NCT02481453

Rapamycine vs Placebo for the Treatment of Inclusion Body Myositis

Étude de l'Effet de la Rapamycine Sur la Force Musculaire et la réponse Immunitaire au Cours de la Myosite à Inclusions: étude RAPAMI"

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Sporadic Inclusion Body Myositis (IBM) is the most frequent inflammatory myopathy in patients over 50. It is a slowly progressive, but today untreatable (notably by classical immunosuppressants) disease. Rapamycin used in organ transplantation blocks the activity of T effector cells, preserves T regulatory cells and induces autophagy (protein degradation), all parameters impaired during IBM. RAPAMI is a prospective, randomised, controlled, double blind, monocentric, phase IIb trial evaluating rapamycine against placebo.

Conditions

• Inclusion Body Myositis (IBM)

Interventions

Type	Name	Description
DRUG	Rapamycin	Experimental: rapamycin oral solution, 2 mg/day during one year Comparator: placebo
DRUG	Placebo	Comparator: placebo

Timeline

• Start date: 2015-07-15
• Primary completion: 2018-01-22
• Completion: 2018-01-22
• First posted: 2015-06-25
• Last updated: 2025-09-02

Locations

1 site across 1 country: France