NCT03710941

Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenously Administered REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy of REGN2477+REGN1033 in combination on total lean mass, as measured by Dual-energy X-ray absorptiometry (DXA) in patients with sporadic inclusion body myositis (sIBM). The secondary objectives of the study are: * To evaluate the efficacy of REGN2477+REGN1033 on the IBM-Functional Rating Scale (IBM-FRS) * To evaluate the efficacy of REGN2477+REGN1033 on the sIBM Physical Functioning Assessment (sIFA) * To evaluate the safety and tolerability of REGN2477+REGN1033 * To evaluate the effects of REGN2477+REGN1033 on body composition by DXA, including appendicular lean mass and total fat mass * To evaluate the efficacy of REGN2477+REGN1033 on measures of muscle performance and physical function * To evaluate the efficacy of REGN2477+REGN1033 on patient reported outcome measures including the fear of falling, falls and near falls, and health-related quality of life * To evaluate the pharmacokinetic(s) (PK) profile of REGN2477+REGN1033, including functional REGN2477 and functional REGN1033 concentrations in serum over time * To evaluate the immunogenicity of REGN2477+REGN1033

Conditions

• Sporadic Inclusion Body Myositis

Interventions

Type	Name	Description
DRUG	REGN2477+REGN1033	Single, sequential, repeat-dose Intravenous (IV) or matching placebo
DRUG	Matching placebo	Single, sequential, repeat-dose Intravenous (IV)

Timeline

• Start date: 2019-02-19
• Primary completion: 2020-08-27
• Completion: 2020-11-05
• First posted: 2018-10-18
• Last updated: 2019-04-29

Regulatory

• FDA-regulated drug study