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An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

NCT ID: NCT03510884

Last Updated: 2023-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2022-08-05

Brief Summary

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Primary Objective:

To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in participants with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age 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.

Secondary Objectives:

* To evaluate the efficacy of alirocumab versus placebo on LDL-C levels.
* To evaluate the effects of alirocumab versus placebo on other lipid parameters.
* To evaluate the safety and tolerability of alirocumab in comparison with placebo.
* To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment.
* To evaluate the development of anti-alirocumab antibodies.

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Detailed Description

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The study duration was approximately up to 110 weeks (run-in period \[if needed\]: up to 4 weeks \[+2 days\], screening period: up to 2 weeks \[+5 days\], double-blind treatment period: 24 weeks, open label (OL) treatment period: 80 weeks).

Conditions

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Hypercholesterolaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo/Alirocumab Q2W

Participants received subcutaneous (SC) injection of placebo (matched to alirocumab) based on their body weight (BW) (less than \[\<\] 50 kilograms \[kg\] or greater than or equal to \[\>=\] 50 kg) Q2W for 24 weeks in DB treatment period added to stable LMT. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 milligrams (mg) (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).

Group Type EXPERIMENTAL

Alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: subcutaneous injection

Rosuvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

Atorvastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Simvastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Pravastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Lovastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Fluvastatin

Intervention Type DRUG

Pharmaceutical form:Capsule Route of administration: Oral

Ezetimibe

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Cholestyramine

Intervention Type DRUG

Pharmaceutical form:oral suspension Route of administration: oral

Nicotinic acid

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:capsule Route of administration: oral

Placebo

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: subcutaneous injection

Alirocumab Q2W

Participants received SC injection of alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) Q2W for 24 weeks in DB treatment period added to stable LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level was \>=110 milligrams per deciliter (mg/dL) (2.85 millimoles per liter \[mmol/L\]) at Week 8. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW \<50 kg) or 75 mg (for BW \>=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW \<50 kg) or 75 mg to 150 mg (for BW \>=50 kg) or down titrated as 75 mg to 40 mg (for BW \<50 kg) or 150 mg to 75 mg (for BW \>=50 kg).

Group Type EXPERIMENTAL

Alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: subcutaneous injection

Rosuvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

Atorvastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Simvastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Pravastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Lovastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Fluvastatin

Intervention Type DRUG

Pharmaceutical form:Capsule Route of administration: Oral

Ezetimibe

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Cholestyramine

Intervention Type DRUG

Pharmaceutical form:oral suspension Route of administration: oral

Nicotinic acid

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:capsule Route of administration: oral

Placebo/Alirocumab Q4W

Participants received SC injection of placebo (matched to alirocumab) based on their BW (\<50 kg or \>=50 kg) Q4W for 24 weeks in DB treatment period added to stable LMT. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).

Group Type EXPERIMENTAL

Alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: subcutaneous injection

Rosuvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

Atorvastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Simvastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Pravastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Lovastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Fluvastatin

Intervention Type DRUG

Pharmaceutical form:Capsule Route of administration: Oral

Ezetimibe

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Cholestyramine

Intervention Type DRUG

Pharmaceutical form:oral suspension Route of administration: oral

Nicotinic acid

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:capsule Route of administration: oral

Placebo

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: subcutaneous injection

Alirocumab Q4W

Participants received SC injection of alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) Q4W for 24 weeks in DB treatment period added to stable LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level \>=110 mg/dL (2.85 mmol/L) at Week 8. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW \<50 kg) or 300 mg (for BW \>=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from \<50 kg to \>=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW \<50 kg) or 300 mg Q4W to 150 mg Q2W (for BW \>=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW \<50 kg) or 150 mg Q2W to 75 mg Q2W (for BW \>=50 kg).

Group Type EXPERIMENTAL

Alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: subcutaneous injection

Rosuvastatin

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

Atorvastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Simvastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Pravastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Lovastatin

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Fluvastatin

Intervention Type DRUG

Pharmaceutical form:Capsule Route of administration: Oral

Ezetimibe

Intervention Type DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Cholestyramine

Intervention Type DRUG

Pharmaceutical form:oral suspension Route of administration: oral

Nicotinic acid

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:capsule Route of administration: oral

Interventions

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Alirocumab SAR236553 (REGN727)

Pharmaceutical form:solution Route of administration: subcutaneous injection

Intervention Type DRUG

Rosuvastatin

Pharmaceutical form:tablet Route of administration: oral

Intervention Type DRUG

Atorvastatin

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type DRUG

Simvastatin

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type DRUG

Pravastatin

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type DRUG

Lovastatin

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type DRUG

Fluvastatin

Pharmaceutical form:Capsule Route of administration: Oral

Intervention Type DRUG

Ezetimibe

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type DRUG

Cholestyramine

Pharmaceutical form:oral suspension Route of administration: oral

Intervention Type DRUG

Nicotinic acid

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:capsule Route of administration: oral

Intervention Type DRUG

Placebo

Pharmaceutical form:solution Route of administration: subcutaneous injection

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 8 to 17 years of age at the time of signed informed consent.
* Participants with diagnosis of 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 except for participants who have previously participated in the DFI14223 (NCT02890992) study.
* A signed informed consent indicating parental permission with or without participant assent.

