ALXN2220
DrugTo be administered as an IV infusion
Other names: Cliramitug, NI006
Not yet recruiting
NCT Number: NCT07789483
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of ALXN2220 in Adults With Transthyretin Amyloid Cardiomyopathy
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.
Not yet recruiting
Trial opening soon.
Get NotifiedKey information
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Research Site, Buenos Aires, Argentina
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
- Inclusion Criteria
- Type of Participant: Participants who have completed the Blinded Treatment Period (including the PC visit) of Study 301.
- Sex and Contraceptive/Barrier Requirements: Male and/or female (according to their reproductive organs and functions assigned by chromosomal complement).
- Informed Consent: Participant, or legally authorized representative where relevant and allowed by law, is willing and able to comply with all study requirements and to provide signed informed consent.
- Exclusion Criteria
- Participants who permanently discontinued study intervention in Study 301
- Participants who withdrew full consent during Study 301.
- Medical Conditions: Suspected or known intolerance/allergy to proteins or any components of ALXN2220. Has had a heart transplant or permanent CMAD implantation. Has any new or worsening of existing medical or psychological condition or risk factor that in the opinion of the Investigator or Sponsor might jeopardize participant's safety or compliance with the protocol, or pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
- Prior/Concurrent/Future Clinical Study Experience: Current or future participation in another investigational clinical study or intake of investigational drug within 30 calendar days or 5 half-lives of the study intervention, whichever is longer, before signing the ICF, except for study intervention used in Study 301.
Treatment and study plan
Primary outcomes
-
Percentage of participants with TEAEs
Time frame: Up to 24 months
To evaluate the long-term safety and tolerability of ALXN2220 in participants with ATTR-CM
Secondary outcomes
-
Total occurrence of ACM and CV clinical events
Time frame: Up to 24 months
To evaluate the long-term efficacy of ALXN2220 on ACM and CV clinical events
-
Total occurrence of CV clinical events
Time frame: Up to 24 months
To evaluate the long-term efficacy of ALXN2220 on CV clinical events
-
Time to ACM
Time frame: Up to 24 months
To evaluate the long-term efficacy of ALXN2220 on ACM
-
Time to first CV clinical event or ACM
Time frame: Up to 24 months
To evaluate the long-term efficacy of ALXN2220 on first CV clinical event or ACM
-
Time to CVM
Time frame: Up to 24 months
To evaluate the long-term efficacy of ALXN2220 on CVM
-
Change from baseline in KCCQ-OS by visit
Time frame: Up to 24 months
To assess the long-term efficacy of ALXN2220 on symptoms, functionality, and health-related QoL.
-
Change from baseline in 6MWT by visit
Time frame: Up to 24 months
To assess the long-term efficacy of ALXN2220 on functional capacity
-
ADA incidence, response categories, and titer
Time frame: Up to 24 months
To assess long-term immunogenicity to ALXN2220
-
NAb incidence and response categories
Time frame: Up to 24 months
To assess long-term immunogenicity to ALXN2220
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Alexion Pharmaceuticals, Inc.
Industry
Registry information
Official study title
An Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of ALXN2220 in Adult Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Acronym: LTSAFE-ALXN
Important dates
- Study start
- 2027
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Aug 28, 2026
- Registry last updated
- Aug 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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