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

NCT05380453 PHASE3 COMPLETED

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.

Details

Lead sponsorNovartis Pharmaceuticals
PhasePHASE3
StatusCOMPLETED
Enrolment151
Start dateThu Sep 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionTue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Germany