An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of ALXN2220 in Adults With Transthyretin Amyloid Cardiomyopathy

Study Identifier:
D6810C00002
ClinicalTrials.gov Identifier:
NCT07789483
EudraCT Identifier:
N/A
EU CT ID:
2026-526755-57-00
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Will Be Recruiting

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN2220
Date
Nov 2027 - Jul 2030
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
  • 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.
Sex
Female & Male
Age
N/A

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN2220
Date
Nov 2027 - Jul 2030
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
  • 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.

Protocol Summary

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.

Trial Locations

Location
Status
Location
Research Site
Irvine, California, United States, 92614
Status
N/A
Location
Research Site
La Jolla, California, United States, 92037
Status
N/A
Location
Research Site
Palo Alto, California, United States, 94304
Status
N/A
Location
Research Site
San Francisco, California, United States, 94143
Status
N/A
Location
Research Site
Aurora, Colorado, United States, 80045
Status
N/A
Location
Research Site
Washington D.C., District of Columbia, United States, 20010
Status
N/A
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