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Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1080 days

154 Participants Needed

Inclisiran for High Cholesterol
(V-PEDS-OLE Trial)

Recruiting at 48 trial locations

Overseen ByNovartis Pharmaceuticals

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: Inclisiran

Disqualifiers: Uncontrolled disease, Serious condition, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies.

Do I have to stop taking my current medications for the Inclisiran trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How is the drug Inclisiran different from other treatments for high cholesterol?

Inclisiran is unique because it works by using small interfering RNA (siRNA) to target and reduce the production of a protein called PCSK9, which helps lower cholesterol levels. Unlike many cholesterol treatments that require daily dosing, Inclisiran is administered as an injection only twice a year, making it more convenient for patients.¹ ² ³ ⁴ ⁵

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for men and women who have a condition called HeFH or HoFH, which are types of high cholesterol, and have already been part of the ORION-16 or ORION-13 studies. They should have seen benefits from taking inclisiran previously without serious safety issues.

Inclusion Criteria

People who were part of the ORION-16 or ORION-13 studies and have been diagnosed with HeFH or HoFH.

Your doctor believes that you benefited from taking inclisiran in the ORION-16 or ORION-13 studies.

Exclusion Criteria

Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk

I was previously in ORION-16 or ORION-13 studies but had to stop due to serious side effects or other reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inclisiran sodium 300mg in an open-label extension to evaluate long-term safety and tolerability

Up to 1080 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Inclisiran

Trial OverviewThe study is testing the long-term safety and how well people can tolerate inclisiran, a medication for lowering cholesterol levels in patients with HeFH or HoFH who completed prior related studies.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: InclisiranExperimental Treatment1 Intervention

Inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution

Inclisiran is already approved in European Union, United States, China for the following indications:

Approved in European Union as Leqvio for:

Primary hypercholesterolemia (heterozygous familial and non-familial)
Mixed dyslipidemia

Approved in United States as Leqvio for:

Heterozygous familial hypercholesterolemia (HeFH)
Clinical atherosclerotic cardiovascular disease (ASCVD)
Primary hypercholesterolemia

Approved in China as Leqvio for:

Primary hypercholesterolemia (heterozygous familial and non-familial)
Mixed dyslipidemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Findings from Research

Acitretin is a non-immunosuppressive oral medication that has been used for treating psoriasis, providing efficacy without the risks associated with immunosuppressive therapies.

Tofacitinib, an oral Janus kinase inhibitor, also shows effectiveness in psoriasis treatment but comes with significant safety concerns, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small Molecules for Psoriasis.Leonardi, CL.[2016]

In a pilot study of nine patients with severe chronic hand dermatitis (CHD), acitretin showed promising results, with 33.3% of patients achieving a physician global assessment (PGA) of clear or almost clear skin after treatment.

The study found a significant reduction in symptoms, with a 45% decrease in the modified total lesion symptom score (mTLSS), indicating that acitretin may be an effective treatment option for severe CHD, although further research is needed to confirm its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label exploratory study of acitretin for the treatment of severe chronic hand dermatitis.Tan, J., Maari, C., Nigen, S., et al.[2018]

Acitretin is a valuable treatment option for psoriasis, effective both alone and in combination with other therapies, due to its long-term efficacy and lack of direct immunosuppressive effects.

The consensus guidelines from the Spanish Academy of Dermatology provide comprehensive information on the safe use of acitretin, including its pharmacological properties, indications, contraindications, and treatment strategies for clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for the use of acitretin in psoriasis. Psoriasis Group of the Spanish Academy of Dermatology and Venereology.Carretero, G., Ribera, M., Belinchón, I., et al.[2022]