This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.
This randomized, double-blind, placebo-controlled, multicenter, phase 2 study aims to evaluate the efficacy of abrocitinib in 84 adult subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
Abrocitinib will be available in 100 mg strength tablet
Abrocitinib will be available in 100 mg strength tablet
Placebo tablet
INNO-6052 Site 12
Fredericton, New Brunswick, Canada
INNO-6052 Site 13
Cobourg, Ontario, Canada
INNO-6052 Site 11
Montreal, Quebec, Canada
INNO-6052 Site 19
Krakow, Poland
Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)
The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, oedema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale.These ratings are then added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease).
Time frame: Week 16
Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)
The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, oedema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale.These ratings are then added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease).
Time frame: Weeks 2, 4 and 12
Reduction from baseline in hand Physician's Global Assessment (PGA)
The PGA is a global assessment of the current state of the disease and will be completed specific to the hands. It is a 5-point scale of overall disease severity by rating the particular signs and symptoms of chronic hand eczema (erythema, scaling, hyperkeratosis/lichenification, vesiculation, oedema, fissures and pruritus/pain).
Time frame: Weeks 2, 4, 12 and 16
Change from baseline in Hand Eczema Severity Index (HECSI)
The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.
Time frame: Weeks 2, 4, 12 and 16
Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE)
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INNO-6052 Site 17
Lodz, Poland
INNO-6052 Site 21
Lublin, Poland
INNO-6052 Site 23
Mikołów, Poland
INNO-6052 Site 18
Osielsko, Poland
INNO-6052 Site 15
Pomorskie, Poland
INNO-6052 Site 20
Szczecin, Poland
...and 2 more locations
The Extent of Disease will be estimated by the physician as the percentage of hand area (palmar and dorsal) affected by eczema, both hands (both surface) cumulating 100%.
Time frame: Weeks 2, 4, 12 and 16
Patient Global Assessment (PaGA) measurements
Using the PaGA chart, subjects will be asked by the investigator to grade their overall change from baseline in their CHE by selecting the description which best matches their perception of treatment effect.
Time frame: Weeks 2, 4, 12 and 16
Change from baseline in hand Dermatology Life Quality Index (DLQI)
The DLQI is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions.
Time frame: Weeks 2, 4, 12 and 16
Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. The QOLHEQ total-score ranges from 0-127 points.
Time frame: Weeks 2, 4, 12 and 16
Change from baseline in pain Numerical Rating Scale (NRS)
The intensity of pain related to CHE will be recorded using a NRS. Pain intensity will be evaluated by asking subjects to assign a numerical score representing of the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst imaginable symptoms.
Time frame: Weeks 2, 4, 12 and 16
Change from baseline in itch Numerical Rating Scale (NRS)
The intensity of pruritus associated with CHE will be recorded using an NRS. This will be evaluated by asking subjects to assign a numerical score between 0 and 10 corresponding to their worst itching over the past 24 hours, with 0 indicating no itch and 10 indicating worst imaginable itch.
Time frame: Weeks 2, 4, 12 and 16