A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511066-36-00

Acronym

NEOD001-301

Enrollment

157

Registered

2024-11-11

Start date

2021-10-13

Completion date

2025-05-23

Last updated

2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Light Chain (AL) Amyloidosis

Brief summary

Time to all-cause mortality during the Double-blind Phase

Detailed description

Change from baseline to Month 9 of the Double-blind Phase in the 6MWT distance (meters), Change from baseline to Month 9 of the Double-blind Phase in the Physical Component Summary (PCS) score of the SF-36v2

Interventions

DRUGBORTEZOMIB

DRUGBirtamimab

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to all-cause mortality during the Double-blind Phase	—

Secondary

Measure	Time frame
Change from baseline to Month 9 of the Double-blind Phase in the 6MWT distance (meters), Change from baseline to Month 9 of the Double-blind Phase in the Physical Component Summary (PCS) score of the SF-36v2	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026