Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis (NCT NCT03011892)
NCT ID: NCT03011892
Last Updated: 2021-04-09
Results Overview
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
307 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2021-04-09
Participant Flow
A total of 307 participants were randomized and 306 were treated at 50 study centers in the United States and Canada from 9 January 2017 to 12 March 2018.
307 participants randomized to 6 treatment groups (ruxolitinib cream 1.5% BID, or QD, 0.5% or 0.15% QD, vehicle BID, \& TAC 0.1% BID). Participants applied blinded study drug for 8 weeks, TAC 0.1% BID for 4 weeks followed by vehicle BID for 4 weeks in DB period. After DB period, participants who met criteria (compliant with the protocol and no safety concerns) offered OL treatment with ruxolitinib 1.5% BID for 4 weeks. Out of 261 participants who completed DB Period, 252 entered the OL Period.
Participant milestones
| Measure |
Double Blind (DB): Vehicle BID
Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.
|
DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID
Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
|
DB: Ruxolitinib 0.15% Once Daily (QD)
Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: TAC BID/ Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% Cream BID for 8 Weeks in DB Period.
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double Blind (DB) Period
STARTED
|
52
|
51
|
51
|
51
|
52
|
50
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
Treated in DB Period
|
52
|
51
|
51
|
51
|
51
|
50
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
NOT COMPLETED
|
11
|
10
|
6
|
7
|
7
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open Label (OL) Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
41
|
40
|
45
|
41
|
42
|
43
|
|
Open Label (OL) Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
37
|
43
|
41
|
40
|
40
|
|
Double Blind (DB) Period
Completed Treatment Through Week 4
|
44
|
46
|
48
|
47
|
49
|
49
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
COMPLETED
|
41
|
41
|
45
|
44
|
45
|
45
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open Label (OL) Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
3
|
2
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Double Blind (DB): Vehicle BID
Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.
|
DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID
Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
|
DB: Ruxolitinib 0.15% Once Daily (QD)
Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: TAC BID/ Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% Cream BID for 8 Weeks in DB Period.
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Double Blind (DB) Period
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
Lost to Follow-up
|
0
|
3
|
2
|
5
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
Other
|
1
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
Physician Decision
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
Withdrawal by Subject
|
7
|
5
|
1
|
2
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period
Randomized but not treated
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open Label (OL) Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
1
|
0
|
1
|
1
|
|
Open Label (OL) Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
0
|
1
|
2
|
|
Open Label (OL) Period
Reason not specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Double Blind (DB): Vehicle BID
n=52 Participants
Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.
|
DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID
n=51 Participants
Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
|
DB: Ruxolitinib 0.15% Once Daily (QD)
n=51 Participants
Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
|
DB : Ruxolitinib 0.5% QD
n=51 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB : Ruxolitinib 1.5% QD
n=52 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB : Ruxolitinib 1.5% Cream Twice Daily (BID)
n=50 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 15.04 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 16.19 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 13.83 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 13.73 • n=4 Participants
|
39.1 years
STANDARD_DEVIATION 14.54 • n=21 Participants
|
39.0 years
STANDARD_DEVIATION 15.72 • n=8 Participants
|
38.1 years
STANDARD_DEVIATION 14.82 • n=8 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
168 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
139 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
285 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
172 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
85 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID or ruxolitinib 1.5% BID, with available data were included in the analysis.
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Outcome measures
| Measure |
DB: Vehicle BID
n=44 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=49 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID
|
-11.90 percent change
Standard Error 6.65
|
-71.57 percent change
Standard Error 6.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Participants from Intent to treat (ITT) population, all participants who are randomized to vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD in the DB Period, with available data were included in the analysis
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Outcome measures
| Measure |
DB: Vehicle BID
n=44 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=47 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
n=47 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
n=49 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID
|
-11.90 percent change
Standard Error 6.65
|
-44.92 percent change
Standard Error 6.47
|
-52.80 percent change
Standard Error 6.52
|
-66.72 percent change
Standard Error 6.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Participants from ITT population, all participants who are randomized to TAC 0.1% BID followed by vehicle BID and ruxolitinib 0.15% or 0.5% or 1.5% QD/BID in the DB Period, with available data were included in the analysis.
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Outcome measures
| Measure |
DB: Vehicle BID
n=46 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=47 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
n=47 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
n=49 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=49 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle
|
-59.54 percent change
Standard Error 6.53
|
-44.92 percent change
Standard Error 6.47
|
-52.80 percent change
Standard Error 6.52
|
-66.72 percent change
Standard Error 6.36
|
-71.57 percent change
Standard Error 6.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and 8Population: ITT Population included all participants who are randomized to Vehicle BID, TAC 0.1% BID/Vehicle Cream BID, Ruxolitinib 0.15%, 0.5%, 1.5%, 1.5% QD/BID in the DB Period. The overall number of participants analyzed are participants with data available for analysis for this Outcome Measure and "n" signifies number of participants with data available at specific timepoint.
