A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
← catalyst calendarNCT07007637 · readout in 664 d
Sponsored by MoonLake Immunotherapeutics AG (industry) · MLTX — their whole pipeline →.
Phase
Phase 3
Status
Enrolling by invitation
Study type
Interventional
Design
Na · None · Treatment
Enrollment
835estimated
Sites
166
Countries
Belgium, Bulgaria, Canada +13
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-27 | actual | When the study began enrolling |
| Primary completion | 2028-06-13 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-06-13 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hidradenitis Suppurativa
Intervention
- Drug: Sonelokimab
Primary outcomes
what the primary-completion date above is the date OFLong-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab
measured 2.5-3 years
Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)
measured 2.5-3 years
Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)
measured 2.5-3 years
Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs
measured 2.5-3 years
Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters
measured 2.5-3 years
Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram
measured 2.5-3 years
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