By InvitationPhase 3

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

United States, Belgium, Bulgaria835 participantsStarted 2025-06-27

Plain-language summary

This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab

Timeframe: 2.5-3 years

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

Timeframe: 2.5-3 years

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

Timeframe: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs

Timeframe: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters

Timeframe: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram

Timeframe: 2.5-3 years

Trial details

NCT IDNCT07007637

SponsorMoonLake Immunotherapeutics AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-13

View on ClinicalTrials.gov More Hidradenitis Suppurativa trials

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab

Timeframe: 2.5-3 years

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

Timeframe: 2.5-3 years

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

Timeframe: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs

Timeframe: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters

Timeframe: 2.5-3 years

Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram

Timeframe: 2.5-3 years