A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

Summary

The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA).

Timeline

Start

2020-12-10

Primary completion

2024-05-22

Completion

2024-05-22

Outcome

Missed primary endpoint

Stopped: “The study primary endpoint was not met”

registry analysis (superiority test); Main Study: Guselkumab vs Main Study: Placebo; p =0.638 NCT04633447 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Guselkumab	Monoclonal antibody	—	Subcutaneous

Indications