Open Label Study of Long Term Safety Evaluation of Alirocumab

NCT01954394 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: LTS134632013-002572-40U1111-1143-3810
• Study Type: interventional
• Target: 986
• Locations: 24 countries
• Sites: 177

Brief Summary

Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives:

• To evaluate the long-term efficacy of alirocumab on lipid parameters.
• To evaluate the long-term immunogenicity of alirocumab.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Experienced Adverse Events (AEs)

  Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.

  Up to 10 weeks after last study drug administration (maximum of 176 weeks)

Secondary Outcomes (14)

• Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

  Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

• Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

  Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

• Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168

  Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

• Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time

  Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

• Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time

  Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Study Arms (1)

Alirocumab 75 or 150 mg Q2W

EXPERIMENTAL

Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.

Drug: Alirocumab; Drug: Lipid-Modifying Therapy (LMT)

Interventions

Alirocumab DRUG

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

Also known as: SAR236553, REGN727, Praluent

Alirocumab 75 or 150 mg Q2W

Lipid-Modifying Therapy (LMT) DRUG

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Alirocumab 75 or 150 mg Q2W

Eligibility Criteria

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

You may qualify if:

• Participants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).

You may not qualify if:

• Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (177)

Investigational Site Number 840321

Huntsville, Alabama, 35801, United States

Location

Investigational Site Number 840341

Tempe, Arizona, 85282, United States

Location

Investigational Site Number 840334

Bell Gardens, California, 90201, United States

Location

Investigational Site Number 840319

Fountain Valley, California, 92708, United States

Location

Investigational Site Number 840336

Los Angeles, California, 90048, United States

Location

Investigational Site Number 840339

Mission Viejo, California, 92691, United States

Location

Investigational Site Number 840337

Newport Beach, California, 92663, United States

Location

Investigational Site Number 840306

Golden, Colorado, 80401, United States

Location

Investigational Site Number 840328

Washington D.C., District of Columbia, 20037, United States

Location

Investigational Site Number 840344

Atlantis, Florida, 33462, United States

Location

Investigational Site Number 840353

Clearwater, Florida, 33756, United States

Location

Investigational Site Number 840318

Fort Lauderdale, Florida, 33308-4311, United States

Location

Investigational Site Number 840327

Jacksonville, Florida, 32216, United States

Location

Investigational Site Number 840309

Miami, Florida, 33174, United States

Location

Investigational Site Number 840351

Sarasota, Florida, 34239, United States

Location

Investigational Site Number 840315

Evanston, Illinois, 60201, United States

Location

Investigational Site Number 840305

Oakbrook Terrace, Illinois, 60181, United States

Location

Investigational Site Number 840333

Iowa City, Iowa, 52242, United States

Location

Investigational Site Number 840329

Kansas City, Kansas, 66160, United States

Location

Investigational Site Number 840345

Auburn, Maine, 04210, United States

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Investigational Site Number 840338

Biddeford, Maine, 04005, United States

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Investigational Site Number 840322

Boston, Massachusetts, 02114, United States

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Investigational Site Number 840346

Framingham, Massachusetts, 01702, United States

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Investigational Site Number 840317

St Louis, Missouri, 63110, United States

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Investigational Site Number 840349

St Louis, Missouri, 63136, United States

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Investigational Site Number 840314

Morristown, New Jersey, 07901, United States

Location

Investigational Site Number 840316

New York, New York, 10032, United States

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Investigational Site Number 840324

Poughkeepsie, New York, 12601, United States

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Investigational Site Number 840303

Charlotte, North Carolina, 28204, United States

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Investigational Site Number 840320

Durham, North Carolina, 27710, United States

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Investigational Site Number 840348

Raleigh, North Carolina, 27609, United States

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Investigational Site Number 840340

Cincinnati, Ohio, 45227, United States

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Investigational Site Number 840302

Marion, Ohio, 43302, United States

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Investigational Site Number 840330

Portland, Oregon, 97239, United States

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Investigational Site Number 840352

