This is a study to demonstrate the long-term safety, tolerability and clinical efficacy of sonelokimab in the treatment of patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302)
M1095-PSA-303 is a Phase 3, multicenter, open-label extension study to investigate the long-term safety, tolerability and clinical efficacy of sonelokimab 60 mg subcutaneously every 4 weeks in patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,560
Open-label
Clinical Site
Avondale, Arizona, United States
Clinical Site
Mesa, Arizona, United States
Clinical Site
Long-term safety and tolerability of sonelokimab:
Treatment-emergent adverse events (TEAEs)
Time frame: 52 weeks
Long-term safety and tolerability of sonelokimab:
Serious adverse events (SAEs)
Time frame: 52 weeks
Long-term safety and tolerability of sonelokimab:
TEAEs leading to study withdrawal
Time frame: 52 weeks
Long-term safety and tolerability of sonelokimab:
Adverse events of special interest (AESIs)
Time frame: 52 weeks
Long-term safety and tolerability of sonelokimab:
Clinically significant changes in vital signs and standard 12-lead electrocardiogram Measure description: Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline
Time frame: 52 weeks
Long-term safety and tolerability of sonelokimab:
Clinically significant changes in clinical laboratory parameters Measure description: Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Time frame: 52 weeks
Long-term efficacy of sonelokimab:
Proportion of participants achieving American College of Rheumatology (ACR) 20/50/70% improvement criteria over time
Time frame: 52 weeks
Long-term efficacy of sonelokimab:
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Phoenix, Arizona, United States
Clinical Site
Scottsdale, Arizona, United States
Clinical Site
Tucson, Arizona, United States
Clinical Site
Jonesboro, Arkansas, United States
Clinical Site
Upland, California, United States
Clinical Site
Avon Park, Florida, United States
Clinical Site
Clearwater, Florida, United States
Clinical Site
Tampa, Florida, United States
...and 7 more locations
Change over time in Minimal disease activity (MDA)
Time frame: 52 weeks
Long-term efficacy of sonelokimab:
Change over time in Health assessment questionnaire-disability index (HAQ-DI)
Time frame: 52 weeks
Long-term efficacy of sonelokimab:
Change over time in Tender joint count (TJC)68/ swollen joint count (SJC)66
Time frame: 52 weeks
Long-term efficacy of sonelokimab:
Proportion of participants achieving Psoriasis Area and Severity Index (PASI) 75/90/100 over time
Time frame: 52 weeks
Long-term efficacy of sonelokimab:
Change over time in Modified Nail Psoriasis Severity Index (mNAPSI)
Time frame: 52 weeks
Long-term efficacy of sonelokimab:
Proportion of participants achieving Very low disease activity (VLDA) over time
Time frame: 52 weeks
Long-term efficacy of sonelokimab:
Proportion of participants achieving SpondyloArthritis Research Consortium of Canada (SPARCC) over time
Time frame: 52 weeks
Long-term efficacy of sonelokimab:
Change over time in Leeds Enthesitis Index (LEI)
Time frame: 52 weeks
Long term efficacy of sonelokimab
Proportion of participants achieving both an ACR 50/ACR70 and PASI90/100 improvement over time
Time frame: 52 weeks