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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
Bialystok, Chorzów, Gdansk, Katowice, Kielce, Krakow, Lodz, Lublin, Ossy, Poznan, Sosnowiec, Szczecin, Warsaw, and Wroclaw, PolandSee the 14 sites
Phase
Phase 3

Where in Poland

  • BialystokHospital not named in the registryNo longer taking part
  • ChorzówHospital not named in the registryNo longer taking part
  • GdanskHospital not named in the registryNo longer taking part
  • KatowiceHospital not named in the registryNo longer taking part
  • KielceHospital not named in the registryNo longer taking part
  • KrakowHospital not named in the registryNo longer taking part
  • LodzHospital not named in the registryNo longer taking part
  • LublinHospital not named in the registryNo longer taking part
  • OssyHospital not named in the registryNo longer taking part
  • PoznanHospital not named in the registryNo longer taking part
  • SosnowiecHospital not named in the registryNo longer taking part
  • SzczecinHospital not named in the registryNo longer taking part
  • WarsawHospital not named in the registryNo longer taking part
  • WroclawHospital 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