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

Status: Recruiting
Location: See all (154) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must be ≥18 years of age .

• 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.

• Participants have moderate to severe active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).

• Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.

• Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.

Locations
United States
Arizona
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Avondale
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Chandler
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Flagstaff
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Mesa
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Phoenix
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Scottsdale
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Tucson
California
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San Diego
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Upland
Florida
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Avon Park
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Clearwater
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Hialeah
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Tampa
Illinois
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Springfield
Louisiana
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Lake Charles
Michigan
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Grand Blanc
North Carolina
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Leland
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Salisbury
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Statesville
Ohio
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Middleburg Heights
Oregon
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Portland
Tennessee
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Memphis
Texas
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Allen
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Colleyville
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Lubbock
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Plano
West Virginia
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Beckley
Other Locations
Bulgaria
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Pleven
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Plovdiv
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Plovdiv
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Plovdiv
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Plovdiv
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Rousse
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Sofia
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Stara Zagora
Canada
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Calgary
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Trois-rivières
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Waterloo
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Winnipeg
Croatia
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Rijeka
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Zagreb
Estonia
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Tallinn
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Tallinn
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Tartu
Finland
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Kuopio
France
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Cahors
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Caluire-et-cuire
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Échirolles
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Montpellier
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Narbonne
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Nice
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Rouen
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Tours
Georgia
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Kutaisi
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Tbilisi
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Tbilisi
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Tbilisi
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Tbilisi
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Tbilisi
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Tbilisi
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Tbilisi
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Tbilisi
Germany
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Bad Bentheim
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Berlin
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Berlin
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Berlin
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Erlangen
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Hamburg
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Herne
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München
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Munich
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Munich
Greece
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Heraklion
Hungary
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Budapest
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Budapest
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Budapest
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Debrecen
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Gyula
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Hódmezővásárhely
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Kalocsa
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Kistarcsa
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Nyíregyháza
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Székesfehérvár
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Veszprém
Latvia
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Ādaži
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Riga
Lithuania
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Kaunas
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Šiauliai
Poland
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Bialystok
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Bialystok
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Bydgoszcz
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Bydgoszcz
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Bytom
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Częstochowa
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Dąbrówka
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Elblag
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Gdynia
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Krakow
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Krakow
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Krakow
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Lodz
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Lublin
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Lublin
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Nadarzyn
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Nowa Sól
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Olsztyn
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Poznan
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Poznan
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Poznan
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Poznan
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Poznan
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Poznan
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Siedlce
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Sochaczew
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Swidnica
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Torun
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Warsaw
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Warsaw
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Warsaw
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Warsaw
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Warsaw
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Warsaw
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Warsaw
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Wołomin
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Wroclaw
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Wroclaw
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Wroclaw
Portugal
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Braga
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Braga
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Lisbon
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Lisbon
Romania
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Bucharest
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Bucharest
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Bucharest
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Bucharest
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Bucharest
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Timișoara
Serbia
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Novi Sad
Slovakia
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Košice
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Martin
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Poprad
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Rimavská Sobota
Spain
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A Coruña
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Castelló
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Madrid
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Madrid
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Málaga
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Sabadell
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Santiago De Compostela
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Santiago De Compostela
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Seville
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Seville
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Seville
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Valencia
Contact Information
Primary
Moonlake Clinical Trial Helpdesk
ClinicalTrials@moonlaketx.com
+41 41 510 8022
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 960
Treatments
Experimental: 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.
Experimental: sonelokimab dose without an induction regimen
Subjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks.
Placebo_comparator: Placebo
Subjects randomized to this arm will receive placebo subcutaneously.
Related Therapeutic Areas
Sponsors
Leads: MoonLake Immunotherapeutics AG

This content was sourced from clinicaltrials.gov