Trial Outcomes & Findings for Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement (NCT NCT05127421)

Last Updated: 2024-08-15

Results Overview

The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) 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. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

Baseline; Week 4

Results posted on

2024-08-15

Participant Flow

This decentralized clinical study was conducted through 1 virtual meta-site in the United States.

Participant milestones

Participant milestones
Measure	Double-Blind Period: Vehicle Cream BID Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.	Open-Label Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 4 assessments with no safety concerns could continue into the 4-week Open-Label Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 4 weeks in the Open-Label Period.	Open-Label Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 4 assessments with no safety concerns could continue into the 4-week Open-Label Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 4 weeks in the Open-Label Period.
4-Week Double-Blind Period STARTED	23	54	0	0
4-Week Double-Blind Period COMPLETED	18	48	0	0
4-Week Double-Blind Period NOT COMPLETED	5	6	0	0
4-Week Open-Label Period STARTED	0	0	17	47
4-Week Open-Label Period COMPLETED	0	0	16	44
4-Week Open-Label Period NOT COMPLETED	0	0	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Double-Blind Period: Vehicle Cream BID Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.	Open-Label Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 4 assessments with no safety concerns could continue into the 4-week Open-Label Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 4 weeks in the Open-Label Period.	Open-Label Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 4 assessments with no safety concerns could continue into the 4-week Open-Label Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 4 weeks in the Open-Label Period.
4-Week Double-Blind Period Lost to Follow-up	1	0	0	0
4-Week Double-Blind Period Physician Decision	1	0	0	0
4-Week Double-Blind Period Withdrawal by Subject	3	1	0	0
4-Week Double-Blind Period Withdrawn by Sponsor	0	4	0	0
4-Week Double-Blind Period Withdrawn Due to E-diary Compliance	0	1	0	0
4-Week Open-Label Period Lost to Follow-up	0	0	0	1
4-Week Open-Label Period Withdrawal by Subject	0	0	1	1
4-Week Open-Label Period Withdrawn by Sponsor	0	0	0	1

Baseline Characteristics

Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-Blind Period: Vehicle Cream BID n=23 Participants Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=54 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.	Total n=77 Participants Total of all reporting groups
Age, Continuous	41.0 years STANDARD_DEVIATION 13.44 • n=5 Participants	37.9 years STANDARD_DEVIATION 14.37 • n=7 Participants	38.8 years STANDARD_DEVIATION 14.08 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	46 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	49 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	11 Participants n=5 Participants	20 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Black/African-American	10 Participants n=5 Participants	24 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized American-Indian/Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black, Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Captured as "Hispanic" in the Database	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black and Phillipino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Mexican	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Indian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Mexican and Spanish	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Week 4

Population: Full Analysis Population: all participants enrolled in the study who had at least 1 application of study drug. Missing post-Baseline values were imputed as Non-Responders at Week 4. The 95% confidence interval for the difference was computed based on a large-sample normal approximation with continuity correction.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Vehicle Cream BID n=23 Participants Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=54 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.
Percentage of Participants Who Achieve a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) of the Head and Neck Region at Week 4	17.4 percentage of participants Interval 5.0 to 38.8	37.0 percentage of participants Interval 24.3 to 51.3

SECONDARY outcome

Timeframe: Baseline; Weeks 2 and 8

Population: Full Analysis Population. Only participants with available data were analyzed. The 95% confidence interval for the difference was computed based on a large-sample normal approximation with continuity correction.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Vehicle Cream BID n=18 Participants Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=48 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.
Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8 Week 2	16.7 percentage of participants Interval 3.6 to 41.4	14.6 percentage of participants Interval 6.1 to 27.8
Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8 Week 8	35.3 percentage of participants Interval 14.2 to 61.7	53.3 percentage of participants Interval 37.9 to 68.3

SECONDARY outcome

Timeframe: Baseline; Weeks 2, 4, and 8

The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) 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

Outcome measures
Measure	Double-Blind Period: Vehicle Cream BID n=18 Participants Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=48 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.
Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8 Week 2	5.6 percentage of participants Interval 0.1 to 27.3	10.4 percentage of participants Interval 3.5 to 22.7
Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8 Week 4	33.3 percentage of participants Interval 13.3 to 59.0	29.2 percentage of participants Interval 17.0 to 44.1
Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8 Week 8	35.3 percentage of participants Interval 14.2 to 61.7	33.3 percentage of participants Interval 20.0 to 49.0

SECONDARY outcome

Timeframe: up to approximately 4 weeks plus 30 days

Population: Full Analysis Population

A TEAE was defined as any adverse event (AE) either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An 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 have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Vehicle Cream BID n=23 Participants Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=54 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.
Double-Blind Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	5 Participants	6 Participants

SECONDARY outcome

Timeframe: from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days)

Population: Open-Label Evaluable Population: all participants who applied at least 1 dose of ruxolitinib cream during the Open-Label Period

Outcome measures

Outcome measures
Measure	Double-Blind Period: Vehicle Cream BID n=17 Participants Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=47 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.
Open-Label Period: Number of Participants With Any TEAE	4 Participants	9 Participants

SECONDARY outcome

Timeframe: up to approximately 4 weeks plus 30 days

Population: Full Analysis Population

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 the study drug. An 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. The severity of AEs was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grades 1 to 5). Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Vehicle Cream BID n=23 Participants Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=54 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.
Double-Blind Period: Number of Participants With Any Grade 3 or Higher TEAE	0 Participants	1 Participants

SECONDARY outcome

Timeframe: from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days)

Population: Open-Label Evaluable Population

Outcome measures

Outcome measures
Measure	Double-Blind Period: Vehicle Cream BID n=17 Participants Participants applied matching vehicle cream BID for 4 weeks.	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=47 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 4 weeks.
Open-Label Period: Number of Participants With Any Grade 3 or Higher TEAE	1 Participants	1 Participants

Adverse Events

Vehicle Cream BID

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Ruxolitinib Cream 1.5% BID

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vehicle Cream BID n=23 participants at risk Participants applied matching vehicle cream twice a day (BID) for 4 weeks in the Double-Blind Period.	Ruxolitinib Cream 1.5% BID n=71 participants at risk Participants applied ruxolitinib cream during the Double-Blind Period and the Open-Label Period. Participants who completed the Week 4 assessments with no safety concerns could continue into the 4-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 4 weeks in the Open-Label Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 4 weeks in the Open-Label Period.
General disorders Application site reaction	8.7% 2/23 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 8 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of pre-existing events after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Full Analysis Population: all participants who had at least 1 application of study drug.. For the Open-Label Period, TEAEs are reported for the Open-Label Evaluable Population: all participants who applied at least 1 dose of ruxolitinib cream during the Open-Label Period.	1.4% 1/71 • 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 Week 8 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of pre-existing events after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Full Analysis Population: all participants who had at least 1 application of study drug.. For the Open-Label Period, TEAEs are reported for the Open-Label Evaluable Population: all participants who applied at least 1 dose of ruxolitinib cream during the Open-Label Period.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

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