This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Open label
Clinical Site
North Little Rock, Arkansas, United States
RECRUITINGClinical Site
Pharmacokinetics (PK) of sonelokimab in adolescents
PK (trough concentrations) of sonelokimab over 24 weeks of treatment
Time frame: Week 24
Adverse events (AEs) following treatment with sonelokimab in adolescents
Incidence, relatedness, severity and seriousness of all AEs over 24 weeks of treatment from baseline
Time frame: Week 24
Discontinuation of sonelokimab treatment due to AEs
Number of participants discontinued from sonelokimab treatment due to AE over 24 weeks of treatment from baseline
Time frame: Week 24
Clinically significant changes in clinical laboratory parameters
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Time frame: Week 24
Clinically significant changes in vital signs
Number of participants with clinically significant changes in vital signs from baseline
Time frame: Week 24
Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals
Number of participants with clinically significant changes in 12-lead ECG intervals from baseline
Time frame: Week 24
Hidradenitis Suppurativa Clinical Response (HiSCR)75
Percentage of participants achieving a HiSCR75 response over time
Time frame: Week 24
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Stanford, California, United States
Clinical Site
Washington D.C., District of Columbia, United States
RECRUITINGClinical Site
Hollywood, Florida, United States
RECRUITINGClinical Site
Miami, Florida, United States
RECRUITINGClinical Site
Macon, Georgia, United States
RECRUITINGClinical Site
Sandy Springs, Georgia, United States
RECRUITINGClinical Site
Chicago, Illinois, United States
RECRUITINGClinical Site
Columbus, Indiana, United States
RECRUITINGClinical Site
Murray, Kentucky, United States
RECRUITING...and 8 more locations
Hidradenitis Suppurativa Clinical Response (HiSCR) 50
Percentage of participants achieving a HiSCR50 response over time
Time frame: Week 24
International Hidradenitis Suppurativa Severity Score System (IHS4)
Absolute change in IHS4 score over time
Time frame: Week 24
Children's Dermatology Life Quality Index (CDLQI)
Percentage of participants achieving a CDLQI total reduction of ≥2.5 over time among participants with a baseline CDLQI ≥2.5
Time frame: Week 24
Numerical Rating Scale (NRS) 30
Percentage of participants achieving a ≥30% reduction and a ≥2-unit reduction over time in the NRS30 for pain in PGA among participants with a baseline NRS ≥3
Time frame: Week 24