Trial Outcomes & Findings for Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis (NCT NCT05456529)
NCT ID: NCT05456529
Last Updated: 2025-06-25
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
103 participants
Primary outcome timeframe
up to 462 days
Results posted on
2025-06-25
Participant Flow
This study was conducted at 25 study centers in the United States and Canada.
Participant milestones
| Measure |
Ruxolitinib 1.5% Cream BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
8-week Continuous Treatment (CT) Period
STARTED
|
103
|
|
8-week Continuous Treatment (CT) Period
COMPLETED
|
92
|
|
8-week Continuous Treatment (CT) Period
NOT COMPLETED
|
11
|
|
44-week Long-term Safety Period
STARTED
|
92
|
|
44-week Long-term Safety Period
COMPLETED
|
61
|
|
44-week Long-term Safety Period
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Ruxolitinib 1.5% Cream BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
8-week Continuous Treatment (CT) Period
Lost to Follow-up
|
5
|
|
8-week Continuous Treatment (CT) Period
Lack of Efficacy
|
2
|
|
8-week Continuous Treatment (CT) Period
Protocol-specified Withdrawal Criterion Met
|
1
|
|
8-week Continuous Treatment (CT) Period
Withdrawal by Subject
|
3
|
|
44-week Long-term Safety Period
Lost to Follow-up
|
12
|
|
44-week Long-term Safety Period
Lack of Efficacy
|
1
|
|
44-week Long-term Safety Period
Physician Decision
|
2
|
|
44-week Long-term Safety Period
Protocol-specified Withdrawal Criterion Met
|
1
|
|
44-week Long-term Safety Period
Withdrawal by Subject
|
12
|
|
44-week Long-term Safety Period
Withdrawal by Sponsor
|
2
|
|
44-week Long-term Safety Period
Unable to Attend the Follow-up Visit
|
1
|
Baseline Characteristics
Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 1.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/White
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern (Arab)
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Indian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, Dominican, Cuban
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 462 daysPopulation: Full Analysis Set: all participants who applied ruxolitinib cream at least once
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
42 Participants
|
PRIMARY outcome
Timeframe: up to 462 daysPopulation: Full Analysis Set
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Number of Participants With ≥Grade 3 TEAEs
|
3 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10\^9 cells per liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, normal
|
94 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, high
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, missing
|
8 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, normal
|
83 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, high
|
19 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, low
|
18 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, normal
|
83 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, high
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, low
|
7 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, normal
|
95 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, normal
|
92 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, high
|
10 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, low
|
13 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, normal
|
87 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, high
|
2 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, low
|
5 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, normal
|
75 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, high
|
21 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, low and high
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, missing
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuk), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, normal
|
84 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, high
|
18 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, normal
|
73 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, high
|
29 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, low
|
29 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, normal
|
47 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, high
|
22 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, low and high
|
4 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, low
|
3 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, normal
|
94 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, high
|
5 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, low
|
6 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, normal
|
66 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, high
|
30 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, missing
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, low
|
3 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, normal
|
88 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, high
|
11 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, missing
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, low
|
5 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, normal
|
97 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, missing
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10\^12/Liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Low
|
14 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Normal
|
66 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
High
|
22 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Missing
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Low
|
2 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Normal
|
88 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
High
|
12 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Missing
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Low
|
19 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Normal
|
79 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
High
|
4 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Missing
|
1 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: Long-term Safety (LTS) Evaluable Population: all participants who applied ruxolitinib cream at least once during the LTS Period
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10\^9 cells per liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, low
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, normal
|
85 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, high
|
2 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Basophils, missing
|
5 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, low
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, normal
|
63 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, high
|
25 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Eosinophils, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, low
|
20 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, normal
|
62 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, high
|
6 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Leukocytes, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, low
|
5 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, normal
|
82 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, high
|
1 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Lymphocytes, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, low
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, normal
|
75 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, high
|
13 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Monocytes, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, low
|
12 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, normal
|
66 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, high
|
10 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Neutrophils, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, low
|
3 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, normal
|
60 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, high
|
25 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Platelets, missing
|
4 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuko), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, low
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, normal
|
67 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, high
|
21 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Basophils/leukocytes, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, low
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, normal
|
49 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, high
|
39 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Eosinophils/leukocytes, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, low
|
39 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, normal
|
29 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, high
|
18 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, low and high
|
2 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Lymphocytes/leukocytes, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, low
|
13 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, normal
|
68 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, high
|
