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 both in combination with a glucocorticoid taper regimen in patients with giant cell arteritis (GCA) (GCAptAIN)

Brief description of study

The purpose of the study is to demonstrate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously in adult patients with newly diagnosed or relapsing giant cell arteritis (GCA). The study will take about 2 years and during that time, patients will visit the Study Doctor about 26 times. At the study visits, the following procedures should happen: Blood tests, other study specific assessments and study treatment injection. Patients will receive on of the following treatments: Group 1: secukinumab 300 mg (2 mL PFS) s.c. at Baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4 in addition to prednisone with dosing tapered over a period up to 26 weeks. Patients have a two in three possibility of getting this treatment. Group 2: placebo to secukinumab 300 mg (2 mL PFS) s.c at Baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4 in addition to prednisone with dosing tapered over a period up to 52 weeks. Patients have a one in three possibility of getting placebo, which has no active ingredients


Clinical Study Identifier: s21-00814
ClinicalTrials.gov Identifier: NCT04930094


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