001 ^[1]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

8.84

Confidence interval

level

95%

sides

2-sided

lower limit

4.125

upper limit

21.202

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 1.5% Cream BID

Number of subjects included in analysis

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[2]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

15.8

Confidence interval

level

95%

sides

2-sided

lower limit

7.354

upper limit

38.061

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

Secondary: Proportion of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8

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End point title

Proportion of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8

End point description

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) 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) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata 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	118	231	228
Units: percentage of participants
number (confidence interval 95%)	14.4 (8.6 to 22.1)	51.5 (44.9 to 58.1)	61.8 (55.2 to 68.2)

Exact Logistic regression

Comparison groups

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

Number of subjects included in analysis

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[3]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

10.67

Confidence interval

level

95%

sides

2-sided

lower limit

5.775

upper limit

20.732

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 0.75% Cream BID

Number of subjects included in analysis

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[4]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

6.84

Confidence interval

level

95%

sides

2-sided

lower limit

3.723

upper limit

13.184

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

Secondary: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8

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End point title

Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8

End point description

The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch using a diary. 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 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	80	157	146
Units: percentage of participants
number (not applicable)	16.3	42.7	50.7

Exact Logistic regression

Comparison groups

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

Number of subjects included in analysis

226

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[5]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

5.8

Confidence interval

level

95%

sides

2-sided

lower limit

2.833

upper limit

12.657

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

237

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[6]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

4.17

Confidence interval

level

95%

sides

2-sided

lower limit

2.045

upper limit

9.036

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

Secondary: Proportion 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 at Week 8

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End point title

Proportion 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 at Week 8

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

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	110	213	211
Units: percentage of participants
number (not applicable)	19.1	20.7	25.6

Exact Logistic regression

Comparison groups

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

Number of subjects included in analysis

323

Analysis specification

Pre-specified

Analysis type

P-value

= 0.8553 ^[7]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

1.11

Confidence interval

level

95%

sides

2-sided

lower limit

0.598

upper limit

2.094

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 1.5% Cream BID

Number of subjects included in analysis

321

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2359 ^[8]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

1.47

Confidence interval

level

95%

sides

2-sided

lower limit

0.805

upper limit

2.741

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

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

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End point title

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

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

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	111	215	212
Units: percentage of participants
number (not applicable)	13.5	20.0	23.1

Exact Logistic regression

Comparison groups

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

Number of subjects included in analysis

326

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1784 ^[9]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

1.62

Confidence interval

level

95%

sides

2-sided

lower limit

0.827

upper limit

3.342

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

323

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0472 ^[10]

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

1.96

Confidence interval

level

95%

sides

2-sided

lower limit

1.007

upper limit

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

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

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End point title

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

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 date of first application 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	124	248	246
Units: percentage of participants
number (not applicable)
TEAE	31.5	29.0	23.6
Treatment Emergent SAE	0.0	1.2	0.4

No statistical analyses for this end point

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

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End point title

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

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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	53	52	204	221
Units: percentage of participants
number (not applicable)
TEAE	58.5	65.4	66.2	54.3
Treatment Emergent SAE	3.8	0.0	2.5	1.4

No statistical analyses for this end point

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

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End point title

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

End point description

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	118	231	228
Units: percentage of participants
number (not applicable)
Week 2	4.2	17.3	25.0
Week 4	5.9	35.5	43.4

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving an IGA of 0 or 1 During the VC Period

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End point title

Percentage of Participants Achieving an IGA of 0 or 1 During the VC Period

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	118	231	228
Units: percentage of participants
number (not applicable)
Week 2	9.3	24.2	34.6
Week 4	16.9	45.9	52.6
Week 8	16.1	51.1	62.3

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving an IGA of 0 or 1 During the LTS Period

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End point title

Percentage of Participants Achieving an IGA of 0 or 1 During the LTS Period

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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	50	49	187	203
Units: percentage of participants
number (not applicable)
Week 8	26.0	10.2	57.5	65.5
Week 12	59.6	45.8	59.6	73.0
Week 16	59.6	59.6	68.9	74.1
Week 20	69.0	58.7	71.1	74.5
Week 24	61.0	67.4	70.4	72.4
Week 28	67.6	67.4	74.1	72.0
Week 32	77.1	72.7	74.2	73.8
Week 36	81.3	69.8	73.3	79.3
Week 40	77.1	66.7	76.0	79.3
Week 44	74.3	70.5	75.2	80.1
Week 48	79.4	69.8	75.2	75.9
Week 52	79.4	74.4	76.7	80.1

No statistical analyses for this end point

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

Top of page

End point title

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), of the worst level of itch intensity using a ediary. 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	80	157	146
Units: percentage of participants
number (not applicable)
Week 2	5.0	27.4	32.2
Week 4	12.5	38.2	45.2

No statistical analyses for this end point

Secondary: Percentage of Participants Who Achieved EASI50 During the VC Period

Top of page

End point title

Percentage of Participants Who Achieved EASI50 During the VC Period

End point description

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) 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) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata 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

Baseline to 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	118	231	228
Units: percentage of participants
number (not applicable)
Week 2	16.1	45.5	53.5
Week 4	28.8	69.7	71.9
Week 8	33.9	75.8	79.8

