Clinical trials: sponsored by Sanofi
Plasma Cell Myeloma
Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone…
- Trial name
- ICARIA-MM (NCT02990338)
- Testing
- Isatuximab, Pomalidomide, Dexamethasone
- Where
- 111 sites in United States, Australia and 22 more
- Volunteers
- 307 people
- Sponsor
- Sanofi
Hepatic Function Abnormal
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function
The purpose of this parallel group, Phase 1, open-label, 2-arm, single dose, multi-center study is to assess the effect of mild hepatic impairment on pharmacokinetics (PK), safety and tolerability of tolebrutinib compared with…
- Trial name
- NCT05283915
- Testing
- tolebrutinib
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Sanofi
Amyotrophic Lateral Sclerosis, Healthy Volunteer
A Study to Assess the Effect of Erythromycin on the Test Medicine (SAR443820) When Given Orally as Tablets to Healthy Adult Male and Female Participants (Part A); and the Effect of Itraconazole on the Test Medicine (SAR443820) When Given Orally as Capsules to Healthy Adult Male Participants (Part B)
This is a Phase 1, cross-over, 2-part study for pharmacokinetic (PK) assessment of SAR443820 when co-administered with cytochrome P450 3A4 (CYP3A4) inhibitors (erythromycin ethyl succinate (EES) in Part A and possibly…
- Trial name
- NCT05797753
- Testing
- SAR443820, Erythromycin ethyl succinate, Itraconazole
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Sanofi
Non Small Cell Lung Cancer, Lung Cancer
Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients
Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread.
- Trial name
- ZEAL (NCT00418886)
- Testing
- Vandetanib, Pemetrexed
- Where
- 110 sites in United States, Argentina and 19 more
- Volunteers
- 698 people
- Sponsor
- Genzyme, a Sanofi Company
Symptomatic, Aggressive, Sporadic, Unresectable, Locally, Advanced/Metastatic Medullary Thyroid Cancer (MTC)
Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer
This is a European multinational, multicenter, non-interventional (observational) and prospective study. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative…
- Trial name
- Caprelsa104 (NCT01945762)
- Testing
- Vandetanib 300 mg
- Where
- 8 sites in Belgium, France and 6 more
- Volunteers
- 31 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Graft-versus-host-disease
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of KD025 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least 2 prior lines of systemic therapy
- Trial name
- NCT03640481
- Testing
- Belumosudil (KD025)
- Where
- 35 sites in United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Asthma
A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma
Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: To evaluate the effect of dupilumab on additional participant reported sleep outcomes To evaluate the effect of dupilumab on objective sleep…
- Trial name
- MORPHEO (NCT04502862)
- Testing
- SAR231893
- Where
- 55 sites in United States, Argentina and 9 more
- Volunteers
- 202 people
- Sponsor
- Sanofi
Warm Autoimmune Hemolytic Anemia (wAIHA)
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
Primary Objectives: Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA Part B: To evaluate the efficacy of the selected dose in adults with wAIHA Secondary Objectives…
- Trial name
- NCT04661033
- Testing
- Isatuximab SAR650984
- Where
- 6 sites in United States, France and 4 more
- Volunteers
- 8 people
- Sponsor
- Sanofi
Pneumococcal Immunization
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy…
- Trial name
- NCT06698198
- Testing
- Pneumococcal Conjugate Vaccine, Prevnar 13®
- Where
- 2 sites in United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Gaucher Disease
Implementation and Evaluation of a Rare Disease Algorithm to Identify Persons at Risk of Gaucher Disease Using Data From Electronic Health Records (EHRs) in the United States (Project Searchlight)
This is a three-phase study comprising both retrospective and prospective components, as follows: Phase I: Deployment of Rare Disease Algorithm: A diagnostic screening algorithm was developed using advanced analytical methods to…
- Trial name
- NCT05908656
- Testing
- Investigational procedure
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Sanofi
Asthma
An Observational, Retrospective Multicentre Medical Record Review to Describe the Post-authorisation Early Clinical Experience of Dupilumab in the Treatment of Adult Severe Asthma
The purpose of this retrospective medical record review is to describe the real-world clinical effectiveness of dupilumab with patients in the United Kingdom with severe asthma.
- Trial name
- DUPIAZA (NCT06064526)
- Testing
- No intervention
- Where
- France
- Volunteers
- 144 people
- Sponsor
- Sanofi
Sphingomyelin Lipidosis
Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
Primary Objective: The primary objective of this phase 2/3 study was to evaluate the efficacy of olipudase alfa (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for 52 weeks in adult…
- Trial name
- ASCEND (NCT02004691)
- Testing
- Olipudase alfa
- Where
- 24 sites in United States, Argentina and 15 more
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Hematological Malignancy
Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab).
- Trial name
- NCT01084252
- Testing
- Isatuximab SAR650984, Dexamethasone
- Where
- 59 sites in United States, Argentina and 15 more
- Volunteers
- 351 people, healthy volunteers welcome
- Sponsor
- Sanofi
Venous Thromboembolism
A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis (i.e., Preventive Treatment) for Venous Thromboembolism (VTE, i.e., Blood Clots in the Veins) and Bleeding Event Risk in a Population With Acute Medical Illness
Venous Thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with an increase in risk of mortality and long-term disability and is a major contributor to global disease burden.
- Trial name
- NCT05819112
- Where
- United States
- Volunteers
- 14,799 people
- Sponsor
- Sanofi
Venous Thromboembolism
Comparison of the Risk of Venous Thromboembolism (i.e., Blood Clots in the Veins) and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis (i.e., Preventive Treatment) With Enoxaparin
In individuals with obesity, the optimal dosing and duration of venous thromboembolism (VTE) prophylaxis in settings representing acute medical illness or surgery is limited due to lack of randomized controlled trials (RCTs)…
- Trial name
- NCT05819125
- Where
- United States
- Volunteers
- 21,000 people
- Sponsor
- Sanofi
Juvenile Idiopathic Arthritis
An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)
Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in participants aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate…
- Trial name
- SKYPP (NCT02776735)
- Testing
- Sarilumab
- Where
- 30 sites in United States, Argentina and 13 more
- Volunteers
- 102 people
- Sponsor
- Sanofi
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers…
- Trial name
- NCT03537508
- Testing
- MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine
- Where
- 70 sites in United States, Puerto Rico
- Volunteers
- 2,627 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue Fever, Dengue Hemorrhagic Fever
Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine
The aim of this study is to evaluate the safety profile of Dengvaxia® when used in the real-world immunization setting Primary Objective: To measure the incidence of selected adverse events (AEs) and serious AEs (SAEs) occurring…
- Trial name
- NCT02948933
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Obstructive Pulmonary Disease
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
This Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered…
- Trial name
- NCT06114238
- Testing
- Itepekimab AI, Itepekimab PFS
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi
Respiratory Syncytial Virus Infections
Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers
The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease…
- Trial name
- NCT05964582
- Where
- 15 sites in United States, Finland and 5 more
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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