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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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516219-25-00
Acronym
M1095-PSA-302
Enrollment
372
Registered
2025-03-07
Start date
2025-03-25
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriatic arthritis

Brief summary

1. Proportion of participants achieving ACR50 (ie, ≥50% response on the ACR response criteria) at Week 16

Detailed description

1. Proportion of participants achieving ACR20 (ie, ≥20% response 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 PASI90 response at Week 16 in the subset of participants with PsO involving ≥3% body surface area at Baseline, 5. Change from Baseline in SF-36 PCS at Week 16, 6. Proportion of participants achieving ACR50 at Week 16, 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)

Interventions

DRUGPlacebo is a sterile solution in a single use prefilled syringe (PFS) intended for subcutaneous administration.

Sponsors

MoonLake Immunotherapeutics AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Proportion of participants achieving ACR50 (ie, ≥50% response on the ACR response criteria) at Week 16

Secondary

MeasureTime frame
1. Proportion of participants achieving ACR20 (ie, ≥20% response 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 PASI90 response at Week 16 in the subset of participants with PsO involving ≥3% body surface area at Baseline, 5. Change from Baseline in SF-36 PCS at Week 16, 6. Proportion of participants achieving ACR50 at Week 16, 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)

Countries

Bulgaria, Czechia, France, Germany, Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026