An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Novartis

Status and phase: Active, not recruiting; Phase 3

Conditions: Cardiovascular Disease and Lipoprotein(a)

Treatments: Drug: Pelacarsen (TQJ230)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07517263

CTQJ230A12301E1

2024-519870-38-00 (Other Identifier)

Details and patient eligibility

About

This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.

Full description

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).

Enrollment: 5,700 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 EOS visit while still on assigned investigational product.

Exclusion criteria

• Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
• Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
• Participants are receiving another investigational drug or device before the open-label treatment period.
• Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,700 participants in 1 patient group

Pelacarsen (TQJ230)

Experimental group

Description:

open-label pelacarsen 80mg

Treatment:

Drug: Pelacarsen (TQJ230)