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| IZAR-OLE | Other Identifier | Sponsor |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: sonelokimab dose | Experimental | All participants will receive sonelokimab subcutaneously every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonelokimab | Drug | Open-label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety and tolerability of sonelokimab: | Treatment-emergent adverse events (TEAEs) | 52 weeks |
| Long-term safety and tolerability of sonelokimab: | Serious adverse events (SAEs) | 52 weeks |
| Long-term safety and tolerability of sonelokimab: | TEAEs leading to study withdrawal | 52 weeks |
| Long-term safety and tolerability of sonelokimab: | Adverse events of special interest (AESIs) | 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 | 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 | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term efficacy of sonelokimab: | Proportion of participants achieving American College of Rheumatology (ACR) 20/50/70% improvement criteria over time | 52 weeks |
| Long-term efficacy of sonelokimab: |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Avondale | Arizona | 85392 | United States | ||
| Clinical Site |
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Change over time in Minimal disease activity (MDA)
| 52 weeks |
| Long-term efficacy of sonelokimab: | Change over time in Health assessment questionnaire-disability index (HAQ-DI) | 52 weeks |
| Long-term efficacy of sonelokimab: | Change over time in Tender joint count (TJC)68/ swollen joint count (SJC)66 | 52 weeks |
| Long-term efficacy of sonelokimab: | Proportion of participants achieving Psoriasis Area and Severity Index (PASI) 75/90/100 over time | 52 weeks |
| Long-term efficacy of sonelokimab: | Change over time in Modified Nail Psoriasis Severity Index (mNAPSI) | 52 weeks |
| Long-term efficacy of sonelokimab: | Proportion of participants achieving Very low disease activity (VLDA) over time | 52 weeks |
| Long-term efficacy of sonelokimab: | Proportion of participants achieving SpondyloArthritis Research Consortium of Canada (SPARCC) over time | 52 weeks |
| Long-term efficacy of sonelokimab: | Change over time in Leeds Enthesitis Index (LEI) | 52 weeks |
| Long term efficacy of sonelokimab | Proportion of participants achieving both an ACR 50/ACR70 and PASI90/100 improvement over time | 52 weeks |
| Mesa |
| Arizona |
| 85210 |
| United States |
| Clinical Site | Phoenix | Arizona | 85032 | United States |
| Clinical Site | Tucson | Arizona | 85748 | United States |
| Clinical Site | Jonesboro | Arkansas | 72401 | United States |
| Clinical Site | Upland | California | 91786 | United States |
| Clinical Site | Avon Park | Florida | 33825 | United States |
| Clinical Site | Clearwater | Florida | 33765 | United States |
| Clinical Site | Tampa | Florida | 33607 | United States |
| Clinical Site | Charlotte | North Carolina | 28262 | United States |
| Clinical Site | Leland | North Carolina | 28451 | United States |
| Clinical Site | Middleburg Heights | Ohio | 44130 | United States |
| Clinical Site | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Site | Memphis | Tennessee | 38119 | United States |
| Clinical Site | Baytown | Texas | 77521 | United States |
| Clinical Site | Lubbock | Texas | 79424 | United States |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000720946 | sonelokimab |
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