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

NCT06641089 · MoonLake Immunotherapeutics AG
In plain English

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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
About this study
M1095-PSA-302 is 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 sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
Eligibility criteria
Inclusion Criteria: 1. Participants must be ≥18 years of age . 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: 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 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
Study design
Enrollment target: 600 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2024-10-15
Estimated completion: 2027-01-15
Last updated: 2026-03-30
Interventions
Drug: SonelokimabDrug: PlaceboDrug: Risankizumab
Primary outcomes
  • Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) (Week 16 compared to placebo)
Sponsor
MoonLake Immunotherapeutics AG · industry
Contacts & investigators
ContactMoonlake Clinical Trial Helpdesk · contact · ClinicalTrials@moonlaketx.com · +41 41 510 8022
All 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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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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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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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