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NCT07007637

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

Enrolling by Invitation
PHASE3Ages 12+InterventionalTreatment
MoonLake Immunotherapeutics AG
~835 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Sonelokimab

At a glance

Recruiting sites
0 of 166 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab
Measured over 2.5-3 years
+5 more outcomes measured

Conditions

Hidradenitis Suppurativa

Explore related trials

Hidradenitis Suppurativa

Where it's being run

166 sites across 44 states
Poland22
Germany20
Spain17
Italy13
Ontario12
Florida9
Texas5
Michigan4

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
Female participants are eligible to participate if they are not pregnant or breastfeeding
Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.

Exclusion

Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol.
Participants who plan to participate in another interventional study for a drug or device during this study.

What this trial measures

  • Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab2.5-3 years

    Incidence, relatedness, severity and seriousness of all AEs

  • Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)2.5-3 years

    Incidence, relatedness, severity and seriousness of all TEAEs

  • Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)2.5-3 years

    Incidence, relatedness, severity and seriousness of all AESIs

  • Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs2.5-3 years

    Number of participants discontinued from sonelokimab treatment due to AEs

  • Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters2.5-3 years

    Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline

  • Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram2.5-3 years

    Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline