The purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (HS) in adults.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties
Percent change from Baseline in AN (abscesses and nodules) count at Week 16
Total count of abscess and inflammatory nodules
Time frame: Day 1 to Week 16
Change from Baseline in abscess, nodule, and draining fistula counts at Week 16
Total count of abscess, inflammatory nodules, and draining fistula
Time frame: Day 1 to Week 16
Change from Baseline in IHS4 value at Week 16
ISH4 is a validated international clinimetric scale. The score is based on a count of inflamed lesions. The resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4).
Time frame: Day 1 to Week 16
Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16
Completion of questionnaire covering skin pain Patient's Global Assessment of Skin Pain (0=no pain, 10=worst imaginable pain) 0-10 Numerical Rating Scale (NRS).
Time frame: Day 1 to Week 16
Change from Baseline in HiSQOL Total Score at Week 16
Patient completion of the Hidradenitis Suppurativa Quality of Life (HiSQOL) questionnaire that contains Hidradenitis Suppurativa specific items such as drainage and odor in addition to more general skin specific items
Time frame: Change from Baseline in HiSQOL Total Score at Week 16
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