Hidradenitis Suppurativa
Conditions
Sponsors
AbbVie G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant with moderate to severe Hidradenitis Suppurativa (HS) for at least one year prior to Baseline visit. - HS lesions present in at least two distinct anatomical areas. - Draining fistula count of = 5 at Baseline visit. - Participants are required to use a daily antiseptic wash on their HS lesions . - Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS
Exclusion criteria
Exclusion criteria: - Participant has a history of active skin disease other than HS that could interfere with the assessment of HS. - Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immuno deficiency virus (HIV) infection. - Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline. - Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit. - Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit. - Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 16 ] HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1.Percentage of participants achieving at least 30% reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) at Week 8 among participants with Baseline Numerical Rating Scale (NRS) >= 3 [ Time Frame: Baseline (Week 0) to approximately Week 8 ] NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain). 2.Percentage of participants achieving at least 30% reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) at Week 16 among participants with Baseline Numerical Rating Scale (NRS) >= 3 [ Time Frame: Baseline (Week 0) to approximately Week 16 ] NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain). 3.Percentage of participants who experience at least 25% increase in AN counts with a minimum increase of 2 relative to Baseline [ Time Frame: Baseline (Week 0) to approximately Week 16 ] Percentage of participants who experience at least 25% increase in AN counts with a minimum increase of 2 relative to Baseline is evaluated 4.Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline (Week 0) to approximately Week 16 ] The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. 5.Change from Baseline in HS-related swelling assessed based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) [ Time Frame: Baseline (Week 0) to approximately Week 16 ] HSSA is a 9-item patient reported outcome (PRO) questionnaire developed to assess the symptoms of HS on a 0 to 11-point numerical rating scale (NRS), where 0 represen | — |
Countries
Japan, North America, Oceania
Outcome results
None listed