NCT03906136

AScalate: Treat-to-target in Axial Spondyloarthritis

A Randomized, Open Label Multicenter Trial to Investigate the Efficacy of a Treat-to-target (T2T) Treatment Strategy With Secukinumab (AIN457) as a First-line Biologic Compared to a Standard-of-care (SOC) Treatment Over 36 Weeks in Patients With Active Axial Spondyloarthritis (axSpA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study included an 8-week Screening period, a 36-week treatment period, and a 20-week safety follow-up period. Neither investigators nor patients were blinded. The primary endpoint was the percentage of patients achieving an ASAS40 response at Week 24. At Baseline, patients were randomized equally to one of two treatment groups (T2T or SOC). Patients were evaluated every 12 weeks from Baseline through to Week 36. Safety evaluations were included in the regular visits; in addition, a safety follow-up visit was performed 20 weeks after the last study visit (i.e. Week 36) and took place at Week 56 for patients completing the study according to the protocol. Patients assigned to the SOC treatment group received SOC treatment at the discretion of the investigator in accordance with current clinical practice. Patients assigned to the T2T treatment group received first line biological treatment with secukinumab 150 mg. Responders were defined as those patients with an ASDAS clinically important improvement of ≥ 1.1. At week 12 responders continued secukinumab 150 mg, whereas treatment was escalated to 300 mg for non-responders. At week 24, disease activity was assessed again. Patients who qualify as responders continued the treatment they received prior (either secukinumab 150 mg or 300 mg), patients who were non-responders at week 24 were escalated in treatment: patients who received secukinumab 300 mg before were switched to Adalimumab, and patients who received secukinumab 150mg before were escalated to secukinumab 300mg.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Secukinumab/Adalimumab-Biosimilar	Secukinumab 150 mg, s.c. Secukinumab 300 mg, s.c. Adalimumab biosimilar 40 mg, s.c.
OTHER	Standard-of-care	Treatment according to local practice standards by the rheumatologist following latest treatment recommendations with NSAIDs as the first-choice drug treatment and DMARDs for patients with active disease despite the use (or intolerance/contraindication) of NSAIDs.

Timeline

• Start date: 2019-06-04
• Primary completion: 2022-02-04
• Completion: 2022-09-22
• First posted: 2019-04-08
• Last updated: 2025-04-29
• Results posted: 2025-04-16

Locations

47 sites across 2 countries: France, Germany