Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
NCT ID: NCT06641076
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
960 participants
INTERVENTIONAL
2024-10-15
2027-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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sonelokimab dose with an induction regimen
Subjects randomized to this arm will receive sonelokimab subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dosing starting at Week 8.
Sonelokimab
Randomized treatment, parallel-group
sonelokimab dose without an induction regimen
Subjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks.
Sonelokimab
Randomized treatment, parallel-group
Placebo
Subjects randomized to this arm will receive placebo subcutaneously.
Placebo
Randomized treatment, parallel-group
Interventions
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Sonelokimab
Randomized treatment, parallel-group
Placebo
Randomized treatment, parallel-group
Eligibility Criteria
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Inclusion Criteria
2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
3. Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
Exclusion Criteria
2. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
3. Participants with a diagnosis of inflammatory bowel disease.
4. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
5. Participants who have an established diagnosis of arthritis mutilans.
6. Previous exposure to sonelokimab.
7. Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.
18 Years
ALL
No
Sponsors
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MoonLake Immunotherapeutics AG
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Avondale, Arizona, United States
Clinical Site
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
Clinical Site
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
Clinical SIte
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
Clinical Site
Castelló, , Spain
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Madrid, , Spain
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Madrid, , Spain
Clinical Site
Málaga, , Spain
Clinical Site
Sabadell, , Spain
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Santiago de Compostela, , Spain
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Santiago de Compostela, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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M1095-PSA-301
Identifier Type: -
Identifier Source: org_study_id