Trial Outcomes & Findings for A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis (NCT NCT06238817)
NCT ID: NCT06238817
Last Updated: 2026-05-22
Results Overview
EASI75 was defined as achieving a ≥75% improvement in the EASI score compared to the baseline score. The EASI scoring system is a validated scoring system that grades the physical signs of atopic dermatitis (AD) to provide a measure of AD severity (ranging from 0 to 72). The disease severity strata for the EASI are: 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
241 participants
Primary outcome timeframe
Baseline; Week 8
Results posted on
2026-05-22
Participant Flow
This study was conducted at 75 study centers in Europe, North America, and Australia. Participants could have entered the open-label Escape Arm either at Week 8 (end of the VC Period) or anytime during the VCE DB Period.
Participant milestones
| Measure |
Vehicle Cream
During the 8-week vehicle-controlled (VC) period, participants applied vehicle cream twice daily (BID) to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the Eczema Area and Severity Index (EASI) score from baseline (EASI50), continued blinded treatment with vehicle cream BID and were evaluated for durability of response during an additional 16-week period vehicle-controlled extension double-blind period (VCE DB).
|
Ruxolitinib 1.5% Cream
During the 8-week VC period, participants applied ruxolitinib 1.5% cream BID to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the EASI score from baseline (EASI50), continued blinded treatment with ruxolitinib 1.5% cream BID and were evaluated for durability of response during an additional 16-week period VCE DB period.
|
Vehicle Cream to Ruxolitinib 1.5% Cream
Participants who were randomized to receive vehicle cream BID at the beginning of the VC period and did not have an adequate response at Week 8 or had lost EASI50 response (i.e., \<EASI50 must have been observed at 2 consecutive visits at least 1 week apart) during the VCE DB period received ruxolitinib 1.5% cream BID between Weeks 8 and 24 weeks in an open-label escape arm.
|
Ruxolitinib 1.5% Cream to Ruxolitinib 1.5% Cream
Participants who were randomized to receive ruxolitinib 1.5% cream BID at the beginning of the VC period and did not have an adequate response at Week 8 or had lost EASI50 response (i.e., \<EASI50 must have been observed at 2 consecutive visits at least 1 week apart) during the VCE DB period received ruxolitinib 1.5% cream BID between Weeks 8 and 24 weeks in an open-label escape arm.
|
|---|---|---|---|---|
|
Blinded-Treatment 8-Week VC Period
STARTED
|
81
|
160
|
0
|
0
|
|
Blinded-Treatment 8-Week VC Period
Entered Escape Arm at Week 8
|
40
|
32
|
0
|
0
|
|
Blinded-Treatment 8-Week VC Period
COMPLETED
|
60
|
155
|
0
|
0
|
|
Blinded-Treatment 8-Week VC Period
NOT COMPLETED
|
21
|
5
|
0
|
0
|
|
Blinded-Treatment 16-Week VCE DB Period
STARTED
|
20
|
121
|
0
|
0
|
|
Blinded-Treatment 16-Week VCE DB Period
Entered Escape Arm During VCE DB Period
|
4
|
7
|
0
|
0
|
|
Blinded-Treatment 16-Week VCE DB Period
COMPLETED
|
3
|
23
|
0
|
0
|
|
Blinded-Treatment 16-Week VCE DB Period
NOT COMPLETED
|
17
|
98
|
0
|
0
|
|
Open-Label Escape 16-Week VCE DB Period
STARTED
|
0
|
0
|
44
|
39
|
|
Open-Label Escape 16-Week VCE DB Period
COMPLETED
|
0
|
0
|
12
|
17
|
|
Open-Label Escape 16-Week VCE DB Period
NOT COMPLETED
|
0
|
0
|
32
|
22
|
Reasons for withdrawal
| Measure |
Vehicle Cream
During the 8-week vehicle-controlled (VC) period, participants applied vehicle cream twice daily (BID) to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the Eczema Area and Severity Index (EASI) score from baseline (EASI50), continued blinded treatment with vehicle cream BID and were evaluated for durability of response during an additional 16-week period vehicle-controlled extension double-blind period (VCE DB).
|
Ruxolitinib 1.5% Cream
During the 8-week VC period, participants applied ruxolitinib 1.5% cream BID to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the EASI score from baseline (EASI50), continued blinded treatment with ruxolitinib 1.5% cream BID and were evaluated for durability of response during an additional 16-week period VCE DB period.
|
Vehicle Cream to Ruxolitinib 1.5% Cream
Participants who were randomized to receive vehicle cream BID at the beginning of the VC period and did not have an adequate response at Week 8 or had lost EASI50 response (i.e., \<EASI50 must have been observed at 2 consecutive visits at least 1 week apart) during the VCE DB period received ruxolitinib 1.5% cream BID between Weeks 8 and 24 weeks in an open-label escape arm.
