This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
234
randomized treatment; parallel-group
randomized treatment; parallel-group
randomized treatment; parallel-group
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 12
Hidradenitis Suppurativa Clinical Response 50
Proportion of participants achieving HiSCR50
Time frame: Week 12
Change in International Hidradenitis Suppurativa Severity Score System
Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) The IHS4 score is calculated as follows: number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the 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 12
Dermatology Life Quality Index (DLQI)
Proportion of participants achieving a Dermatology Life Quality Index (DLQI) total score of ≤5 The 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 12
Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
Proportion of participants achieving at least 30% reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3 The NRS is a numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Site
Fountain Valley, California, United States
Clinical Site
Los Angeles, California, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Ormond Beach, Florida, United States
Clinical Site
St. Petersburg, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Indianapolis, Indiana, United States
Clinical Site
Beverly, Massachusetts, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Omaha, Nebraska, United States
...and 47 more locations
Time frame: Week 12