An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-15

Study Completion Date

2019-02-22

Brief Summary

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Primary Objective:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C \>=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre \[mmol/L\]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period.

Secondary Objective:

* To evaluate the safety and tolerability of alirocumab.
* To evaluate the pharmacokinetics profile of alirocumab.
* To evaluate the effects of alirocumab on other lipid parameters.

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Detailed Description

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For Cohorts 1 to 3, a study duration of approximately 16-23 weeks (screening period: up to 6 (+1) weeks, open-label dose finding treatment period: 8 weeks, follow up period: 6-8 weeks).

For Cohort 4, a study duration of approximately 14-19 weeks (screening period up to 6 \[+1\] weeks, open-label dose finding treatment period: 12 weeks).

Optional extension period: up to a maximum of 2 years for the first participants enrolled in Cohorts 1 to 3, but a maximum of approximately 5 months for the first participants enrolled in Cohort 4.

For all participants who declined participation in the phase 3 study, their last alirocumab injection was on December 2018.

Conditions

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Hypercholesterolaemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1 - Alirocumab 30 mg Q2W: <50 kg

Period 1: Participants with body weight less than (\<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 30 milligram(mg) administered every 2 weeks (Q2W) up to 8 weeks added to lipid modifying therapy (LMT).

Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until they started receiving dose matching to Cohort 2 dosage including dose adjustment to body weight as required. Cohort 2 dosage was: if body weight was still \< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

statins

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

ezetimibe

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

cholestyramine

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

fenofibrate

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

omega-3 fatty acids

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

nicotinic acid

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg

Period 1: Participants with body weight greater than or equal to (\>=) 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.

Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

statins

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

ezetimibe

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

cholestyramine

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

fenofibrate

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

omega-3 fatty acids

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

nicotinic acid

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

Cohort 2 - Alirocumab 40 mg Q2W: <50 kg

Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.

Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still \< 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

statins

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

ezetimibe

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

cholestyramine

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

fenofibrate

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

omega-3 fatty acids

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

nicotinic acid

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg

Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.

Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

statins

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

ezetimibe

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

cholestyramine

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

fenofibrate

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

omega-3 fatty acids

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

nicotinic acid

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

Cohort 3 - Alirocumab 75 mg Q4W: <50 kg

Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered every 4 weeks (Q4W) up to 8 weeks added to LMT.

Period 2: Participants with body weight \< 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

statins

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

ezetimibe

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

cholestyramine

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

fenofibrate

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

omega-3 fatty acids

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

nicotinic acid

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg

Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.

Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

statins

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

ezetimibe

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

cholestyramine

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

fenofibrate

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

omega-3 fatty acids

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

nicotinic acid

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

Cohort 4 - Alirocumab 150 mg Q4W: <50 kg

Period 1: Participants with body weight \< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.

Period 2: Participants with body weight \< 50 kg received SC injection of Alirocumab 150 mg administered Q4W from Week 12 until Week 48.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

statins

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

ezetimibe

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

cholestyramine

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

fenofibrate

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

omega-3 fatty acids

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

nicotinic acid

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg

Period 1: Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.

Period 2: Participants with body weight \>= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

statins

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

ezetimibe

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

cholestyramine

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

fenofibrate

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

omega-3 fatty acids

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

nicotinic acid

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

Interventions

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alirocumab SAR236553 (REGN727)

Pharmaceutical form: solution Route of administration: subcutaneous injection

Intervention Type DRUG

statins

Pharmaceutical form: tablet Route of administration: oral

Intervention Type DRUG

ezetimibe

Pharmaceutical form:tablet Route of administration: oral

Intervention Type DRUG

cholestyramine

Pharmaceutical form:tablet Route of administration: oral

Intervention Type DRUG

fenofibrate

Pharmaceutical form: tablet Route of administration: oral

Intervention Type DRUG

omega-3 fatty acids

Pharmaceutical form: tablet Route of administration: oral

Intervention Type DRUG

nicotinic acid

Pharmaceutical form: tablet Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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Praluent

Eligibility Criteria

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Inclusion Criteria

* Children and adolescent male and female participants aged of 8 to 17 years at the time of signed informed consent. For Russia only: Male and female participants aged \>=12 and \<=17 years at the time of signed informed consent.
* Participants with diagnosis of heterozygous familial hypercholesterolemia (heFH) through genotyping or clinical criteria.
* Participants treated with optimal dose of statin +/- other LMT(s) or non-statin LMT(s) if statin intolerant at stable dose for at least 4 weeks prior to screening lipid sampling.
* Participants with calculated LDL-C greater than or equal to 130 mg/dL (\>=3.37 mmol/L) at the screening visit.
* Participants with body weight greater than or equal to 25 kg.
* Participants aged of 8 to 9 years to be at Tanner stage 1 and participants aged of 10 to 17 years to be at least at Tanner stage 2 in their development.
* A signed informed consent indicating parental permission with or without participant assent.

Exclusion Criteria

* Participant with secondary hyperlipidemia.
* Diagnosis of homozygous familial hypercholesterolemia.
* Participant who had received lipid apheresis treatment within 2 months prior to the screening period, or has plans to receive it during the study.
* Known history of type 1 or type 2 diabetes mellitus.
* Known history of thyroid disease.
* Known history of hypertension.
* Fasting triglycerides \>350 mg/dL (3.95 mmol/L).
* Severe renal impairment (i.e., estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m\^2).
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 x upper limit of normal (ULN).
* Creatinine phosphokinase (CPK) \>3 x ULN.

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 8400002

St Louis, Missouri, United States

Site Status

Investigational Site Number 8400005

Charlotte, North Carolina, United States

Site Status

Investigational Site Number 8400001

Cincinnati, Ohio, United States

Site Status

Investigational Site Number 1240001

Québec, , Canada

Site Status

Investigational Site Number 2030001

Brno, , Czechia

Site Status

Investigational Site Number 2030003

Praha 5 - Motol, , Czechia

Site Status

Investigational Site Number 2030002

Zlín, , Czechia

Site Status

Investigational Site Number 2500001

Bron, , France

Site Status

Investigational Site Number 5280001

Amsterdam, , Netherlands

Site Status

Investigational Site Number 5780001

Oslo, , Norway

Site Status

Investigational Site Number 6430001

Kemerovo, , Russia

Site Status

Investigational Site Number 6430004

Saint Petersburg, , Russia

Site Status

Investigational Site Number 7100001

Parow, , South Africa

Site Status

Investigational Site Number 7240004

A Coruña, , Spain

Site Status

Investigational Site Number 7240001

Madrid, , Spain

Site Status

Investigational Site Number 7520001

Stockholm, , Sweden

Site Status

Countries

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United States Canada Czechia France Netherlands Norway Russia South Africa Spain Sweden

References

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Daniels S, Caprio S, Chaudhari U, Manvelian G, Baccara-Dinet MT, Brunet A, Scemama M, Loizeau V, Bruckert E. PCSK9 inhibition with alirocumab in pediatric patients with heterozygous familial hypercholesterolemia: The ODYSSEY KIDS study. J Clin Lipidol. 2020 May-Jun;14(3):322-330.e5. doi: 10.1016/j.jacl.2020.03.001. Epub 2020 Mar 28.

Reference Type DERIVED

PMID: 32331936 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-003766-85

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1178-4764

Identifier Type: OTHER

Identifier Source: secondary_id

DFI14223

Identifier Type: -

Identifier Source: org_study_id

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