The purpose of Study ALXN2220-ATTRCM-302 is to evaluate the long-term safety, tolerability and efficacy of ALXN2220 in adult participants with ATTR-CM treated with ALXN2220 in addition to SoC who have completed Study ALXN2220-ATTRCM-301.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,180
To be administered as an IV infusion
Percentage of participants with TEAEs
To evaluate the long-term safety and tolerability of ALXN2220 in participants with ATTR-CM
Time frame: Up to 24 months
Total occurrence of ACM and CV clinical events
To evaluate the long-term efficacy of ALXN2220 on ACM and CV clinical events
Time frame: Up to 24 months
Total occurrence of CV clinical events
To evaluate the long-term efficacy of ALXN2220 on CV clinical events
Time frame: Up to 24 months
Time to ACM
To evaluate the long-term efficacy of ALXN2220 on ACM
Time frame: Up to 24 months
Time to first CV clinical event or ACM
To evaluate the long-term efficacy of ALXN2220 on first CV clinical event or ACM
Time frame: Up to 24 months
Time to CVM
To evaluate the long-term efficacy of ALXN2220 on CVM
Time frame: Up to 24 months
Change from baseline in KCCQ-OS by visit
To assess the long-term efficacy of ALXN2220 on symptoms, functionality, and health-related QoL.
Time frame: Up to 24 months
Change from baseline in 6MWT by visit
To assess the long-term efficacy of ALXN2220 on functional capacity
Time frame: Up to 24 months
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Research Site
Irvine, California, United States
Research Site
La Jolla, California, United States
Research Site
Palo Alto, California, United States
Research Site
San Francisco, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville, Florida, United States
Research Site
Weston, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
...and 185 more locations
ADA incidence, response categories, and titer
To assess long-term immunogenicity to ALXN2220
Time frame: Up to 24 months
NAb incidence and response categories
To assess long-term immunogenicity to ALXN2220
Time frame: Up to 24 months