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

Phase 3 Completed 354 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

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)

Timeline

Start: 2021-10-06
Primary completion: 2025-04-11
Completion: 2026-02-18

Outcome

Missed primary endpoint

paper marginal difference: 8.7 percentage points; 95% confidence interval [CI], -1.3 to 18.8; P=0.09 PMID 42234457 ↗

release “The GCAptAIN study did not meet its primary endpoint of sustained remission at Week 52 in adults with newly diagnosed or relapsing GCA” novartis.com ↗

Publications

Stone JH, Venhoff N, Buttgereit F, Dejaco C, Schmidt WA, Spiera R, Blanco R, Rubbert-Roth A, Von Frenckell C, Blockmans D, Terrier B, Tracey G, Hauge EM, Keyport MP, Ng J, Hiremath R, Fu R, Cho G, Bacher G, Thiel J, Mendelson MH. Secukinumab for Giant Cell Arteritis. NEJM Evid. 2026 Jul;5(7):EVIDoa2600112. doi: 10.1056/EVIDoa2600112. Epub 2026 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Secukinumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Secukinumab	Monoclonal antibody	300 mg	Subcutaneous