Clinical trials: sponsored by Sanofi
Dengue Fever, Dengue Hemorrhagic Fever
Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
The aim of the study was to assess the efficacy of Sanofi Pasteur's CYD dengue vaccine in preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin America.
- Conditions
- Dengue Fever, Dengue Hemorrhagic Fever, Dengue
- Trial name
- NCT01374516
- Testing
- Live, attenuated, dengue serotype 1, 2, 3, 4 virus
- Where
- 22 sites in Brazil, Colombia and 3 more
- Volunteers
- 20,869 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Systemic Sclerosis
Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT02921971
- Testing
- SAR156597
- Where
- 44 sites in United States, Argentina and 11 more
- Volunteers
- 97 people
- Sponsor
- Sanofi
Dengue, Dengue Hemorrhagic Fever
Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives: To describe the immune response to dengue viruses before and after each vaccination…
- Trial name
- NCT01187433
- Testing
- Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus, NaCl 0.9%, Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
- Where
- Brazil
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
T-cell Type Acute Leukemia-Precursor, T-lymphoblastic Lymphoma/Leukaemia
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: To evaluate the safety profile of isatuximab. To evaluate the duration of response (DOR).
- Trial name
- ISLAY (NCT02999633)
- Testing
- Isatuximab SAR650984, dexamethasone, acetaminophen
- Where
- 17 sites in United States, Finland and 5 more
- Volunteers
- 14 people
- Sponsor
- Sanofi
Dengue, Dengue Fever
Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia
The aim of the trial was to assess the efficacy of the CYD dengue vaccine in preventing symptomatic, virologically-confirmed dengue (VCD) cases.
- Conditions
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- Trial name
- NCT01373281
- Testing
- Live, attenuated, dengue serotype 1, 2, 3, 4 virus
- Where
- 12 sites in Indonesia, Malaysia and 3 more
- Volunteers
- 10,275 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue Fever, Dengue Hemorrhagic Fever
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Primary Objectives: To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period.
- Conditions
- Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus, Dengue Diseases
- Trial name
- NCT00880893
- Testing
- CYD Dengue vaccine, NaCl + influenza virus or hepatitis A vaccine
- Where
- 5 sites in Singapore
- Volunteers
- 1,198 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Plasmodium Falciparum Infection
Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria
Primary Objective: To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction…
- Trial name
- NCT03660839
- Testing
- Artefenomel (OZ439), Ferroquine (SSR97193)
- Where
- 7 sites in Benin, Burkina Faso and 3 more
- Volunteers
- 140 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately…
- Trial name
- AMPLITUDE-S (NCT03770728)
- Testing
- Efpeglenatide SAR439977, Background therapy: Metformin alone or in combination with SU
- Where
- 48 sites in United States, China and 1 more
- Volunteers
- 312 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately…
- Trial name
- AMPLITUDE-L (NCT03713684)
- Testing
- Efpeglenatide SAR439977, Background therapy
- Where
- 47 sites in United States, China and 1 more
- Volunteers
- 370 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Primary Objective: To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes…
- Trial name
- AMPLITUDE-D (NCT03684642)
- Testing
- Efpeglenatide, Dulaglutide, Background therapy Metformin
- Where
- 45 sites in United States, Hungary and 2 more
- Volunteers
- 908 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Effect of Efpeglenatide on Cardiovascular Outcomes
Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.
- Trial name
- AMPLITUDE-O (NCT03496298)
- Testing
- Efpeglenatide (SAR439977)
- Where
- 353 sites in United States, Argentina and 26 more
- Volunteers
- 4,076 people
- Sponsor
- Sanofi
Triple Negative Breast Cancer
Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer
Primary Objective: To evaluate the tumor Objective Response Rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of SAR566658 in participants with anti-carbonic anhydrase 6 (CA6)-positive…
- Trial name
- NCT02984683
- Testing
- SAR566658 (ACT14884)
- Where
- 13 sites in Belgium, Czechia and 3 more
- Volunteers
- 23 people
- Sponsor
- Sanofi
Pompe Disease
Alglucosidase Alfa Pompe Safety Sub-Registry
To collect uniform and meaningful data on patients with Pompe disease who experience anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic immune complex-mediated reactions following treatment…
- Trial name
- NCT01710813
- Testing
- alglucosidase alfa
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 110 people
- Sponsor
- Genzyme, a Sanofi Company
Plasma Cell Myeloma
SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients
Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM).
- Trial name
- PomdeSAR (NCT02283775)
- Testing
- Isatuximab SAR650984, Pomalidomide, Dexamethasone
- Where
- 13 sites in United States
- Volunteers
- 54 people
- Sponsor
- Sanofi
Anemia
Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.
- Trial name
- NCT00223938
- Testing
- Oral Iron, sodium ferric gluconate
- Where
- 8 sites in United States
- Volunteers
- 112 people
- Sponsor
- Sanofi
Fabry Disease
Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease
Primary Objective: To assess the long-term safety of GZ/SAR402671 in adult male participants with Fabry disease who previously completed study ACT13739 (NCT02489344).
- Trial name
- NCT02489344
- Testing
- GZ/SAR402671
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 8 people
- Sponsor
- Genzyme, a Sanofi Company
Progressive Multiple Sclerosis
A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis
Primary Objective: To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab administered by subcutaneous injection and 2 treatment courses of alemtuzumab administered by intravenous infusion in patients…
- Trial name
- SCALA (NCT02583594)
- Testing
- Acyclovir, Methylprednisolone, alemtuzumab GZ402673
- Where
- Spain
- Volunteers
- 24 people
- Sponsor
- Genzyme, a Sanofi Company
Multiple Myeloma
An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells
The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor…
- Trial name
- NCT01753453
- Testing
- Plerixafor, Granulocyte-colony stimulating factor (G-CSF)
- Where
- 5 sites in Belgium, Estonia and 2 more
- Volunteers
- 23 people
- Sponsor
- Sanofi
Myelodysplastic Syndromes
Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be effective treatment for myelodysplastic syndrome.
- Trial name
- NCT00017550
- Testing
- anti-thymocyte globulin
- Where
- 28 sites in United States, Canada
- Sponsor
- Genzyme, a Sanofi Company
Acne Vulgaris
Acne Vulgaris Related Microbiology and Serology
This will be an investigation to determine the quality of the serological immune responses against Propionibacterium acnes (P. acnes) in acne patients compared to healthy individuals.
- Trial name
- NCT04056598
- Testing
- Study of humoral immunity
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Sanofi
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