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
- Ann Arbor, Aventura, Baltimore, Baton Rouge, Birmingham, Canton, Clarkston, Columbus, Dallas, Fargo, Fountain Valley, Hialeah, Las Vegas, Miami, Milwaukee, Morgantown, Murfreesboro, Murray, New Brighton, New York, North Little Rock, Ocala, Omaha, Plainfield, Plano, San Antonio, Santa Monica, Skokie, Tampa, and Waterford, United StatesSee the 30 sites
- Phase
- Phase 3
Where in United States
- Ann Arbor, MichiganHospital not named in the registryNo longer taking part
- Aventura, FloridaHospital not named in the registryNo longer taking part
- Baltimore, MarylandHospital not named in the registryNo longer taking part
- Baton Rouge, LouisianaHospital not named in the registryNo longer taking part
- Birmingham, AlabamaHospital 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
- Dallas, TexasHospital not named in the registryNo longer taking part
- Fargo, North DakotaHospital not named in the registryNo longer taking part
- Fountain Valley, CaliforniaHospital not named in the registryNo longer taking part
- Hialeah, FloridaHospital not named in the registryNo longer taking part
- Las Vegas, NevadaHospital not named in the registryNo longer taking part
- Miami, FloridaHospital not named in the registryNo longer taking part
- Milwaukee, WisconsinHospital 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 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
- Ocala, FloridaHospital 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
- Plano, TexasHospital not named in the registryNo longer taking part
- San Antonio, TexasHospital not named in the registryNo longer taking part
- Santa Monica, CaliforniaHospital not named in the registryNo longer taking part
- Skokie, IllinoisHospital not named in the registryNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
- Waterford, ConnecticutHospital not named in the registryNo longer taking part
Trial details
- Who runs it
- MoonLake Immunotherapeutics AG
- Trial code
- NCT06411379
- Record updated
- 8 June 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.