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Long Term Safety Study of PRALUENT

Primary Purpose

Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Praluent
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heterozygous Familial Hypercholesterolemia

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug.

Key Exclusion Criteria:

  1. Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance
  2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682).
  3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study
  4. Known hypersensitivity to monoclonal antibody or any component of the drug product
  5. Pregnant or breastfeeding women

Note: Other inclusion/ exclusion criteria apply

Sites / Locations

  • Regeneron Research Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks
An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.

Secondary Outcome Measures

Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Percent Change in LDL-C From Baseline Over Time
Total Cholesterol (Total-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Percent Change From Baseline in Total-C Over Time
Lipoprotein a (Lp(a)) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Percent Change From Baseline in Lp(a) Over Time
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Percent Change From Baseline in Non-HDL-C Over Time
High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Percent Change From Baseline in HDL-C Over Time
Fasting Triglycerides (TGs) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Percent Change From Baseline in Fasting TGs Over Time
Apolipoprotein B (Apo B) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Percent Change From Baseline in Apo B Over Time
Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Percent Change From Baseline in Apo A1 Over Time
Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time
Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time
Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time
Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time
Alanine Aminotransferase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Change From Baseline in Alanine Aminotransferase Over Time
Aspartate Aminotransferase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Change From Baseline in Aspartate Aminotransferase Over Time
Alkaline Phosphatase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Change From Baseline in Alkaline Phosphatase Over Time
Total Bilirubin Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Change From Baseline in Total Bilirubin Over Time

Full Information

First Posted
September 6, 2018
Last Updated
May 20, 2021
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03694197
Brief Title
Long Term Safety Study of PRALUENT
Official Title
Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
The primary objective (to evaluate the long-term safety of Praluent) was adequately evaluated in other studies.
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682). The secondary objectives of the study were: To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C) To evaluate the effect of PRALUENT on other lipid parameters To evaluate the effect of PRALUENT on gonadal steroid hormones

