Hidradenitis suppurativa
Conditions
Sponsors
Abbvie GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline. -Total abscess and inflammatory nodule (AN) count of >= 5 at Baseline, presence of HS lesions in at least 2 distinct anatomical areas, and draining fistula count of <=20 at Baseline. -History of inadequate response or an intolerance to adequate trial of oral antibiotics for treatment of HS. -Required to use a daily antiseptic wash on HS lesions.
Exclusion criteria
Exclusion criteria: History of active skin disease (other than HS) that could interfere with assessment of HS, including skin infections requiring systemic treatment within 4 weeks of the Baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 12 ] HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants Achieving Skin Pain Numeric Rating Scale 30 (NRS30) [ Time Frame: Week 12 ] The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) assesses the worst skin pain and the average skin pain due to HS. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst in participants with NRS >=3 at Baseline are assessed. | — |
Countries
Japan, North America
Outcome results
None listed