Primary Outcome
Open
Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)
Timeframe: Week 16
Eczema
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1
Incyte Study ID:
INCB 18424-313
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Other
Clinical Study Purpose
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jan 2023 - Apr 2024
TYPE
Interventional
PHASE
Phase 3
SEX
Female & Male
AGE
18 - 99 Years
ACCEPTS HEALTHY VOLUNTEERS
No
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months.
- Screening and baseline IGA-CHE 3 or 4.
Exclusion Criteria
- Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
- Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
Clinical Study Locations
Location
Status
Location
LYNDERM RESEARCH INC
MARKHAM, ON, Canada, L3P 1X3
Status
Not yet recruiting
Location
DERMATOLOGY RESEARCH INSTITUTE INC.
CALGARY, AB, Canada, T2J 7E1
Status
Not yet recruiting
Location
CARE CLINIC
RED DEER, AB, Canada, T4P-1K4
Status
Not yet recruiting
Location
FAKULTNI NEMOCNICE U SV. ANNY V BRNE
BRNO, Czech Republic, 656 91
Status
Not yet recruiting
Location
KRAJSKA ZDRAVOTNI A.S. - MASARYKOVA NEMOCNICE V USTI NAD LABEM O.Z.
USTI NAD LABEM, Czech Republic, 401 13
Status
Not yet recruiting
Location
CCR CZECH A.S.
PARDUBICE, Czech Republic, 53000
Status
Not yet recruiting
Protocol Summary
Incyte Study ID:
INCB 18424-313
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Interventions:
Drug
Enrollment:
0
Secondary Outcome
Open
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
Timeframe: Week 16
Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score
Timeframe: Week 16
Change from baseline in the modified Total Lesion Symptom Score (mTLSS)
Timeframe: Up to Week 32
Proportion of participants achieving an IGA-CHE-TS from baseline
Timeframe: Up to Week 32
Change from baseline in CHE-related Itch Numerical Rating Scale (NRS) score (weekly average)
Timeframe: Up to Week 32
Change from baseline in CHE-related Pain NRS score (weekly average)
Timeframe: Up to Week 32
Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score
Timeframe: Up to Week 32
Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score.
Timeframe: Up to Week 32
Percentage change in Hand Eczema Severity Index (HECSI)
Timeframe: Week 16
Proportion of Participants with HECSI-75
Timeframe: Weeks 2, 8, 16 and 32
Proportion of participants with HECSI-90
Timeframe: Weeks 2, 8, 16, and 32
Mean Patient Global Impression of Change (PGIC) score
Timeframe: Up to Week 32
Proportion of participants with each score on the PGIC
Timeframe: Up to Week 32
Proportion of Participants with a score of either 1 or 2 on the PGIC
Timeframe: Up to Week 32