Approval Probability
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SOK583A1 · 3 trials · 2 indications
Number of participants with ocular treatment emergent adverse events were reported.
Number of participants with non-ocular treatment emergent adverse events were reported.
The primary aim of the study is to demonstrate equivalence of change in BCVA score from Baseline at Week 8 between participants with nAMD treated with SOK583A1 and participants treated with Eylea EU. The primary analysis will be performed on the Per-Protocol Set (PPS), which is the most appropriate analysis set to use when testing for equivalence. ETDRS: Early Treatment Diabetic Retinopathy Study EU: European
| Arm | Type | Description |
|---|---|---|
| SOK583A1 | EXPERIMENTAL | SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL) |
| SOK583A1 (40 mg/mL) | EXPERIMENTAL | participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study |
| Eylea EU (40 mg/mL) | ACTIVE_COMPARATOR | IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48. EU: European |
| Name | Type | Description |
|---|---|---|
| SOK583A1 | DRUG | SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL) |
| SOK583A1 (40 mg/mL) | DRUG | SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration |
| Prefilled Syringe (PFS) | DEVICE | Prefilled Syringe (PFS) |
| Eylea EU (40 mg/mL) | BIOLOGICAL | IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48. |
Inclusion Criteria: * Patients ≥ 50 years of age at baseline * Patients diagnosed with nAMD (uni- or bilateral) * Patients already under IVT Eylea treatment (last injection of the induction period or maintenance phase) * Willing and able to comply with all study procedures, and be likely to complet...
SOK583A1 is an investigational monoclonal antibody developed by Novartis AG for the treatment of neovascular age-related macular degeneration, or nAMD. It is administered as an intravitreal injection, meaning it is delivered directly into the eye. It is currently in Phase 3 clinical development and has been studied in three completed trials.
SOK583A1 is being developed to treat neovascular age-related macular degeneration, a condition in which abnormal blood vessels grow beneath the retina and can impair vision. All three of its Phase 3 trials enrolled patients with nAMD. The studies assessed efficacy, safety, and immunogenicity, with participants aged 50 years and older.
SOK583A1 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of all three Phase 3 trials of the asset. The program includes studies of the drug supplied in both a vial kit and a prefilled syringe.
SOK583A1 is in Phase 3 clinical development. Three Phase 3 trials have been completed: NCT05282004, NCT05161806, and NCT04864834. The drug is investigational and has not been approved by the FDA. The largest trial, NCT04864834, compared SOK583A1 with Eylea in patients with nAMD.
SOK583A1 has been studied in three completed Phase 3 trials. NCT04864834 was an active-controlled efficacy, safety, and immunogenicity study versus Eylea with 485 patients across 16 countries. NCT05282004 evaluated a vial kit presentation in 36 patients, and NCT05161806 evaluated a prefilled syringe presentation in 30 patients, both in the United States.