No statistical analyses for this end point

Secondary: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4

Top of page

End point title

Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4

End point description

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	118	231	228
Units: percentage of participants
number (not applicable)
Week 2	4.2	25.5	31.6
Week 4	10.2	42.0	50.4

No statistical analyses for this end point

Secondary: Percentage of Participants Who Achieved EASI90 During the VC Period

Top of page

End point title

Percentage of Participants Who Achieved EASI90 During the VC Period

End point description

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) 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) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata 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

Baseline to 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	118	231	228
Units: percentage of participants
number (not applicable)
Week 2	0.8	10.8	15.8
Week 4	2.5	25.5	32.5
Week 8	4.2	35.1	43.4

No statistical analyses for this end point

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

Top of page

End point title

Percent Change From Baseline in EASI Score During the VC Period

End point description

EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) 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) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 and the severity strata 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	118	231	228
Units: percent change
least squares mean (standard error)
Percent Change From Baseline at Week 2	-13.95 ( 4.02 )	-45.86 ( 2.84 )	-49.08 ( 2.86 )
Percent Change From Baseline at Week 4	-20.45 ( 3.62 )	-65.00 ( 2.50 )	-66.35 ( 2.51 )
Percent Change From Baseline at Week 8	-28.84 ( 3.57 )	-73.37 ( 2.50 )	-74.84 ( 2.46 )

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-31.91

Confidence interval

level

95%

sides

2-sided

lower limit

-41.57

upper limit

-22.25

Variability estimate

Standard error of the mean

Dispersion value

4.92

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

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-35.13

Confidence interval

level

95%

sides

2-sided

lower limit

-44.81

upper limit

-25.44

Variability estimate

Standard error of the mean

Dispersion value

4.93

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-44.56

Confidence interval

level

95%

sides

2-sided

lower limit

-53.19

upper limit

-35.92

Variability estimate

Standard error of the mean

Dispersion value

4.4

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

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-45.91

Confidence interval

level

95%

sides

2-sided

lower limit

-54.55

upper limit

-37.26

Variability estimate

Standard error of the mean

Dispersion value

4.4

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-44.53

Confidence interval

level

95%

sides

2-sided

lower limit

-53.08

upper limit

-35.98

Variability estimate

Standard error of the mean

Dispersion value

4.35

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

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-46

Confidence interval

level

95%

sides

2-sided

lower limit

-54.51

upper limit

-37.48

Variability estimate

Standard error of the mean

Dispersion value

4.33

Secondary: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score During the VC Period

Top of page

End point title

Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score During the VC Period

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	118	231	228
Units: percent change
arithmetic mean (standard deviation)
Percent Change From Baseline at Week 2	-13.87 ( 24.816 )	-39.62 ( 28.061 )	-45.22 ( 28.461 )
Percent Change From Baseline at Week 4	-21.79 ( 30.083 )	-54.85 ( 29.803 )	-58.76 ( 29.580 )
Percent Change From Baseline at Week 8	-23.63 ( 33.918 )	-63.71 ( 28.494 )	-67.39 ( 29.098 )

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-39.4

Confidence interval

level

95%

sides

2-sided

lower limit

-46.48

upper limit

-32.38

Variability estimate

Standard error of the mean

Dispersion value

3.59

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

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-43.5

Confidence interval

level

95%

sides

2-sided

lower limit

-50.51

upper limit

-36.53

Variability estimate

Standard error of the mean

Dispersion value

3.56

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

Top of page

End point title

Change From Baseline in Itch NRS Score During the VC Period

End point description

The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. 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. 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	118	231	228
Units: units on a scale
least squares mean (standard error)
Change From Baseline at Week 2	-0.69 ( 0.21 )	-2.21 ( 0.15 )	-2.43 ( 0.15 )
Change From Baseline at Week 4	-1.03 ( 0.23 )	-2.82 ( 0.17 )	-3.00 ( 0.17 )
Change From Baseline at Week 8	-1.39 ( 0.25 )	-3.28 ( 0.18 )	-3.09 ( 0.17 )

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.52

Confidence interval

level

95%

sides

2-sided

lower limit

-2.02

upper limit

-1.01

Variability estimate

Standard error of the mean

Dispersion value

0.26

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

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.74

Confidence interval

level

95%

sides

2-sided

lower limit

-2.24

upper limit

-1.24

Variability estimate

Standard error of the mean

Dispersion value

0.26

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.79

Confidence interval

level

95%

sides

2-sided

lower limit

-2.36

upper limit

-1.23

Variability estimate

Standard error of the mean

Dispersion value

0.29

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

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.97

Confidence interval

level

95%

sides

2-sided

lower limit

-2.53

upper limit

-1.4

Variability estimate

Standard error of the mean

Dispersion value

0.29

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.89

Confidence interval

level

95%

sides

2-sided

lower limit

-2.49

upper limit

-1.29

Variability estimate

Standard error of the mean

Dispersion value

0.31

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

346

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

-2.3

upper limit

-1.1

Variability estimate

Standard error of the mean

Dispersion value

0.3

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

Top of page

End point title

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

End point description

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	118	231	228
Units: days
median (confidence interval 95%)
≥ 2-Point Improvement in Itch NRS Score	20.0 (13.0 to 24.0)	5.0 (4.0 to 6.0)	4.0 (4.0 to 5.0)
≥ 3-Point Improvement in Itch NRS Score	44.0 (25.0 to 99999)	8.0 (6.0 to 13.0)	8.0 (6.0 to 11.0)

