Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis
Summary
The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis
Timeline
- Start
- 2018-12-19
- Primary completion
- 2019-11-19
- Completion
- 2020-08-05
Outcome
Met primary endpoint
registry analysis (superiority test); Secukinumab 2 mL Auto-injector vs Placebo; p <0.0001; Odds Ratio (OR) 1014.07 (95% CI 68.83 to 14940.62); Regression, Logistic NCT03589885 ↗
registry analysis (superiority test); Secukinumab 1 mL Prefilled Syringe vs Placebo; p <0.0001; Odds Ratio (OR) 96.23 (95% CI 17.22 to 537.78); Regression, Logistic NCT03589885 ↗
registry analysis (superiority test); Secukinumab 2 mL Auto-injector vs Placebo; p <0.0001; Odds Ratio (OR) 51.46 (95% CI 11.95 to 221.64); Regression, Logistic NCT03589885 ↗
registry analysis (superiority test); Secukinumab 1 mL Prefilled Syringe vs Placebo; p <0.0001; Odds Ratio (OR) 29.70 (95% CI 7.38 to 119.57); Regression, Logistic NCT03589885 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |