Clinical trials: sponsored by Sanofi
Osteochondrodysplasia
A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects
The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple…
- Trial name
- NCT05846009
- Testing
- SAR442501
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Sanofi
Malignant Solid Tumor
A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors
Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in…
- Trial name
- NCT03192345
- Testing
- SAR439459, Cemiplimab REGN2810
- Where
- 34 sites in United States, Australia and 11 more
- Volunteers
- 161 people
- Sponsor
- Sanofi
Differentiated Thyroid Cancer
Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer
Primary Objective: To determine the efficacy (as assessed by progression-free survival [PFS]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic…
- Trial name
- VERIFY (NCT01876784)
- Testing
- Vandetanib (SAR390530)
- Where
- 61 sites in United States, Brazil and 10 more
- Volunteers
- 238 people
- Sponsor
- Genzyme, a Sanofi Company
Dengue Fever, Dengue Hemorrhagic Fever
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
The aim of the study was to evaluate the safety and immunogenicity of the Dengue vaccine in a population of special interest, such as HIV-positive adults previously exposed to dengue.
- Conditions
- Dengue Fever, Dengue Hemorrhagic Fever, Human Immunodeficiency Virus
- Trial name
- NCT02741128
- Testing
- CYD Dengue Vaccine
- Where
- 4 sites in Brazil
- Volunteers
- 133 people
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Atopic Dermatitis
A Study in Male and Female Adult Patients With Atopic Dermatitis Treated With Dupilumab in Taiwan
Primary objective: To characterize the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment for adult AD patients, who are eligible for dupilumab reimbursement in Taiwan (e.g., used regimens, reason…
- Trial name
- NCT05442645
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps
A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region
Primary Objective: To describe the clinical characteristics of participants with chronic rhinosinusitis with nasal polyps (CRSwNP) in terms of disease severity, Type 2 inflammation-related comorbidities (such as asthma and…
- Trial name
- NCT05649813
- Where
- Kuwait
- Volunteers
- 148 people
- Sponsor
- Sanofi
Sphingomyelin Lipidosis
A Long-Term Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
The primary objective of this study was to obtain data regarding the safety of olipudase alfa in participants with acid sphingomyelinase deficiency (ASMD) who were exposed to long term treatment with olipudase alfa.
- Trial name
- NCT02004704
- Testing
- GZ402665
- Where
- 9 sites in United States, Belgium and 5 more
- Volunteers
- 25 people
- Sponsor
- Genzyme, a Sanofi Company
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses…
- Trial name
- NCT03691610
- Testing
- Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
- Where
- 47 sites in United States, Puerto Rico
- Volunteers
- 950 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Plasma Cell Myeloma
Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Primary Objectives: To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma.
- Trial name
- NCT03194867
- Testing
- Isatuximab SAR650984, Cemiplimab REGN2810
- Where
- 30 sites in United States, Australia and 8 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Hepatic Function Abnormal, Healthy Volunteers
A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
- Trial name
- NCT06444204
- Testing
- Rilzabrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Principia Biopharma, a Sanofi Company
Healthy Volunteers
Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects
This is a single-dose and multiple doses study to assess the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the tolerability of rilzabrutinib in Japanese and Caucasian Healthy Male and Female subjects.
- Trial name
- NCT06444191
- Testing
- Rilzabrutinib
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Principia Biopharma, a Sanofi Company
Hemophilia A, Hemophilia B
An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B
Primary Objective: To evaluate the long-term safety and tolerability of fitusiran in male patients with moderate or severe hemophilia A or B Secondary Objectives: To investigate the long-term efficacy of fitusiran To characterize…
- Trial name
- NCT02554773
- Testing
- Fitusiran (SAR439774)
- Where
- 12 sites in United States, Bulgaria and 3 more
- Volunteers
- 34 people
- Sponsor
- Genzyme, a Sanofi Company
Healthy Volunteers
A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants
The purpose of this study is to assess in healthy adult male participants the effects of itraconazole on the pharmacokinetics of venglustat and to assess the safety and tolerability of venglustat with and without coadministration…
- Trial name
- NCT06421714
- Testing
- Venglustat, Itraconazole
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Healthy Volunteers
A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants
The purpose of this study is to assess the bioequivalent effect of venglustat in tablet and hard capsule form when give with water under fasting conditions.
- Trial name
- NCT06418607
- Testing
- Venglustat
- Where
- 2 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteers
A Study of the Safety, Tolerability, and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants
The purpose of this study is to assess the effect of food on the bioavailability of venglustat and to assess the relative bioavailability of venglustat tablet swallowed whole with water versus a tablet chewed and then swallowed…
- Trial name
- NCT06418620
- Testing
- Venglustat
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Sanofi
Respiratory Syncytial Virus (RSV)
Burden of Respiratory Syncytial Virus (RSV) in Children in Sweden (BRICS): A Retrospective Study in Sweden
Primary Objective: -Estimate the hospital-associated healthcare resource use (HCRU), and associated costs, of RSV infection in children in comparison to the non-RSV control cohort (general population) and patients with rhinovirus…
- Trial name
- NCT05622331
- Volunteers
- 1,100,000 people
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Thyroid Neoplasms
Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer
This was a parallel group, randomized, double blind, placebo controlled, multicentre study designed to assess whether vandetanib (ZD6474) conferred an improvement in PFS as compared to placebo in participants with locally…
- Trial name
- NCT00537095
- Testing
- Vandetanib
- Where
- 15 sites in Belgium, Denmark and 5 more
- Volunteers
- 164 people
- Sponsor
- Genzyme, a Sanofi Company
Type 1 Diabetes Mellitus
Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Primary Objective: To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in…
- Trial name
- GEMELLI X (NCT03874715)
- Testing
- Insulin Aspart SAR341402, Insulin Aspart, Insulin glargine U100
- Where
- 33 sites in United States
- Volunteers
- 210 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus (T2DM)
A Study to Observe How Insulin Glargine 300 U/ml is Working and is Tolerated in Elderly Patients ≥75 Years of Age With Type 2 Diabetes
Primary objective: Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice Secondary objective: Treatment satisfaction
- Trial name
- ELDERLY-T (NCT05607160)
- Where
- Germany
- Volunteers
- 82 people
- Sponsor
- Sanofi
Fabry Disease, Alpha Galactosidase A Deficiency
Study of the Effects of Fabrazyme Treatment on Lactation and Infants
The study was planned for up to 2 years (24 months). Planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full…
- Trial name
- NCT00230607
- Testing
- agalsidase beta
- Where
- 5 sites in United States, Austria and 1 more
- Volunteers
- 7 people
- Sponsor
- Genzyme, a Sanofi Company
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