7 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Monocytes/leukocytes, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, low
|
8 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, normal
|
43 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, high
|
37 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Neutrophils/leukocytes, missing
|
4 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, low
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, normal
|
56 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, high
|
28 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Erythrocyte mean corpuscular volume, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, low
|
11 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, normal
|
77 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Mean platelet volume, missing
|
4 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10\^12/Liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Low
|
19 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Normal
|
42 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
High
|
26 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Low and high
|
1 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Missing
|
4 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Normal
|
49 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Low
|
2 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
High
|
37 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Missing
|
4 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Low
|
26 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Normal
|
55 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
High
|
7 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Missing
|
4 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) were measured in units per liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, normal
|
100 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, high
|
3 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, low
|
14 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, normal
|
89 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, normal
|
102 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, high
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, low
|
3 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, normal
|
77 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, high
|
22 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, low and high
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, low
|
7 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, normal
|
91 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, high
|
5 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, missing
|
0 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Normal
|
23 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
High
|
80 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Missing
|
0 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, low
|
31 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, normal
|
68 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, high
|
4 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, low
|
54 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, normal
|
49 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, normal
|
4 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, missing
|
99 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, normal
|
84 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, high
|
19 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, low
|
52 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, normal
|
51 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, low
|
13 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, normal
|
86 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, high
|
4 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, normal
|
82 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, high
|
21 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, normal
|
80 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, high
|
23 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, low
|
8 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, normal
|
93 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, high
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, low and high
|
1 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, missing
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, low
|
2 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, normal
|
86 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, high
|
15 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, missing
|
0 Participants
|
SECONDARY outcome
Timeframe: up to Week 8Population: Full Analysis Set
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\^2).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Low
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Normal
|
2 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
High
|
4 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Low and high
|
0 Participants
|
|
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Missing
|
97 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. ALT, ALP, AST, CK, and LDH were measured in units per liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, low
|
5 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, normal
|
78 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, high
|
5 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALT, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, low
|
14 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, normal
|
69 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, high
|
5 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
ALP, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, low
|
2 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, normal
|
82 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, high
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
AST, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, low
|
5 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, normal
|
56 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, high
|
27 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
CK, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, low
|
9 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, normal
|
72 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, high
|
7 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
LDH, missing
|
4 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Low
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Normal
|
19 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
High
|
69 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Missing
|
4 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, low
|
40 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, normal
|
43 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, high
|
5 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Bilirubin, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, low
|
58 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, normal
|
30 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Creatinine, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, low
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, normal
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Direct bilirubin, missing
|
88 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, low
|
2 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, normal
|
72 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, high
|
14 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Calcium, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, low
|
54 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, normal
|
34 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Chloride, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, low
|
12 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, normal
|
72 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, high
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Glucose, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, low
|
1 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, normal
|
62 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, high
|
25 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Phosphate, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, low
|
1 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, normal
|
66 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, high
|
21 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Potassium, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, low
|
17 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, normal
|
70 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, low and high
|
1 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Sodium, missing
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, low
|
4 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, normal
|
65 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, high
|
19 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Urea nitrogen, missing
|
4 Participants
|
SECONDARY outcome
Timeframe: from Week 9 up to Week 52 (44 weeks)Population: LTS Evaluable Population
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\^2).
