Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly schedule.
Lipoprotein apheresis to date is the only approved therapeutic option for cardiovascular (CV) risk reduction in patients with severely elevated Lp(a) levels in Germany. Lipoprotein apheresis is an expensive, burdensome, and time-consuming procedure. The current study (CTQJ230A12302) will investigate if treatment with pelacarsen (TQJ230) 80 mg Q4W vs placebo reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia(a) and established CV disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
Pelacarsen (TQJ230) 80 mg s.c. Q4W
Placebo to Pelacarsen
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany
Novartis Investigative Site
Geilenkirchen, North Rhine-Westphalia, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Cloppenburg, Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Erlangen, Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Göttingen, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
München, Germany
...and 3 more locations
Rate of lipoprotein apheresis sessions performed over 52 weeks normalized to the weekly lipoprotein apheresis schedule
Demonstrate superiority of pelacarsen (TQJ230) compared to placebo in reducing the rate of lipoprotein apheresis sessions in patients with hyperlipoproteinemia(a) and established CVD during 52 weeks of treatment
Time frame: Over 52 Weeks
Time to lipoprotein apheresis avoidance (where lipoprotein apheresis avoidance is defined as at least 24 weeks of no lipoprotein apheresis until end of study)
Demonstrate superiority of pelacarsen (TQJ230) compared to placebo in reducing the time to lipoprotein apheresis avoidance
Time frame: At least 24 weeks up to Week 52
Total avoidance of lipoprotein apheresis from week 12 to week 52
Demonstrate superiority of pelacarsen (TQJ230) vs placebo in avoiding the performance of any lipoprotein apheresis in the last 40 weeks of the study
Time frame: Week 12 to Week 52
Change from baseline to week 52 in the log-transformed Lp(a) (measured prior to planned lipoprotein apheresis)
Demonstrate superiority of pelacarsen (TQJ230) vs placebo in lowering Lp(a) after 52 weeks
Time frame: 52 weeks
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