Clinical trials: sponsored by Sanofi
Glycogen Storage Disease Type II
A Prospective Study to Observe & Describe Clinical Outcomes of Alglucosidase Alfa Treatment in Patients ≤6 Months of Age With Infantile-onset Pompe Disease (IOPD)
Primary Objective: To describe the effect of routine practice with alglucosidase alfa in patients with IOPD ≤6 months of age, on invasive ventilation-free survival after 52 weeks of treatment.
- Trial name
- NCT04848779
- Testing
- Alglucosidase alfa GZ419829
- Where
- 15 sites in United States, Belgium and 7 more
- Volunteers
- 16 people
- Sponsor
- Sanofi
Colitis Ulcerative
A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))
The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active…
- Trial name
- NCT05731128
- Testing
- Dupilumab
- Where
- 77 sites in United States, Argentina and 9 more
- Volunteers
- 68 people
- Sponsor
- Sanofi
Solid Tumor
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with…
- Trial name
- NCT05584670
- Testing
- SAR445877, Cetuximab, ADG126
- Where
- 22 sites in United States, Chile and 4 more
- Volunteers
- 542 people
- Sponsor
- Sanofi
Cardiac Repolarization, Healthy Volunteers
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single dose, placebo- and positive-controlled, 4-sequence, 4-treatment, 4-period crossover study.
- Trial name
- NCT07272629
- Testing
- Balinatunfib, Moxifloxacin
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sanofi
Respiratory Syncytial Virus Immunization
Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants
In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season.
- Trial name
- Vakzimeter RSV (NCT06824207)
- Where
- Germany
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Immune Thrombocytopenia
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment.
- Trial name
- LUNA 4 (NCT07007962)
- Testing
- rilzabrutinib
- Where
- 36 sites in United States, Austria and 7 more
- Volunteers
- 60 people
- Sponsor
- Sanofi
Gaucher's Disease Type I, Gaucher's Disease Type III
Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3
Primary Objective: Evaluated the safety and pharmacokinetics of eliglustat in pediatric participants (≥2 to <18 years old). Secondary Objective: Evaluated the efficacy of eliglustat and quality of life in pediatric participants…
- Trial name
- ELIKIDS (NCT03485677)
- Testing
- Eliglustat GZ385660, Imiglucerase GZ437843
- Where
- 21 sites in Argentina, Canada and 8 more
- Volunteers
- 57 people
- Sponsor
- Sanofi
Epstein-Barr Virus (EBV), Healthy Volunteers
A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 Years
This multi-center, prospective, longitudinal cohort study is designed to gather immunological and clinical data on EBV reactivation in EBV seropositive adults aged 18 to 29 years.
- Trial name
- NCT07536048
- Testing
- Investigational Procedure
- Where
- 2 sites in Australia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rheumatoid Arthritis, Psoriatic Arthritis
A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
The main objective of this post-authorization safety study is to assess healthcare professionals' awareness, knowledge, and behavior related to receipt and reading of the Direct Healthcare Professional Communication and…
- Trial name
- ARAVA PASS (NCT06714461)
- Testing
- Leflunomide
- Where
- France
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- Sanofi
Influenza, Healthy Volunteers
A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose…
- Trial name
- NCT06744205
- Testing
- Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1, TIV mRNA-neuraminidase (NA), TIV mRNA-HA Vaccine 2
- Where
- 24 sites in United States, Australia
- Volunteers
- 1,162 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
COVID-19, SARS-CoV-2 Infection
Safety and Immunogenicity of NVX-CoV2705
This study is a Phase 3 trial designed to check the safety and immune response to a new Omicron JN.1 COVID-19 vaccine. Study researchers will give a single dose of this vaccine, called NVX-CoV2705, to approximately 120…
- Trial name
- COVID-19 (NCT07079670)
- Testing
- NVX-CoV2705
- Where
- 10 sites in United States
- Volunteers
- 676 people, healthy volunteers welcome
- Sponsor
- Sanofi
Asthma
A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®)
Primary objective: Describe the characteristics of enrolled severe asthma patients Secondary objectives: Assess the control of asthma under dupilumab (Dupixent®) treatment until 1 year Assess the clinical objectives of the asthma…
- Trial name
- PEDIASTHMA (NCT05070663)
- Where
- France
- Volunteers
- 105 people
- Sponsor
- Sanofi
Acute Myeloid Leukaemia
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia
This is a single group, Phase 1, single-arm, dose escalation study to determine the candidate dose(s), and evaluate safety, tolerability, and preliminary anti-tumor activity of SAR445419 administered after fludarabine and…
- Trial name
- NCT05712278
- Testing
- SAR445419, fludarabine, cytarabine
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sanofi
Warm Autoimmune Hemolytic Anemia (wAIHA)
Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
All participants will receive rilzabrutinib orally. The screening period is up to 28 days, followed by a treatment period of 24 weeks for Part A.
- Trial name
- LUMINA 2 (NCT05002777)
- Testing
- rilzabrutinib
- Where
- 27 sites in United States, Austria and 7 more
- Volunteers
- 22 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyposis
Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France
This is a multicentre, non-interventional, single arm study that aims to describe the treatment patterns in France: patients' characteristics, disease characteristics, prior treatments for Severe chronic rhinosinusitis with nasal…
- Trial name
- OPALE (NCT06393946)
- Testing
- Dupilumab
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Sanofi
COVID-19
Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older
The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a…
- Trial name
- VAT00008 (NCT04904549)
- Testing
- SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series), SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series), SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
- Where
- 86 sites in United States, Colombia and 9 more
- Volunteers
- 23,670 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Yellow Fever
Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia
VYF03 is a phase II, randomized, parallel-group prevention study with 2 arms, active-controlled (Stamaril), observer-blind, multi-center study to assess the non-inferiority of the immune response, in terms of seroconversion rates…
- Trial name
- NCT05011123
- Testing
- Yellow fever vaccine (produced on serum-free Vero cells), Yellow fever vaccine
- Where
- 23 sites in Finland, France and 4 more
- Volunteers
- 690 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Multiple Sclerosis
LEMTRADA Pregnancy Registry in Multiple Sclerosis
Primary Objective: The primary goal of this registry is to assess the risk of spontaneous abortion in prospective enrolled women exposed to LEMTRADA for multiple sclerosis.
- Trial name
- NCT03774914
- Testing
- Alemtuzumab (GZ402673)
- Where
- 12 sites in United States, Australia and 10 more
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Chronic Graft Versus Host Disease
A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
This is a single group, Phase 4, single-arm post-marketing study for treatment. The purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescent participants…
- Trial name
- NCT06616415
- Testing
- Belumosudil
- Where
- 2 sites in China
- Volunteers
- 6 people
- Sponsor
- Sanofi
Relapsed/Refractory Multiple Myeloma, Amyloid Light-chain Amyloidosis
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
This is a first-in-human (FIH) Phase 1/Phase 2 study for evaluating SAR445514 in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light chain amyloidosis (RRLCA).
- Trial name
- NCT05839626
- Testing
- SAR445514
- Where
- 16 sites in Australia, Belgium and 5 more
- Volunteers
- 32 people
- Sponsor
- Sanofi
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