No statistical analyses for this end point

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

Top of page

End point title

Change From Baseline in Skin Pain NRS Score During the VC Period

End point description

The Skin Pain NRS is a daily patient-reported measure (24-hour recall), of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain) using a diary. Participants were 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	118	231	228
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-0.53 ( 1.677 )	-1.78 ( 2.145 )	-1.73 ( 2.125 )
Change From Baseline at Week 4	-0.93 ( 1.964 )	-2.28 ( 2.449 )	-2.27 ( 2.262 )
Change From Baseline at Week 8	-1.35 ( 2.540 )	-2.45 ( 2.575 )	-2.37 ( 2.428 )

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-1.5

Confidence interval

level

95%

sides

2-sided

lower limit

-1.94

upper limit

-0.97

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 1.5% Cream BID

Number of subjects included in analysis

346

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

-1.72

upper limit

-0.76

Variability estimate

Standard error of the mean

Dispersion value

0.25

Secondary: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep Disturbance (8b) 24-Hour Recall Score at Weeks 2, 4 and 8

Top of page

End point title

Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep Disturbance (8b) 24-Hour Recall Score 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	110	213	211
Units: percentage of participants
number (not applicable)
Week 2	10.0	14.6	18.0
Week 4	12.7	16.9	18.0
Week 8	19.1	20.7	25.6

No statistical analyses for this end point

Secondary: Proportion of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep-Related Impairment (8a) 24-Hour Recall Score at Weeks 2, 4 and 8

Top of page

End point title

Proportion of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep-Related Impairment (8a) 24-Hour Recall Score 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	111	215	212
Units: percentage of participants
number (not applicable)
Week 2	7.2	10.7	13.2
Week 4	9.0	13.0	19.8
Week 8	13.5	20.0	23.1

No statistical analyses for this end point

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

Top of page

End point title

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

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	118	231	228
Units: units on a scale
least squares mean (standard error)
Change From Baseline at Week 2	-1.32 ( 0.46 )	-1.92 ( 0.33 )	-2.30 ( 0.33 )
Change From Baseline at Week 4	-2.02 ( 0.50 )	-2.32 ( 0.35 )	-2.88 ( 0.35 )
Change From Baseline at Week 8	-2.60 ( 0.60 )	-3.30 ( 0.42 )	-3.40 ( 0.41 )

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

349

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2903

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-1.71

upper limit

0.51

Variability estimate

Standard error of the mean

Dispersion value

0.57

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

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0837

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.98

Confidence interval

level

95%

sides

2-sided

lower limit

-2.09

upper limit

0.13

Variability estimate

Standard error of the mean

Dispersion value

0.57

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

349

Analysis specification

Pre-specified

Analysis type

P-value

= 0.6272

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

0.91

Variability estimate

Standard error of the mean

Dispersion value

0.61

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

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1609

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.86

Confidence interval

level

95%

sides

2-sided

lower limit

-2.07

upper limit

0.34

Variability estimate

Standard error of the mean

Dispersion value

0.61

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

349

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3362

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.13

upper limit

0.73

Variability estimate

Standard error of the mean

Dispersion value

0.73

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

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.269

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-2.23

upper limit

0.62

Variability estimate

Standard error of the mean

Dispersion value

0.73

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

Top of page

End point title

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

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	118	231	228
Units: units on a scale
least squares mean (standard error)
Change From Baseline at Week 2	-0.80 ( 0.44 )	-1.87 ( 0.31 )	-2.00 ( 0.31 )
Change From Baseline at Week 4	-1.37 ( 0.49 )	-2.13 ( 0.35 )	-2.91 ( 0.35 )
Change From Baseline at Week 8	-2.08 ( 0.55 )	-3.26 ( 0.39 )	-3.31 ( 0.38 )

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

349

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0482

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.07

Confidence interval

level

95%

sides

2-sided

lower limit

-2.13

upper limit

-0.01

Variability estimate

Standard error of the mean

Dispersion value

0.54

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

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0271

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-2.26

upper limit

-0.14

Variability estimate

Standard error of the mean

Dispersion value

0.54

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

349

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2091

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-0.76

Confidence interval

level

95%

sides

2-sided

lower limit

-1.94

upper limit

0.42

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 4

Comparison groups

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

Number of subjects included in analysis

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0111

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

-2.71

upper limit

-0.35

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 8

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

= 0.0802

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

-2.51

upper limit

0.14

Variability estimate

Standard error of the mean

Dispersion value

0.68

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

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0666

Method

Mixed-Model with Repeated Measures

Parameter type

Least Squares Mean Difference

Point estimate

-1.24

Confidence interval

level

95%

sides

2-sided

lower limit

-2.56

upper limit

0.09

Variability estimate

Standard error of the mean

Dispersion value

0.67

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

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End point title

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

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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	45	46	171	180
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-1.73 ( 4.019 )	-2.04 ( 6.282 )	-0.32 ( 4.724 )	-0.04 ( 3.914 )
Change From Baseline at Week 24	-0.47 ( 4.695 )	-1.04 ( 5.969 )	-0.11 ( 5.136 )	0.22 ( 4.868 )
Change From Baseline at Week 52	-1.48 ( 5.304 )	-2.33 ( 6.582 )	-0.24 ( 5.660 )	-0.69 ( 5.483 )

