NCT02753530

Study of Arimoclomol in Inclusion Body Myositis (IBM)

Phase II Study of Arimoclomol for the Treatment of Sporadic Inclusion Body Myositis (IBM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: ZevraDenmark · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Funding Source - FDA Office of Orphan Products Development (OOPD). The purpose of this study is to evaluate the safety and efficacy of the study drug, arimoclomol in IBM patients.

Detailed description

A Phase 2/3, randomized, double-blind, placebo-controlled, international, 20-month intervention study in patients with IBM.

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
OTHER	Placebo	2 matched placebo capsules taken 3 times daily during breakfast, early afternoon, and at bedtime

Timeline

• Start date: 2017-08-16
• Primary completion: 2021-01-11
• Completion: 2021-01-11
• First posted: 2016-04-28
• Last updated: 2023-05-10
• Results posted: 2023-05-10

Locations

12 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study