Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
Summary
Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.
Timeline
- Start
- 2013-06-19
- Primary completion
- 2016-11-02
- Completion
- 2016-11-02
Outcome
Met primary endpoint
registry NUMBER AIN457 150mg: 22 Percentages of participants NCT01806597 ↗
registry analysis (superiority or other test); AIN457 150mg vs Placebo; p = 0.0002; Odds Ratio (OR) 19.3 (95% CI 2.4 to 154.6); Cochran-Mantel-Haenszel NCT01806597 ↗
registry analysis (superiority or other test); AIN457 300 mg vs Placebo; p <0.0001; Odds Ratio (OR) 29.4 (95% CI 4.1 to 211.9); Cochran-Mantel-Haenszel NCT01806597 ↗
release “In the GESTURE study in patients with moderate-to-severe palmoplantar psoriasis, Cosentyx (300 mg) was superior to placebo at Week 16” novartis.com ↗
release “Cosentyx (secukinumab) met the primary endpoints of superiority compared to placebo in patients with difficult-to-treat psoriasis of the nails, palms and soles” novartis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |