This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
422
Sonelokimab
Placebo
Hidradenitis Suppurativa Clinical Response 75
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
Time frame: Week 16
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Percentage of participants achieving HiSCR50
Time frame: Week 16
Change in International Hidradenitis Suppurativa Severity Score System
Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
Time frame: Week 16
Dermatology Life Quality Index (DLQI)
Percentage of participants achieving a DLQI total reduction of ≥4 minimal clinically important difference among participants with a baseline DLQI ≥4. DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health related quality of life impairment.
Time frame: Week 16
Reduction from Numerical Rating Scale (NRS30 & NR550) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
Percentage of participants achieving at least ≥30% (and ≥50%) reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30 \& NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3
Time frame: Week 16
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Clinical Site
Los Angeles, California, United States
Clinical Site
Northridge, California, United States
Clinical Site
Sacramento, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
Coral Gables, Florida, United States
Clinical Site
Coral Springs, Florida, United States
Clinical Site
Hollywood, Florida, United States
Clinical Site
Margate, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Tampa, Florida, United States
...and 99 more locations
Patient Global Impression-Severity of Illness-Hidradenitis Suppurativa at Week 16
Percentage of participants with minimal or absent symptoms using the Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16. Participants choose the response that best describes the severity of their disease. The question is rated on a 7-point scale ranging from 0 to 6 (0=absent; 1=minimal; 2=mild; 3=moderate; 4=moderately severe; 5=severe; 6=very severe).
Time frame: Week 16
Resolution of draining tunnels (DT100)
Percentage of participants with zero draining tunnels in the subgroup of participants with at least one draining tunnel at baseline (DT100)
Time frame: Week 16 and Week 52