Beaver, Pennsylvania, 15009, United States

Location

Investigational Site Number 840308

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational Site Number 840342

Scranton, Pennsylvania, 18503, United States

Location

Investigational Site Number 840304

Summerville, South Carolina, 29485, United States

Location

Investigational Site Number 840311

Dallas, Texas, 75216, United States

Location

Investigational Site Number 840312

Dallas, Texas, 75226, United States

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Investigational Site Number 840301

Fort Worth, Texas, 76104, United States

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Investigational Site Number 840343

Bountiful, Utah, 84010, United States

Location

Investigational Site Number 840354

Chesapeake, Virginia, 23320, United States

Location

Investigational Site Number 840350

Spokane, Washington, 99204, United States

Location

Investigational Site Number 032302

Caba, C1119ACN, Argentina

Location

Investigational Site Number 032301

Coronel Suárez, B7540GHD, Argentina

Location

Investigational Site Number 040302

Graz, 8036, Austria

Location

Investigational Site Number 040303

Sankt Stefan, 8511, Austria

Location

Investigational Site Number 040301

Vienna, 1130, Austria

Location

Investigational Site Number 056301

Natoye, 5360, Belgium

Location

Investigational Site Number 100302

Sofia, 1233, Bulgaria

Location

Investigational Site Number 100301

Sofia, 1527, Bulgaria

Location

Investigational Site Number 124303

Chicoutimi, G7H 7K9, Canada

Location

Investigational Site Number 124302

Montreal, H1W 2R7, Canada

Location

Investigational Site Number 124301

Québec, G1V 4W2, Canada

Location

Investigational Site Number 124306

Sherbrooke, J1H 5N4, Canada

Location

Investigational Site Number 124305

Toronto, M5C 2T2, Canada

Location

Investigational Site Number 124304

Victoria, V8T 5G4, Canada

Location

Investigational Site Number 203307

Hradec Králové, 500 05, Czechia

Location

Investigational Site Number 203305

Prague, 12808, Czechia

Location

Investigational Site Number 203301

Prague, 14021, Czechia

Location

Investigational Site Number 203303

Prague, 180 81, Czechia

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Investigational Site Number 203306

Praha 5 - Motol, 15006, Czechia

Location

Investigational Site Number 203309

Trutnov, 54121, Czechia

Location

Investigational Site Number 203304

Uherské Hradiště, 68601, Czechia

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Investigational Site Number 203302

Zlín, 76275, Czechia

Location

Investigational Site Number 208301

Aalborg, 9000, Denmark

Location

Investigational Site Number 208306

Aarhus, 8200, Denmark

Location

Investigational Site Number 208302

Esbjerg, 6700, Denmark

Location

Investigational Site Number 208303

Roskilde, 4000, Denmark

Location

Investigational Site Number 208304

Svendborg, 5700, Denmark

Location

Investigational Site Number 246302

Joensuu, 80100, Finland

Location

Investigational Site Number 246301

Kokkola, 67100, Finland

Location

Investigational Site Number 246304

Vantaa, 01600, Finland

Location

Investigational Site Number 250303

Dijon, 21000, France

Location

Investigational Site Number 250304

Lille, 59037, France

Location

Investigational Site Number 250302

Nantes, 44093, France

Location

Investigational Site Number 250301

Paris, 75013, France

Location

Investigational Site Number 250305

Pessac, 33604, France

Location

Investigational Site Number 250306

Rennes, 35033, France

Location

Investigational Site Number 276302

Berlin, 10117, Germany

Location

Investigational Site Number 276305

Frankfurt A.M., 60596, Germany

Location

Investigational Site Number 276306

Leipzig, 04103, Germany

Location

Investigational Site Number 276301

Magdeburg, 39120, Germany

Location

Investigational Site Number 276307

Witten, 58455, Germany

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Investigational Site Number 348301