No statistical analyses for this end point

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

Top of page

End point title

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

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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	45	46	171	180
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-2.00 ( 4.973 )	-1.80 ( 5.588 )	-0.37 ( 4.621 )	-0.32 ( 4.466 )
Change From Baseline at Week 24	-0.97 ( 6.188 )	-1.87 ( 5.691 )	-0.03 ( 4.688 )	0.06 ( 5.376 )
Change From Baseline at Week 52	-1.39 ( 7.198 )	-2.88 ( 7.235 )	-0.36 ( 6.049 )	-0.42 ( 5.950 )

No statistical analyses for this end point

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

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End point title

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

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. Use 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	118	231	228
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-0.48 ( 3.008 )	-2.92 ( 3.944 )	-3.99 ( 4.636 )
Change From Baseline at Week 4	-1.62 ( 3.338 )	-4.77 ( 4.711 )	-5.45 ( 5.223 )
Change From Baseline at Week 8	-2.13 ( 4.671 )	-6.00 ( 4.845 )	-6.61 ( 5.479 )

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3.9

Confidence interval

level

95%

sides

2-sided

lower limit

-4.84

upper limit

-2.97

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 1.5% Cream BID

Number of subjects included in analysis

346

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

-5.47

upper limit

-3.63

Variability estimate

Standard error of the mean

Dispersion value

0.47

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

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End point title

Change From Baseline in Atopic Dermatitis Afflicted %BSA During the LTS Period

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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	50	49	187	203
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-3.89 ( 5.530 )	-4.71 ( 4.980 )	-6.61 ( 4.395 )	-7.69 ( 5.106 )
Change From Baseline at Week 16	-4.41 ( 5.553 )	-5.47 ( 5.289 )	-6.77 ( 5.270 )	-7.80 ( 5.096 )
Change From Baseline at Week 20	-4.88 ( 5.210 )	-6.27 ( 6.193 )	-7.48 ( 4.900 )	-8.05 ( 4.920 )
Change From Baseline at Week 24	-4.70 ( 4.775 )	-6.37 ( 5.817 )	-7.49 ( 4.988 )	-8.00 ( 5.071 )
Change From Baseline at Week 28	-4.59 ( 4.677 )	-6.21 ( 6.597 )	-7.48 ( 4.827 )	-8.07 ( 5.099 )
Change From Baseline at Week 32	-5.10 ( 5.203 )	-6.79 ( 5.960 )	-7.69 ( 4.891 )	-7.89 ( 5.004 )
Change From Baseline at Week 36	-4.65 ( 5.266 )	-6.16 ( 6.045 )	-7.79 ( 4.856 )	-8.38 ( 5.119 )
Change From Baseline at Week 40	-4.59 ( 5.196 )	-6.42 ( 5.887 )	-7.83 ( 4.976 )	-8.44 ( 5.090 )
Change From Baseline at Week 44	-5.18 ( 4.901 )	-6.56 ( 6.200 )	-7.92 ( 5.082 )	-8.43 ( 5.122 )
Change From Baseline at Week 48	-5.30 ( 5.130 )	-6.61 ( 5.897 )	-7.64 ( 5.380 )	-8.33 ( 5.204 )
Change From Baseline at Week 52	-5.12 ( 5.114 )	-6.83 ( 5.837 )	-7.92 ( 4.823 )	-8.42 ( 4.973 )

No statistical analyses for this end point

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

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End point title

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

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	118	231	228
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-2.06 ( 5.371 )	-8.21 ( 6.694 )	-8.86 ( 6.807 )
Change From Baseline at Week 4	-4.01 ( 6.125 )	-9.59 ( 6.883 )	-9.97 ( 6.839 )
Change From Baseline at Week 8	-4.18 ( 6.574 )	-10.34 ( 6.835 )	-10.08 ( 7.167 )

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-6.1

Confidence interval

level

95%

sides

2-sided

lower limit

-7.38

upper limit

-4.86

Variability estimate

Standard error of the mean

Dispersion value

0.64

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

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-5.9

Confidence interval

level

95%

sides

2-sided

lower limit

-7.17

upper limit

-4.67

Variability estimate

Standard error of the mean

Dispersion value

0.64

Secondary: Change From Baseline in POEM Score During the LTS Period

Top of page

End point title

Change From Baseline in POEM Score During the LTS Period

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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	50	49	187	203
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-5.65 ( 7.460 )	-6.04 ( 7.269 )	-9.72 ( 6.571 )	-10.58 ( 6.883 )
Change From Baseline at Week 24	-4.03 ( 7.006 )	-5.71 ( 6.567 )	-10.30 ( 6.675 )	-10.58 ( 6.848 )
Change From Baseline at Week 52	-6.15 ( 7.304 )	-6.28 ( 7.340 )	-10.29 ( 6.187 )	-10.65 ( 6.699 )

No statistical analyses for this end point

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

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End point title

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

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	105	194	202
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-0.91 ( 4.679 )	-5.40 ( 5.874 )	-5.14 ( 5.394 )
Change From Baseline at Week 4	-3.00 ( 4.962 )	-6.62 ( 5.966 )	-6.16 ( 5.771 )
Change From Baseline at Week 8	-3.30 ( 5.353 )	-7.18 ( 6.004 )	-6.41 ( 5.731 )