|
Ruxolitinib 1.5% Cream to Ruxolitinib 1.5% Cream
Participants who were randomized to receive ruxolitinib 1.5% cream BID at the beginning of the VC period and did not have an adequate response at Week 8 or had lost EASI50 response (i.e., \<EASI50 must have been observed at 2 consecutive visits at least 1 week apart) during the VCE DB period received ruxolitinib 1.5% cream BID between Weeks 8 and 24 weeks in an open-label escape arm.
|
|---|---|---|---|---|
|
Blinded-Treatment 8-Week VC Period
Adverse Event
|
7
|
0
|
0
|
0
|
|
Blinded-Treatment 8-Week VC Period
Death
|
1
|
0
|
0
|
0
|
|
Blinded-Treatment 8-Week VC Period
Lack of Efficacy
|
4
|
2
|
0
|
0
|
|
Blinded-Treatment 8-Week VC Period
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Blinded-Treatment 8-Week VC Period
Withdrawal by Subject
|
8
|
1
|
0
|
0
|
|
Blinded-Treatment 8-Week VC Period
Unable to Comply with Study Visit Requirements
|
0
|
1
|
0
|
0
|
|
Blinded-Treatment 8-Week VC Period
Non-compliance
|
0
|
1
|
0
|
0
|
|
Blinded-Treatment 16-Week VCE DB Period
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Blinded-Treatment 16-Week VCE DB Period
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Blinded-Treatment 16-Week VCE DB Period
Pregnancy
|
0
|
1
|
0
|
0
|
|
Blinded-Treatment 16-Week VCE DB Period
Ongoing
|
13
|
88
|
0
|
0
|
|
Blinded-Treatment 16-Week VCE DB Period
Entered the Escape Arm
|
4
|
7
|
0
|
0
|
|
Open-Label Escape 16-Week VCE DB Period
Lack of Efficacy
|
0
|
0
|
0
|
2
|
|
Open-Label Escape 16-Week VCE DB Period
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
|
Open-Label Escape 16-Week VCE DB Period
Sponsor Decision
|
0
|
0
|
0
|
1
|
|
Open-Label Escape 16-Week VCE DB Period
Ongoing
|
0
|
0
|
31
|
18
|
Baseline Characteristics
A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Total
n=241 Participants
Total of all reporting groups
|
Vehicle Cream
n=81 Participants
Participants applied vehicle cream twice daily (BID) for 8 weeks to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also have been treated after consultation with the investigator up to a maximum of 20% body surface area (BSA).
|
Ruxolitinib 1.5% Cream
n=160 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also have been treated after consultation with the investigator up to a maximum of 20% BSA.
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 16.27 • n=6 Participants
|
39.7 years
STANDARD_DEVIATION 16.33 • n=2 Participants
|
39.0 years
STANDARD_DEVIATION 16.29 • n=4 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=6 Participants
|
45 Participants
n=2 Participants
|
86 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=6 Participants
|
36 Participants
n=2 Participants
|
74 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
194 Participants
n=6 Participants
|
68 Participants
n=2 Participants
|
126 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
14 Participants
n=6 Participants
|
7 Participants
n=2 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
25 Participants
n=6 Participants
|
5 Participants
n=2 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
1 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Phillipino
|
1 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mix of White and American-Indian
|
1 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
4 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
226 Participants
n=6 Participants
|
78 Participants
n=2 Participants
|
148 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 8Population: Intent-to-Treat (ITT) Population: all participants who were randomized to the study. Treatment groups were defined according to the treatment assignment at the time of randomization, regardless of the actual study treatment applied. The confidence interval was calculated based on exact methods for binomial distribution. Nonresponder imputation: missing postbaseline values were imputed as nonresponders at Week 8.
EASI75 was defined as achieving a ≥75% improvement in the EASI score compared to the baseline score. The EASI scoring system is a validated scoring system that grades the physical signs of atopic dermatitis (AD) to provide a measure of AD severity (ranging from 0 to 72). The disease severity strata for the EASI are: 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.
Outcome measures
| Measure |
Vehicle Cream
n=81 Participants
Participants applied vehicle cream twice daily (BID) for 8 weeks to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also have been treated after consultation with the investigator up to a maximum of 20% body surface area (BSA).
|
Ruxolitinib 1.5% Cream
n=160 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also have been treated after consultation with the investigator up to a maximum of 20% BSA.
|
|---|---|---|
|
Percentage of Participants Achieving a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) at Week 8
|
18.5 percentage of participants
Interval 10.8 to 28.7
|
70.0 percentage of participants
Interval 62.3 to 77.0
|
PRIMARY outcome
Timeframe: Baseline; Week 8Population: ITT Population. The confidence interval was calculated based on exact methods for binomial distribution. Nonresponder imputation: missing postbaseline values were imputed as nonresponders at Week 8.
