A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Key facts
- Where
- Boardman, Boston, Charleston, Columbus, Coral Gables, Coral Springs, Dayton, Dearborn, Forest, Frisco, Hollywood, Houston, Las Vegas, Los Angeles, Louisville, Macon, Margate, Mayfield Heights, Metairie, Miami, Mill Creek, Nashville, New Albany, New York, Northridge, Oklahoma City, Sacramento, San Diego, Sandy Springs, South Jordan, Tampa, The Bronx, Warren, and West Dundee, United StatesSee the 34 sites
- Phase
- Phase 3
Where in United States
- Boardman, OhioHospital not named in the registryNo longer taking part
- Boston, MassachusettsHospital not named in the registryNo longer taking part
- Charleston, South CarolinaHospital 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
- Coral Springs, FloridaHospital not named in the registryNo longer taking part
- Dayton, OhioHospital not named in the registryNo longer taking part
- Dearborn, MichiganHospital not named in the registryNo longer taking part
- Forest, VirginiaHospital not named in the registryNo longer taking part
- Frisco, TexasHospital 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
- Margate, FloridaHospital not named in the registryNo longer taking part
- Mayfield Heights, OhioHospital 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
- Nashville, TennesseeHospital not named in the registryNo longer taking part
- New Albany, IndianaHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- Northridge, CaliforniaHospital not named in the registryNo longer taking part
- Oklahoma City, OklahomaHospital not named in the registryNo longer taking part
- Sacramento, CaliforniaHospital not named in the registryNo longer taking part
- San Diego, CaliforniaHospital not named in the registryNo longer taking part
- Sandy Springs, GeorgiaHospital 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
- Warren, MichiganHospital not named in the registryNo longer taking part
- West Dundee, IllinoisHospital not named in the registryNo longer taking part
Trial details
- Who runs it
- MoonLake Immunotherapeutics AG
- Trial code
- NCT06411899
- Record updated
- 12 August 2026
- Original description
This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.Read full original descriptionShow less
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
Inclusion: Participants must be at least 18 years of age at the time of signing the informed consent; Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent; Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion; Participants who have a total AN count of ≥5; Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).
Exclusion: Participants with a known hypersensitivity to sonelokimab or any of its excipients; Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS; Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk; Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol; Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS; Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.