Baja, 6500, Hungary

Location

Investigational Site Number 376302

Holon, 58100, Israel

Location

Investigational Site Number 376304

Jerusalem, 91120, Israel

Location

Investigational Site Number 376303

Safed, 13110, Israel

Location

Investigational Site Number 376301

Tel Litwinsky, 52621, Israel

Location

Investigational Site Number 380302

Chieti, 66100, Italy

Location

Investigational Site Number 380304

Milan, 20138, Italy

Location

Investigational Site Number 380303

Napoli, 80131, Italy

Location

Investigational Site Number 380301

Palermo, 90127, Italy

Location

Investigational Site Number 484301

México, 03300, Mexico

Location

Investigational Site Number 528317

Alkmaar, 1815 JD, Netherlands

Location

Investigational Site Number 528301

Amsterdam-Zuidoost, 1105 AZ, Netherlands

Location

Investigational Site Number 528320

Apeldoorn, 7314 ET, Netherlands

Location

Investigational Site Number 528309

Delfzijl, 9934 JD, Netherlands

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Investigational Site Number 528313

Eindhoven, 5616GB, Netherlands

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Investigational Site Number 528319

Enschede, 7513 ER, Netherlands

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Investigational Site Number 528322

Goes, 4462 RA, Netherlands

Location

Investigational Site Number 528325

Groningen, 9713 GZ, Netherlands

Location

Investigational Site Number 528302

Groningen, 9728 NT, Netherlands

Location

Investigational Site Number 528324

Hoogeveen, 7909 AA, Netherlands

Location

Investigational Site Number 528318

Hoorn, 1624 NP, Netherlands

Location

Investigational Site Number 528305

Leiden, 2333 ZA, Netherlands

Location

Investigational Site Number 528311

Maastricht, 6229 HX, Netherlands

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Investigational Site Number 528312

Nijmegen, 6500 HB, Netherlands

Location

Investigational Site Number 528315

Rotterdam, 3021 HC, Netherlands

Location

Investigational Site Number 528326

Rotterdam, 3045 PM, Netherlands

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Investigational Site Number 528303

Utrecht, 3582 KE, Netherlands

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Investigational Site Number 528323

Utrecht, 3584 CX, Netherlands

Location

Investigational Site Number 528321

Venlo, 5912 BL, Netherlands

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Investigational Site Number 528316

Waalwijk, 5141 BM, Netherlands

Location

Investigational Site Number 578301

Bodø, 8092, Norway

Location

Investigational Site Number 578305

Oslo, 0407, Norway

Location

Investigational Site Number 578304

Oslo, Norway

Location

Investigational Site Number 620302

Funchal, 9004-514, Portugal

Location

Investigational Site Number 620301

Lisbon, 1169-024, Portugal

Location

Investigational Site Number 642302

Timișoara, 300358, Romania

Location

Investigational Site Number 643304

Arkhangelsk, 163000, Russia

Location

Investigational Site Number 643303

Kazan', 420012, Russia

Location

Investigational Site Number 643302

Moscow, 111539, Russia

Location

Investigational Site Number 643308

Moscow, 121552, Russia

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Investigational Site Number 643305

Moscow, 129301, Russia

Location

Investigational Site Number 643310

Novosibirsk, 630089, Russia

Location

Investigational Site Number 643301

Saint Petersburg, 194156, Russia

Location

Investigational Site Number 643306

Saint Petersburg, 194291, Russia

Location

Investigational Site Number 643312

Saint Petersburg, 196084, Russia

Location

Investigational Site Number 710311

Bellville, 7530, South Africa

Location

Investigational Site Number 710307

Bloemfontein, 9301, South Africa

Location

Investigational Site Number 710306

Cape Town, 7700, South Africa

Location

Investigational Site Number 710302

Cape Town, 7925, South Africa

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Investigational Site Number 710309

Centurion, 0158, South Africa

Location

Investigational Site Number 710312

Parktown, 2193, South Africa

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Investigational Site Number 710304

Parow, 7500, South Africa

Location

Investigational Site Number 710313

Pretoria, 0002, South Africa

Location

Investigational Site Number 710303

Pretoria, 0084, South Africa

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Investigational Site Number 710305

