Trial Outcomes & Findings for The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance. (NCT NCT05696392)

Last Updated: 2025-12-19

Results Overview

TST is the total amount of time spent during a planned sleep episode. Decreased TST is indicative of increased sleep disturbance. Baseline TST was the average hours of sleep within the last 7 nights prior to Visit 1. The Week 8 TST was the average hours of sleep within the last 7 nights prior to Visit 3/Week 8. Change from baseline was calculated as the post-baseline value minus the baseline value.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

47 participants

Primary outcome timeframe

Baseline; Week 8

Results posted on

2025-12-19

Participant Flow

This study was conducted at 17 study centers in the United States.

Participant milestones

Participant milestones
Measure	Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area.
Overall Study STARTED	47
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area.
Overall Study Lost to Follow-up	3
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ruxolitinib 1.5% Cream BID n=47 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area.
Age, Continuous	40.9 years STANDARD_DEVIATION 16.43 • n=8 Participants
Sex: Female, Male Female	27 Participants n=8 Participants
Sex: Female, Male Male	20 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian	8 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=8 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=8 Participants
Race/Ethnicity, Customized Captured as "Other" in Database	1 Participants n=8 Participants
Race/Ethnicity, Customized White	21 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline; Week 8

Population: Per Protocol Population: all participants who had no important protocol deviations. Participants must have had ≥4 nights worth of sleep data in order for the average to have been calculated; otherwise, it was set to missing. The average was based on non-missing nights of sleep data. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID n=11 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area.
Change From Baseline in Total Sleep Time (TST) as Measured by Ōura Ring Wearable Device at Week 8 Baseline	5.69 hours Standard Deviation 0.956
Change From Baseline in Total Sleep Time (TST) as Measured by Ōura Ring Wearable Device at Week 8 Change from baseline at Week 8	0.09 hours Standard Deviation 1.145

SECONDARY outcome

Timeframe: Baseline; Week 8

Population: Intent-to-Treat (ITT) Population: all participants who enrolled in the study. Only participants with available data were analyzed.

The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 8b is a validated instrument used to measure the severity of sleep disturbance. The PROMIS score includes 8 items, each of which asks the participant to rate the severity of their sleep disturbance on a daily basis on a severity scale of 1 to 5. The PROMIS total score is calculated as the sum of the 8 items and ranges from 8 to 40. A higher PROMIS score indicates more severe sleep disturbance. The baseline score was the 7-day average of nonmissing scores for the 6 days preceding a participant's Visit 1 and their response at Visit 1. Week 8 scores comprised the 7-day average of nonmissing scores for the 6 days preceding a participant's Visit 3 and their response at Visit 3. The average was not valid and was set to missing if scores were missing on 4 or more days. Change from baseline was calculated as the post-baseline value minus the baseline value.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID n=34 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area.
Change From Baseline in PROMIS Sleep Disturbance - Short Form 8b Score (24-hour Recall) at Week 8 Baseline	27.58 scores on a scale Standard Deviation 4.955
Change From Baseline in PROMIS Sleep Disturbance - Short Form 8b Score (24-hour Recall) at Week 8 Change from baseline at Week 8	-7.47 scores on a scale Standard Deviation 7.802

Adverse Events

Ruxolitinib 1.5% Cream BID

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ruxolitinib 1.5% Cream BID n=47 participants at risk Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area.
General disorders Application site pain	2.1% 1/47 • up to 12 weeks Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 application of study drug during the treatment period.
Infections and infestations Nasopharyngitis	2.1% 1/47 • up to 12 weeks Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 application of study drug during the treatment period.
Infections and infestations Upper respiratory tract infection	4.3% 2/47 • up to 12 weeks Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 application of study drug during the treatment period.
Injury, poisoning and procedural complications Fall	2.1% 1/47 • up to 12 weeks Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 application of study drug during the treatment period.
Injury, poisoning and procedural complications Muscle strain	2.1% 1/47 • up to 12 weeks Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 application of study drug during the treatment period.
Investigations Blood creatine phosphokinase increased	2.1% 1/47 • up to 12 weeks Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 application of study drug during the treatment period.
Musculoskeletal and connective tissue disorders Joint swelling	2.1% 1/47 • up to 12 weeks Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 application of study drug during the treatment 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