Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
NCT ID: NCT06641089
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
600 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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Placebo
Subjects randomized to this arm will receive placebo SC
Placebo
Placebo
risankizumab
Subjects randomized to this arm will receive risankizumab SC
Risankizumab
Active comparator
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.
Sonelokimab
Sonelokimab
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.
Sonelokimab
Sonelokimab
Interventions
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Sonelokimab
Sonelokimab
Placebo
Placebo
Risankizumab
Active comparator
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.
6. Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one 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.
Exclusion Criteria
2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
4. Participants with a diagnosis of inflammatory bowel disease.
5. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
6. Participants who have an established diagnosis of arthritis mutilans.
7. Previous exposure to sonelokimab.
8. Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα
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
Clinical Site
Flagstaff, Arizona, United States
Clinical Site
Mesa, Arizona, United States
Clinical Site
Phoenix, Arizona, United States
Clinical Site
Scottsdale, Arizona, United States
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Tucson, Arizona, United States
Clinical Site
Jonesboro, Arkansas, United States
Clinical Site
Pomona, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
Santa Monica, California, United States
Clinical Site
Thousand Oaks, California, United States
Clinical Site
Upland, California, United States
Clinical Site
Avon Park, Florida, United States
Clinical Site
Clearwater, Florida, United States
Clinical Site
Hialeah, Florida, United States
Clinical Site
Miami Gardens, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Zephyrhills, Florida, United States
Clinical Site
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
Clinical Site
Leland, North Carolina, United States
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Middleburg Heights, Ohio, United States
Clinical Site
Portland, Oregon, United States
Clinical Site
Duncansville, Pennsylvania, United States
Clinical Site
Jackson, Tennessee, United States
Clinical Site
Memphis, Tennessee, United States
Clinical Site
Murfreesboro, Tennessee, United States
Clinical Site
Allen, Texas, United States
Clinical Site
Austin, Texas, United States
Clinical Site
Baytown, Texas, United States
Clinical Site
Colleyville, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Lubbock, Texas, United States
Clinical Site
Plano, Texas, United States
Clinical Site
Seattle, Washington, United States
Clinical Site
Beckley, West Virginia, United States
Clinical Site
Pleven, , Bulgaria
Clinical Site
Plovdiv, , Bulgaria
Clinical Site
Plovdiv, , Bulgaria
Clinical Site
Plovdiv, , Bulgaria
Clinical Site
Plovdiv, , Bulgaria
Clinical Site
Rousse, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Stara Zagora, , Bulgaria
Clinical Site
Toronto, Ontario, Canada
Clinical Site
Calgary, , Canada
Clinical Site
Trois-Rivières, , Canada
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Waterloo, , Canada
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Winnipeg, , Canada
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Brno, , Czechia
Clinical Site
Ostrava, , Czechia
Clinical Site
Studénka, , Czechia
Clinical Site
Zlín, , Czechia
Clinical Site
Caluire-et-Cuire, , France
Clinical Site
Montpellier, , France
Clinical Site
Narbonne, , France
Clinical Site
Nice, , France
Clinical Site
Rouen, , France
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Tours, , France
Clinical Site
Tbilisi, , Georgia
Clinical Site
Tbilisi, , Georgia
Clinical Site
Tbilisi, , Georgia
Clinical Site
Tbilisi, , Georgia
Clinical Site
Tbilisi, , Georgia
Clinical Site
Tbilisi, , Georgia
Clinical Site
Berlin, , Germany
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Berlin, , Germany
Clinical Site
Berlin, , Germany
Clinical Site
Erlangen, , Germany
Clinical Site
Hamburg, , Germany
Clinical Site
Herne, , Germany
Clinical Site
Munich, , Germany
Clinical Site
Munich, , Germany
Clinical Site
München, , Germany
Clinical Site
Budapest, , Hungary
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Budapest, , Hungary
Clinical Site
Debrecen, , Hungary
Clinical SIte
Gyula, , Hungary
Clinical Site
Hódmezővásárhely, , Hungary
Clinical Site
Nyíregyháza, , Hungary
Clinical Site
Székesfehérvár, , Hungary
Clinical Site
Veszprém, , Hungary
Clinical Site
Bialystok, , Poland
Clinical Site
Bydgoszcz, , Poland
Clinical Site
Częstochowa, , Poland
Clinical Site
Elblag, , Poland
Clinical Site
Krakow, , Poland
Clinical Site
Krakow, , Poland
Clinical Site
Nadarzyn, , Poland
Clinical Site
Poznan, , Poland
Clinical Site
Poznan, , Poland
Clinical Site
Poznan, , Poland
Clinical Site
Poznan, , Poland
Clinical Site
Sochaczew, , Poland
Clinical Site
Swidnica, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Wołomin, , Poland
Clinical Site
Wroclaw, , Poland
Clinical Site
Wroclaw, , Poland
Clinical Site
A Coruña, , Spain
Clinical Site
Castellon, , Spain
Clinical Site
Madrid, , Spain
Clinical SIte
Sabadell, , Spain
Clinical Site
Santiago de Compostela, , Spain
Clinical Site
Santiago de Compostela, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Westcliff-on-Sea, Essex, United Kingdom
Clinical Site
Barnet, , United Kingdom
Clinical Site
Leeds, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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M1095-PSA-302
Identifier Type: -
Identifier Source: org_study_id