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RECRUITING
NCT06641089
PHASE3

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

Sponsor: MoonLake Immunotherapeutics AG

View on ClinicalTrials.gov

Summary

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Official title: A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-10-15

Completion Date

2027-01-15

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Sonelokimab

Sonelokimab

DRUG

Placebo

Placebo

DRUG

Risankizumab

Active comparator

Locations (128)

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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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Jonesboro, Arkansas, United States

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La Jolla, California, United States

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Pomona, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Thousand Oaks, 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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Miami Gardens, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Gainesville, Georgia, 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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Brooklyn, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Leland, 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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Duncansville, Pennsylvania, United States

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Jackson, Tennessee, United States

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Memphis, Tennessee, United States

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Murfreesboro, Tennessee, United States

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Allen, Texas, United States

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Austin, Texas, United States

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Baytown, Texas, United States

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Colleyville, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Plano, Texas, United States

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Seattle, Washington, 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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Toronto, Ontario, Canada

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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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Brno, Czechia

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Ostrava, Czechia

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Studénka, Czechia

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Zlín, Czechia

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Caluire-et-Cuire, 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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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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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Dresden, 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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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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Nyíregyháza, Hungary

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Székesfehérvár, Hungary

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Veszprém, Hungary

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Bialystok, Poland

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Bydgoszcz, Poland

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Częstochowa, 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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Nadarzyn, 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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Sochaczew, Poland

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Swidnica, 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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A Coruña, Spain

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Castellon, 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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Westcliff-on-Sea, Essex, United Kingdom

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Barnet, United Kingdom

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Leeds, United Kingdom