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

299

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3.3

Confidence interval

level

95%

sides

2-sided

lower limit

-4.19

upper limit

-2.32

Variability estimate

Standard error of the mean

Dispersion value

0.48

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

307

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-3.67

upper limit

-1.83

Variability estimate

Standard error of the mean

Dispersion value

0.47

Secondary: Change From Baseline in DLQI Score During the LTS Period

Top of page

End point title

Change From Baseline in DLQI Score During the LTS Period

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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	47	41	157	180
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-2.09 ( 3.611 )	-2.79 ( 5.542 )	-7.07 ( 5.931 )	-7.06 ( 6.044 )
Change From Baseline at Week 24	-1.22 ( 3.293 )	-3.08 ( 3.759 )	-7.17 ( 6.152 )	-7.01 ( 5.754 )
Change From Baseline at Week 52	-3.09 ( 3.753 )	-3.20 ( 4.234 )	-7.49 ( 5.776 )	-7.28 ( 6.196 )

No statistical analyses for this end point

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

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End point title

Change from Baseline in Children Dermatology Life Quality Index (CDLQI) Score During the VC Period

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	13	37	26
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	-1.67 ( 5.416 )	-3.45 ( 4.570 )	-3.58 ( 4.032 )
Change From Baseline at Week 4	-3.10 ( 6.488 )	-4.82 ( 4.934 )	-4.52 ( 5.221 )
Change From Baseline at Week 8	-2.36 ( 7.500 )	-4.56 ( 5.061 )	-4.12 ( 6.418 )

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

= 0.0099

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-4.1

Confidence interval

level

95%

sides

2-sided

lower limit

-7.24

upper limit

-1.03

Variability estimate

Standard error of the mean

Dispersion value

1.55

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

= 0.0542

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3.1

Confidence interval

level

95%

sides

2-sided

lower limit

-6.3

upper limit

0.06

Variability estimate

Standard error of the mean

Dispersion value

1.59

Secondary: Change from Baseline in CDLQI Score During the LTS Period

Top of page

End point title

Change from Baseline in CDLQI Score During the LTS Period

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 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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	3	8	30	23
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 12	-7.50 ( 2.121 )	-4.88 ( 5.436 )	-5.54 ( 5.153 )	-5.57 ( 5.482 )
Change From Baseline at Week 24	-8.50 ( 2.121 )	-4.88 ( 4.549 )	-5.72 ( 6.066 )	-5.68 ( 7.326 )
Change From Baseline at Week 52	-8.00 ( 1.414 )	-6.38 ( 9.023 )	-5.35 ( 4.902 )	-6.57 ( 5.983 )

No statistical analyses for this end point

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

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End point title

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	118	231	228
Units: score on a scale
arithmetic mean (standard deviation)
Week 2	3.32 ( 1.268 )	2.19 ( 1.019 )	1.95 ( 0.980 )
Week 4	2.99 ( 1.259 )	1.95 ( 0.980 )	1.71 ( 0.852 )
Week 8	2.93 ( 1.380 )	1.73 ( 0.906 )	1.70 ( 0.909 )

No statistical analyses for this end point

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

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End point title

Proportion 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	118	231	228
Units: percentage of participants
number (not applicable)
Week 2 - Very Much Improved: 1	4.6	32.1	41.0
Week 2 - Much Improved: 2	20.2	27.1	30.9
Week 2 - Minimally Improved: 3	38.5	32.1	20.7
Week 2 - No Change: 4	21.1	7.8	6.5
Week 2 - Minimally Worse: 5	7.3	0.5	0.9
Week 2 - Much Worse: 6	7.3	0.5	0.0
Week 2 - Very Much Worse: 7	0.9	0.0	0.0
Week 4 - Very Much Improved: 1	10.0	41.9	49.1
Week 4 - Much Improved: 2	29.0	28.6	35.2
Week 4 - Minimally Improved: 3	29.0	22.1	12.0
Week 4 - No Change: 4	20.0	6.9	2.8
Week 4 - Minimally Worse: 5	8.0	0.5	0.9
Week 4 - Much Worse: 6	4.0	0.0	0.0
Week 4 - Very Much Worse: 7	0.0	0.0	0.0
Week 8 - Very Much Improved: 1	16.8	52.7	51.6
Week 8 - Much Improved: 2	24.8	26.1	32.6
Week 8 - Minimally Improved: 3	23.8	16.3	12.1
Week 8 - No Change: 4	22.8	4.9	1.9
Week 8 - Minimally Worse: 5	7.9	0.0	1.4
Week 8 - Much Worse: 6	3.0	0.0	0.5
Week 8 - Very Much Worse: 7	1.0	0.0	0.0

No statistical analyses for this end point

Secondary: Proportion 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

Proportion 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	118	231	228
Units: percentage of participants
number (confidence interval 95%)
Week 2	24.8 (17.0 to 34.0)	59.2 (52.3 to 65.8)	71.9 (65.4 to 77.8)
Week 4	39.0 (29.4 to 49.3)	70.5 (64.0 to 76.5)	84.3 (78.7 to 88.8)
Week 8	41.6 (31.9 to 51.8)	78.8 (72.5 to 84.2)	84.2 (78.6 to 88.8)

