Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
Summary
This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.
Timeline
- Start
- 2012-01
- Primary completion
- 2014-12
- Completion
- 2014-12
Outcome
Met primary endpoint
registry NUMBER AIN457 300mg: 56.5 percentage of participants NCT01537432 ↗
registry analysis (superiority or other test); AIN457 300mg vs Placebo; p <0.001; difference in proportions 0.565 (95% CI 0.363 to 0.768); Fisher Exact NCT01537432 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |