Overall trial status: Ongoing, recruiting
Trial title: 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
Medical conditions: Psoriatic arthritis
Status in each country: Hungary:Ongoing, recruiting, Romania:Ongoing, recruiting, Spain:Ongoing, recruiting, Greece:Authorised, recruitment pending, Latvia:Ongoing, recruiting, Lithuania:Ongoing, recruiting, Poland:Authorised, recruitment pending, Croatia:Authorised, recruiting, Czechia:Ongoing, recruiting, Finland:Ongoing, recruiting, Estonia:Ongoing, recruiting, France:Ongoing, recruiting, Slovakia:Ongoing, recruiting, Germany:Ongoing, recruiting, Bulgaria:Ongoing, recruiting, Portugal:Authorised, recruiting
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Proportion of participants achieving ACR50 (ie, ≥50% improvement on the ACR response criteria) at Week 16
Secondary end point: 1. Proportion of participants achieving ACR20 (ie, ≥20% improvement on the ACR response criteria) at Week 16, 2. Proportion of participants achieving Minimal Disease Activity (MDA) at Week 16, 3. Change from Baseline in Health Assessment Questionnaire—Disability Index (HAQ-DI) at Week 16, 4. Proportion of participants achieving a decrease of ≥90% in the Psoriasis Area and Severity Index (PASI90) response at Week 16 in the subgroup of participants with PsO involving ≥3% body surface area at Baseline, 5. Change from Baseline in SF-36 PCS at Week 16, 6. Change from Baseline to Week 16 in joint/bone structural damage (van der Heijde modified Total Sharp Score), 7. Incidence, relatedness, severity, and seriousness of TEAEs, 8. Withdrawal due to TEAEs, 9. Clinically relevant abnormalities in vital signs (blood pressure and heart rate) and body weight, 10. Clinically relevant abnormalities in 12-lead ECG variables, 11. Clinically relevant abnormalities in laboratory parameters (hematology, biochemistry, and urinalysis)
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 590
Sponsor: MoonLake Immunotherapeutics AG
Sponsor type: Pharmaceutical company
Trial product: Placebo is a sterile solution in a single use prefilled syringe (pfs) intended for subcutaneous administration, Sonelokimab
Results posted: No
Overall decision date: 10/03/2025
Countries decision date: BG: 12/03/2025, HR: 17/03/2025, CZ: 12/03/2025, EE: 17/03/2025, FR: 10/03/2025, HU: 14/03/2025, LV: 12/03/2025, LT: 13/03/2025, PT: 13/03/2025, ES: 11/03/2025, SK: 10/03/2025, FI: 21/03/2025, RO: 17/03/2025, PL: 26/03/2025, DE: 13/03/2025, GR: 11/03/2025
Last updated date: 30/05/2025
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