Pelacarsen Roll-over Extension Program

Novartis

Status and phase

Begins enrollment this month

Phase 3

Conditions

Atherosclerotic Cardiovascular Disease

Treatments

Drug: Pelacarsen (TQJ230)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06875973

CTQJ230A12305B

Details and patient eligibility

About

This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).

Full description

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
Participants who have completed the parent study and received the assigned study treatment at the time of its completion

Exclusion criteria

Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
Participants who are receiving another investigational drug or device before the open-label treatment period
Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator

Other protocol-defined inclusion/exclusion criteria may apply.