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

5.16

Confidence interval

level

95%

sides

2-sided

lower limit

2.987

upper limit

9.049

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

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Conditional Exact Test

Parameter type

Odds ratio (OR)

Point estimate

7.47

Confidence interval

level

95%

sides

2-sided

lower limit

4.23

upper limit

13.415

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

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End point title

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

End point description

EQ-5D-5L questionnaire has: 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 state. 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	118	231	228
Units: units on a scale
arithmetic mean (standard deviation)
Change From Baseline at Week 2	1.43 ( 13.975 )	6.16 ( 14.409 )	6.98 ( 15.956 )
Change From Baseline at Week 4	3.31 ( 15.061 )	6.38 ( 17.512 )	8.55 ( 17.244 )
Change From Baseline at Week 8	2.97 ( 15.946 )	7.16 ( 18.245 )	8.36 ( 16.767 )

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

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0044

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

5.1

Confidence interval

level

95%

sides

2-sided

lower limit

1.59

upper limit

8.54

Variability estimate

Standard error of the mean

Dispersion value

1.77

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

349

Analysis specification

Pre-specified

Analysis type

P-value

= 0.015

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

4.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

7.86

Variability estimate

Standard error of the mean

Dispersion value

1.78

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

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End point title

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

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	118	231	228
Units: units on a scale
arithmetic mean (standard deviation)
% Work Missed : Change From Baseline at Week 2	4.77 ( 23.348 )	0.64 ( 19.190 )	2.53 ( 17.803 )
% Work Missed :Change From Baseline at Week 4	3.22 ( 22.497 )	-0.15 ( 22.299 )	4.31 ( 19.679 )
% Work Missed :: Change From Baseline at Week 8	10.03 ( 24.477 )	3.50 ( 24.760 )	3.51 ( 18.479 )
% Impairment While Working : Baseline at Week 2	-4.49 ( 25.500 )	-12.76 ( 21.371 )	-13.24 ( 19.958 )
% Impairment While Working: Baseline at Week 4	-12.05 ( 24.514 )	-15.25 ( 22.648 )	-18.10 ( 19.832 )
% Impairment While Working: Baseline at Week 8	-10.93 ( 25.618 )	-18.83 ( 23.365 )	-17.32 ( 19.013 )
% Overall Work Impairment: Baseline at Week 2	-2.78 ( 31.057 )	-12.58 ( 24.670 )	-11.10 ( 23.717 )
% Overall Work Impairment: Baseline at Week 4	-10.41 ( 26.627 )	-15.14 ( 25.543 )	-16.19 ( 22.037 )
% Overall Work Impairment:: Baseline at Week 8	-2.06 ( 29.625 )	-17.00 ( 25.916 )	-13.65 ( 22.476 )
% Activity Impairment : Baseline at Week 2	-4.63 ( 21.243 )	-12.79 ( 23.462 )	-16.68 ( 23.295 )
% Activity Impairment : Baseline at Week 4	-8.38 ( 20.981 )	-17.24 ( 24.715 )	-18.70 ( 23.550 )
% Activity Impairment : Baseline at Week 8	-9.50 ( 25.361 )	-19.66 ( 25.157 )	-18.60 ( 25.557 )

