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Clinical Trials/2023-509029-29-00
2023-509029-29-00RecruitingPhase 3

ISIS 678354-CS13: An Open-Label Extension Study of AKCEA-APOCIII-LRX Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS)

Ionis Pharmaceuticals Inc.14 sites in 7 countries30 target enrollmentStarted: August 12, 2024Last updated:
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Drugs

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
30
Locations
14
Primary Endpoint
The primary objective is to evaluate safety and tolerability of treatment with olezarsen
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To evaluate the effect of olezarsen on the percent change in fasting triglycerides (TG) from Baseline

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Satisfactory completion of the ISIS 678354 CS3 index study (last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgement
  • •Willing to follow a diet comprising ≤ 20 g fat per day during the study

Exclusion Criteria

  • •Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study, including need for treatment with medications disallowed in the index study (ISIS 678354-CS3)

Outcomes

Primary Outcomes

The primary objective is to evaluate safety and tolerability of treatment with olezarsen

The primary objective is to evaluate safety and tolerability of treatment with olezarsen

Secondary Outcomes

  • Proportion of patients who achieve fasting TG ≤ 500 mg/dL at Month 6, 12, 24, 36, 48
  • Proportion of patients who achieve ≥ 70% reduction in fasting TG from Baseline at Month 6, 12, 24, 36, 48
  • Percent change in fasting TG from Baseline at Month 6 (average of Weeks 23, 25 and 27)
  • Percent change in fasting TG from Baseline at Month 12 (average of Week 51 and 53), Month 24 (average of Week 103 and Week 105) and Month 36 (average of Week 155 and Week 157), and Month 48 (average of Week 205 and 209)
  • Proportion of patients who achieve ≥ 40% reduction in fasting TG from Baseline at Month 6, 12, 24, 36, 48
  • Percent change in fasting apoB48 from Baseline at Month 6, 12, 24, 36, 48
  • Percent change in fasting apoC-III from Baseline at Month 6, 12, 24, 36, 48
  • Percent change in fasting non-HDL from Baseline at Month 6, 12, 24, 36, 48
  • Proportion of patients who achieve fasting TG 880mg/dL at Month 6, 12, 24, 36, 48
  • Adjudicated acute pancreatitis event rate during the Treatment Period (Week 1 through Week 53, 105, 157 or 209)
  • Adjudicated acute pancreatitis event rate during the Treatment Period (Week 1 through Week 53, 105 157 or 209), in patients with ≥ 2 events of adjudicated acute pancreatitis in 5 years prior to treatment with study drug in the index study
  • Adjudicated acute pancreatitis event rate during the Treatment Period (Week 1 through Week 53, 105 157 or 209) in patient with a prior history of pancreatitis within 10 years prior to Screening in the index study

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Global Regulatory Affairs

Scientific

Ionis Pharmaceuticals Inc.

Study Sites (14)

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