NCT04049097

Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial

An Open-label, Non-randomized Trial to Investigate the Efficacy and Safety of Early Versus Delayed Start of Arimoclomol in Patients With Sporadic Inclusion Body Myositis Who Have Completed the IBM4809 Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: ZevraDenmark · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, nonrandomized, open-label, uncontrolled clinical extension trial designed to compare the efficacy and safety of early versus delayed start of arimoclomol in the treatment of Inclusion Body Myositis (IBM)

Detailed description

This was planned to be a 40-month open-label extension trial of the 20-month randomized, double-blind, placebo-controlled IBM4809 trial. The open-label trial was terminated early by the sponsor as a consequence of the results of IBM4809 which did not meet any of its efficacy endpoints. Therefore, the actual average duration of open-label treatment was approximately 28 weeks.

Conditions

• Inclusion Body Myositis

Interventions

Type	Name	Description
DRUG	Arimoclomol	2 capsules (2 x 124 mg arimoclomol base; equivalent to 2 x 200 mg arimoclomol citrate) taken 3 times daily during breakfast, early afternoon, and at bedtime

Timeline

• Start date: 2019-05-20
• Primary completion: 2021-11-15
• Completion: 2021-11-15
• First posted: 2019-08-07
• Last updated: 2023-09-15
• Results posted: 2023-09-15

Locations

12 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study