A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen

Launched by IONIS PHARMACEUTICALS, INC. · Dec 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called olezarsen for adults with Familial Chylomicronemia Syndrome (FCS), a rare condition that affects how the body processes fats. The trial aims to understand how safe and effective olezarsen is for patients who have previously been treated with another medication called volanesorsen. If you have FCS and have been treated with volanesorsen in the past, you might be eligible to participate in this trial.

To join, you should be between the ages of 65 and 74, and you should have a confirmed diagnosis of FCS. You can still take certain other medications for your condition while participating, as long as they remain the same throughout the study. If you decide to take part, you'll be monitored closely to ensure your safety and to track how well the new treatment is working. It's important to know that this trial is currently active but not recruiting new participants, so check with your healthcare provider for the most up-to-date information.

Gender

ALL

Eligibility criteria

• • 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