Open-Label Extension of Study R727-CL-1003 to Evaluate the Long-Term Safety and Efficacy of REGN727 (SAR236553) in Patients With Hypercholesterolemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01576484
First received: March 27, 2012
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

This is a phase 2, open-label extension study to assess the long-term safety and efficacy of REGN727 (SAR236553) administered by subcutaneous (SC) injection in patients previously participating in the R727-CL-1003 study.


Condition Intervention Phase
Hypercholesterolemia
Drug: REGN727 (SAR236553)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Extension of Study R727-CL-1003 to Evaluate the Long-Term Safety and Efficacy of REGN727 Administered by Subcutaneous Injection in Patients With Heterozygous Familial Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of AEs from baseline to end of study [ Time Frame: Baseline (Day 1) to week 218 (End of study) ] [ Designated as safety issue: Yes ]
    Incidence of AEs from baseline (Day 1) to week 218 (end of study)


Secondary Outcome Measures:
  • Percent change in LDL-C: Baseline to weeks 12, 24, 52 and 218 [ Time Frame: Baseline (Day 1) to weeks 12, 24, 52 and 218 (End of study) ] [ Designated as safety issue: No ]
    Percent change in calculated serum LDL-C (Low-density lipoprotein cholesterol) from baseline (average of values calculated at Screening Visit and Baseline [Day 1] visits) in the current study to weeks 12, 24, 52 and 218.

  • Changes in other lipids and other lipoproteins [ Time Frame: Baseline (Day 1) and week 218 (End of study) ] [ Designated as safety issue: No ]
    To evaluate the effect of REGN727 on other lipid parameters.


Enrollment: 58
Study Start Date: March 2012
Estimated Study Completion Date: September 2016
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label Drug: REGN727 (SAR236553)
REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Key Inclusion Criteria

  1. Prior participation in and the successful completion of the R727-CL-1003 study.
  2. Patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study
  3. A negative urine pregnancy at the screening/baseline visit for women of childbearing potential

Exclusion Criteria:

Key Exclusion Criteria

  1. Reported a drug-related SAE or drug-related clinical or laboratory AE in the R727-CL-1003 study that resulted in early termination or withdrawal
  2. Significant protocol deviation in R727-CL-1003, such as non-compliance by the investigator or patient
  3. LDL apheresis within 12 months before the screening/baseline visit
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576484

Locations
United States, California
Mission Viejo, California, United States
Newport Beach, California, United States
Thousand Oaks, California, United States
United States, Florida
Miami, Florida, United States
Port Orange, Florida, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Maine
Auburn, Maine, United States
United States, Missouri
St. Louis, Missouri, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cincinnatti, Ohio, United States
United States, Texas
Houston, Texas, United States
Canada, Quebec
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01576484     History of Changes
Other Study ID Numbers: R727-CL-1032
Study First Received: March 27, 2012
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014