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Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission (GigAINt)
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 sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 151 |
| Start date | Thu Sep 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Giant Cell Arteritis
Interventions
- Secukinumab 300 mg, s.c.
- Placebo to match Secukinumab, s.c.
Countries
Germany