drugset / Trial / NCT03906136
AScalate: Treat-to-target in Axial Spondyloarthritis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FKB327 | Protein / enzyme biologic | 40 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |