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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
Ann Arbor, Aventura, Birmingham, Boardman, Boston, Canton, Clarkston, Columbus, Coral Gables, Dallas, Dayton, Fargo, Hialeah, Hollywood, Houston, Las Vegas, Los Angeles, Louisville, Macon, Metairie, Miami, Mill Creek, Morgantown, Murfreesboro, Murray, New Albany, New Brighton, New York, North Little Rock, Northridge, Ocala, Oklahoma City, Omaha, Plainfield, San Antonio, Sandy Springs, Skokie, South Jordan, Tampa, The Bronx, Waterford, and West Dundee, United StatesSee the 42 sitesAlso in 15 other countries, 94 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 United States

Also in 15 other countries, 94 sites

  • Ann Arbor, MichiganHospital not named in the registryNo longer taking part
  • Aventura, FloridaHospital not named in the registryNo longer taking part
  • Birmingham, AlabamaHospital not named in the registryNo longer taking part
  • Boardman, OhioHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Canton, MichiganHospital not named in the registryNo longer taking part
  • Clarkston, MichiganHospital not named in the registryNo longer taking part
  • Columbus, IndianaHospital not named in the registryNo longer taking part
  • Coral Gables, FloridaHospital not named in the registryNo longer taking part
  • Dallas, TexasHospital not named in the registryNo longer taking part
  • Dayton, OhioHospital not named in the registryNo longer taking part
  • Fargo, North DakotaHospital not named in the registryNo longer taking part
  • Hialeah, FloridaHospital not named in the registryNo longer taking part
  • Hollywood, FloridaHospital not named in the registryNo longer taking part
  • Houston, TexasHospital not named in the registryNo longer taking part
  • Las Vegas, NevadaHospital not named in the registryNo longer taking part
  • Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
  • Louisville, KentuckyHospital not named in the registryNo longer taking part
  • Macon, GeorgiaHospital not named in the registryNo longer taking part
  • Metairie, LouisianaHospital not named in the registryNo longer taking part
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Mill Creek, WashingtonHospital not named in the registryNo longer taking part
  • Morgantown, West VirginiaHospital not named in the registryNo longer taking part
  • Murfreesboro, TennesseeHospital not named in the registryNo longer taking part
  • Murray, KentuckyHospital not named in the registryNo longer taking part
  • New Albany, IndianaHospital not named in the registryNo longer taking part
  • New Brighton, MinnesotaHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • North Little Rock, ArkansasHospital not named in the registryNo longer taking part
  • Northridge, CaliforniaHospital not named in the registryNo longer taking part
  • Ocala, FloridaHospital not named in the registryNo longer taking part
  • Oklahoma City, OklahomaHospital not named in the registryNo longer taking part
  • Omaha, NebraskaHospital not named in the registryNo longer taking part
  • Plainfield, IndianaHospital not named in the registryNo longer taking part
  • San Antonio, TexasHospital not named in the registryNo longer taking part
  • Sandy Springs, GeorgiaHospital not named in the registryNo longer taking part
  • Skokie, IllinoisHospital not named in the registryNo longer taking part
  • South Jordan, UtahHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • The Bronx, New YorkHospital not named in the registryNo longer taking part
  • Waterford, ConnecticutHospital not named in the registryNo longer taking part
  • West Dundee, IllinoisHospital 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