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 · Phase 3

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT07007637

Run by

MoonLake Immunotherapeutics AG

People needed

835

Starts

2025-06-27

Expected to finish

2028-06-13

Last updated by the study team

2026-06-08

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Site — North Little Rock, Arkansas, United States
• Clinical Site — Los Angeles, California, United States
• Clinical Site — Northridge, California, United States
• Clinical Site — Aventura, Florida, United States
• Clinical Site — Coral Gables, Florida, United States
• Clinical Site — Hialeah, Florida, United States
• Clinical Site — Hollywood, Florida, United States
• Clinical Site — Miami, Florida, United States
• Clinical Site — Miami, Florida, United States
• Clinical Site — Ocala, Florida, United States
• Clinical Site — Tampa, Florida, United States
• Clinical Site — Tampa, Florida, United States
• Clinical Site — Macon, Georgia, United States
• Clinical Site — Sandy Springs, Georgia, United States
• Clinical Site — Skokie, Illinois, United States
• Clinical Site — West Dundee, Illinois, United States
• Clinical Site — Columbus, Indiana, United States
• Clinical Site — New Albany, Indiana, United States
• Clinical Site — Plainfield, Indiana, United States
• Clinical Site — Louisville, Kentucky, United States
• Clinical Site — Murray, Kentucky, United States
• Clinical Site — Metairie, Louisiana, United States
• Clinical Site — Boston, Massachusetts, United States
• Clinical Site — Boston, Massachusetts, United States
• Clinical Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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