NCT04930094

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Investigate the Efficacy and Safety of Secukinumab 300 mg and 150 mg Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA) (GCAptAIN)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)

Detailed description

Randomized, parallel-group, double-blind, placebo-controlled, multi-center, Phase III study to evaluate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) (GCAptAIN)

Conditions

• Giant Cell Arteritis (GCA)

Interventions

Type	Name	Description
BIOLOGICAL	Secukinumab 300 mg	Secukinumab 300 mg
OTHER	Placebo	Placebo
BIOLOGICAL	Secukinumab 150 mg	Secukinumab

Timeline

• Start date: 2021-10-06
• Primary completion: 2025-04-11
• Completion: 2026-02-18
• First posted: 2021-06-18
• Last updated: 2026-03-31

Locations

104 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Israel, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study