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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05130450
Other study ID # ISIS 678354-CS13
Secondary ID 2021-003280-95
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 18, 2021
Est. completion date April 2025

Study information

Verified date May 2024
Source Ionis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of olezarsen (formerly known as AKCEA-APOCIII-LRx) on the percent change in fasting triglycerides (TG) from baseline.


Description:

This is a multi-center, open-label extension (OLE) study of up to 60 participants with FCS rolling-over from Study ISIS 678354-CS3 (NCT04568434). Participants will receive olezarsen during a 157-week treatment period, followed by a 13-week post-treatment follow-up period. The length of participation in this study is approximately 201 weeks, which includes an up to 31-day qualification period, a 157-week treatment period, and a 13-week post-treatment evaluation period. Treatment has been extended to obtain additional safety assessments and efficacy data and to provide patients with continued access to ISIS 678354 until the drug may be available commercially.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date April 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: • Satisfactory completion of treatment with olezarsen in the index study (ISIS 678354-CS3, last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgement. Exclusion Criteria: • Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Olezarsen
Olezarsen will be administered by SC injection.

Locations

Country Name City State
Canada Ecogene-21 Chicoutimi Quebec
Canada Institute de Recherches Cliniques de Montreal Montreal Quebec
Canada Nathalie Saint-Pierre Montréal Quebec
Canada Clinique des Maladies Lipidiques de Quebec Inc. Québec Quebec
France Groupement Hospitalier Est- Pharmacie Secteur Essais Clinique Bron
France Hôpital Bicêtre Le Kremlin-Bicêtre
France Pharmacie Hopital de la Conception Marseille
Italy Via Sergio Pansini 5 Napoli
Italy UOC di Farmacia AOUP PAOLO GIACCONE Palermo
Italy Azienda Ospedaliero Universitaria Policlinico Umberto I Rome
Netherlands Academisch Medisch Centrum Goederenontvangst Apotheek t.a.v. Kenniscentrum Amsterdam Noor-Holland
Norway Oslo Hospital Pharmacy Rikshospitalet Oslo
Portugal Hospital da Senhora da Oliveira Guimaraes Creixomil
Portugal Dra Margarida Falcao Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz Lisboa
Slovakia Metabolicke centrum MU Bratislava
Spain Hospital Clínic Barcelona C/ Villarroel Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Virgen del Rocío Sevilla
Sweden Apokteket AB Malmö
United Kingdom Royal Manchester Children's Hospital Manchester
United States Excel Medical Clinical Trials, LLC Boca Raton Florida
United States Diabetes/Lipid Management & Research Center Huntington Beach California
United States University of Kansas Medical Center (KUMC) Kansas City Kansas
United States CTSI Investigational Pharmacy New York New York
United States Milstein Hospital New York New York
United States Department of Pharmacy Park Ridge Illinois
United States IDS Central Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Netherlands,  Norway,  Portugal,  Slovakia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Fasting TG at 6 Months (Average of Weeks 23, 25, and 27) Compared to Baseline Baseline and 6 months
Secondary Percent Change From Baseline in Fasting TG at 12 Months (Average of Weeks 51 and 53) at 24 Months (Average of Week 103 and Week 105) and 36 Months (Average of Week 155 and Week 157) Baseline and 36 months
Secondary Percentage of Participants Who Achieve = 40% Reduction in Fasting TG From Baseline at 6 Months At 6 months
Secondary Percentage of Participants Who Achieve = 40% Reduction in Fasting TG From Baseline at 12, 24, 36 Months At 12, 24, 36 months
Secondary Percent Change in Fasting apoC-III from Baseline at Month 6 Baseline and 6 months
Secondary Percent Change in Fasting apoC-III from Month 12, 24, 36 At 12, 24, 36 months
Secondary Percent Change From Baseline in Fasting Apolipoprotein 48 (apoB48) at 6 Months At 6 months
Secondary Percent Change From Baseline in Fasting apoB48 at 12, 24, 36 Months At 12, 24, 36 months
Secondary Percent Change in Fasting non-HDL-C from Baseline at Month 6 Baseline and 6 months
Secondary Percent Change in Fasting non-HDL-C from Months 12, 24, 36 At 12, 24, 36 months
Secondary Percentage of Participants Who Achieve Fasting TG = 880 milligrams per deciliter (mg/dL) at 6 Months At 6 months
Secondary Percentage of Participants Who Achieve Fasting TG = 880 mg/dL at 12, 24, 36 months At 12, 24, 36 months
Secondary Adjudicated Acute Pancreatitis Event Rate During the Treatment Period in Participants With = 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Treatment With Study Drug in the Index Study Week 1 through Week 157
Secondary Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Week 1 through Weeks 53, 105, or 157
Secondary Adjudicated Acute Pancreatitis Event Rate During the Treatment Period in Patients with a Prior History of Pancreatitis within 10 Years Prior to Screening in the Index Study Week 1 through Weeks 53, 105, or 157
Secondary Percentage of Participants Who Achieve = 70% Reduction in Fasting TG From Baseline at 6 Months At 6 months
Secondary Percentage of Participants Who Achieve = 70% Reduction in Fasting TG From Baseline at 12, 24, 36 Months At 12, 24, 36 months
Secondary Percentage of Participants Who Achieve Fasting TG = 500 mg/dL at 6 Months At 6 months
Secondary Percentage of Participants Who Achieve Fasting TG = 500 mg/dL at 12, 24, 36 Months At 12, 24, 36 months
See also
  Status Clinical Trial Phase
Completed NCT04223908 - InFocus France Epidemiological Study of Health Burden in Major Hypertriglyceridemia
Completed NCT04568434 - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS) Phase 3
Completed NCT03912181 - Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes
Not yet recruiting NCT05902598 - A Phase 3 Study of VSA001 in Chinese Adults With Familial Chylomicronemia Syndrome Phase 3
Active, not recruiting NCT05185843 - A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen Phase 3
Completed NCT02658175 - The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome Phase 3
Completed NCT03360747 - Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS) Phase 2
Completed NCT02211209 - The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome Phase 3
Available NCT06360237 - Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)