Clinical trials: sponsored by Sanofi
Hypercholesterolemia, Acute Coronary Syndrome
Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia
Primary Objective: To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary atheroma progression (percent change in normalized total atheroma volume [TAV]) after 9 months of treatment in…
- Trial name
- ODYSSEY J-IVUS (NCT02984982)
- Testing
- Alirocumab SAR236553, Atorvastatin, Rosuvastatin
- Where
- 39 sites in Japan
- Volunteers
- 206 people
- Sponsor
- Sanofi
Hypercholesterolaemia
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years…
- Trial name
- ODYSSEY KIDS (NCT02890992)
- Testing
- alirocumab SAR236553 (REGN727), statins, ezetimibe
- Where
- 16 sites in United States, Canada and 8 more
- Volunteers
- 42 people
- Sponsor
- Sanofi
Rheumatoid Arthritis
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
The primary objective of this study is: To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).
- Trial name
- NCT02287922
- Testing
- ALX-0061, Tocilizumab
- Where
- 83 sites in United States, Belgium and 12 more
- Volunteers
- 251 people
- Sponsor
- Ablynx, a Sanofi company
Rheumatoid Arthritis
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX…
- Trial name
- NCT02309359
- Testing
- ALX-0061, Methotrexate
- Where
- 94 sites in United States, Belgium and 12 more
- Volunteers
- 345 people
- Sponsor
- Ablynx, a Sanofi company
Respiratory Syncytial Virus Lower Respiratory Tract Infection
Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
This was a randomized, double-blind, multicenter, Phase II study (NCT03418571) designed to support the selection of an optimal dose of inhaled ALX-0171 for further clinical development, taking ethnicity into consideration.
- Trial name
- NCT03418571
- Testing
- ALX-0171 1.5 mg/kg
- Where
- 25 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Ablynx, a Sanofi company
Rheumatoid Arthritis
An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis
This was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously (s.c.) in subjects with active rheumatoid…
- Trial name
- NCT02518620
- Testing
- ALX-0061
- Where
- 57 sites in Belgium, Bulgaria and 10 more
- Volunteers
- 406 people
- Sponsor
- Ablynx, a Sanofi company
Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
Primary Objective: To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity…
- Trial name
- SINUS-24 (NCT02912468)
- Testing
- Dupilumab SAR231893 (REGN668), Mometasone furoate 50 micrograms
- Where
- 76 sites in United States, Bulgaria and 11 more
- Volunteers
- 276 people
- Sponsor
- Sanofi
Dengue Fever, Dengue Hemorrhagic Fever
Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
The purpose of this study was to demonstrate that different CYD dengue vaccine lots manufactured using the same method and in the same location but at different times produce an equivalent immunological response after 3 doses.
- Trial name
- NCT01134263
- Testing
- Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
- Where
- 8 sites in Australia
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Alport Syndrome Patients With eGFR Between 45-90 ml/Min/1.73 m2
ATHENA: Natural History of Disease Study in Alport Syndrome Patients
There is limited published clinical data about the natural history of renal disease in Alport syndrome. The RG012-01 study will collect data to characterize the progression of renal dysfunction in Alport syndrome patients.
- Trial name
- RG012-01 (NCT02136862)
- Where
- 15 sites in United States, Australia and 4 more
- Volunteers
- 165 people
- Sponsor
- Genzyme, a Sanofi Company
Prostate Cancer Metastatic
Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide
Primary Objective: To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m^2) plus prednisone (Arm A) versus either enzalutamide at 160…
- Trial name
- PRIMCAB (NCT02379390)
- Testing
- Cabazitaxel XRP6258, Ezalutamide, Abiraterone acetate
- Where
- 24 sites in United States, Canada
- Volunteers
- 8 people
- Sponsor
- Sanofi
Dengue Fever, Dengue Hemorrhagic Fever
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue…
- Conditions
- Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus
- Trial name
- NCT00617344
- Testing
- Tetravalent CYD Dengue Vaccine , 5555 formulation, Tetravalent CYD Dengue Vaccine , 5553 formulation, Tetravalent CYD Dengue Vaccine, 4444 formulation
- Where
- 5 sites in United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Sanofi
Prostate Cancer
Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
Primary Objective: To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic…
- Trial name
- FIRSTANA (NCT01308567)
- Testing
- Cabazitaxel (XRP6258), Docetaxel (XRP6976), Prednisone
- Where
- 167 sites in United States, Australia and 23 more
- Volunteers
- 1,168 people
- Sponsor
- Sanofi
Yellow Fever
Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea
This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.
- Trial name
- NCT03541694
- Testing
- Stamaril®
- Where
- South Korea
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Atherosclerotic Cardiovascular Disease
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and…
- Trial name
- NCT01663402
- Testing
- Alirocumab, LMT
- Where
- 1,388 sites in United States, Argentina and 55 more
- Volunteers
- 18,924 people
- Sponsor
- Sanofi
Respiratory Syncytial Virus Lower Respiratory Tract Infection
Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection
The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell…
- Trial name
- NCT03468829
- Testing
- ALX-0171 Dose 1, ALX-0171 Dose 2
- Where
- 5 sites in Australia, Belgium and 1 more
- Sponsor
- Ablynx, a Sanofi company
Lupus Erythematosus, Systemic
A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
Primary objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared…
- Trial name
- NCT02437890
- Testing
- ALX-0061
- Where
- 118 sites in United States, Argentina and 15 more
- Volunteers
- 312 people
- Sponsor
- Ablynx, a Sanofi company
Hypercholesterolemia
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest…
- Trial name
- ODYSSEY-NIPPON (NCT02584504)
- Testing
- Alirocumab, Atorvastatin, Non-statin Lipid-Modifying Therapy
- Where
- 30 sites in Japan
- Volunteers
- 163 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey
Primary Objective: To assess the mean change in HbA1c (glycated haemoglobin). Secondary Objectives: To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of: Targeted HbA1c; Targeted fasting self…
- Trial name
- EASE (NCT02954692)
- Testing
- INSULIN GLARGINE (U300), metformin, sulfonylurea
- Where
- Turkey (Türkiye)
- Volunteers
- 112 people
- Sponsor
- Sanofi
Respiratory Syncytial Virus Infection
A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171
The primary objective of the study is to investigate the safety and tolerability of ALX-0171. The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic…
- Trial name
- NCT02309320
- Testing
- ALX-0171
- Where
- 59 sites in Australia, Belgium and 12 more
- Volunteers
- 53 people
- Sponsor
- Ablynx, a Sanofi company
Rheumatoid Arthritis
Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients
The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the receptor for interleukin 6 (IL6R), is safe and effective after single or multiple administrations to patients with rheumatoid arthritis…
- Trial name
- NCT01284569
- Testing
- ALX-0061
- Where
- 7 sites in Czechia, Hungary and 1 more
- Volunteers
- 65 people
- Sponsor
- Ablynx, a Sanofi company
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