NCT02613182

Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Prothena Biosciences Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be continued in this study.

Detailed description

The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be continued in this study. The primary objective of the study is to evaluate long-term safety and tolerability of NEOD001 and the secondary objectives are to assess the immunogenicity of NEOD001 and to incorporate serum NEOD001 concentrations in a population pharmacokinetic (PK) analysis.

Conditions

• AL Amyloidosis

Interventions

Type	Name	Description
DRUG	NEOD001	NEOD001

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-11-24
• Last updated: 2019-05-16
• Results posted: 2019-05-16

Locations

5 sites across 1 country: United States