The primary completion of the Phase 3 trial (NCT05380453) for secukinumab in patients with new-onset giant cell arteritis who are in clinical remission was posted on ClinicalTrials.gov on 2026-02-24. This marks a significant milestone in the study of secukinumab for this condition.

Background

The trial, titled "Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission," aimed to demonstrate the efficacy and safety of secukinumab 300 mg administered subcutaneously. The study's objective was to evaluate secukinumab in combination with a glucocorticoid taper regimen compared to placebo plus a glucocorticoid taper regimen in adult patients with new onset of giant cell arteritis (GCA). This research is intended to support health technology assessments of secukinumab.

Trial design

The study, identified as NCT05380453, is a Phase 3 trial with an overall status of COMPLETED. It enrolled 151 participants diagnosed with Giant Cell Arteritis. The interventions included secukinumab 300 mg, s.c., and placebo to match secukinumab, s.c., both in combination with a glucocorticoid taper regimen.

What this means

The primary completion of this Phase 3 trial indicates that the main data collection period has concluded for the study evaluating secukinumab in new-onset giant cell arteritis patients. While specific efficacy and safety results are not yet publicly available, the completion of this phase is a necessary step towards the potential future analysis and dissemination of findings. These results will be crucial for understanding the role of secukinumab in managing GCA in this specific patient population and for informing future clinical practice and treatment guidelines.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05380453, titled "Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission," was posted on 2026-02-24 on clinicaltrials.gov.