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ACTIVE NOT RECRUITING
NCT06411379
PHASE3

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

View on ClinicalTrials.gov

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

418

Start Date

2024-05-14

Completion Date

2026-06-17

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

DRUG

Sonelokimab

Sonelokimab

DRUG

Placebo

Placebo

Locations (106)

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Birmingham, Alabama, United States

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North Little Rock, Arkansas, United States

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Fountain Valley, California, United States

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Santa Monica, California, United States

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Aventura, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Tampa, Florida, United States

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Skokie, Illinois, United States

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Plainfield, Indiana, United States

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Murray, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Ann Arbor, Michigan, United States

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Canton, Michigan, United States

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Clarkston, Michigan, United States

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Waterford, Michigan, United States

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New Brighton, Minnesota, United States

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Omaha, Nebraska, 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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Fargo, North Dakota, United States

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Columbus, Ohio, United States

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Murfreesboro, Tennessee, United States

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Dallas, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Woluwe-Saint-Lambert, Belgium

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Stara Zagora, Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Guelph, Ontario, Canada

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Peterborough, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Saskatoon, Saskatchewan, Canada

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Ostrava, Czechia

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Prague, Czechia

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Prague, Czechia

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Antony, France

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Besançon, France

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Brest, France

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Dijon, France

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Le Mans, France

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Lyon, France

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Montpellier, France

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Rouen, France

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Saint-Mandé, France

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Saint-Priest-en-Jarez, France

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Toulouse, France

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Augsburg, Germany

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Bad Bentheim, Germany

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Berlin, Germany

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Bielefeld, Germany

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Bochum, Germany

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Bramsche, Germany

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Darmstadt, Germany

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Dresden, Germany

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Gera, Germany

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Hamburg, Germany

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Kiel, Germany

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Lübeck, Germany

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Würzburg, Germany

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Dublin, Ireland

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Rotterdam, Netherlands

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Chorzów, Poland

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Katowice, Poland

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Kielce, Poland

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Olsztyn, Poland

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Poznan, Poland

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Szczecin, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Trnava, Slovakia

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Alcorcón, Spain

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Alicante, Spain

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Badalona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Cadiz, Spain

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Córdoba, Spain

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Granada, Spain

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Granada, Spain

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Granollers, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Manises, Spain

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Málaga, Spain

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Santiago de Compostela, Spain

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Seville, Spain

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Valencia, Spain

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Valencia, Spain