Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3) (NCT NCT04921969)
NCT ID: NCT04921969
Last Updated: 2025-03-28
Results Overview
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
330 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2025-03-28
Participant Flow
A total of 330 participants were enrolled at 48 study centers in the United States and Canada.
Participants who completed Week 8 assessments of the Vehicle-controlled (VC) Period with no safety concerns continued in the 44-week Long-term Safety (LTS) Period. Participants who were on active treatment during the VC Period continued with the same treatment regimen in the LTS Period, and those who applied vehicle cream during the VC Period were equally randomized into 1 of the 2 active treatment groups (ruxolitinib 0.75%, ruxolitinib 1.5%) cream during the LTS Period.
Participant milestones
| Measure |
VC Period: Vehicle Cream BID
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID
Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID
Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
LTS Period: Ruxolitinib 0.75% Cream BID
Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|---|---|---|
|
VC Period (Day 1 to Week 8)
STARTED
|
65
|
134
|
131
|
0
|
0
|
0
|
0
|
|
VC Period (Day 1 to Week 8)
COMPLETED
|
49
|
120
|
115
|
0
|
0
|
0
|
0
|
|
VC Period (Day 1 to Week 8)
NOT COMPLETED
|
16
|
14
|
16
|
0
|
0
|
0
|
0
|
|
LTS Period (Weeks 8 to 52)
STARTED
|
0
|
0
|
0
|
25
|
24
|
119
|
114
|
|
LTS Period (Weeks 8 to 52)
COMPLETED
|
0
|
0
|
0
|
18
|
15
|
71
|
77
|
|
LTS Period (Weeks 8 to 52)
NOT COMPLETED
|
0
|
0
|
0
|
7
|
9
|
48
|
37
|
Reasons for withdrawal
| Measure |
VC Period: Vehicle Cream BID
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID
Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID
Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
LTS Period: Ruxolitinib 0.75% Cream BID
Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|---|---|---|
|
VC Period (Day 1 to Week 8)
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
VC Period (Day 1 to Week 8)
Lack of Efficacy
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
VC Period (Day 1 to Week 8)
Lost to Follow-up
|
2
|
5
|
5
|
0
|
0
|
0
|
0
|
|
VC Period (Day 1 to Week 8)
Physician Decision
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
VC Period (Day 1 to Week 8)
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
VC Period (Day 1 to Week 8)
Withdrawal by Subject
|
9
|
5
|
8
|
0
|
0
|
0
|
0
|
|
VC Period (Day 1 to Week 8)
Protocol-specified Withdrawal Criterion Met
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
|
LTS Period (Weeks 8 to 52)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
LTS Period (Weeks 8 to 52)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
3
|
2
|
|
LTS Period (Weeks 8 to 52)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
6
|
18
|
9
|
|
LTS Period (Weeks 8 to 52)
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
|
LTS Period (Weeks 8 to 52)
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
3
|
22
|
18
|
|
LTS Period (Weeks 8 to 52)
Protocol-specified Withdrawal Criterion Met
|
0
|
0
|
0
|
1
|
0
|
1
|
2
|
|
LTS Period (Weeks 8 to 52)
Non-compliance with Study Drug
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
LTS Period (Weeks 8 to 52)
Follow-up Not Performed per Protocol
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)
Baseline characteristics by cohort
| Measure |
VC Period: Vehicle Cream BID
n=65 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=134 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=131 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
6.3 years
STANDARD_DEVIATION 3.12 • n=5 Participants
|
6.6 years
STANDARD_DEVIATION 2.83 • n=7 Participants
|
6.4 years
STANDARD_DEVIATION 2.94 • n=5 Participants
|
6.5 years
STANDARD_DEVIATION 2.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
37 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
19 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American-Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American and White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed, Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Captured as Hispanic or Latino in Database
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian and North African
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caregiver Did Not Identify
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Puerto Rican
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black and Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African-American/Black, Hispanic, and Caucasian/White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Portuguese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Brazilian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Intent-to-Treat (ITT) Population: all participants who were randomized to the study. Treatment groups for this population were defined according to the treatment assignment at the time of randomization.
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=65 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=134 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=131 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
|
10.8 percentage of participants
Interval 4.4 to 20.9
|
36.6 percentage of participants
Interval 28.4 to 45.3
|
56.5 percentage of participants
Interval 47.6 to 65.1
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis.
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=37 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=80 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=76 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8
|
29.7 percentage of participants
Interval 15.873 to 46.98
|
37.5 percentage of participants
Interval 26.919 to 49.035
|
43.4 percentage of participants
Interval 32.083 to 55.288
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 7 (Week 1)Population: ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis. Missing Day 7 Itch scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors, Baseline, and post-Baseline Day 1 to Day 7 Itch NRS Score as predicators.
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=37 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=79 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=76 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)
|
11.5 percentage of participants
|
23.5 percentage of participants
|
28.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 3Population: ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis. Missing Day 3 Itch scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors, Baseline, and post-Baseline Day 1 to Day 7 Itch NRS Score as predicators.
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=37 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=79 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=76 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3
|
4.1 percentage of participants
|
14.6 percentage of participants
|
12.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: from Baseline up to Week 8Population: Safety Population: all randomized participants who applied ruxolitinib cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1.
