Back to resultsThe Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis (SCRATCH-AD)
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
ruxolitinib cream
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring ruxolitinib, Itch, Chronic Pruritus
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.
Sites / Locations
- Innovaderm Research Inc.
- Innovoderm Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group : Ruxolitinib
Arm Description
ruxolitinib cream 1.5% will be applied twice daily as a thin film.
Outcomes
Primary Outcome Measures
Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline
PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable". Participants will be evaluated by asking to assign a numerical score representing their itch at the worst moment during the previous 24 hours.
Secondary Outcome Measures
modified Peak Pruritus Numerical Rating Scale (mPP-NRS)
mPP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable". Participants will be asked to evaluate the current intensity of their itch at the time of assessment.
Change in Peak Pruritus Numerical Rating Scale (PPR-NRS) from baseline
PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable". Participants will be evaluated by asking to assign a numerical score representing their itch at the worst moment during the previous 24 hours.
1-grade decrease in mPP-NRS
Define as proportion of participants achieving at least a 1-grade decrease from baseline in mPP-NRS.
1-grade decrease in PP-NRS
Define as proportion of participants achieving at least a 1-grade decrease from baseline in PP-NRS.
2-grade decrease in mPP-NRS
Define as proportion of participants achieving at least a 2-grade decrease from baseline in mPP-NRS.
2-grade decrease in PP-NRS
Define as proportion of participants achieving at least a 2-grade decrease from baseline in PP-NRS.
Time to achieve Minimal Clinically Important Difference (MCID)
Defined as ≥ 2-grade reduction in PP-NRS and mPP-NRS from baseline.
Change in Investigator Global Assessment (IGA) from baseline
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Proportion of participants achieving the Investigator Global Assessment-Treatment Success (IGA-TS)
Defined as IGA score of 0 or 1 in IGA with at least a 2-grade reduction from baseline.
Incidence and severity of local and systemic Adverse Events (AEs)
Local and systemic Adverse Events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04839380
Brief Title
The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
Acronym
SCRATCH-AD
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
November 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
ruxolitinib, Itch, Chronic Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group : Ruxolitinib
Arm Type
Experimental
Arm Description
ruxolitinib cream 1.5% will be applied twice daily as a thin film.
Intervention Type
Drug
Intervention Name(s)
ruxolitinib cream
Other Intervention Name(s)
INCB018424
Intervention Description
ruxolitinib cream 1.5% will be applied twice daily as a thin film
Primary Outcome Measure Information:
Title
Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline
Description
PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable". Participants will be evaluated by asking to assign a numerical score representing their itch at the worst moment during the previous 24 hours.
Time Frame
2 Days
Secondary Outcome Measure Information:
Title
modified Peak Pruritus Numerical Rating Scale (mPP-NRS)
Description
mPP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable". Participants will be asked to evaluate the current intensity of their itch at the time of assessment.
Time Frame
1 Day
Title
Change in Peak Pruritus Numerical Rating Scale (PPR-NRS) from baseline
Description
PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable". Participants will be evaluated by asking to assign a numerical score representing their itch at the worst moment during the previous 24 hours.
Time Frame
Day 3 through Day 29
Title
1-grade decrease in mPP-NRS
Description
Define as proportion of participants achieving at least a 1-grade decrease from baseline in mPP-NRS.
Time Frame
1 Day
Title
1-grade decrease in PP-NRS
Description
Define as proportion of participants achieving at least a 1-grade decrease from baseline in PP-NRS.
Time Frame
Day 2 through Day 29
Title
2-grade decrease in mPP-NRS
Description
Define as proportion of participants achieving at least a 2-grade decrease from baseline in mPP-NRS.
Time Frame
1 Day
Title
2-grade decrease in PP-NRS
Description
Define as proportion of participants achieving at least a 2-grade decrease from baseline in PP-NRS.
Time Frame
Day 2 through Day 29
Title
Time to achieve Minimal Clinically Important Difference (MCID)
Description
Defined as ≥ 2-grade reduction in PP-NRS and mPP-NRS from baseline.
Time Frame
29 Days
Title
Change in Investigator Global Assessment (IGA) from baseline
Description
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time Frame
Days 8,15, and 29
Title
Proportion of participants achieving the Investigator Global Assessment-Treatment Success (IGA-TS)
Description
Defined as IGA score of 0 or 1 in IGA with at least a 2-grade reduction from baseline.
Time Frame
Days 8, 15, and 29
Title
Incidence and severity of local and systemic Adverse Events (AEs)
Description
Local and systemic Adverse Events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time Frame
Up to 85 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Innovoderm Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4LS
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
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