Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.
This is a placebo controlled study where subjects with severe chronic hand eczema will be randomized (1:1:1) to receive ASN002 at 40 mg, 80 mg, or placebo once daily for 16 weeks (Part A). Then, in Part B, subjects who were assigned to placebo in the first part of the study will receive the highest dose of ASN002 (80 mg) for the rest of the treatment period (up to Week 32). The subjects who were assigned ASN002 in the first part of the study will continue on the same assigned treatment dose during the second part of the study (Week 16 to Week 32). The total treatment period of 32 weeks will be followed by a 4 week follow-up period.This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
97
Daily dose of ASN002 for 32 weeks
Daily dose of Placebo Oral Tablet for 16 weeks
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
Percent change from baseline in hand mTLSS at Week 16. The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, edema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale. The ratings are 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: 16 weeks
Change From Baseline in Hand Physician Global Assessment (PGA)
Proportion of participants with a response of Physicians Global Assessment achieving clear (0) or almost clear (1)
Time frame: 16 weeks
Change From Baseline in Hand Patient Global Assessment (PaGA)
Reduction of PaGA compared to baseline where marked improvement was noted with at least 75% clear
Time frame: 16 weeks
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