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

349

Analysis specification

Pre-specified

Analysis type

P-value

= 0.142

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-5.6

Confidence interval

level

95%

sides

2-sided

lower limit

-13.12

upper limit

1.89

Variability estimate

Standard error of the mean

Dispersion value

3.81

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

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0375

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-8

Confidence interval

level

95%

sides

2-sided

lower limit

-15.51

upper limit

-0.47

Variability estimate

Standard error of the mean

Dispersion value

3.82

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

349

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0012

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-9.1

Confidence interval

level

95%

sides

2-sided

lower limit

-14.48

upper limit

-3.63

Variability estimate

Standard error of the mean

Dispersion value

2.75

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

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0095

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-7.2

Confidence interval

level

95%

sides

2-sided

lower limit

-12.58

upper limit

-1.77

Variability estimate

Standard error of the mean

Dispersion value

2.74

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-15.2

Confidence interval

level

95%

sides

2-sided

lower limit

-22.69

upper limit

-7.73

Variability estimate

Standard error of the mean

Dispersion value

3.8

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

346

Analysis specification

Pre-specified

Analysis type

P-value

= 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-12.6

Confidence interval

level

95%

sides

2-sided

lower limit

-20.1

upper limit

-5.18

Variability estimate

Standard error of the mean

Dispersion value

3.79

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

349

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-12.1

Confidence interval

level

95%

sides

2-sided

lower limit

-16.18

upper limit

-7.95

Variability estimate

Standard error of the mean

Dispersion value

2.09

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

346

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-10.4

Confidence interval

level

95%

sides

2-sided

lower limit

-14.53

upper limit

-6.37

Variability estimate

Standard error of the mean

Dispersion value

2.08

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

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End point title

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

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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	50	49	187	203
Units: units on a scale
arithmetic mean (standard deviation)
%Work Time Missed Baseline to Week 12	-4.26 ( 24.958 )	-0.81 ( 17.257 )	-0.17 ( 24.581 )	3.48 ( 16.470 )
%Work Time Missed Baseline to Week 24	-2.06 ( 28.778 )	-11.35 ( 22.947 )	-0.38 ( 23.511 )	5.13 ( 24.419 )
%Work Time Missed Baseline to Week 36	-1.04 ( 23.312 )	-5.44 ( 27.625 )	-0.02 ( 20.410 )	3.37 ( 20.967 )
%Work Time Missed Baseline to Week 52	-2.29 ( 25.148 )	3.60 ( 24.186 )	0.50 ( 28.348 )	6.36 ( 21.806 )
% Impairment While Working Baseline to Week 12	-5.91 ( 10.075 )	-13.50 ( 29.784 )	-19.87 ( 21.572 )	-22.02 ( 19.652 )
% Impairment While Working Baseline to Week 24	-7.14 ( 22.835 )	-16.47 ( 18.007 )	-19.74 ( 23.719 )	-22.56 ( 22.433 )
% Impairment While Working Baseline to Week 36	-7.33 ( 15.337 )	-11.43 ( 21.432 )	-18.79 ( 21.232 )	-24.61 ( 20.359 )
% Impairment While Working Baseline to Week 52	-16.00 ( 24.129 )	-13.85 ( 17.578 )	-20.00 ( 25.312 )	-21.86 ( 25.836 )
% Overall Work Impairment : Baseline tp Week 12	-11.64 ( 20.194 )	-10.72 ( 23.285 )	-17.40 ( 23.123 )	-17.91 ( 24.692 )
% Overall Work Impairment : Baseline tp Week 24	-10.99 ( 33.070 )	-25.22 ( 25.009 )	-17.83 ( 27.226 )	-19.31 ( 26.893 )
% Overall Work Impairment : Baseline tp Week 36	-7.77 ( 25.443 )	-15.27 ( 30.360 )	-17.70 ( 23.161 )	-21.84 ( 27.812 )
% Overall Work Impairment : Baseline tp Week 52	-17.29 ( 33.754 )	-10.17 ( 27.793 )	-18.62 ( 28.397 )	-16.20 ( 32.59 )
% Overall Work Impairment : Baseline to Week 12	-7.78 ( 24.016 )	-11.74 ( 22.736 )	-21.17 ( 25.287 )	-21.92 ( 26.378 )
% Overall Work Impairment : Baseline to Week 24	-7.18 ( 26.552 )	-13.78 ( 19.690 )	-22.42 ( 25.547 )	-22.32 ( 26.481 )
% Overall Work Impairment : Baseline to Week 36	-10.65 ( 23.655 )	-15.24 ( 20.150 )	-23.43 ( 25.748 )	-25.34 ( 26.927 )
% Overall Work Impairment : Baseline to Week 52	-10.88 ( 28.001 )	-14.88 ( 20.044 )	-22.95 ( 24.656 )	-23.93 ( 27.743 )

No statistical analyses for this end point

Secondary: Trough Plasma Concentrations of Ruxolitinib During the VC Period

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End point title

Trough Plasma Concentrations of Ruxolitinib During the VC Period ^[11]

End point description

End point type

Secondary

End point timeframe

Weeks 2, 4 and 8

Notes
[11] - 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: No C trough values calculated for the Vehicle group

End point values	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	236	238
Units: nanomole per litre (nM)
arithmetic mean (standard deviation)
Week 2	25.2 ( 37.4 )	38.5 ( 64.5 )
Week 4	22.6 ( 35.2 )	41.8 ( 83.6 )
Week 8	22.4 ( 36.1 )	36.1 ( 66.6 )

No statistical analyses for this end point

Secondary: Trough Plasma Concentrations of Ruxolitinib During the LTS Period

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End point title

Trough Plasma Concentrations of Ruxolitinib During the LTS Period

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 BID	LTS Period: Ruxolitinib 1.5% Cream BID
Number of subjects analysed	50	51	198	215
Units: nM
arithmetic mean (standard deviation)
Week 12	13.8 ( 22.7 )	23.9 ( 55.2 )	14.3 ( 26.9 )	22.6 ( 46.6 )
Week 16	12.3 ( 22.8 )	16.1 ( 27.7 )	15.1 ( 28.3 )	23.9 ( 45.9 )
Week 20	18.8 ( 41.0 )	25.3 ( 43.9 )	13.6 ( 20.5 )	26.8 ( 55.9 )
Week 24	11.7 ( 26.0 )	27.6 ( 62.4 )	18.5 ( 49.8 )	25.7 ( 56.9 )
Week 28	20.4 ( 39.9 )	17.6 ( 32.2 )	16.1 ( 36.1 )	20.8 ( 39.8 )
Week 32	14.6 ( 30.6 )	26.4 ( 51.3 )	14.0 ( 23.2 )	25.9 ( 67.8 )
Week 36	11.4 ( 23.7 )	29.9 ( 52.8 )	15.0 ( 28.4 )	22.0 ( 40.1 )
Week 40	12.6 ( 36.7 )	32.8 ( 59.4 )	20.0 ( 51.1 )	26.3 ( 59.4 )
Week 44	15.9 ( 31.9 )	23.0 ( 33.7 )	14.8 ( 28.8 )	24.1 ( 40.9 )
Week 48	16.8 ( 38.6 )	35.7 ( 64.5 )	23.4 ( 58.1 )	26.3 ( 54.3 )
Week 52	12.9 ( 21.8 )	35.7 ( 65.2 )	17.7 ( 33.9 )	23.3 ( 48.1 )

No statistical analyses for this end point

Adverse events

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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

VC and LTS Period: Vehicle Cream BID‌ 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 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.

