SCRATCH-AD: The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Group : Ruxolitinib ruxolitinib cream 1.5% will be applied twice daily as a thin film. |
Drug: ruxolitinib cream
ruxolitinib cream 1.5% will be applied twice daily as a thin film
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline [2 Days]
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) [1 Day]
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 [Day 3 through Day 29]
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 [1 Day]
Define as proportion of participants achieving at least a 1-grade decrease from baseline in mPP-NRS.
- 1-grade decrease in PP-NRS [Day 2 through Day 29]
Define as proportion of participants achieving at least a 1-grade decrease from baseline in PP-NRS.
- 2-grade decrease in mPP-NRS [1 Day]
Define as proportion of participants achieving at least a 2-grade decrease from baseline in mPP-NRS.
- 2-grade decrease in PP-NRS [Day 2 through Day 29]
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) [29 Days]
Defined as ≥ 2-grade reduction in PP-NRS and mPP-NRS from baseline.
- Change in Investigator Global Assessment (IGA) from baseline [Days 8,15, and 29]
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) [Days 8, 15, and 29]
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) [Up to 85 Days]
Local and systemic Adverse Events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant has clinically confirmed diagnosis of active AD for at least a 6-months.
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Participant has chronic pruritus related to AD for at least 3 months .
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Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds) affected by AD of 1%-20% on Day 1.
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Participant has an IGA score of at least 2 on Day 1.
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Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening visit.
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Willingness to avoid pregnancy or fathering children.
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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.
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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.
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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.
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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.
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Participant has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the run-in period.
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Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Innovoderm Research | Montreal | Quebec | Canada | H2K 4LS |
Sponsors and Collaborators
- Incyte Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INCB 18424-901