A Phase 3 interventional study of Sonelokimab in Hidradenitis Suppurativa, sponsored by MoonLake Immunotherapeutics AG. Completed at 18 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by MoonLake Immunotherapeutics AG · Phase 3, Interventional, and Treatment
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.
This study's enrollment of 35 is below the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →MoonLake Immunotherapeutics AG is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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Subjects will receive sonelokimab 120mg subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dose starting at Week 8
Drug: Sonelokimab
Open label
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
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sonelokimab
MoonLake Immunotherapeutics AG