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1389 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open label
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Praluent
Other Intervention Name(s)
Alirocumab, REGN727, SAR236553
Intervention Description
Subcutaneous (SC) administration
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks
Description
An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.
Time Frame
After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks
Secondary Outcome Measure Information:
Title
Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Percent Change in LDL-C From Baseline Over Time
Time Frame
Up to week 72
Title
Total Cholesterol (Total-C) Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Percent Change From Baseline in Total-C Over Time
Time Frame
Up to week 72
Title
Lipoprotein a (Lp(a)) Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Percent Change From Baseline in Lp(a) Over Time
Time Frame
Up to week 72
Title
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Percent Change From Baseline in Non-HDL-C Over Time
Time Frame
Up to week 72
Title
High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Percent Change From Baseline in HDL-C Over Time
Time Frame
Up to week 72
Title
Fasting Triglycerides (TGs) Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Percent Change From Baseline in Fasting TGs Over Time
Time Frame
Up to week 72
Title
Apolipoprotein B (Apo B) Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Percent Change From Baseline in Apo B Over Time
Time Frame
Up to week 72
Title
Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Percent Change From Baseline in Apo A1 Over Time
Time Frame
Up to week 72
Title
Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time
Time Frame
Up to week 72
Title
Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time
Time Frame
Up to week 72
Title
Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time
Time Frame
Up to week 72
Title
Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time
Time Frame
Up to week 72
Title
Alanine Aminotransferase Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Change From Baseline in Alanine Aminotransferase Over Time
Time Frame
Up to week 72
Title
Aspartate Aminotransferase Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Change From Baseline in Aspartate Aminotransferase Over Time
Time Frame
Up to week 72
Title
Alkaline Phosphatase Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Change From Baseline in Alkaline Phosphatase Over Time
Time Frame
Up to week 72
Title
Total Bilirubin Values From Baseline Over Time
Description
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame
Up to week 72
Title
Change From Baseline in Total Bilirubin Over Time
Time Frame
Up to week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug. Key Exclusion Criteria: Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682). Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study Known hypersensitivity to monoclonal antibody or any component of the drug product Pregnant or breastfeeding women Note: Other inclusion/ exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Research Site
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36830
Country
United States
Facility Name
Regeneron Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Regeneron Research Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Regeneron Research Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Regeneron Research Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Regeneron Research Site
City
Port Hueneme
State/Province
California
ZIP/Postal Code
93041
Country
United States
Facility Name
Regeneron Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Regeneron Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
Regeneron Research Site
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Regeneron Research Site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Regeneron Research Site
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61822
Country
United States
Facility Name
Regeneron Research Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Regeneron Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Regeneron Research Site
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010-30144
Country
United States
Facility Name
Regeneron Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Regeneron Research Site
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
Regeneron Research Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Regeneron Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Regeneron Research Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Regeneron Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Regeneron Research Site
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Regeneron Research Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Regeneron Research Site
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Regeneron Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Regeneron Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Regeneron Research Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Regeneron Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Regeneron Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Regeneron Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Regeneron Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Regeneron Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Regeneron Research Site
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Regeneron Research Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Regeneron Research Site
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Regeneron Research Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Regeneron Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Regeneron Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Regeneron Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Regeneron Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Regeneron Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Regeneron Research Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Regeneron Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Regeneron Research Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Regeneron Research Site 2
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37760
Country
United States
Facility Name
Regeneron Research Site 3
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
Regeneron Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Regeneron Research Site
City
Powell
State/Province
Tennessee
ZIP/Postal Code
37849
Country
United States
Facility Name
Regeneron Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Regeneron Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Regeneron Research Site
City
Schertz
State/Province
Texas
ZIP/Postal Code
78154
Country
United States
Facility Name
Regeneron Research Site
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Regeneron Research Site
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Regeneron Research Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Regeneron Research Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Regeneron Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Regeneron Research Site
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Regeneron Research Site
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54220
Country
United States
Facility Name
Regeneron Research Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Regeneron Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Regeneron Research Site
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Regeneron Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Regeneron Research Site #2
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Regeneron Research Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Regeneron Research Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Regeneron Research Site
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Regeneron Research Site
City
Paide
ZIP/Postal Code
72713
Country
Estonia
Facility Name
Regeneron Research Site #2
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
Regeneron Research Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Regeneron Research Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Regeneron Research Site
City
Ekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Ivanovo
ZIP/Postal Code
153012
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Rostov-na-Donu
ZIP/Postal Code
344068
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Saint Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Saint-Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Regeneron Research Site #2
City
St. Petersburg
ZIP/Postal Code
192288
Country
Russian Federation
Facility Name
Regeneron Research Site
City
St. Petersburg
ZIP/Postal Code
192288
Country
Russian Federation
Facility Name
Regeneron Research Site
City
St. Petersburg
ZIP/Postal Code
195112
Country
Russian Federation
Facility Name
Regeneron Research Site
City
St. Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Regeneron Research Site
City
St. Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Sverdlovskaya
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Tyumen
ZIP/Postal Code
625032
Country
Russian Federation
Facility Name
Regeneron Research Site 1
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Regeneron Research Site 2
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Regeneron Research Site
City
Kuilsrivier
State/Province
Cape Town
ZIP/Postal Code
7580
Country
South Africa
Facility Name
Regeneron Research Site
City
Parow
State/Province
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Regeneron Research Site
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Regeneron Research Site
City
Halfway House
State/Province
Gauteng
ZIP/Postal Code
1685
Country
South Africa
Facility Name
Regeneron Research Site
City
Pretoria West
State/Province
Gauteng
ZIP/Postal Code
183
Country
South Africa
Facility Name
Regeneron Research Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Regeneron Research Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Regeneron Research Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Regeneron Research Site
City
Kempton Park
State/Province
Johannesburg
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Regeneron Research Site
City
Soweto
State/Province
Johannesburg
ZIP/Postal Code
1818
Country
South Africa
Facility Name
Regeneron Research Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Regeneron Research Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Regeneron Research Site
City
George
State/Province
Western Cape
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Regeneron Research Site
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Regeneron Research Site
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Regeneron Research Site
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Regeneron Research Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Regeneron Research Site
City
Claremont
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Regeneron Research Site
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Regeneron Research Site #2
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Regeneron Research Site
City
Kharkov
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Regeneron Research Site
City
Kiev
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
Regeneron Research Site
City
Kyiv
ZIP/Postal Code
02002
Country
Ukraine
Facility Name
Regeneron Research Site
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Regeneron Research Site
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Regeneron Research Site
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Regeneron Research Site
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Regeneron Research Site #2
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Regeneron Research Site
City
Kyiv
Country
Ukraine
Facility Name
Regeneron Research Site
City
Lviv
ZIP/Postal Code
79015
Country
Ukraine
Facility Name
Regeneron Research Site
City
Uzhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Regeneron Research Site
City
Vinnitsa
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Regeneron Research Site
City
Vinnitsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Regeneron Research Site
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine

12. IPD Sharing Statement

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Long Term Safety Study of PRALUENT

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