Pretoria, 0157, South Africa

Location

Investigational Site Number 710314

Pretoria, 0184, South Africa

Location

Investigational Site Number 710315

Roodepoort, 1724, South Africa

Location

Investigational Site Number 710310

Somerset West, 7130, South Africa

Location

Investigational Site Number 710308

Witbank, South Africa

Location

Investigational Site Number 724303

A Coruña, 15001, Spain

Location

Investigational Site Number 724308

Barcelona, 08036, Spain

Location

Investigational Site Number 724306

Córdoba, 14004, Spain

Location

Investigational Site Number 724312

Granada, 18012, Spain

Location

Investigational Site Number 724307

L'Hospitalet de Llobregat, 08907, Spain

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Investigational Site Number 724301

Madrid, 28007, Spain

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Investigational Site Number 724309

Madrid, 28029, Spain

Location

Investigational Site Number 724305

Madrid, 28040, Spain

Location

Investigational Site Number 724311

Madrid, 28040, Spain

Location

Investigational Site Number 724314

Málaga, 29010, Spain

Location

Investigational Site Number 724315

Quart de Poblet, 46930, Spain

Location

Investigational Site Number 724310

Sabadell, 08208, Spain

Location

Investigational Site Number 724313

Seville, 41013, Spain

Location

Investigational Site Number 724304

Tarragona, 43204, Spain

Location

Investigational Site Number 724302

Zaragoza, 50009, Spain

Location

Investigational Site Number 752302

Gothenburg, 41345, Sweden

Location

Investigational Site Number 752301

Stockholm, 111 35, Sweden

Location

Investigational Site Number 752304

Stockholm, 14186, Sweden

Location

Investigational Site Number 826318

Birmingham, B15 2SQ, United Kingdom

Location

Investigational Site Number 826304

Brighton, BN1 9PH, United Kingdom

Location

Investigational Site Number 826301

Bristol, BS2 8HW, United Kingdom

Location

Investigational Site Number 826311

Cambridge, CB2 OQQ, United Kingdom

Location

Investigational Site Number 826310

Cardiff, CF14 5GJ, United Kingdom

Location

Investigational Site Number 826302

Dundee, DD1 9SY, United Kingdom

Location

Investigational Site Number 826317

Liverpool, L22 0LG, United Kingdom

Location

Investigational Site Number 826306

Liverpool, L7 8XP, United Kingdom

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Investigational Site Number 826312

Manchester, M13 9WL, United Kingdom

Location

Investigational Site Number 826303

Manchester, M23 9LT, United Kingdom

Location

Investigational Site Number 826305

Middlesex, HA6 2RN, United Kingdom

Location

Investigational Site Number 826313

Newcastle upon Tyne, NEI 4LP, United Kingdom

Location

Investigational Site Number 826309

Reading, RG2 0TG, United Kingdom

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Investigational Site Number 826315

West Bromwich, B71 4HJ, United Kingdom

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Investigational Site Number 826316

West Bromwich, B71 4HJ, United Kingdom

Location

Related Publications (3)

• Dufour R, Hovingh GK, Guyton JR, Langslet G, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial. J Clin Lipidol. 2019 Jan-Feb;13(1):138-147. doi: 10.1016/j.jacl.2018.11.007. Epub 2018 Nov 30.

  PMID: 30591415 DERIVED

• Farnier M, Hovingh GK, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Guyton JR. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis. 2018 Nov;278:307-314. doi: 10.1016/j.atherosclerosis.2018.08.036. Epub 2018 Sep 1.

  PMID: 30293878 DERIVED

• Hovingh GK, Guyton JR, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Alirocumab dosing patterns during 40 months of open-label treatment in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2018 Nov-Dec;12(6):1463-1470. doi: 10.1016/j.jacl.2018.08.011. Epub 2018 Aug 30.

  PMID: 30287210 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: October 1, 2013
• Study Start: December 17, 2013
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 24, 2018
• Results First Posted: July 24, 2018

Record last verified: 2018-06

Locations

ES (15); CA (6); IL (4); AR (2); AU (3); ME (1); GB (15); IT (4); CZ (8); BU (2); FI (3); NL (20); NO (3); PT (2); RO (1); US (44); HU (1); BE (1); ZA (14); DK (5); SE (3); FR (6); DE (5); RU (9)