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Outcome measures
| Measure |
DB: Vehicle BID
n=52 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=51 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
n=51 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
n=51 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=52 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=50 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
Week 2
|
-4.84 percent change
Standard Error 5.34
|
-39.94 percent change
Standard Error 5.29
|
-29.96 percent change
Standard Error 5.23
|
-45.88 percent change
Standard Error 5.41
|
-49.88 percent change
Standard Error 5.18
|
-52.68 percent change
Standard Error 5.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
Week 8
|
-21.86 percent change
Standard Error 7.09
|
-58.02 percent change
Standard Error 6.94
|
-50.24 percent change
Standard Error 6.82
|
-58.37 percent change
Standard Error 6.93
|
-67.05 percent change
Standard Error 6.72
|
-79.01 percent change
Standard Error 6.83
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2, 4 and 8Population: ITT Population included all participants who are randomized to the study.
The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).
Outcome measures
| Measure |
DB: Vehicle BID
n=52 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=51 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
n=51 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
n=51 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=52 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=50 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
Week 2
|
13.5 percentage of participants
|
43.1 percentage of participants
|
31.4 percentage of participants
|
57.1 percentage of participants
|
50.0 percentage of participants
|
52.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
Week 4
|
23.1 percentage of participants
|
66.7 percentage of participants
|
52.9 percentage of participants
|
58.8 percentage of participants
|
73.1 percentage of participants
|
78.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
Week 8
|
26.9 percentage of participants
|
60.8 percentage of participants
|
54.9 percentage of participants
|
62.7 percentage of participants
|
69.2 percentage of participants
|
76.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at Week 4.
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Outcome measures
| Measure |
DB: Vehicle BID
n=44 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=46 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
n=47 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
n=47 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=49 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=49 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in EASI Score at Week 4
|
-15.5 percent change
Standard Deviation 65.71
|
-59.8 percent change
Standard Deviation 35.71
|
-45.4 percent change
Standard Deviation 53.96
|
-52.2 percent change
Standard Deviation 48.32
|
-67.0 percent change
Standard Deviation 26.28
|
-71.6 percent change
Standard Deviation 25.27
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: ITT population included all participants who are randomized to the study.
Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.
Outcome measures
| Measure |
DB: Vehicle BID
n=52 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=51 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
n=51 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
n=51 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=52 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=50 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Achieve EASI-50
|
4 week
Interval 0.0 to 8.0
|
2 week
Interval 0.0 to 8.0
|
4 week
Interval 0.0 to 8.0
|
2 week
Interval 0.0 to 8.0
|
2 week
Interval 0.0 to 8.0
|
2 week
Interval 0.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2, 4 and 8Population: ITT Population included all participants who are randomized to the study.
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Outcome measures
| Measure |
DB: Vehicle BID
n=52 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=51 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
n=51 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
n=51 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=52 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=50 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8
Week 2
|
1.9 percentage of participants
|
11.8 percentage of participants
|
5.9 percentage of participants
|
4.1 percentage of participants
|
13.5 percentage of participants
|
8.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8
Week 4
|
7.7 percentage of participants
|
25.5 percentage of participants
|
9.8 percentage of participants
|
13.7 percentage of participants
|
21.2 percentage of participants
|
38.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8
Week 8
|
9.6 percentage of participants
|
17.6 percentage of participants
|
15.7 percentage of participants
|
31.4 percentage of participants
|
30.8 percentage of participants
|
48.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4 and 8Population: ITT Population included all participants who are randomized to the study. Overall number of participants analyzed are participants with data available for analysis at specified time-point and 'n' signifies number of participants evaluable for this outcome measure.
The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity 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. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.
Outcome measures
| Measure |
DB: Vehicle BID
n=48 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=44 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
n=46 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
n=48 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=48 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=47 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
Baseline
|
6.0 score on scale
Standard Deviation 2.11
|
5.2 score on scale
Standard Deviation 2.22
|
6.1 score on scale
Standard Deviation 2.23
|
6.2 score on scale
Standard Deviation 1.71
|
6.2 score on scale
Standard Deviation 2.14
|
5.9 score on scale
Standard Deviation 2.25
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
Change from Baseline at Week 2
|
-0.7 score on scale
Standard Deviation 1.46
|
-2.2 score on scale
Standard Deviation 1.75
|
-1.9 score on scale
Standard Deviation 1.97
|
-2.5 score on scale
Standard Deviation 2.23
|
-3.1 score on scale
Standard Deviation 2.14
|
-3.7 score on scale
Standard Deviation 2.56
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
Change from Baseline at Week 4
|
-1.0 score on scale
Standard Deviation 1.79
|
-2.5 score on scale
Standard Deviation 1.94
|
-2.3 score on scale
Standard Deviation 2.08
|
-2.6 score on scale
Standard Deviation 2.22
|
-3.3 score on scale
Standard Deviation 2.24
|
-4.0 score on scale
Standard Deviation 2.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
Change from Baseline at Week 8
|
-1.2 score on scale
Standard Deviation 2.13
|
-2.2 score on scale
Standard Deviation 1.86
|
-3.0 score on scale
Standard Deviation 2.49
|
-2.9 score on scale
Standard Deviation 2.41
|
-3.8 score on scale
Standard Deviation 2.39
|
-4.2 score on scale
Standard Deviation 2.91
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Safety Population in the DB treatment period included all enrolled participants who applied at least 1 dose of ruxolitinib cream, triamcinolone cream, or vehicle cream.
