Clinical trials: sponsored by Sanofi
Healthy Volunteers (Meningococcal Infection)
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135)…
- Trial name
- MET41 (NCT03673462)
- 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 (MENVEO®), Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
- Where
- 69 sites in United States, Puerto Rico
- Volunteers
- 2,797 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Gastric Cancer
Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
Primary Objective: To compare the 3-year progression free survival (PFS) in the two treatment arms. Secondary Objectives: Overall survival (OS). Postoperative pathological stage and R0 (complete) resection rate.
- Trial name
- PRODIGY (NCT01515748)
- Testing
- Docetaxel (XRP6976), Oxaliplatin (SR96669), S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)
- Where
- South Korea
- Volunteers
- 530 people
- Sponsor
- Sanofi
Meningococcal Immunization
A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study
The study will include groups of adults, toddlers, and infants who will receive different formulations of TetraMen-T, and one group of infants who will receive a control vaccine, Menjugate®.
- Trial name
- NCT06165276
- Testing
- Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T)., Meningococcal Group C-CRM197 Conjugate Vaccine
- Volunteers
- 285 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rheumatoid Arthritis
Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects
Primary objective: To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single…
- Trial name
- NCT06159452
- Testing
- SAR153191-P3 drug product, SAR153191-P2 drug product, SAR153191-C1F3 drug product
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Sanofi
Dermatitis Atopic
A Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Male and Female Participants of Atleast 12 Years Old Receiving Dupilumab Injections in Gulf Countries
Primary objective: To assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment.
- Trial name
- AD-impaCT (NCT05214326)
- Where
- 3 sites in Kuwait, Saudi Arabia and 1 more
- Volunteers
- 187 people
- Sponsor
- Sanofi
Gaucher's Disease Type I
A Study to Evaluate Absolute Bioavailability, Absorption, Metabolism, and Excretion of Genz-112638 in Healthy Male Participants
Objectives: To determine pharmacokinetic (PK) variables, including absolute bioavailability (F), of Genz-99067, the free base of the L-tartaric acid salt of Genz-112638 as it exists in plasma, after a single intravenous (IV) dose…
- Trial name
- NCT06143904
- Testing
- Genz-112638, [14C]-Genz-112638
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
The primary objective of the study was to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal assay using human complement (hSBA) vaccine…
- Trial name
- NCT03632720
- Testing
- Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine, Meningococcal group B vaccine, Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
- Where
- 13 sites in United Kingdom
- Volunteers
- 788 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza, Influenza Immunization
Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an…
- Trial name
- NCT06118151
- Testing
- Influenza Hemagglutinin mRNA vaccine, Quadrivalent Recombinant Influenza Vaccine
- Where
- 20 sites in United States
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Multiple Sclerosis
Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect…
- Trial name
- NCT06106074
- Testing
- Tolebrutinib
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteers (Meningococcal Infection)
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
Primary Objective: 1. To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by…
- Trial name
- MET33 (NCT03630705)
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live
- Where
- 11 sites in Mexico, Russia
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue Virus Infection
Study on Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update
The primary objective of the study is to evaluate the effectiveness of additional risk minimization measures material by assessing the knowledge and understanding of healthcare professionals regarding the key safety messages…
- Trial name
- DNG00042 (NCT04170140)
- Testing
- No intervention
- Where
- France
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Multiple Myeloma
Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
Primary Objective: To evaluate the pharmacokinetics (PK) of isatuximab. Secondary Objectives: To evaluate the safety and tolerability of isatuximab. To assess the preliminary antitumor effect of isatuximab.
- Trial name
- NCT03733717
- Testing
- Isatuximab SAR650984
- Where
- 3 sites in China
- Volunteers
- 25 people
- Sponsor
- Sanofi
System; Sclerosis, Diffuse Cutaneous Systemic Sclerosis
KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
This randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis.
- Trial name
- NCT03919799
- Testing
- Belumosudil (KD025)
- Where
- 26 sites in United States
- Volunteers
- 36 people
- Sponsor
- Kadmon, a Sanofi Company
Multiple Sclerosis
An Observational Study on Teriflunomide-exposed Pregnancies
Primary Objective: To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies.
- Trial name
- NCT03198351
- Testing
- Teriflunomide (HMR1726)
- Where
- 2 sites in United States, Canada
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Sanofi
Sphingomyelin Lipidosis
A Prospective and Retrospective Cohort Study in Patients With Chronic Forms of Acid Sphingomyelinase Deficiency (ASMD)
Primary Objective: To describe the clinical features and their severity at the time of diagnosis and their evolution over time in patients with confirmed chronic visceral and chronic neurovisceral forms of ASMD To describe…
- Trial name
- NCT04106544
- Testing
- Investigational Procedures
- Where
- 28 sites in United States, Argentina and 11 more
- Volunteers
- 84 people
- Sponsor
- Sanofi
Healthy Volunteer
A Study to Investigate the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants
This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of 2 different dupilumab drug product in healthy volunteers. The duration per participant is up to 11 weeks.
- Trial name
- NCT05976360
- Testing
- Dupilumab (SAR231893)
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteers
A Study to Investigate the Pharmacokinetics (PK), Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants.
This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.
- Trial name
- NCT05976373
- Testing
- Dupilumab (SAR231893)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Sanofi
Pemphigus
A Study of PRN1008 in Patients With Pemphigus
This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment [BT] period) followed by an open-label extension [OLE] period intended to evaluate the efficacy and safety of oral PRN1008…
- Trial name
- NCT03762265
- Testing
- Rilzabrutinib
- Where
- 88 sites in United States, Argentina and 17 more
- Volunteers
- 131 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Cutaneous Squamous Cell Carcinoma
Real World Study on the Use of Cemiplimab in Adult Patients in UK
The primary objective is to describe the real-world clinical effectiveness of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) or metastatic cutaneous squamous cell carcinoma (mCSCC) treated…
- Trial name
- REACT-CEMI (NCT05493826)
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 110 people
- Sponsor
- Sanofi
Plasma Cell Myeloma
SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients
Primary Objectives: To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and dexamethasone (LD) in patients with relapsed or refractory multiple myeloma.
- Trial name
- NCT01749969
- Testing
- isatuximab SAR650984, lenalidomide, dexamethasone
- Where
- 5 sites in United States
- Volunteers
- 57 people
- Sponsor
- Sanofi
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