Clinical trials: sponsored by Sanofi
Breast Cancer
Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer
Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole.
- Trial name
- AMEERA-4 (NCT04191382)
- Testing
- Amcenestrant (SAR439859), Letrozole
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 105 people
- Sponsor
- Sanofi
Hemophilia A
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
Primary objective To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection Secondary objectives To characterize additional pharmacokinetic…
- Trial name
- NCT05042440
- Testing
- Efanesoctocog alfa, Octocog alfa, Rurioctocog alfa pegol
- Where
- Bulgaria
- Volunteers
- 13 people
- Sponsor
- Sanofi
COVID-19
Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older
The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve…
- Trial name
- NCT04762680
- Testing
- SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1, SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2, SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
- Where
- 66 sites in United States, Australia and 5 more
- Volunteers
- 3,159 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rabies (Healthy Volunteers)
Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults
Primary Objective: To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG)…
- Trial name
- NCT03965962
- Testing
- VRVg-2, Purified Inactivated Rabies Vaccine, Human Diploid Cell Vaccine (HDCV)
- Where
- 2 sites in France
- Volunteers
- 640 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rheumatoid Arthritis
A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.
This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male…
- Trial name
- NCT05858788
- Testing
- SAR441566
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Sanofi
Immune System Disorder
Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
Primary Objectives: Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant candidates. Phase 2: To evaluate the efficacy of isatuximab in desensitization of participants awaiting kidney…
- Trial name
- NCT04294459
- Testing
- Isatuximab SAR650984, Acetaminophen (paracetamol) or equivalent, Ranitidine or equivalent
- Where
- 6 sites in United States, Spain
- Volunteers
- 23 people
- Sponsor
- Sanofi
Atopic Dermatitis
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD).
- Trial name
- NCT04033367
- Testing
- Dupilumab
- Where
- 42 sites in United States, Australia and 8 more
- Volunteers
- 188 people
- Sponsor
- Sanofi
Congenital Cystic Kidney Disease
Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat
Primary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- STAGED-PKD-EXT (NCT04705051)
- Testing
- Venglustat GZ402671
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 24 people
- Sponsor
- Sanofi
Factor VIII Deficiency
A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A
Primary Objective: To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. Secondary Objectives: To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
- Trial name
- XTEND-1 (NCT04161495)
- Testing
- efanesoctocog alfa (BIVV001)
- Where
- 47 sites in United States, Argentina and 17 more
- Volunteers
- 159 people
- Sponsor
- Bioverativ, a Sanofi company
Neurodermatitis
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)
Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable.
- Trial name
- NCT04183335
- Testing
- Dupilumab SAR231893, Moisturizers, Low to medium potent topical corticosteroids
- Where
- 63 sites in United States, Argentina and 6 more
- Volunteers
- 151 people
- Sponsor
- Sanofi
Neurodermatitis
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable.
- Trial name
- NCT04202679
- Testing
- Dupilumab SAR231893, Moisturizers, Low to medium potent topical corticosteroids
- Where
- 57 sites in United States, Canada and 9 more
- Volunteers
- 160 people
- Sponsor
- Sanofi
COVID-19 (Healthy Volunteers)
Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older
The primary objectives of the study were: To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group.
- Trial name
- NCT04537208
- Testing
- CoV2 preS dTM-AF03 (low-dose), CoV2 preS dTM-AF03 (high-dose), CoV2 preS dTM-AS03 (low-dose)
- Where
- 11 sites in United States
- Volunteers
- 441 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunisation, Healthy Volunteers
Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects
The primary objectives of the study are: To describe the safety profile of the different formulations in all participants To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against…
- Trial name
- FBP00004 (NCT04451954)
- Testing
- Quadrivalent RIV with H3 strain 1, Quadrivalent RIV with H3 strain 1 and adjuvant, Quadrivalent RIV with H3 strain 2
- Where
- 5 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Multiple Sclerosis
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
This is a Phase 1, single-center, open-label, non-randomized study to assess the effects of CYP2C8 inhibition using gemfibrozil, and CYP3A4 and CYP2C8 induction using rifampicin on the pharmacokinetics of SAR442168 in healthy…
- Trial name
- NCT06064539
- Testing
- Tolebrutinib, gemfibrozil, rifampicin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Sanofi
Disorders of Sphingolipid Metabolism, Healthy Volunteers
Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects
Primary Objectives: To determine the excretion balance and systemic exposure of radioactivity after oral administration of [14C]-venglustat.
- Trial name
- NCT05238714
- Testing
- venglustat
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Mucopolysaccharidosis I
China Post-marketing Surveillance (PMS) Study of Aldurazyme®
This is a single treatment arm study that is open-label to be conducted in Chinese participants with MPS I. Trial Objectives are to evaluate the safety and tolerability of Aldurazyme in Chinese MPS I participants, and to evaluate…
- Trial name
- NCT05134571
- Testing
- Laronidase
- Where
- 5 sites in China
- Volunteers
- 12 people
- Sponsor
- Genzyme, a Sanofi Company
Meningococcal Infection, Healthy Volunteers
Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam
The MEQ00074 study was a Phase III, open-label, single-center study aimed at describing the immunogenicity and safety of a single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y)…
- Trial name
- NCT06228586
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine
- Where
- 4 sites in Vietnam
- Volunteers
- 447 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza (Healthy Volunteers)
Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older
Primary Objective: To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations.
- Trial name
- NCT04137887
- Testing
- Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD), Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD)
- Where
- Finland
- Volunteers
- 33,096 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Relapsing Multiple Sclerosis
Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis
Primary Objective: To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary Objectives: To evaluate efficacy of SAR442168 on disease activity as assessed by imaging…
- Trial name
- NCT03889639
- Testing
- SAR442168, Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
- Where
- 48 sites in United States, Canada and 8 more
- Volunteers
- 130 people
- Sponsor
- Sanofi
Influenza
Study of Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age
The primary objectives of the study were: To demonstrate the non-inferiority of the immune response in terms of geometric mean titers (GMTs) and seroconversion rates of the SP Shz QIV compared with the SP Shz TIV containing the…
- Trial name
- NCT04210349
- Testing
- Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine 1 SP Shz TIV1, Trivalent Influenza Vaccine 2 SP Shz TIV2
- Where
- 7 sites in China
- Volunteers
- 7,106 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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