ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01954394
Recruitment Status : Completed
First Posted : October 1, 2013
Results First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Alirocumab Drug: Lipid-Modifying Therapy (LMT) Phase 3

Detailed Description:
The maximum study duration will be 176 weeks per participant.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 986 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia
Study Start Date : December 17, 2013
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Alirocumab 75 or 150 mg Q2W
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.
Drug: Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
Other Names:
  • SAR236553
  • REGN727
  • Praluent

Drug: Lipid-Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.




Primary Outcome Measures :
  1. Percentage of Participants Who Experienced Adverse Events (AEs) [ Time Frame: 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 :
  1. Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [ Time Frame: 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.

  2. Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [ Time Frame: 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.

  3. Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [ Time Frame: 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.

  4. Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time [ Time Frame: 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.

  5. Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time [ Time Frame: 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.

  6. 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 [ Time Frame: 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.

  7. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [ Time Frame: 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.

  8. Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [ Time Frame: 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.

  9. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [ Time Frame: 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.

  10. Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [ Time Frame: 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.

  11. Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 [ Time Frame: 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.

  12. Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 [ Time Frame: 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.

  13. Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 [ Time Frame: 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.

  14. Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954394


  Show 177 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  Study Documents (Full-Text)

Documents provided by Sanofi:
Study Protocol  [PDF] July 10, 2015
Statistical Analysis Plan  [PDF] January 25, 2016


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01954394     History of Changes
Other Study ID Numbers: LTS13463
2013-002572-40 ( EudraCT Number )
U1111-1143-3810 ( Other Identifier: UTN )
First Posted: October 1, 2013    Key Record Dates
Results First Posted: July 24, 2018
Last Update Posted: July 24, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs