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An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) (OLE)

Primary Purpose

Hyperlipoproteinemia (a)

Status

Recruiting

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Pelacarsen

About this trial

This is an interventional treatment trial for Hyperlipoproteinemia (a) focused on measuring Lipoprotein(a), Cardiovascular disease, Apheresis, Post trial access, pelacarsen (TQJ230)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement. Exclusion Criteria: Any medical condition(s) that may put the participant at risk in the investigator's opinion Pregnant or nursing (lactating) women Women of child-bearing potential, unless they are using effective methods of contraception during dosing and for 16 weeks (= 5 times the terminal half-life) after stopping of study medication

Sites / Locations

Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pelacarsen (TQJ230)

Arm Description

open-label pelacarsen 80 mg

Outcomes

Primary Outcome Measures

Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.

Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established cardiovascular disease who have competed the parent study

Duration of drug exposure

Duration of drug exposure will be collected

Secondary Outcome Measures

Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5

Evaluate the long-term effect of pelacarsen on the need for lipoprotein apheresis.

Absolute change in Lp(a) compared to baseline of the parent study.

Evaluate the long-term effect of pelacarsen on Lp(a) change.

Percentage change in Lp(a) compared to baseline of the parent study.

Evaluate the long-term effect of pelacarsen on Lp(a) change.

Full Information

NCT ID

NCT05900141

First Posted

June 2, 2023

Last Updated

October 6, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05900141

Brief Title

An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Acronym

OLE

Official Title

A Single Arm, Open Label Extension (OLE), Multicenter Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Patients With Cardiovascular Disease Who Have Successfully Completed the Apheresis Parent Study.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 29, 2023 (Actual)

Primary Completion Date

August 24, 2028 (Anticipated)

Study Completion Date

August 24, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This non-randomized, open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the double-blind parent study (CTQJ230A12302).

Detailed Description

This study will allow to evaluate a long-term safety and tolerability of pelacarsen (TQJ230) 80 mg QM in patients. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study. The maximum duration of this study is approximately 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipoproteinemia (a)

Keywords

Lipoprotein(a), Cardiovascular disease, Apheresis, Post trial access, pelacarsen (TQJ230)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

Open-label extension (OLE) study

Masking

None (Open Label)

Masking Description

Open label study

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pelacarsen (TQJ230)

Arm Type

Experimental

Arm Description

open-label pelacarsen 80 mg

Intervention Type

Drug

Intervention Name(s)

Pelacarsen

Other Intervention Name(s)

TQJ230

Intervention Description

Pelacarsen 80mg s.c. monthly

Primary Outcome Measure Information:

Title

Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.

Description

Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established cardiovascular disease who have competed the parent study

Time Frame

60 months

Title

Duration of drug exposure

Description

Duration of drug exposure will be collected

Time Frame

60 months

Secondary Outcome Measure Information:

Title

Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5

Description

Evaluate the long-term effect of pelacarsen on the need for lipoprotein apheresis.

Time Frame

60 months

Title

Absolute change in Lp(a) compared to baseline of the parent study.

Description

Evaluate the long-term effect of pelacarsen on Lp(a) change.

Time Frame

month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)

Title

Percentage change in Lp(a) compared to baseline of the parent study.

Description

Evaluate the long-term effect of pelacarsen on Lp(a) change.

Time Frame

month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

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