Atopic Dermatitis
Conditions
Keywords
ruoltitinib, atopic dermatitis, sleep distubance, itch, Opzelura
Brief summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.
Interventions
DRUGruxolitinib cream
ruxolitinib cream 1.5% will be applied twice daily as a thin film
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria. * Has at least a 2-year history of AD (information obtained from medical chart, participant's physician, or directly from the participant). * Has an overall BSA affected by AD of 3%-20% (excluding scalp) at the screening and baseline visits. * Has an IGA score ≥ 2 at the screening and baseline visits. * Has an Itch NRS score ≥ 4 at the screening and baseline visits. * Willing to complete the once-daily Itch NRS (24-hour recall period) entries at approximately the same time each day during the study. * Agrees to maintain a regular sleep schedule during the study period. * Willing and able to follow required study procedures for measuring sleep for the duration of the study.
Exclusion criteria
* Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study. * Currently has a schedule that includes nighttime work shifts. * Has had significant flares or unstable course in AD (ie, condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening (information obtained from medical chart, participant's physician, or directly from the participant). * Has received any ultraviolet B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to the screening period. * Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period. * Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study. * Has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the screening period. * Has had prior treatment with a JAK inhibitor that was discontinued for safety reasons or tolerance problems. * Has a known or suspected allergy to ruxolitinib or any component of the study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Sleep Time (TST) as Measured by Ōura Ring Wearable Device at Week 8 | Baseline; Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PROMIS Sleep Disturbance - Short Form 8b Score (24-hour Recall) at Week 8 | Baseline; Week 8 | 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. |
Countries
United States
Participant flow
Pre-assignment details
This study was conducted at 17 study centers in the United States.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ruxolitinib 1.5% Cream BID |
|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 16.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 16 Participants |
| Race/Ethnicity, Customized Captured as Other in Database | 1 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants |
| Race/Ethnicity, Customized White | 21 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 7 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Change From Baseline in Total Sleep Time (TST) as Measured by Ōura Ring Wearable Device at Week 8
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
p-value: 0.8357paired t-test
Secondary
Change From Baseline in PROMIS Sleep Disturbance - Short Form 8b Score (24-hour Recall) at Week 8
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.
Time frame: Baseline; Week 8
Population: Intent-to-Treat (ITT) Population: all participants who enrolled in the study. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
p-value: 0.0001paired t-test