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
Status: Recruiting
Location: See all (111) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
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.
• Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with the TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.
Locations
United States
Arkansas
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Jonesboro
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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Pomona
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San Diego
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Thousand Oaks
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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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Miami Gardens
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Tampa
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Zephyrhills
Georgia
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Gainesville
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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Charlotte
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Leland
Ohio
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Middleburg Heights
Oregon
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Portland
Pennsylvania
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Duncansville
Tennessee
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Jackson
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Memphis
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Murfreesboro
Texas
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Allen
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Austin
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Baytown
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Colleyville
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Houston
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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
France
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Caluire-et-cuire
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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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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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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
Hungary
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Budapest
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Budapest
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Debrecen
Clinical SIte
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Gyula
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Hódmezővásárhely
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Nyíregyháza
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Székesfehérvár
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Veszprém
Poland
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Bialystok
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Bydgoszcz
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Częstochowa
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Elblag
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Krakow
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Krakow
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Nadarzyn
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Poznan
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Poznan
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Poznan
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Poznan
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Sochaczew
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Swidnica
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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
Clinical Site
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Wroclaw
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Wroclaw
Spain
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A Coruña
Clinical Site
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Castellon
Clinical Site
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Madrid
Clinical SIte
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Sabadell
Clinical Site
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Santiago De Compostela
Clinical Site
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Santiago De Compostela
Clinical Site
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Seville
Clinical Site
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Seville
Clinical Site
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Seville
United Kingdom
Clinical Site
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Barnet
Clinical Site
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Leeds
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:600
Treatments
Experimental: sonelokimab dose 1 with an induction regimen
Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8.
Experimental: sonelokimab dose 2 with an induction regimen
Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8.
Placebo_comparator: Placebo
Subjects randomized to this arm will receive placebo SC
Active_comparator: risankizumab
Subjects randomized to this arm will receive risankizumab SC