A Phase 2, Single Arm, Multicenter Study to Evaluate the Pharmacodynamics and Safety of Re-Treatment with ALXN2220 in Patients with Transthyretin Amyloid Cardiomyopathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520506-35-00

Acronym

NI006-102

Enrollment

Registered

2025-06-24

Start date

2025-06-30

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Adults with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Brief summary

Change from baseline to Visit 16 in cMRI, Change from baseline to Visit 16 in scintigraphy

Detailed description

Incidence of TEAEs, including serious TEAEs, Change from baseline by visit for vital signs and physical examination, Change from baseline by visit in clinical laboratory parameters, Change from baseline by visit for ECG parameters, ALXN2220 serum concentrations, ADA incidence, response category and titer

Interventions

DRUGRecombinant human anti-ATTR immunoglobulin G1 (IgG1) monoclonal antibody (mAb)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to Visit 16 in cMRI, Change from baseline to Visit 16 in scintigraphy	—

Secondary

Measure	Time frame
Incidence of TEAEs, including serious TEAEs, Change from baseline by visit for vital signs and physical examination, Change from baseline by visit in clinical laboratory parameters, Change from baseline by visit for ECG parameters, ALXN2220 serum concentrations, ADA incidence, response category and titer	—

Countries

France, Germany, Netherlands, Spain

Outcome results

None listed

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