KPL-301 for Subjects With Giant Cell Arteritis

Status Completed

Clinical Trial Summary

The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

Clinical Trial Description

This Phase 2 randomized, double-blind, placebo-controlled proof of concept study will evaluate the efficacy and safety of mavrilimumab co-administered with a 26-week corticosteroid taper in subjects with GCA. The study will consist of a screening period (up to 6 weeks), a 26-week double-blind placebo-controlled period during which subjects will receive blinded mavrilimumab or placebo co-administered with a 26-week corticosteroid taper, and a 12-week washout safety follow-up period during which subjects will discontinue and wash off blinded mavrilimumab or placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03827018
Study type	Interventional
Source	Kiniksa Pharmaceuticals, Ltd.
Contact
Status	Completed
Phase	Phase 2
Start date	September 20, 2018
Completion date	November 25, 2020

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See also
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