Open Label Study of Long Term Safety Evaluation of Alirocumab (ODYSSEY OLE)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Lipid-Modifying Therapy (LMT); Drug: Alirocumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01954394

U1111-1143-3810 (Other Identifier)

2013-002572-40 (EudraCT Number)

LTS13463

Details and patient eligibility

About

Primary Objective:

To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).

Secondary Objectives:

• To evaluate the long-term efficacy of alirocumab on lipid parameters.
• To evaluate the long-term immunogenicity of alirocumab.

Full description

The maximum study duration will be 176 weeks per participant.

Enrollment: 986 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).

Exclusion criteria

Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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986 participants in 1 patient group

Alirocumab 75 or 150 mg Q2W

Experimental group

Description:

Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.

Treatment:

Drug: Alirocumab

Drug: Lipid-Modifying Therapy (LMT)