A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis
Status:
Completed
Trial end date:
2021-06-08
Target enrollment:
Participant gender:
Summary
This randomized, parallel-group, double-blind, placebo-controlled, multicenter, Phase II
study is designed to evaluate the efficacy and safety of secukinumab compared to placebo to
maintain disease remission up to 28 weeks including corticosteroid tapering, as well as up to
1 year (52 weeks) in patients with newly diagnosed or relapsing giant cell arteritis (GCA)
who are naïve to biological therapy.
The study will consist of 6-week (maximum duration) screening period, a 52-week treatment
period and a 8-week safety follow-up period.
Patients who do not achieve remission by Week 12, experience a flare after remission or
cannot adhere to the prednisolone taper regimen will enter "escape". Upon entering "escape",
patients will receive prednisolone at a dose determined by the physician's clinical judgment
and continue to receive secukinumab or placebo in a blinded manner.
Safety evaluation will be included in all visits including two safety follow-up visits
performed 8 and 12 weeks after the last study drug administration.