Clincosm LogoSign in Get a demo

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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03409744
Collaborator
(none)
116
Enrollment
38
Locations
1
Arm
58.4
Anticipated Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 evaluate the effect of evinacumab on lipid parameters in adolescent patients with HoFH

  • To evaluate the potential development of anti-evinacumab antibodies

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
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 :
Mar 13, 2018
Anticipated Primary Completion Date :
Jan 25, 2023
Anticipated Study Completion Date :
Jan 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: evinacumab

Drug: evinacumab
Intravenous (IV) administration
Other Names:
  • REGN1500
  • EVKEEZA®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of treatment-emergent adverse events (TEAEs) [Up to 192 weeks]

    Secondary Outcome Measures

    1. Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) over time [Up to 192 weeks]

    2. Absolute change in LDL-C over time [Up to 192 weeks]

    3. Percent change in Apolipoprotein B (Apo B) over time [Up to 192 weeks]

    4. Absolute change in Apo B over time [Up to 192 weeks]

    5. Percent change in non-High-Density Lipoprotein Cholesterol (HDL-C) over time [Up to 192 weeks]

    6. Absolute change in non-HDL-C over time [Up to 192 weeks]

    7. Percent change in Total Cholesterol (TC) over time [Up to 192 weeks]

    8. Absolute change in TC over time [Up to 192 weeks]

    9. Percent change in Triglycerides (TGs) over time [Up to 192 weeks]

    10. Absolute change in TGs over time [Up to 192 weeks]

    11. Presence of anti-evinacumab antibodies [Up to 192 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trial Site Los Angeles California United States 90048
    2 Clinical Trial Site Boca Raton Florida United States 33434
    3 Clinical Trial Site Boston Massachusetts United States 02114
    4 Clinical Trial Site New York New York United States 10029
    5 Clinical Trial Site Cincinnati Ohio United States 45227
    6 Clinical Trial Site Portland Oregon United States 97239
    7 Clinical Trial Site Philadelphia Pennsylvania United States 19104
    8 Clinical Trial Site Dallas Texas United States 75226
    9 Clinical Trial Site Dallas Texas United States 75390
    10 Clinical Trial Site Camperdown New South Wales Australia 2050
    11 Clinical Trial Site Perth Western Australia Australia 6000
    12 Regeneron Study Site Vienna Wien Austria 1090
    13 Regeneron Study Site Innsbruck Austria 6020
    14 Clinical Trial Site Chicoutimi Quebec Canada G7H 7K9
    15 Clinical Trial Site Quebec Canada G1V 4W2
    16 Regeneron Study Site Praha 2 Kateřinská Czechia 121 08
    17 Clinical Trial Site Paris Cedex 13 France 75651
    18 Clinical Trial Site Marseille Cedex 5 France 13385
    19 Clinical Trial Site Dijon Cedex France 21079
    20 Regeneron Study Site Kallithea Athens Greece 17674
    21 Clinical Trial Site Ioannina Greece 45500
    22 Clinical Trial Site Napoli Campania Italy 80131
    23 Clinical Trial Site Roma Rome Italy 161
    24 Clinical Trial Site Obu Aichi Japan 474-8710
    25 Regeneron Study Site Kurume Fukuoka Japan 830-8522
    26 Regeneron Study Site Nishinomiya Hyogo Japan 662-0918
    27 Regeneron Study Site Kanazawa Ishikawa Japan 920-8641
    28 Regeneron Study Site Kita-ku Osaka Japan 530-0001
    29 Regeneron Study Site Suita Osaka Japan 564-8565
    30 Regeneron Study Site Suita Osaka Japan 565-0871
    31 Clinical Trial Site Amsterdam Netherlands 1105 AZ
    32 Regeneron Study Site Johannesburg Gauteng South Africa 2000
    33 Regeneron Study Site Cape Town Western Cape South Africa 7925
    34 Clinical Trial Site Ivano-Frankivsk Ukraine 76075
    35 Clinical Trial Site #1 Kharkiv Ukraine 61039
    36 Clinical Trial Site #2 Kharkiv Ukraine 61176
    37 Clinical Trial Site Kyiv Ukraine 02660
    38 Rgeneron Study Site Kyiv Ukraine 3680

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03409744
    Other Study ID Numbers:
    • R1500-CL-1719
    • 2017-003170-13
    First Posted:
    Jan 24, 2018
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    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:
    Hyperlipoproteinemia Type II
    Hypercholesterolemia

    Study Results

    No Results Posted as of Mar 4, 2022