Clinical trials: sponsored by Sanofi
Type 2 Diabetes Mellitus
Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin
Primary Objective: To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in…
- Trial name
- Lixilan-L-CN (NCT03798080)
- Testing
- Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Metformin
- Where
- 45 sites in China
- Volunteers
- 426 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
Primary Objectives: The co-primary objective of this study is: To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by…
- Trial name
- Lixilan-O-AP (NCT03798054)
- Testing
- Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Lixisenatide (AVE0010)
- Where
- 79 sites in China, Malaysia and 2 more
- Volunteers
- 878 people
- Sponsor
- Sanofi
Hepatic Impairment
KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment
This is a study to characterize the pharmacokinetics, safety and tolerability of KD025 and KD025 metabolites in subjects with mild, moderate or severe hepatic impairment compared to healthy subjects with normal hepatic function.
- Trial name
- NCT04166942
- Testing
- KD025
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Gaucher Disease
Phase 3b Study to Evaluate Skeletal Response to Eliglustat in Adult Patients Who Completed Phase 2 or Phase 3 Studies
Primary Objective: Evaluate long term skeletal response to eliglustat in adult participants who successfully completed one of the Phase 2 or Phase 3 eliglustat studies.
- Trial name
- EXOSKEL (NCT02536755)
- Testing
- Eliglustat, GZ385660
- Where
- 4 sites in Canada, Russia and 1 more
- Volunteers
- 31 people
- Sponsor
- Genzyme, a Sanofi Company
Asthma
Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
Primary Objective: To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events.
- Trial name
- NCT03387852
- Testing
- SAR440340, Dupilumab, Fluticasone or Fluticasone/salmeterol combination
- Where
- 71 sites in United States, Argentina and 6 more
- Volunteers
- 296 people
- Sponsor
- Sanofi
Polymyalgia Rheumatica
Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter…
- Trial name
- NCT03600818
- Testing
- Sarilumab SAR153191 (REGN88), Prednisone
- Where
- 84 sites in United States, Argentina and 15 more
- Volunteers
- 118 people
- Sponsor
- Sanofi
Multinodular Goiter
Study to Determine the Dose, the Safety and Effectiveness of a New Drug, Modified Release rhTSH, in Patients With Multinodular Goiter
The purpose of this study is to determine the safety and effectiveness of 2 different doses of modified-release recombinant human thyroid stimulating hormone (MRrhTSH) when administered with radioiodine in patients with…
- Trial name
- NCT00454220
- Testing
- MRrhTSH
- Where
- 11 sites in United States, Brazil and 6 more
- Volunteers
- 96 people
- Sponsor
- Genzyme, a Sanofi Company
Influenza
Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) in Subjects Aged 3 Years Old and Above
The objective is to describe the safety profile after 1 dose of VaxigripTetra inj. administered in subjects aged 3 years old and above under routine clinical practice.
- Trial name
- NCT05406180
- Testing
- VaxigripTetra inj.
- Where
- 10 sites in South Korea
- Volunteers
- 675 people, healthy volunteers welcome
- Sponsor
- Sanofi
Leukemia, Lymphoblastic, Acute, Pediatric
Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment…
- Trial name
- NCT00042341
- Testing
- clofarabine (IV formulation)
- Where
- 14 sites in United States
- Volunteers
- 60 people
- Sponsor
- Genzyme, a Sanofi Company
Prostate Cancer Metastatic
Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent
Primary Objective: To compare the radiographic progression-free survival (rPFS) (using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan…
- Trial name
- CARD (NCT02485691)
- Testing
- cabazitaxel XRP6258, enzalutamide, abiraterone acetate
- Where
- 65 sites in Austria, Belgium and 11 more
- Volunteers
- 255 people
- Sponsor
- Sanofi
Parkinson's Disease
A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation
Primary Objectives: Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's…
- Trial name
- MOVES-PD (NCT02906020)
- Testing
- venglustat GZ/SAR402671
- Where
- 52 sites in United States, Austria and 14 more
- Volunteers
- 273 people
- Sponsor
- Genzyme, a Sanofi Company
Leukaemia
First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome
Primary Objective: Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic…
- Trial name
- NCT03594955
- Testing
- SAR440234
- Where
- 4 sites in United States, France
- Volunteers
- 7 people
- Sponsor
- Sanofi
Influenza
Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring
Primary Objective: To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the…
- Trial name
- VAP00007 (NCT04460781)
- Testing
- Flublok Quadrivalent influenza vaccine RIV4, Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4
- Where
- United States
- Volunteers
- 96,175 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Prostate Cancer, Non-small Cell Lung Cancer
Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies
Primary Objectives: To characterize the safety and tolerability of isatuximab in combination with REGN2810 in participants with metastatic, castration-resistant prostate cancer (mCRPC) who were naïve to anti-programmed cell…
- Trial name
- NCT03367819
- Testing
- Isatuximab SAR650984, Cemiplimab REGN2810
- Where
- 16 sites in United States, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Sanofi
Progressive Multiple Sclerosis
A Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668
Primary Objective: To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who received prior treatment during the TDU13475 or TDU14981 studies.
- Trial name
- NCT02313285
- Where
- Germany
- Volunteers
- 64 people
- Sponsor
- Genzyme, a Sanofi Company
Gastroesophageal Reflux Disease
PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
Primary Objective: Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.
- Trial name
- NCT03069963
- Testing
- Z0063, Gaviscon
- Where
- France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sanofi
Diphtheria, Tetanus
Post Marketing Surveillance for ADACEL™ in South Korea
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT01137435
- Testing
- ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
- Where
- 2 sites in South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Tetanus, Diphtheria
Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine.
- Conditions
- Tetanus, Diphtheria, Pertussis, Whooping Cough
- Trial name
- NCT01439165
- Testing
- Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine, Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
- Where
- 33 sites in United States, Canada
- Volunteers
- 1,330 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rheumatoid Arthritis
Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis
Primary Objective: To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid…
- Trial name
- SariPRO (NCT03449758)
- Testing
- SARILUMAB, Azathioprine, Chloroquine
- Where
- 33 sites in France
- Volunteers
- 84 people
- Sponsor
- Sanofi
Usher Syndrome, Retinitis Pigmentosa
Study of SAR421869 in Participants With Retinitis Pigmentosa Associated With Usher Syndrome Type 1B
To evaluate the safety and tolerability of ascending doses of subretinal injections of SAR421869 in participants with Usher syndrome type 1B. To evaluate for possible biological activity of SAR421869.
- Trial name
- NCT01505062
- Testing
- SAR421869
- Where
- 2 sites in United States, France
- Volunteers
- 9 people
- Sponsor
- Sanofi
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