Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Anti-Inflammatory Agents, Sonelokimab, Nanobody, Apocrine Gland Disease
Brief summary
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
Interventions
DRUGSonelokimab
Open label
Sponsors
MoonLake Immunotherapeutics AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent. 2. Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent. 3. Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III). 4. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS . 5. Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study. 6. Participants with a body weight of ≥ 40 kg.
Exclusion criteria
1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants with a draining fistula count of ≥20 at the Screening Visit. 3. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS. 4. Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk. 5. Participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk. 6. Participants with any other skin disease or other medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS. 7. Participants with a confirmed or suspected diagnosis of inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals | Week 24 | Number of participants with clinically significant changes in 12-lead ECG intervals from baseline |
| Pharmacokinetics (PK) of sonelokimab in adolescents | Week 24 | PK (trough concentrations) of sonelokimab over 24 weeks of treatment |
| Adverse events (AEs) following treatment with sonelokimab in adolescents | Week 24 | Incidence, relatedness, severity and seriousness of all AEs over 24 weeks of treatment from baseline |
| Discontinuation of sonelokimab treatment due to AEs | Week 24 | Number of participants discontinued from sonelokimab treatment due to AE over 24 weeks of treatment from baseline |
| Clinically significant changes in clinical laboratory parameters | Week 24 | Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline |
| Clinically significant changes in vital signs | Week 24 | Number of participants with clinically significant changes in vital signs from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hidradenitis Suppurativa Clinical Response (HiSCR) 50 | Week 24 | Percentage of participants achieving a HiSCR50 response over time |
| International Hidradenitis Suppurativa Severity Score System (IHS4) | Week 24 | Absolute change in IHS4 score over time |
| Children's Dermatology Life Quality Index (CDLQI) | Week 24 | Percentage of participants achieving a CDLQI total reduction of ≥2.5 over time among participants with a baseline CDLQI ≥2.5 |
| Numerical Rating Scale (NRS) 30 | Week 24 | 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 |
| Hidradenitis Suppurativa Clinical Response (HiSCR)75 | Week 24 | Percentage of participants achieving a HiSCR75 response over time |
Countries
United States
Contacts
Primary ContactMoonlake Clinical Trial Helpdesk
Outcome results
None listed