Clinical trials: sponsored by Sanofi
Atopic Dermatitis
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18…
- Trial name
- NCT05018806
- Testing
- Rilzabrutinib
- Where
- 31 sites in United States, Canada and 5 more
- Volunteers
- 124 people
- Sponsor
- Sanofi
Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological…
- Conditions
- Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasia
- Trial name
- NCT05086315
- Testing
- SAR443579
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 101 people
- Sponsor
- Sanofi
Secondary Hyperparathyroidism-Chronic Kidney Disease
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: Evaluated the safety profile of Hectorol® capsules versus Rocaltrol®…
- Trial name
- NCT02859896
- Testing
- Doxercalciferol (GZ427397), Calcitriol
- Where
- 23 sites in United States, Chile
- Volunteers
- 21 people
- Sponsor
- Sanofi
Osteochondrodysplasia
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAR442501 in Pediatric Participants With Achondroplasia
This is a Phase 2, open-label, multicenter, study to evaluate safety, tolerability and efficacy of SAR442501 in children from birth up to 12 years of age with Achondroplasia.
- Trial name
- upreACH-2 (NCT06067425)
- Testing
- SAR442501
- Where
- 9 sites in Australia, China and 3 more
- Volunteers
- 16 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
Non-small Cell Lung Cancer Metastatic
SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
Primary Objectives: Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) Study…
- Trial name
- CARMEN-LC03 (NCT04154956)
- Testing
- SAR408701, Docetaxel
- Where
- 169 sites in United States, Argentina and 24 more
- Volunteers
- 389 people
- Sponsor
- Sanofi
Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment
The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib
- Trial name
- NCT01298323
- Testing
- Patient outreach, Vandetanib
- Where
- 66 sites in Australia, Austria and 18 more
- Volunteers
- 205 people
- Sponsor
- Sanofi
Acid Sphingomyelinase Deficiency
A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in France
This was an open-label study to evaluate safety and tolerability and provide enzyme replacement therapy (ERT) with olipudase alfa to patients with acid sphingomyelinase deficiency (ASMD) who completed the DFI12712 or the LTS13632…
- Trial name
- NCT06949358
- Testing
- Olipudase alfa
- Where
- 2 sites in France
- Volunteers
- 3 people
- Sponsor
- Sanofi
Systemic Lupus Erythematosus
PRV-3279-2a Trial in Systemic Lupus
The PREVAIL-2 study was designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) participants with active disease after amelioration induced by corticosteroid…
- Trial name
- PREVAIL-2 (NCT05087628)
- Testing
- PRV-3279
- Where
- 36 sites in United States, China and 2 more
- Volunteers
- 28 people
- Sponsor
- Provention Bio, a Sanofi Company
Asthma
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
This was a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment.
- Trial name
- TIDE-asthma (NCT05421598)
- Testing
- Amlitelimab
- Where
- 113 sites in United States, Argentina and 12 more
- Volunteers
- 437 people
- Sponsor
- Sanofi
Breast Cancer Metastatic
Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer
Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic…
- Trial name
- AMEERA-3 (NCT04059484)
- Testing
- Amcenestrant, Fulvestrant, Anastrozole
- Where
- 109 sites in United States, Argentina and 21 more
- Volunteers
- 367 people
- Sponsor
- Sanofi
Immune Thrombocytopenia
A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
This was a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/μL on two…
- Trial name
- NCT03395210
- Testing
- Rilzabrutinib
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 86 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Rabies, Healthy Volunteers
Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults
The primary objective of this study is: To demonstrate the VRVg-2 is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose PrEP regimen, in terms of…
- Trial name
- VRV12 (NCT04127786)
- Testing
- Purified vero rabies vaccine - serum free - VRVg-2, Purified inactivated rabies vaccine - Verorab®, Purified inactivated rabies vaccine - Imovax® Rabies
- Where
- 4 sites in Thailand
- Volunteers
- 1,708 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Plasma Cell Myeloma
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of…
- Trial name
- IKEMA (NCT03275285)
- Testing
- isatuximab SAR650984, carfilzomib, dexamethasone
- Where
- 70 sites in United States, Australia and 14 more
- Volunteers
- 302 people
- Sponsor
- Sanofi
Cystic Fibrosis
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis
This Phase 1/2, first-in-human study evaluated the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of adult subjects with cystic fibrosis (CF).
- Trial name
- RESTORE-CF (NCT03375047)
- Testing
- MRT5005, Normal saline
- Where
- 16 sites in United States
- Volunteers
- 42 people
- Sponsor
- Sanofi
Malignant Melanoma, Squamous Cell Carcinoma of Skin
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
Primary Objective: -To determine the antitumor activity of SAR444245 in combination with cemiplimab. Secondary Objectives: To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with…
- Trial name
- NCT04913220
- Testing
- THOR-707, Cemiplimab
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 46 people
- Sponsor
- Sanofi
Glycogen Storage Disease Type II-Pompe's Disease
A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa
This is a multi-stage, phase 2, open-label, multicenter, multinational, ascending dose cohort, repeated intravenous (IV) infusion study of avalglucosidase alfa in pediatric patients with Infantile-Onset Pompe Disease (IOPD) who…
- Trial name
- Mini-COMET (NCT03019406)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Hidradenitis Suppurativa
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.
- Trial name
- HS OBTAIN (NCT05849922)
- Testing
- SAR442970
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 86 people
- Sponsor
- Sanofi
Tay-Sachs Disease, Sandhoff Disease
A Multinational, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of Venglustat in Late-onset GM2
Primary Objectives: Primary population (adult participants with late-onset GM2 gangliosidosis): To assess the efficacy and pharmacodynamics (PD) of daily oral dosing of venglustat when administered over a 104-week period…
- Trial name
- AMETHIST (NCT04221451)
- Testing
- venglustat GZ402671
- Where
- 23 sites in United States, Argentina and 11 more
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company