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Enrolling 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

Key facts

Where
Oslo, NorwaySee the site
Phase
Phase 3

Where in Norway

  • OsloHospital not named in the registryNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
MoonLake Immunotherapeutics AG
Trial code
NCT07007637
Record updated
8 June 2026
Original description
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.Read full original descriptionShow less

A Phase 3, Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

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.

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 plan to participate in another interventional study for a drug or device during this study; 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.

ClinicalTrials.gov NCT07007637