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.
Outcome measures
| Measure |
DB: Vehicle BID
n=52 Participants
Participants applied vehicle cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=51 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 0.5% QD
n=51 Participants
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% QD
n=51 Participants
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=51 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
DB: Ruxolitinib 1.5% BID
n=50 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
|
OL: Vehicle BID to Ruxolitinib 1.5% BID
n=41 Participants
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks
|
OL: TAC BID/Vehicle Cream BID to Ruxolitinib 1.5% BID
n=40 Participants
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
n=45 Participants
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
n=41 Participants
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
n=42 Participants
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
OL: Ruxolitinib 1.5% BID
n=43 Participants
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
Grade 3 and Higher
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
At Least One AE
|
17 Participants
|
17 Participants
|
19 Participants
|
11 Participants
|
17 Participants
|
12 Participants
|
5 Participants
|
11 Participants
|
11 Participants
|
8 Participants
|
11 Participants
|
17 Participants
|
Adverse Events
Vehicle BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Triamcinolone 0.1% BID for 4 Weeks Then 4 Week Vehicle BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
INCB018424 0.15% QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
INCB018424 0.5% QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
INCB018424 1.5% QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
INCB018424 1.5% BID
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle BID
n=52 participants at risk
Participants applied vehicle cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
Triamcinolone 0.1% BID for 4 Weeks Then 4 Week Vehicle BID
n=51 participants at risk
Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks. At Week 8, participants who met criteria were offered open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
INCB018424 0.15% QD
n=51 participants at risk
Participants applied Ruxolitinib 0.15% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
INCB018424 0.5% QD
n=51 participants at risk
Participants applied Ruxolitinib 0.5% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
INCB018424 1.5% QD
n=51 participants at risk
Participants applied Ruxolitinib 1.5% QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
INCB018424 1.5% BID
n=259 participants at risk
Participants applied Ruxolitinib 1.5% cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/52 • Up to Week 24
|
2.0%
1/51 • Number of events 1 • Up to Week 24
|
0.00%
0/51 • Up to Week 24
|
0.00%
0/51 • Up to Week 24
|
0.00%
0/51 • Up to Week 24
|
0.00%
0/259 • Up to Week 24
|
Other adverse events
| Measure |
Vehicle BID
n=52 participants at risk
Participants applied vehicle cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
Triamcinolone 0.1% BID for 4 Weeks Then 4 Week Vehicle BID
n=51 participants at risk
Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks. At Week 8, participants who met criteria were offered open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
|
INCB018424 0.15% QD
n=51 participants at risk
Participants applied Ruxolitinib 0.15% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
INCB018424 0.5% QD
n=51 participants at risk
Participants applied Ruxolitinib 0.5% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
INCB018424 1.5% QD
n=51 participants at risk
Participants applied Ruxolitinib 1.5% QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
INCB018424 1.5% BID
n=259 participants at risk
Participants applied Ruxolitinib 1.5% cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.7%
4/52 • Number of events 5 • Up to Week 24
|
3.9%
2/51 • Number of events 2 • Up to Week 24
|
2.0%
1/51 • Number of events 1 • Up to Week 24
|
0.00%
0/51 • Up to Week 24
|
3.9%
2/51 • Number of events 2 • Up to Week 24
|
1.5%
4/259 • Number of events 5 • Up to Week 24
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
4/52 • Number of events 6 • Up to Week 24
|
0.00%
0/51 • Up to Week 24
|
5.9%
3/51 • Number of events 3 • Up to Week 24
|
2.0%
1/51 • Number of events 1 • Up to Week 24
|
7.8%
4/51 • Number of events 4 • Up to Week 24
|
5.0%
13/259 • Number of events 17 • Up to Week 24
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
3/52 • Number of events 3 • Up to Week 24
|
2.0%
1/51 • Number of events 1 • Up to Week 24
|
3.9%
2/51 • Number of events 2 • Up to Week 24
|
2.0%
1/51 • Number of events 1 • Up to Week 24
|
2.0%
1/51 • Number of events 1 • Up to Week 24
|
2.7%
7/259 • Number of events 8 • Up to Week 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER