drugset / Trial / NCT01807520

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis

NCT01807520 ↗

Phase 3 Completed 198 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.

Timeline

Start
2013-06-20
Primary completion
2017-01-03
Completion
2017-01-03

Outcome

Met primary endpoint

registry AIN457 150 mg vs Placebo; p <0.0001; Mean Difference (Net) -26.7 (95% CI -39.1 to -14.3) NCT01807520 ↗

registry AIN457 300 mg vs Placebo; p <0.0001; Mean Difference (Net) -34.4 (95% CI -45.2 to -23.5) NCT01807520 ↗

release “Similarly, in the TRANSFIGURE study in patients with significant nail 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

EvaluationDrugModalityDoseRoute
Subject Secukinumab Monoclonal antibody 150 mg Subcutaneous
Subject Secukinumab Monoclonal antibody 300 mg Subcutaneous

Indications

No indication recorded.