Exclusion Criteria

* Participant with body weight \< 25 kg.
* Participants aged of 8 to 9 years not at Tanner stage 1 and participants aged of 10 to 17 years not at least at Tanner stage 2 in their development.
* Participants 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.
* Participants with uncontrolled type 1 or type 2 diabetes mellitus.
* Participants with known uncontrolled thyroid disease.
* Participants with uncontrolled hypertension.
* Fasting triglycerides greater than (\>) 350 mg/dL (3.95 mmol/L).
* Severe renal impairment (ie, estimated glomerular filtration rate \<30 mL/min/1.73 m\^2).
* Alanine aminotransferase or aspartate aminotransferase \>2\*upper limit of normal (ULN).
* Creatinine phosphokinase (CPK) \>3\*ULN.

The above information was 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

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

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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Excel Medical Clinical Trials, LLC-Site Number:8400001

Boca Raton, Florida, United States

Site Status

Washington University School of Medicine-Site Number:8400006

St Louis, Missouri, United States

Site Status

Presbyterian Novant Heart & Wellness-Site Number:8400002

Charlotte, North Carolina, United States

Site Status

Cincinnati Children's Hospital Medical Center-Site Number:8400005

Cincinnati, Ohio, United States

Site Status

Vanderbilt University-Site Number:8400003

Nashville, Tennessee, United States

Site Status

Investigational Site Number :0320001

Buenos Aires, , Argentina

Site Status

Investigational Site Number :0400001

Vienna, , Austria

Site Status

Investigational Site Number :0760004

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Investigational Site Number :0760001

São Paulo, , Brazil

Site Status

Investigational Site Number :1000002

Plovdiv, , Bulgaria

Site Status

Investigational Site Number :1240001

Québec, , Canada

Site Status

Investigational Site Number :2030002

Brno, , Czechia

Site Status

Investigational Site Number :2030001

Praha 5 - Motol, , Czechia

Site Status

Investigational Site Number :2080001

Copenhagen, , Denmark

Site Status

Investigational Site Number :2460001

HUS, , Finland

Site Status

Investigational Site Number :2500001

Bron, , France

Site Status

Investigational Site Number :2500002

Nantes, , France

Site Status

Investigational Site Number :3480001

Budapest, , Hungary

Site Status

Investigational Site Number :3800003

Milan, , Italy

Site Status

Investigational Site Number :3800001

Palermo, , Italy

Site Status

Investigational Site Number :3800002

Roma, , Italy

Site Status

Investigational Site Number :4220001

Beirut, , Lebanon

Site Status

Investigational Site Number :4220003

Room Hospital Street, Achrafie, , Lebanon

Site Status

Investigational Site Number :4840008

Guadalajara, Jalisco, Mexico

Site Status

Investigational Site Number :4840007

Oaxaca City, , Mexico

Site Status

Investigational Site Number :5280001

Amsterdam, , Netherlands

Site Status

Investigational Site Number :5780001

Oslo, , Norway

Site Status

Investigational Site Number :6160002

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Investigational Site Number :6160001

Lodz, , Poland

Site Status

Investigational Site Number :6430006

Kazan', , Russia

Site Status

Investigational Site Number :6430001

Kemerovo, , Russia

Site Status

Investigational Site Number :6430004

Moscow, , Russia

Site Status

Investigational Site Number :6430002

Ufa, , Russia

Site Status

Investigational Site Number :7050001

Ljubljana, , Slovenia

Site Status

Investigational Site Number :7100002

Parow, , South Africa

Site Status

Investigational Site Number :7240003

Pamplona, Navarre, Spain

Site Status

Investigational Site Number :7240002

A Coruña, , Spain

Site Status

Investigational Site Number :7240004

Badalona, , Spain

Site Status

Investigational Site Number :7240001

Barcelona, , Spain

Site Status

Investigational Site Number :7520001

Stockholm, , Sweden

Site Status

Investigational Site Number :1580001

Taipei, , Taiwan

Site Status

Investigational Site Number :7920002

Ankara, , Turkey (Türkiye)

Site Status

Investigational Site Number :7920001

Izmir, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Austria Brazil Bulgaria Canada Czechia Denmark Finland France Hungary Italy Lebanon Mexico Netherlands Norway Poland Russia Slovenia South Africa Spain Sweden Taiwan Turkey (Türkiye)

References

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Santos RD, Wiegman A, Caprio S, Cariou B, Averna M, Poulouin Y, Scemama M, Manvelian G, Garon G, Daniels S. Alirocumab in Pediatric Patients With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial. JAMA Pediatr. 2024 Mar 1;178(3):283-293. doi: 10.1001/jamapediatrics.2023.6477.

Reference Type DERIVED
PMID: 38315470 (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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2017-001903-60

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1193-0721

Identifier Type: OTHER

Identifier Source: secondary_id

EFC14643

Identifier Type: -

Identifier Source: org_study_id

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