Long Term Safety Study of PRALUENT

NCT03694197 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: R727-CL-16092018-002810-11
• Study Type: interventional
• Target: 1,389
• Locations: 6 countries
• Sites: 123

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

Conditions

Heterozygous Familial Hypercholesterolemia; Non-familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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.

  After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks

Secondary Outcomes (32)

• Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time

  Up to week 72

• Percent Change in LDL-C From Baseline Over Time

  Up to week 72

• Total Cholesterol (Total-C) Values From Baseline Over Time

  Up to week 72

• Percent Change From Baseline in Total-C Over Time

  Up to week 72

• Lipoprotein a (Lp(a)) Values From Baseline Over Time

  Up to week 72

Study Arms (1)

Open label

EXPERIMENTAL

Drug: Praluent

Interventions

Praluent DRUG

Subcutaneous (SC) administration

Also known as: Alirocumab, REGN727, SAR236553

Open label

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (123)

Regeneron Research Site

Auburn, Alabama, 36830, United States

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Mobile, Alabama, 36608, United States

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Beverly Hills, California, 90210, United States

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Los Gatos, California, 95032, United States

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North Hollywood, California, 91606, United States

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Port Hueneme, California, 93041, United States

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Aurora, Colorado, 80012, United States

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Colorado Springs, Colorado, 80906, United States

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Lake Worth, Florida, 33461, United States

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Miami Springs, Florida, 33166, United States

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Champaign, Illinois, 61822, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46237, United States

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Ames, Iowa, 50010-30144, United States

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Iowa City, Iowa, 52242, United States

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Waterloo, Iowa, 50702, United States

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Newton, Kansas, 67114, United States

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Louisville, Kentucky, 40213, United States

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Bangor, Maine, 04401, United States

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Baltimore, Maryland, 21229, United States

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Oxon Hill, Maryland, 20745, United States

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Olive Branch, Mississippi, 38654, United States

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Washington, Missouri, 63090, United States

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Buffalo, New York, 14215, United States

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New Hyde Park, New York, 11042, United States

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Cary, North Carolina, 27518, United States

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Charlotte, North Carolina, 28209, United States

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Charlotte, North Carolina, 28277, United States

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Greensboro, North Carolina, 27401, United States

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Hickory, North Carolina, 28601, United States

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Raleigh, North Carolina, 27609, United States

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Rocky Mount, North Carolina, 27804, United States

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Salisbury, North Carolina, 28144, United States

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Statesville, North Carolina, 28625, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44122, United States

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Dayton, Ohio, 45414, United States

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Charleston, South Carolina, 29407, United States

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Summerville, South Carolina, 29485, United States

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Rapid City, South Dakota, 57701, United States

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Bristol, Tennessee, 37620, United States

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Regeneron Research Site 2

Knoxville, Tennessee, 37760, United States

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Regeneron Research Site 3

Knoxville, Tennessee, 37912, United States

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Knoxville, Tennessee, 37938, United States

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Powell, Tennessee, 37849, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77027, United States

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Schertz, Texas, 78154, United States

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Shavano Park, Texas, 78213, United States

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Shavano Park, Texas, 78231, United States

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Falls Church, Virginia, 22042, United States

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Winchester, Virginia, 22601, United States

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Tacoma, Washington, 98405, United States

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Walla Walla, Washington, 99362, United States

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Manitowoc, Wisconsin, 54220, United States

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Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1407, Bulgaria

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Regeneron Research Site #2

Sofia, 1784, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Varna, 9000, Bulgaria

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Tallinn, Harju, 10138, Estonia

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Paide, 72713, Estonia

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Regeneron Research Site #2

Tallinn, 10128, Estonia

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Tallinn, 10617, Estonia

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Tartu, 51014, Estonia

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Ivanovo, 153012, Russia

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Kirov, 610014, Russia

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Moscow, 121309, Russia

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Moscow, 121359, Russia

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Moscow, 121552, Russia

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Novosibirsk, 630008, Russia

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Rostov-on-Don, 344068, Russia

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Regeneron Research Site #2

Saint Petersburg, 192288, Russia

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Saint Petersburg, 192288, Russia

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Saint Petersburg, 193312, Russia

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Saint Petersburg, 195112, Russia

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Saint Petersburg, 197376, Russia

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Saint Petersburg, 197706, Russia

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Saint Petersburg, 198205, Russia

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Saratov, 410028, Russia

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Sverdlovskaya, 620109, Russia

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Tyumen, 625032, Russia

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Regeneron Research Site 1

Yaroslavl, 150030, Russia

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Regeneron Research Site 2

Yaroslavl, 150030, Russia

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Yekaterinburg, 620109, Russia

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Kuilsrivier, Cape Town, 7580, South Africa

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Parow, Cape Town, 7500, South Africa

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Port Elizabeth, Eastern Cape, 6001, South Africa

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Halfway House, Gauteng, 1685, South Africa

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Pretoria, Gauteng, 0002, South Africa

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Pretoria, Gauteng, 0122, South Africa

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Pretoria, Gauteng, 0184, South Africa

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Pretoria West, Gauteng, 183, South Africa

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Kempton Park, Johannesburg, 1619, South Africa

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Soweto, Johannesburg, 1818, South Africa

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Cape Town, Western Cape, 7530, South Africa

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Cape Town, Western Cape, 7925, South Africa

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George, Western Cape, 6529, South Africa

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Paarl, Western Cape, 7646, South Africa

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Somerset West, Western Cape, 7130, South Africa

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Worcester, Western Cape, 6850, South Africa

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Bloemfontein, 9301, South Africa

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Regeneron Research Site

Claremont, 7708, South Africa

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Regeneron Research Site

Johannesburg, 2013, South Africa

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Regeneron Research Site #2

Kharkiv, 61002, Ukraine

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Regeneron Research Site

Kharkiv, 61039, Ukraine

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Regeneron Research Site

Kiev, 2091, Ukraine

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Kyiv, 02002, Ukraine

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Kyiv, 02660, Ukraine

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Regeneron Research Site

Kyiv, 03037, Ukraine

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Regeneron Research Site

Kyiv, 03049, Ukraine

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Regeneron Research Site

Kyiv, 03115, Ukraine

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Regeneron Research Site #2

Kyiv, 04114, Ukraine

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Regeneron Research Site

Kyiv, Ukraine

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Regeneron Research Site

Lviv, 79015, Ukraine

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Regeneron Research Site

Uzhhorod, 88000, Ukraine

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Regeneron Research Site

Vinnitsa, 21029, Ukraine

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Regeneron Research Site

Vinnitsya, 21018, Ukraine

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Regeneron Research Site

Vinnytsia, 21018, Ukraine

Location

MeSH Terms

Interventions

alirocumab

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: October 3, 2018
• Study Start: September 28, 2018
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

US (57); RU (20); ES (5); ZA (19); UA (15); BU (7)