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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

Who runs it
MoonLake Immunotherapeutics AG
Where
Lisbon and Porto, PortugalSee the 2 sitesAlso in 15 other countries, 134 sites
Trial code
Status
Enrolling by invitation
Phase
Phase 3
People taking part
835 people, planned
Started
27 Jun 2025
Expected to end
13 Jun 2028
Type of study
Interventional
Treatments tested
  • Sonelokimab
Record updated
8 June 2026

Who can take part

Age
12 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Portugal

Also in 15 other countries, 134 sites

  • LisbonHospital not named in the registryNo longer taking part
  • PortoHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • Experimental: sonelokimabTreatment being tested

    All participants will receive sonelokimab 120 mg Q4W for up to 2 years

    Treatment: Sonelokimab

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

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
8 June 2026