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A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Sponsor: MoonLake Immunotherapeutics AG
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
422
Start Date
2024-05-15
Completion Date
2026-06-17
Last Updated
2025-05-21
Healthy Volunteers
No
Conditions
Interventions
Sonelokimab
Sonelokimab
Placebo
Placebo
Locations (109)
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Los Angeles, California, United States
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Northridge, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Coral Gables, Florida, United States
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Coral Springs, Florida, United States
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Hollywood, Florida, United States
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Margate, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Macon, Georgia, United States
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Sandy Springs, Georgia, United States
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West Dundee, Illinois, United States
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Columbus, Indiana, United States
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New Albany, Indiana, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Dearborn, Michigan, United States
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Warren, Michigan, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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The Bronx, New York, United States
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Boardman, Ohio, United States
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Dayton, Ohio, United States
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Mayfield Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Frisco, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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South Jordan, Utah, United States
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Forest, Virginia, United States
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Mill Creek, Washington, United States
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Pleven, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Sherwood Park, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Fredericton, New Brunswick, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Berlin, Germany
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Bochum, Germany
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Buxtehude, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt, Germany
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Halle, Germany
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Hanover, Germany
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Langenau, Germany
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Mahlow, Germany
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München, Germany
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Münster, Germany
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Oldenburg, Germany
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Wuppertal, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Debrecen, Hungary
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Pécs, Hungary
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Brescia, Italy
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Catania, Italy
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Chieti, Italy
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Cona, Italy
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Florence, Italy
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Milan, Italy
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Modena, Italy
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Naples, Italy
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Perugia, Italy
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Pisa, Italy
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Rome, Italy
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Rozzano, Italy
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Torino, Italy
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Torrette, Italy
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Oslo, Norway
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Bialystok, Poland
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Gdansk, Poland
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Krakow, Poland
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Krakow, Poland
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Lodz, Poland
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Lodz, Poland
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Lublin, Poland
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Ossy, Poland
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Poznan, Poland
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Sosnowiec, Poland
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Szczecin, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Lisbon, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Cardiff, United Kingdom
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Dudley, United Kingdom
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Leeds, United Kingdom
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Salford, United Kingdom