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.

Serious adverse events	VC and LTS Period: Vehicle Cream BID‌	VC and LTS Period: Ruxolitinib 1.5% Cream BID‌	VC and LTS Period: Ruxolitinib 0.75% Cream BID‌
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 124 (0.00%)	4 / 298 (1.34%)	8 / 301 (2.66%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	0 / 124 (0.00%)	0 / 298 (0.00%)	1 / 301 (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
Meniscus injury
subjects affected / exposed	0 / 124 (0.00%)	0 / 298 (0.00%)	1 / 301 (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
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 124 (0.00%)	1 / 298 (0.34%)	0 / 301 (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
Cardiac disorders
Arrhythmia
subjects affected / exposed	0 / 124 (0.00%)	1 / 298 (0.34%)	0 / 301 (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
Myocardial infarction
subjects affected / exposed	0 / 124 (0.00%)	0 / 298 (0.00%)	1 / 301 (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
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 124 (0.00%)	1 / 298 (0.34%)	1 / 301 (0.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Ovarian cyst ruptured
subjects affected / exposed	0 / 124 (0.00%)	0 / 298 (0.00%)	1 / 301 (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
Small intestinal obstruction
subjects affected / exposed	0 / 124 (0.00%)	0 / 298 (0.00%)	1 / 301 (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
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 124 (0.00%)	1 / 298 (0.34%)	0 / 301 (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
Pulmonary embolism
subjects affected / exposed	0 / 124 (0.00%)	1 / 298 (0.34%)	0 / 301 (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
Chronic tonsillitis
subjects affected / exposed	0 / 124 (0.00%)	1 / 298 (0.34%)	0 / 301 (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
Pneumonia
subjects affected / exposed	0 / 124 (0.00%)	0 / 298 (0.00%)	1 / 301 (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
Pyelonephritis
subjects affected / exposed	0 / 124 (0.00%)	0 / 298 (0.00%)	1 / 301 (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
Sepsis
subjects affected / exposed	0 / 124 (0.00%)	0 / 298 (0.00%)	1 / 301 (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
Tooth infection
subjects affected / exposed	0 / 124 (0.00%)	0 / 298 (0.00%)	1 / 301 (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

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 1.5% Cream BID‌	VC and LTS Period: Ruxolitinib 0.75% Cream BID‌
Total subjects affected by non serious adverse events
subjects affected / exposed	9 / 124 (7.26%)	51 / 298 (17.11%)	49 / 301 (16.28%)
General disorders and administration site conditions
Application site pain
subjects affected / exposed	8 / 124 (6.45%)	2 / 298 (0.67%)	2 / 301 (0.66%)
occurrences all number	8	3	2
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	1 / 124 (0.81%)	23 / 298 (7.72%)	23 / 301 (7.64%)
occurrences all number	1	28	26
Nasopharyngitis
subjects affected / exposed	0 / 124 (0.00%)	27 / 298 (9.06%)	28 / 301 (9.30%)
occurrences all number	0	39	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: Proportion of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8

Secondary: Proportion of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8

Secondary: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8

Secondary: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8

Secondary: Proportion 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 at Week 8

Secondary: Proportion 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 at Week 8

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

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

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

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

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

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

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

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

Secondary: Percentage of Participants Achieving an IGA of 0 or 1 During the VC Period

Secondary: Percentage of Participants Achieving an IGA of 0 or 1 During the VC Period

Secondary: Percentage of Participants Achieving an IGA of 0 or 1 During the LTS Period

Secondary: Percentage of Participants Achieving an IGA of 0 or 1 During the LTS Period

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

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

Secondary: Percentage of Participants Who Achieved EASI50 During the VC Period

Secondary: Percentage of Participants Who Achieved EASI50 During the VC Period

Secondary: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4

Secondary: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4

Secondary: Percentage of Participants Who Achieved EASI90 During the VC Period

Secondary: Percentage of Participants Who Achieved EASI90 During the VC Period

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

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

Secondary: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score During the VC Period

Secondary: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score During the VC Period

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

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

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

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

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

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

Secondary: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep Disturbance (8b) 24-Hour Recall Score at Weeks 2, 4 and 8

Secondary: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep Disturbance (8b) 24-Hour Recall Score at Weeks 2, 4 and 8

Secondary: Proportion of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep-Related Impairment (8a) 24-Hour Recall Score at Weeks 2, 4 and 8

Secondary: Proportion of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form – Sleep-Related Impairment (8a) 24-Hour Recall Score at Weeks 2, 4 and 8

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary: Change From Baseline in POEM Score During the LTS Period

Secondary: Change From Baseline in POEM Score During the LTS Period

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

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

Secondary: Change From Baseline in DLQI Score During the LTS Period

Secondary: Change From Baseline in DLQI Score During the LTS Period

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

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

Secondary: Change from Baseline in CDLQI Score During the LTS Period

Secondary: Change from Baseline in CDLQI Score During the LTS Period

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

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

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

Secondary: Proportion 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