Atherosclerotic Cardiovascular Disease
Conditions
Keywords
TQJ230, Lp(a), ASCVD
Brief summary
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).
Detailed 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.
Interventions
pelacarsen 80mg s.c. monthly
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label study
Intervention model description
Rollover extension program (REP)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse events (AEs) or serious adverse events (SAEs) | Up to 48 months | Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established atherosclerotic cardiovascular disease who have completed the parent study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study | Baseline of the core study, Month 3, 12, 24, 36, 48 | Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels |
| Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study | Baseline of the REP study, Month 3, 12, 24, 36, 48 | Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels |
Countries
Puerto Rico, United States
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed