Clinical Trials in Sweden / NCT05185843
Active, not recruiting
Phase 3
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen
NCT05185843 · tracked via the Priya Life Science Sweden tracker
Condition(s) studied
Familial Chylomicronemia Syndrome
Investigational drug(s) / intervention(s)
Olezarsen: Olezarsen will be administered by SC injection.
Study summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of olezarsen (formerly known as AKCEA -APOCIII-LRX) in participants with FCS previously treated with volanesorsen.
Eligibility
Key Inclusion Criteria
1. Participants with FCS (clinical or genetic diagnosis) currently on or previously treated with volanesorsen (ISIS 304801)
o Study participants in countries where Waylivra® is commercially approved and available for participants should not be deprived of the treatment option with Waylivra®. Participation in this study for such participants will only be allowed when Waylivra® was discontinued due to AEs
2. The following concomitant medications will be allowed if dosing regimen is expected to remain constant through the end of the study (occasional or intermittent use of over-the-counter (OTC) medications will be allowed at Investigator's discretion):
* Statins, omega-3 fatty acids (prescription and OTC), fibrates, or other lipid-lowering medications. Participants taking OTC omega-3 fatty acids should make every effort to remain on the same brand through the end of the study
* Antidiabetic medications
* Oral anticoagulants (e.g., dabigatran, rivaroxaban, or apixaban, and warfarin with regular clinical monitoring)
* Tamoxifen, estrogens or progestins
Key Exclusion Criteria:
1. Treatment with another investigational drug (non-oligonucleotide), biological agent, or device within 4 weeks of Screening, or 5 half-lives of investigational agent, whichever is longer
2. Concomitant medication/procedure restrictions:
1. Systemic corticosteroids or anabolic steroids within 6 weeks prior to Screening and during the study unless approved by the Sponsor Medical Monitor
2. Plasma apheresis within 4 weeks prior to Screening or planned during the study
Primary outcome measure(s)
- Proportion of Participants With Decrease in Platelet Count by >30% or >50%, or With Platelet Count Value <50,000/cubic millimeter (mm^3) — Baseline to Week 209
- Proportion of Participants With Clinical Bleeding Events — Baseline to Week 209
- Proportion of Participants With Decrease in Estimated Glomerular Filtration Rate (eGFR) by ≥30% or ≥50% — Baseline to Week 209
- Proportion of Participants With Urine Protein/Creatinine Ratio (UPCR) ≥1000 milligram (mg)/gram (g) or with Urine/Albumin Creatinine Ratio (UACR) ≥500 mg/g — Baseline to Week 209
- Proportion of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥5 x Upper Limit of Normal (ULN) — Baseline to Week 209
- Proportion of Participants With ALT or AST ≥3 x ULN and Total Bilirubin > 2 x ULN — Baseline to Week 209
- Proportion of Participants With Total Bilirubin ≥2 mg/deciliter (dL) — Baseline to Week 209
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Diabetes/Lipid Management & Research Center | Huntington Beach | California | |
| Excel Medical Clinical Trials, LLC | Boca Raton | Florida | |
| University of Michigan, Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes (MEND) | Ann Arbor | Michigan | |
| University of Rochester School of Medicine | Rochester | New York | |
| Centre for Heart Lung Innovation | Vancouver | British Columbia | |
| ARC Biosystems, Clinical Assessment Unit (CAU) | Vancouver | British Columbia | |
| St. Boniface General Hospital | Winnipeg | Manitoba | |
| Ecogene-21 | Chicoutimi | Quebec | |
| Clinique des Maladies Lipidiques de Quebec Inc. | Québec | Quebec | |
| Centre Hospitalier Universite de Sherbrooke (CHUS) | Sherbrooke | Quebec | |
| Karolinska University Hospital Huddinge | Stockholm | Sweden |
More Ionis Pharmaceuticals, Inc. trials in Sweden
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)
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CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
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FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05185843 on ClinicalTrials.gov ↗ ← All trials in Sweden