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=92 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Low
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Normal
|
10 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
High
|
11 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Low and high
|
0 Participants
|
|
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Missing
|
71 Participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 8, 44, and 52Population: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Change from Baseline at Week 44, DBP
|
0.1 millimeters of mercury (mmHg)
Standard Deviation 9.31
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Change from Baseline at Week 52, DBP
|
1.0 millimeters of mercury (mmHg)
Standard Deviation 8.04
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Baseline, SBP
|
112.7 millimeters of mercury (mmHg)
Standard Deviation 11.14
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Change from Baseline at Week 8, SBP
|
0.6 millimeters of mercury (mmHg)
Standard Deviation 10.01
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Change from Baseline at Week 44, SBP
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 11.10
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Change from Baseline at Week 52, SBP
|
1.0 millimeters of mercury (mmHg)
Standard Deviation 10.77
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Baseline, DBP
|
71.0 millimeters of mercury (mmHg)
Standard Deviation 8.03
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Change from Baseline at Week 8, DBP
|
0.2 millimeters of mercury (mmHg)
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: Baseline; Weeks 8, 44, and 52Population: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Change From Baseline in Pulse at Weeks 8, 44, and 52
Change from Baseline at Week 52
|
-0.4 beats per minute
Standard Deviation 12.18
|
|
Change From Baseline in Pulse at Weeks 8, 44, and 52
Change from Baseline at Week 44
|
-0.6 beats per minute
Standard Deviation 11.69
|
|
Change From Baseline in Pulse at Weeks 8, 44, and 52
Baseline
|
78.8 beats per minute
Standard Deviation 12.71
|
|
Change From Baseline in Pulse at Weeks 8, 44, and 52
Change from Baseline at Week 8
|
0.5 beats per minute
Standard Deviation 11.23
|
SECONDARY outcome
Timeframe: Baseline; Weeks 8, 44, and 52Population: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Change From Baseline in Respiration Rate at Weeks 8, 44, and 52
Baseline
|
16.1 breaths per minute
Standard Deviation 2.50
|
|
Change From Baseline in Respiration Rate at Weeks 8, 44, and 52
Change from Baseline at Week 8
|
0.7 breaths per minute
Standard Deviation 6.91
|
|
Change From Baseline in Respiration Rate at Weeks 8, 44, and 52
Change from Baseline at Week 44
|
-0.5 breaths per minute
Standard Deviation 1.91
|
|
Change From Baseline in Respiration Rate at Weeks 8, 44, and 52
Change from Baseline at Week 52
|
-0.1 breaths per minute
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Baseline; Weeks 8, 44, and 52Population: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Change From Baseline in Body Temperature at Weeks 8, 44, and 52
Baseline
|
36.5 degrees Celsius
Standard Deviation 0.42
|
|
Change From Baseline in Body Temperature at Weeks 8, 44, and 52
Change from Baseline at Week 8
|
0.0 degrees Celsius
Standard Deviation 0.40
|
|
Change From Baseline in Body Temperature at Weeks 8, 44, and 52
Change from Baseline at Week 44
|
0.1 degrees Celsius
Standard Deviation 0.43
|
|
Change From Baseline in Body Temperature at Weeks 8, 44, and 52
Change from Baseline at Week 52
|
0.1 degrees Celsius
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Baseline; Weeks 8 and 52Population: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Change From Baseline in Height at Weeks 8 and 52
Baseline
|
165.1 centimeters
Standard Deviation 9.88
|
|
Change From Baseline in Height at Weeks 8 and 52
Change from Baseline at Week 8
|
0.7 centimeters
Standard Deviation 1.20
|
|
Change From Baseline in Height at Weeks 8 and 52
Change from Baseline at Week 52
|
3.1 centimeters
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: Baseline; Weeks 8 and 52Population: Full Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Change From Baseline in Weight at Weeks 8 and 52
Baseline
|
65.0 kilograms
Standard Deviation 18.25
|
|
Change From Baseline in Weight at Weeks 8 and 52
Change from Baseline at Week 8
|
0.9 kilograms
Standard Deviation 3.11
|
|
Change From Baseline in Weight at Weeks 8 and 52
Change from Baseline at Week 52
|
3.8 kilograms
Standard Deviation 7.01
|
SECONDARY outcome
Timeframe: prior to study cream application at Weeks 2 and 4Population: Pharmacokinetic (PK) Population: all participants who applied ruxolitinib cream at least once and provided at least 1 postbaseline PK sample (1 PK measurement). Only participants with available data were analyzed.
Blood samples were drawn to assess plasma concentration.
Outcome measures
| Measure |
Ruxolitinib 1.5% Cream BID
n=100 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Plasma Concentration of Ruxolitinib
Week 2
|
21.4 nanomoles per liter (nM)
Standard Deviation 27.7
|
|
Plasma Concentration of Ruxolitinib
Week 4
|
24.6 nanomoles per liter (nM)
Standard Deviation 38.2
|
Adverse Events
Ruxolitinib 1.5% Cream BID
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 participants at risk
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Psychiatric disorders
Depression
|
0.97%
1/103 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to approximately 20 months)
Adverse events were assessed in members of the Full Analysis Set, comprised of all participants who applied ruxolitinib cream at least once.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.97%
1/103 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to approximately 20 months)
Adverse events were assessed in members of the Full Analysis Set, comprised of all participants who applied ruxolitinib cream at least once.
|
Other adverse events
| Measure |
Ruxolitinib 1.5% Cream BID
n=103 participants at risk
Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.7%
9/103 • Number of events 13 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to approximately 20 months)
Adverse events were assessed in members of the Full Analysis Set, comprised of all participants who applied ruxolitinib cream at least once.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
11/103 • Number of events 17 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to approximately 20 months)
Adverse events were assessed in members of the Full Analysis Set, comprised of all participants who applied ruxolitinib cream at least once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER