drugset / Trial / NCT05380453

Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission

NCT05380453

Phase 3 Completed 151 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in clinical remission and who are eligible for treatment with glucocorticoid-monotherapy as per current clinical practice and treatment guidelines for the targeted participant population, thereby supporting health technology assessments (HTAs) of secukinumab in Germany.

Timeline

Start
2022-09-29
Primary completion
2026-02-24
Completion
2026-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Secukinumab Monoclonal antibody 300 mg Subcutaneous

Indications