This study is not yet accepting patients

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

a study on Cardiomyopathy

Summary

Location
at UCSF
Dates
study started
study ends around

Description

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.

Official 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)

Keywords

Transthyretin Amyloid Cardiomyopathy (ATTR-CM), ALXN2220, Cliramitug, NI006, Transthyretin Amyloid Cardiomyopathy, ATTR-CM, Open-Label Extension Study

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Research Site
    San Francisco California 94143 United States
  • Research Site
    La Jolla California 92037 United States
  • Research Site
    Irvine California 92614 United States
  • Research Site
    Palo Alto California 94304 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals, Inc.
ID
NCT07789483
Phase
Phase 3 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 1180 study participants
Last Updated