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COMPLETED
NCT05322473
PHASE2

Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

Sponsor: MoonLake Immunotherapeutics AG

View on ClinicalTrials.gov

Summary

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.

Official title: Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

234

Start Date

2022-04-25

Completion Date

2023-08-30

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

Sonelokimab (M1095)

randomized treatment; parallel-group

DRUG

Adalimumab

randomized treatment; parallel-group

OTHER

Placebo

randomized treatment; parallel-group

Locations (57)

Clinical Site

Fountain Valley, California, United States

Clinical Site

Los Angeles, California, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Ormond Beach, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Indianapolis, Indiana, United States

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Beverly, Massachusetts, United States

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Boston, Massachusetts, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Bellaire, Texas, United States

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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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Winnipeg, Manitoba, Canada

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Fredericton, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hamilton, 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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Peterborough, Ontario, Canada

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Saskatoon, Saskatchewan, Canada

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Bad Bentheim, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Bochum, Germany

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Darmstadt, Germany

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Dresden, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Kiel, Germany

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Lübeck, Germany

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Mahlow, Germany

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München, Germany

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Münster, Germany

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Dublin, Ireland

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Bergen op Zoom, Netherlands

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Rotterdam, Netherlands

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Gdansk, Poland

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Krakow, Poland

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Lodz, Poland

Clinical Site

Olsztyn, Poland

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Ossy, Poland

Clinical Site

Ostrowiec Świętokrzyski, Poland

Clinical Site

Poznan, Poland

Clinical Site

Warsaw, Poland

Clinical Site

Warsaw, Poland

Clinical Site

Wroclaw, Poland

Clinical Site

Wroclaw, Poland