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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAlexion Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

* 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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • ALXN2220

    Drug

    To be administered as an IV infusion

Treatment groups

1,180 Participants
are divided into 1 treatment group
Group A: ALXN2220Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Total occurrence of CV clinical events

To evaluate the long-term efficacy of ALXN2220 on CV clinical events

Time frame
Up to 24 months
3

Time to ACM

To evaluate the long-term efficacy of ALXN2220 on ACM

Time frame
Up to 24 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: