NCT07007637Phase 3Enrolling by invitation

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

Study sponsor: MoonLake Immunotherapeutics AG

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-06-13Estimated

Enrollment · participants835Estimated

Source updated2026-06-08Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Hidradenitis Suppurativa

Treatments or interventions studied

SonelokimabDrug

Primary outcomes · main study measures

Read the study measures

measure: Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab; description: Incidence, relatedness, severity and seriousness of all AEs; timeFrame: 2.5-3 years; measure: Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs); description: Incidence, relatedness, severity and seriousness of all TEAEs; timeFrame: 2.5-3 years; measure: Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs); description: Incidence, relatedness, severity and seriousness of all AESIs; timeFrame: 2.5-3 years; measure: Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs; description: Number of participants discontinued from sonelokimab treatment due to AEs; timeFrame: 2.5-3 years; measure: Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters; description: Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline; timeFrame: 2.5-3 years; measure: Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram; description: Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline; timeFrame: 2.5-3 years

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history