Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy

Summary

The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.

Timeline

Start

2019-11-07

Primary completion

2021-03-04

Completion

2021-06-14

Outcome

Missed primary endpoint

Stopped: “The study was terminated based on the primary efficacy endpoint analysis after the first data lock.”

registry analysis (superiority test); Placebo vs Zilucoplan 0.3 mg/kg; p = 0.464 NCT04025632 ↗

release “In phase 2, zilucoplan did not show a meaningful effect in immune-mediated necrotizing myopathy (IMNM)” ucb.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zilucoplan	Peptide	0.3 mg/kg	Subcutaneous

Indications