A Study to Evaluate the Efficacy and Safety of Concomitant Use of Eplontersen and ALXN2220 Compared With Eplontersen and Placebo for Adults Participants With ATTR-CM

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAstraZeneca

About this trial

The purpose of this randomised, double-blind, placebo-controlled, multicenter study is to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

Eligibility criteria

Qualifiers

Participant must be ≥ 18 years to ≤ 85 years at the time of signing the informed consent.

Endomyocardial biopsy with confirmatory TTR amyloid typing OR

Grade 2 or 3 cardiac uptake on 99mTc scintigraphy in the absence of monoclonal gammopathy OR

Grade 2 or 3 cardiac uptake on 99mTc scintigraphy AND confirmatory TTR amyloid typing in the presence of monoclonal gammopathy.

Disqualifiers

Known leptomeningeal amyloidosis.

Known light chain (AL) or secondary (amyloid A) amyloidosis, or any other form of systemic amyloidosis.

Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy primarily due to hypertension, valvular heart disease, or ischaemic heart disease per Investigator's assessment.

Acute coronary syndrome, unstable angina, stroke, transient ischaemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 12 weeks of Screening.

Trial design

Treatments tested in this trial

  • Eplontersen
  • ALXN2220
  • Placebo

Treatment groups

326 Participants
are divided into 2 treatment groups

Sponsors and collaborators