NCT03827018

KPL-301 for Subjects With Giant Cell Arteritis

A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Kiniksa Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Giant Cell Arteritis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	mavrilimumab	1 mL of 150 mg in a pre-filled syringe
COMBINATION_PRODUCT	placebo	1 mL of placebo in a pre-filled syringe
DRUG	prednisone	Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP)

Timeline

• Start date: 2018-09-20
• Primary completion: 2020-08-13
• Completion: 2020-11-25
• First posted: 2019-02-01
• Last updated: 2023-10-23
• Results posted: 2023-10-17

Locations

49 sites across 15 countries: United States, Australia, Belgium, Croatia, Estonia, Germany, Ireland, Italy, Netherlands, New Zealand, Poland, Serbia, Slovenia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study