Open Label Study of Long Term Safety Evaluation of Alirocumab

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Alirocumab; Drug: Lipid-Modifying Therapy (LMT)

• Registration Number: NCT01954394
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

The maximum study duration will be 176 weeks per participant.

Study Timeline

• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-01
• Study Start: 2013-12-17
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-06
• Results First Submitted: 2018-06-29
• Results First Submitted QC: 2018-06-29
• Last Update Submitted: 2018-06-29
• Results First Posted: 2018-07-24
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 986

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alirocumab 75 or 150 mg Q2W	Lipid-Modifying Therapy (LMT)	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.
Alirocumab 75 or 150 mg Q2W	Alirocumab	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced Adverse Events (AEs)	Up to 10 weeks after last study drug administration (maximum of 176 weeks)	Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168	Parent Baseline, Weeks 48, 96, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168	Parent Baseline, Weeks 48, 96, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168	Parent Baseline, Weeks 48, 96, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168	Parent Baseline, Weeks 48, 96, 144, and 168	Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Trial Locations

Locations (177)

Investigational Site Number 840321; 🇺🇸 Huntsville, Alabama, United States

Investigational Site Number 840341; 🇺🇸 Tempe, Arizona, United States

Investigational Site Number 840334; 🇺🇸 Bell Gardens, California, United States

Investigational Site Number 840319; 🇺🇸 Fountain Valley, California, United States

Investigational Site Number 840336; 🇺🇸 Los Angeles, California, United States

Investigational Site Number 840339; 🇺🇸 Mission Viejo, California, United States

Investigational Site Number 840337; 🇺🇸 Newport Beach, California, United States

Investigational Site Number 840306; 🇺🇸 Golden, Colorado, United States

Investigational Site Number 840328; 🇺🇸 Washington, District of Columbia, United States

Investigational Site Number 840344; 🇺🇸 Atlantis, Florida, United States

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