An adverse event 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 is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=65 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=134 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=130 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
18 Participants
|
35 Participants
|
48 Participants
|
—
|
SECONDARY outcome
Timeframe: From Week 8 up to Week 56Population: LTS Evaluable Population: all participants who applied study drug at least once during the LTS Period
An adverse event 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 is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=25 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=24 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=119 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
n=114 Participants
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
LTS Period: Number of Participants With Any TEAE
|
9 Participants
|
13 Participants
|
57 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: from Baseline up to Week 8Population: Safety Population
A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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 |
VC Period: Vehicle Cream BID
n=65 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=134 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=130 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Number of Participants With Any Grade 3 or Higher TEAE
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From Week 12 up to Week 56Population: LTS Evaluable Population
A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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 |
VC Period: Vehicle Cream BID
n=25 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=24 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=119 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
n=114 Participants
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
LTS Period: Number of Participants With Any Grade 3 or Higher TEAE
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2 and 4Population: ITT Population
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=65 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=134 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=131 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4
Week 2
|
4.6 percentage of participants
Interval 1.0 to 12.9
|
24.6 percentage of participants
Interval 17.6 to 32.8
|
35.1 percentage of participants
Interval 27.0 to 43.9
|
—
|
|
VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4
Week 4
|
12.3 percentage of participants
Interval 5.5 to 22.8
|
36.6 percentage of participants
Interval 28.4 to 45.3
|
48.1 percentage of participants
Interval 39.3 to 57.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2 and 4Population: ITT Population. Only those participants who were at least 6 years of age and had a Baseline Itch NRS Score ≥4 were included in the analysis.
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=37 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=80 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=76 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4
Week 2
|
8.1 percentage of participants
Interval 1.704 to 21.91
|
23.8 percentage of participants
Interval 14.945 to 34.578
|
23.7 percentage of participants
Interval 14.682 to 34.824
|
—
|
|
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4
Week 4
|
10.8 percentage of participants
Interval 3.025 to 25.418
|
33.8 percentage of participants
Interval 23.553 to 45.191
|
36.8 percentage of participants
Interval 26.058 to 48.686
|
—
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, and 8Population: ITT Population
The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of ≥8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l), each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=65 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=134 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=131 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8
Week 4
|
12.3 percentage of participants
Interval 5.466 to 22.819
|
53.0 percentage of participants
Interval 44.178 to 61.658
|
62.6 percentage of participants
Interval 53.718 to 70.89
|
—
|
|
VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8
Week 2
|
6.2 percentage of participants
Interval 1.702 to 15.013
|
35.8 percentage of participants
Interval 27.728 to 44.556
|
43.5 percentage of participants
Interval 34.876 to 52.447
|
—
|
|
VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8
Week 8
|
15.4 percentage of participants
Interval 7.632 to 26.478
|
51.5 percentage of participants
Interval 42.708 to 60.21
|
67.2 percentage of participants
Interval 58.432 to 75.123
|
—
|
SECONDARY outcome
Timeframe: up to Week 8Population: ITT Population. Participants who were at least 6 years of age and had a Baseline Itch NRS score ≥2 (for assessment of improvement of at least 2 points) or ≥4 (for assessment of improvement of at least 4 points), a daily Itch NRS assessment during the VC Period, and available data were included in the analysis.
The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses.
Outcome measures
| Measure |
VC Period: Vehicle Cream BID
n=38 Participants
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 0.75% Cream BID
n=84 Participants
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
VC Period: Ruxolitinib 1.5% Cream BID
n=76 Participants
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
|
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID, as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
|
|---|---|---|---|---|
|
VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points
Improvement of at least 2 points
|
6.0 days
Interval 4.0 to 21.0
|
4.0 days
Interval 3.0 to 5.0
|
5.0 days
Interval 3.0 to 6.0
|
—
|
|
VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points
Improvement of at least 4 points
|
23.0 days
Interval 13.0 to
The upper limit of the 95% confidence interval was not estimable because there were too few participants with events.
|
11.0 days
Interval 9.0 to 20.0
|
13.0 days
Interval 9.0 to 17.0
|
—
|
Adverse Events
Vehicle Cream BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ruxolitinib 0.75% Cream BID
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Ruxolitinib 1.5% Cream BID
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle Cream BID
n=65 participants at risk
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 up to Week 8.
|
Ruxolitinib 0.75% Cream BID
n=159 participants at risk
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 up to Week 8. Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52.
|
Ruxolitinib 1.5% Cream BID
n=154 participants at risk
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 up to Week 8. Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/65 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
0.00%
0/159 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
1.3%
2/154 • Number of events 2 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
|
Infections and infestations
Eczema herpeticum
|
0.00%
0/65 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
0.00%
0/159 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
0.65%
1/154 • Number of events 1 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
Other adverse events
| Measure |
Vehicle Cream BID
n=65 participants at risk
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 up to Week 8.
|
Ruxolitinib 0.75% Cream BID
n=159 participants at risk
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 up to Week 8. Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52.
|
Ruxolitinib 1.5% Cream BID
n=154 participants at risk
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 up to Week 8. Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.5%
1/65 • Number of events 1 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
8.2%
13/159 • Number of events 13 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
7.1%
11/154 • Number of events 11 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/65 • Number of events 1 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
5.7%
9/159 • Number of events 10 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
13.0%
20/154 • Number of events 23 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/65 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
5.7%
9/159 • Number of events 10 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
1.9%
3/154 • Number of events 3 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
|
General disorders
Pyrexia
|
0.00%
0/65 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
6.3%
10/159 • Number of events 12 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
3.9%
6/154 • Number of events 12 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
2/65 • Number of events 3 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
13.8%
22/159 • Number of events 30 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
14.9%
23/154 • Number of events 47 • up to 60 weeks
Adverse events were assessed in members of the Safety Population (all randomized participants who applied ruxolitinib cream or vehicle cream at least once) during the VC Period and in members of the LTS Evaluable Population (all participants who applied study drug at least once during the LTS Period) during the LTS Period. For participants who were on vehicle up to Week 8 and then switched to ruxolitinib, AEs are presented by the treatment they were on at onset of AE.
|
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