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ACTIVE NOT RECRUITING
NCT06641076
PHASE3

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

Sponsor: MoonLake Immunotherapeutics AG

View on ClinicalTrials.gov

Summary

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Official title: A Phase 3, Parallel-group, Randomized, Double-blind, 3-arm, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

960

Start Date

2024-10-15

Completion Date

2027-02-04

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Sonelokimab

Randomized treatment, parallel-group

DRUG

Placebo

Randomized treatment, parallel-group

Locations (168)

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Avondale, Arizona, United States

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Chandler, Arizona, United States

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Flagstaff, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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San Diego, California, United States

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Upland, California, United States

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Avon Park, Florida, United States

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Clearwater, Florida, United States

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Hialeah, Florida, United States

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Tampa, Florida, United States

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Springfield, Illinois, United States

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Lake Charles, Louisiana, United States

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Baltimore, Maryland, United States

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Grand Blanc, Michigan, United States

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Leland, North Carolina, United States

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Salisbury, North Carolina, United States

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Statesville, North Carolina, United States

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Middleburg Heights, Ohio, United States

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Portland, Oregon, United States

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Memphis, Tennessee, United States

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Allen, Texas, United States

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Colleyville, Texas, United States

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Lubbock, Texas, United States

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Plano, Texas, United States

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Beckley, West Virginia, United States

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Plovdiv, Bulgaria

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Plovdiv, Bulgaria

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Plovdiv, Bulgaria

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Rousse, 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, Canada

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Trois-Rivières, Canada

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Waterloo, Canada

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Winnipeg, Canada

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Rijeka, Croatia

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Zagreb, Croatia

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Brno, Czechia

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Břeclav, Czechia

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Ostrava, Czechia

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Prague, Czechia

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Prague, Czechia

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Prague, Czechia

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Prague, Czechia

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Studénka, Czechia

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Zlín, Czechia

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Tallinn, Estonia

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Tallinn, Estonia

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Tartu, Estonia

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Kuopio, Finland

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Cahors, France

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Caluire-et-Cuire, France

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Échirolles, France

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Montpellier, France

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Narbonne, France

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Nice, France

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Rouen, France

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Tours, France

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Kutaisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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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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Erlangen, Germany

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Hamburg, Germany

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Herne, Germany

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Munich, Germany

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Munich, Germany

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München, Germany

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Athens, Attica, Greece

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Heraklion, Greece

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Gyula, Hungary

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Hódmezővásárhely, Hungary

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Kalocsa, Hungary

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Kistarcsa, Hungary

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Nyíregyháza, Hungary

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Székesfehérvár, Hungary

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Veszprém, Hungary

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Ādaži, Latvia

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Riga, Latvia

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Kaunas, Lithuania

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Šiauliai, Lithuania

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Bialystok, Poland

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Bialystok, Poland

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Bydgoszcz, Poland

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Bydgoszcz, Poland

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Bytom, Poland

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Częstochowa, Poland

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Dąbrówka, Poland

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Elblag, Poland

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Gdynia, Poland

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Krakow, Poland

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Krakow, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Lublin, Poland

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Nadarzyn, Poland

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Nowa Sól, Poland

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Olsztyn, Poland

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Poznan, Poland

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Poznan, Poland

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Poznan, Poland

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Poznan, Poland

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Poznan, Poland

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Poznan, Poland

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Siedlce, Poland

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Sochaczew, Poland

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Swidnica, Poland

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Torun, Poland

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Warsaw, Poland

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Warsaw, Poland

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Warsaw, Poland

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Warsaw, Poland

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Warsaw, Poland

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Warsaw, Poland

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Warsaw, Poland

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Wołomin, Poland

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Wroclaw, Poland

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Wroclaw, Poland

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Wroclaw, Poland

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Braga, Portugal

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Braga, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Bucharest, Romania

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Bucharest, Romania

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Bucharest, Romania

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Bucharest, Romania

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Bucharest, Romania

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Timișoara, Romania

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Belgrade, Serbia

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Novi Sad, Serbia

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Košice, Slovakia

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Martin, Slovakia

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Poprad, Slovakia

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Rimavská Sobota, Slovakia

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A Coruña, Spain

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Bilbao, Spain

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Castelló, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Sabadell, Spain

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Santiago de Compostela, Spain

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Santiago de Compostela, Spain

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Seville, Spain

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Seville, Spain

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Seville, Spain

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Valencia, Spain