Clinical trial NCT04839380: The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
Official title: An Open-Label, Single-Arm Study to Evaluate the Effect of Ruxolitinib 1.5% Cream on Itch in Adult Participants With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: ruxolitinib
Itch
Chronic Pruritus
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.


Eligibility criteria: Inclusion Criteria:

* Participant has clinically confirmed diagnosis of active AD for at least a 6-months.
* Participant has chronic pruritus related to AD for at least 3 months .
* Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds) affected by AD of 1%-20% on Day 1.
* Participant has an IGA score of at least 2 on Day 1.
* Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening visit.
* Willingness to avoid pregnancy or fathering children.
* Participant must be willing to comply with all study procedures and restrictions including discontinuation of all current therapies for AD and pruritus (unless otherwise specified), and must be available for the duration of the study.

Exclusion Criteria:

* Female participnat who is breastfeeding, pregnant, or planning to become pregnant during the study.

Participant had significant flares or unstable course in AD.

* Participant has clinically infected AD or has used antibiotics (systemic or topical) for their infected AD within 2 weeks prior to the run-in period.
* Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
* Participant has any clinically significant medical condition or physical/laboratory/vital sign abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
* Participant has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the run-in period.
* Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements.

Primary outcomes:
measure: Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application)
timeFrame: Baseline; Day 2
Secondary outcomes:
measure: Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
timeFrame: Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose)
measure: Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)
timeFrame: Baseline; Day 3 through Day 29
measure: Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
timeFrame: Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose)
measure: Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
timeFrame: Baseline; Day 2 through Day 29
measure: Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1
timeFrame: Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose)
measure: Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29
timeFrame: Baseline; Day 2 through Day 29
measure: Time to Minimal Clinically Important Difference (MCID) for PP-NRS (≥2-grade Reduction in PP-NRS From Baseline )
timeFrame: from Baseline up to Day 29
measure: Time to MCID for mPP-NRS (≥2-grade Reduction in mPP-NRS From Baseline)
timeFrame: Baseline; Day 1
measure: Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29
timeFrame: Baseline; Days 8, 15, and 29
measure: Percentage of Participants Achieving Investigator Global Assessment-Treatment Success (IGA-TS) (Score of 0 or 1 in IGA With a ≥2-grade Reduction From Baseline) at Day 8, Day 15, and Day 29
timeFrame: Baseline; Days 8, 15, and 29
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to Day 43
measure: Number of Participants With Any Grade 3 or Higher TEAE
timeFrame: up to Day 43
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Montreal
country: Canada
facility: Innovoderm Research
state: Quebec
Study officials:
References: