Last updated on May 2019

A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis

Brief description of study

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 in combination with a 26-week prednisolone taper regimen in terms of sustained remission in patients with newly diagnosed or relapsing giant cell arteritis (GCA) who are nave to biological therapy.

The study will consist of 6-week (maximum duration) screening period, a 24-week treatment period and a 12-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.

Clinical Study Identifier: NCT03765788

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Novartis Investigative Site

Berlin, Germany
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Recruitment Status: Open

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