RecruitingPhase 3NCT06875973
Pelacarsen Roll-over Extension Program
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD
Sponsor
Novartis Pharmaceuticals
Enrollment
599 participants
Start Date
May 19, 2025
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria2
- 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 Criteria4
- 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
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Interventions
DRUGPelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Locations(95)
View Full Details on ClinicalTrials.gov
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NCT06875973
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