Dermatitis
The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis
Incyte Study ID:
INCB 18424-901
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Results Available
Protocol
Available Languages: English
Statistical Analysis Plan (SAP)
Available Languages: English
Clinical Study Purpose
The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Oct 2021 - Nov 2022
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18 - 65 Years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Location
Status
Location
Innovoderm Research
Montreal, Quebec, Canada, H2K 4LS
Status
Recruiting
Location
INNOVADERM RESEARCH INC.
MONTREAL, QC, Canada, H2K 4L5
Status
Recruiting
Key Inclusion and Exclusion 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 .
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.
Protocol Summary
Incyte Study ID:
INCB 18424-901
Primary Purpose:
Treatment
Allocation:
N/A
Study Design:
Single Group Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
49
Primary Outcome
Open
Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline
Timeframe: 2 Days
Secondary Outcome
Open
modified Peak Pruritus Numerical Rating Scale (mPP-NRS)
Timeframe: 1 Day
Change in Peak Pruritus Numerical Rating Scale (PPR-NRS) from baseline
Timeframe: Day 3 through Day 29
1-grade decrease in mPP-NRS
Timeframe: 1 Day
1-grade decrease in PP-NRS
Timeframe: Day 2 through Day 29
2-grade decrease in mPP-NRS
Timeframe: 1 Day
2-grade decrease in PP-NRS
Timeframe: Day 2 through Day 29
Time to achieve Minimal Clinically Important Difference (MCID)
Timeframe: 29 Days
Change in Investigator Global Assessment (IGA) from baseline
Timeframe: Days 8,15, and 29
Proportion of participants achieving the Investigator Global Assessment-Treatment Success (IGA-TS)
Timeframe: Days 8, 15, and 29
Incidence and severity of local and systemic Adverse Events (AEs)
Timeframe: Up to 85 Days