IGA-TS was defined as achieving an IGA score of 0 or 1 with a ≥2-grade improvement from baseline. The IGA is an overall eczema severity rating on a 0 to 4 scale. 0: clear; no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1: almost clear; may be trace faint pink erythema, with almost no induration/papulation, and no oozing/crusting. 2: mild; may be faint pink erythema, with mild induration/papulation and no oozing/crusting. 3: moderate; may be pink-red erythema with moderate induration/papulation and may be some oozing/crusting. 4: severe; may be deep or bright red erythema with severe induration/papulation and with oozing/crusting.
Outcome measures
| Measure |
Vehicle Cream
n=81 Participants
Participants applied vehicle cream twice daily (BID) for 8 weeks to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also have been treated after consultation with the investigator up to a maximum of 20% body surface area (BSA).
|
Ruxolitinib 1.5% Cream
n=160 Participants
Participants applied ruxolitinib 1.5% cream BID for 8 weeks to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also have been treated after consultation with the investigator up to a maximum of 20% BSA.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment Treatment Success (IGA-TS) at Week 8
|
13.6 percentage of participants
Interval 7.0 to 23.0
|
61.3 percentage of participants
Interval 53.2 to 68.8
|
SECONDARY outcome
Timeframe: Baseline; Week 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Days 2, 3, and 7Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 12Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 16 weeks (from Week 8 to Week 24)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 150 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 12Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 16 weeks (from Week 8 to Week 24)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 150 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2 and 4Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Day 1Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Day 1Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Day 1Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Days 1 through 56 (8 weeks)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 16 weeks (from Week 8 to Week 24)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 16 weeks (from Week 8 to Week 24)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 16 weeks (from Week 8 to Week 24)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 30 days following Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 16 weeks (from Week 8 to Week 24)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from Week 8 to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from Week 8 to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 16, 20, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 8 and 24Outcome measures
Outcome data not reported
Adverse Events
Vehicle Cream
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
Ruxolitinib 1.5% Cream
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle Cream
n=81 participants at risk
During the 8-week vehicle-controlled (VC) period, participants applied vehicle cream twice daily (BID) to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the Eczema Area and Severity Index (EASI) score from baseline (EASI50), continued blinded treatment with vehicle cream BID and were evaluated for durability of response during an additional 16-week period vehicle-controlled extension double-blind period (VCE DB).
|
Ruxolitinib 1.5% Cream
n=204 participants at risk
During the 8-week VC period, participants applied ruxolitinib 1.5% cream BID to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the EASI score from baseline (EASI50), continued blinded treatment with ruxolitinib 1.5% cream BID and were evaluated for durability of response during an additional 16-week period VCE DB period.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/81 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
0.49%
1/204 • Number of events 1 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
|
Vascular disorders
Hypertension
|
0.00%
0/81 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
0.49%
1/204 • Number of events 1 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/81 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
0.49%
1/204 • Number of events 1 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
|
General disorders
Sudden death
|
1.2%
1/81 • Number of events 1 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
0.00%
0/204 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/81 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
0.49%
1/204 • Number of events 1 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
Other adverse events
| Measure |
Vehicle Cream
n=81 participants at risk
During the 8-week vehicle-controlled (VC) period, participants applied vehicle cream twice daily (BID) to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the Eczema Area and Severity Index (EASI) score from baseline (EASI50), continued blinded treatment with vehicle cream BID and were evaluated for durability of response during an additional 16-week period vehicle-controlled extension double-blind period (VCE DB).
|
Ruxolitinib 1.5% Cream
n=204 participants at risk
During the 8-week VC period, participants applied ruxolitinib 1.5% cream BID to all areas identified for treatment at baseline even if the atopic dermatitis improved and lesions decreased in size. New areas could also be treated after consultation with the investigator up to a maximum of 20% BSA. After completing 8 weeks of continuous treatment, eligible participants with an adequate response, defined as achieving at least a ≥50% improvement in the EASI score from baseline (EASI50), continued blinded treatment with ruxolitinib 1.5% cream BID and were evaluated for durability of response during an additional 16-week period VCE DB period.
|
|---|---|---|
|
General disorders
Application site pain
|
6.2%
5/81 • Number of events 5 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
0.98%
2/204 • Number of events 2 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
4/81 • Number of events 4 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
5.9%
12/204 • Number of events 15 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
4/81 • Number of events 4 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
|
10.3%
21/204 • Number of events 21 • up to approximately 1 year
Adverse events were collected in the Safety Population, comprised of all participants who applied study cream at least once.
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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