Trial record 3 of 42 for:    regeneron | Open Studies

Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy (ODYSSEY ESCAPE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02326220
First received: December 22, 2014
Last updated: March 9, 2015
Last verified: March 2015
  Purpose

This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments in patients with HeFH undergoing LDL apheresis therapy.


Condition Intervention Phase
Heterozygous Familial Hypercholesterolemia
Drug: Alirocumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia Undergoing Lipid Apheresis Therapy

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Rate of apheresis treatments during a 12-week period normalized by the number of planned apheresis treatments according to each patient's established schedule at screening [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) (pre-apheresis) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Standardized rate of apheresis treatments during a 4-week period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in apolipoprotein B (ApoB) (pre-apheresis) (pre-apheresis) to week 6 [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) (pre-apheresis) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Percent change from baseline in total cholesterol (pre-apheresis) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Percent change from baseline in ApoA-1 (pre-apheresis) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Proportion of patients with ≥30% reduction in LDL-C (pre-apheresis) [ Time Frame: At week 6 ] [ Designated as safety issue: No ]
  • Proportion of patients with ≥50% reduction in LDL-C (pre-apheresis) [ Time Frame: At week 6 ] [ Designated as safety issue: No ]
  • Percent change from baseline in LDL-C (pre-apheresis) [ Time Frame: Baseline to week 18 ] [ Designated as safety issue: No ]
  • Percent change from baseline in ApoB (pre-apheresis) [ Time Frame: Baseline to week 18 ] [ Designated as safety issue: No ]
  • Percent change from baseline in non-HDL-C (pre-apheresis) to week 18 [ Time Frame: baseline to week 18 ] [ Designated as safety issue: No ]
  • Percent change from baseline in total cholesterol (pre-apheresis) to week 18 [ Time Frame: baseline to week 18 ] [ Designated as safety issue: No ]
  • Percent change from baseline in ApoA-1(pre-apheresis) to week 18 [ Time Frame: baseline to week 18 ] [ Designated as safety issue: No ]
  • Proportion of patients with ≥30% reduction in LDL-C (pre-apheresis) at week 18 (pre-apheresis) [ Time Frame: At week 18 ] [ Designated as safety issue: No ]
  • Proportion of patients with ≥50% reduction in LDL-C (pre-apheresis) at week 18 [ Time Frame: At week 18 ] [ Designated as safety issue: No ]
  • Change of W-BQ22 (Well-Being Questionnaire 22-item version) from baseline to week 18 [ Time Frame: Baseline to week 18 ] [ Designated as safety issue: No ]
  • Percent change from baseline in lipoprotein (a) [Lp(a)] (pre-apheresis) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Percent change from baseline in HDL-C (pre-apheresis) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Percent change from baseline in triglyceride (TG) levels (pre-apheresis) [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Lp(a) (pre-apheresis) to week 18 [ Time Frame: Baseline to week 18 ] [ Designated as safety issue: No ]
  • Percent change from baseline in HDL-C (pre-apheresis) to week 18 [ Time Frame: Baseline to week 18 ] [ Designated as safety issue: No ]
  • Percent change from baseline in TG levels (pre-apheresis) to week 18 [ Time Frame: Baseline to week 18 ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: March 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab
Alirocumab subcutaneous (SC) dose regimen
Drug: Alirocumab
Other Names:
  • REGN727
  • SAR236553
Placebo Comparator: Placebo
Placebo matching alirocumab subcutaneous (SC) dose regimen
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women ≥18 years of age at the time of the screening visit
  2. Diagnosis of HeFH (Heterozygous familial hypercholesterolemia)
  3. Currently undergoing LDL (low-density lipoprotein) apheresis therapy QW (weekly) or Q2W (every 2 weeks) or at least 8 weeks prior to the screening visit

Exclusion Criteria:

  1. Homozygous FH (familial hypercholesterolemia)
  2. Background medical LMT (lipid-modifying therapy) (if applicable) that has not been stable for at least 8 weeks prior to the screening visit
  3. LDL apheresis schedule/ apheresis settings that have not been stable for at least 8 weeks prior to the screening visit
  4. An LDL apheresis schedule other than QW to Q2W
  5. Initiation of a new exercise program or exercise that has not remained stable within 8 weeks prior to the screening visit (week -2)
  6. Initiation of a new diet or a diet that has not been stable within 8 weeks prior to the screening visit (week -2)
  7. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 8 weeks prior to the screening visit (week -2), or between the screening and randomization visit
  8. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
  9. Known history of a positive test for human immunodeficiency virus
  10. Use of any active investigational drugs within 1 month or 5 half-lives of screening, whichever is longer
  11. Patients who have been treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in any other clinical studies
  12. Pregnant or breastfeeding women
  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: NCT02326220

Contacts
Contact: Clinical Trial Administrator clinicaltrials@regeneron.com

Locations
United States, Connecticut
Recruiting
Hartford, Connecticut, United States
United States, Kansas
Recruiting
Kansas City, Kansas, United States
United States, Minnesota
Not yet recruiting
Rochester, Minnesota, United States
United States, Oregon
Not yet recruiting
Portland, Oregon, United States
United States, Pennsylvania
Not yet recruiting
Philadelphia, Pennsylvania, United States
Germany
Not yet recruiting
Dresden, Sachsen, Germany
Not yet recruiting
Berlin, Germany
Not yet recruiting
Frankfurt, Germany
Not yet recruiting
Muenchen, Germany
Not yet recruiting
Passau, Germany
Recruiting
Rostock, Germany
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Chair: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02326220     History of Changes
Other Study ID Numbers: R727-CL-1216
Study First Received: December 22, 2014
Last Updated: March 9, 2015
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Dyslipidemias
Genetic Diseases, Inborn
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on March 26, 2015