NCT05667493

An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Study Contact:

Ionis Pharmaceuticals - Role: CONTACT - Phone: (844) 520-3239 - Email: ionisATTRCM2study@clinicaltrialmedia.com

Study Phase:

PHASE3

Recruitment Status:

RECRUITING

NCT ID:

NCT05667493

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Summary

The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.

Eligibility

Inclusion Criteria:

1. Satisfactory completion of Treatment Period and the End of Treatment Visit of the Index Study (ION-682884-CS2) OR diagnosis of ATTR-CM and satisfactory participation on ISIS 420915- CS101 study as judged by the Investigator and Sponsor.
2. Investigator is willing to treat the participant with open-label eplontersen.
3. Willingness to adhere to vitamin A supplementation per protocol.

Exclusion Criteria:

1. Permanently discontinued study drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study).
2. Have any new condition or worsening of an existing condition that in the opinion of the Investigator or Sponsor would make the participant unsuitable for enrolment, or which could interfere with the participant participating in or completing the study, including the need for treatment with medications disallowed in the Index Study.

Disease(s) and\or Condition(s)

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Eplontersen
- Description: Eplontersen will be administered by SC injection.
- Arm Group Labels: Eplontersen

Sponsor

Ionis Pharmaceuticals, Inc.