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Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

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: NCT03409744
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objectives of the study are:

  • To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH)
  • To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH

The secondary objectives of the study are:

  • To evaluate the effect of evinacumab on lipid parameters in patients with HoFH
  • To evaluabe the effect of evinacumab on lipd parameters in adolescent patients with HoFH
  • To evaluate the potential development of anti-evinacumab antibodies

Condition or disease Intervention/treatment Phase
Homozygous Familial Hypercholesterolemia Drug: evinacumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : April 18, 2022
Estimated Study Completion Date : April 18, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: evinacumab Drug: evinacumab
Intravenous (IV) administration
Other Name: REGN1500




Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 192 weeks ]

Secondary Outcome Measures :
  1. Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) over time [ Time Frame: Up to 192 weeks ]
  2. Absolute change in LDL-C over time [ Time Frame: Up to 192 weeks ]
  3. Percent change in Apolipoprotein B (Apo B) over time [ Time Frame: Up to 192 weeks ]
  4. Absolute change in Apo B over time [ Time Frame: Up to 192 weeks ]
  5. Percent change in non-High-Density Lipoprotein Cholesterol (HDL-C) over time [ Time Frame: Up to 192 weeks ]
  6. Absolute change in non-HDL-C over time [ Time Frame: Up to 192 weeks ]
  7. Percent change in Total Cholesterol (TC) over time [ Time Frame: Up to 192 weeks ]
  8. Absolute change in TC over time [ Time Frame: Up to 192 weeks ]
  9. Percent change in Triglycerides (TGs) over time [ Time Frame: Up to 192 weeks ]
  10. Absolute change in TGs over time [ Time Frame: Up to 192 weeks ]
  11. Presence of anti-evinacumab antibodies [ Time Frame: Up to 192 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Completion of the parent study in which they participated
  2. Able to understand and complete study-related questionnaires

Key Exclusion Criteria:

  1. Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient
  2. Concomitant medications that have not been stable prior to the baseline visit
  3. Adverse event leading to permanent discontinuation from parent study
  4. Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study
  5. Member of the clinical site study team and/or his/her immediate family
  6. Pregnant or breastfeeding women
  7. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug
  8. Men who are sexually active with women of childbearing potential and are unwilling to use the following forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug: vasectomy with medical assessment of surgical success OR consistent use of a condom.

Note: Other protocol defined Inclusion/Exclusion criteria apply


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): NCT03409744


Locations
Show Show 38 study locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03409744    
Other Study ID Numbers: R1500-CL-1719
2017-003170-13 ( EudraCT Number )
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
HoFH
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias