drugset / Trial / NCT03906136

AScalate: Treat-to-target in Axial Spondyloarthritis

NCT03906136

Phase 3 Completed 304 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This was a randomized, parallel-group, open-label, multicenter study in patients with active axSpA. The aim of the study was to demonstrate that the efficacy of a T2T approach (with secukinumab as a first-line biologic) was superior to a SOC approach in terms of achieving strong clinical efficacy in patients with active axSpA who were naïve to biological therapy and who had an inadequate response to prior non-steroidal anti-inflammatory drug (NSAID) treatment.

Timeline

Start
2019-06-04
Primary completion
2022-02-04
Completion
2022-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject FKB327 Protein / enzyme biologic 40 mg Subcutaneous
Subject Secukinumab Monoclonal antibody 150 mg Subcutaneous
Subject Secukinumab Monoclonal antibody 300 mg Subcutaneous

Indications