Clinical trials: sponsored by Sanofi
Neoplasm
Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies
Primary Objectives: Phase 1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic…
- Trial name
- NCT03637764
- Testing
- Isatuximab SAR650984, Atezolizumab
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 107 people
- Sponsor
- Sanofi
Graft vs Host Disease
A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease
This study was been conducted to evaluate the safety, tolerability, and activity of belumosudil (formerly known as KD025) in adult participants with chronic graft versus host disease (cGVHD).
- Trial name
- NCT02841995
- Testing
- Belumosudil (KD025)
- Where
- 7 sites in United States
- Volunteers
- 54 people
- Sponsor
- Kadmon, a Sanofi Company
Immune System Disorder (Healthy Volunteer)
A Study to Determine the Effect of Multiple Oral Doses of SLx-2119 in Healthy Male Subjects
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants.
- Trial name
- NCT05918627
- Testing
- Belumosudil mesylate
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Immune System Disorder (Healthy Volunteer)
A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple oral doses and regimens of KD025 in healthy male and post-menopausal female participants.
- Trial name
- NCT05918588
- Testing
- Belumosudil mesylate
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Immune System Disorder (Healthy Volunteer)
A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.
- Trial name
- NCT05918614
- Testing
- Belumosudil mesylate
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Diffuse Cutaneous Systemic Sclerosis
Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis
This was a phase 2, open-label, single-cohort, multicenter trial of belumosudil in participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc).
- Trial name
- dcSSC (NCT04680975)
- Testing
- Belumosudil
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Kadmon, a Sanofi Company
Purpura, Thrombocytopenic, Idiopathic
A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)
The purpose of this study is to explore the safety, preliminary clinical benefit, and activity of BIVV009 in patients with chronic immune thrombocytopenia.
- Trial name
- NCT03275454
- Testing
- BIVV009 6.5 grams, BIVV009 7.5 grams
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 12 people
- Sponsor
- Bioverativ, a Sanofi company
Pneumonia
Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia
Primary Objective: To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the end of treatment.
- Trial name
- NCT02332577
- Testing
- PRISTINAMYCIN XRP7263, Amoxicillin
- Where
- 19 sites in France, Tunisia
- Volunteers
- 161 people
- Sponsor
- Sanofi
Hypercholesterolaemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels…
- Trial name
- NCT03510884
- Testing
- Alirocumab SAR236553 (REGN727), Rosuvastatin, Atorvastatin
- Where
- 43 sites in United States, Argentina and 22 more
- Volunteers
- 153 people
- Sponsor
- Sanofi
Influenza
Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra®) in Subjects Aged 6 to 35 Months
Multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in Korea under routine clinical practices.
- Trial name
- NCT05832333
- Testing
- VaxigripTetra®
- Where
- 12 sites in South Korea
- Volunteers
- 682 people, healthy volunteers welcome
- Sponsor
- Sanofi
Relapsing Multiple Sclerosis
To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
Primary Objective: To describe the safety of teriflunomide in patients with relapsing forms of multiple sclerosis. Secondary Objective: To describe the efficacy of teriflunomide in patients with relapsing forms of multiple…
- Trial name
- SAFE (NCT03856619)
- Testing
- TERIFLUNOMIDE HMR1726
- Where
- 14 sites in India
- Volunteers
- 121 people
- Sponsor
- Sanofi
Pertussis (Whooping Cough)
Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States
The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants < 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP)…
- Trial name
- NCT05040802
- Testing
- Not applicable / dataset analysis
- Where
- France
- Volunteers
- 462 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Fabry Disease
To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease
Primary Objective: To assess reduction of plasma lyso-GL3 level after switch to agalsidase beta from agalsidase alfa Secondary Objectives: To assess reduction of kidney podocyte GL3 content after switch to agalsidase beta from…
- Trial name
- BCLEAR1 (NCT04143958)
- Testing
- agalsidase beta (GZ419828), agalsidase alfa
- Sponsor
- Sanofi
Acquired Thrombotic Thrombocytopenic Purpura
Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura
The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis
- Trial name
- HERCULES (NCT02553317)
- Testing
- Caplacizumab
- Where
- 101 sites in United States, Australia and 14 more
- Volunteers
- 145 people
- Sponsor
- Ablynx, a Sanofi company
Amyotrophic Lateral Sclerosis (Healthy Volunteers)
A Study in Healthy Adult Male & Female Participants to Assess the Amount of the Study Medicine (SAR443820) Absorbed by the Body, When Given Orally in Fasted Condition as a Tablet Versus as a Capsule (Part 1) and When Given Orally as a Tablet in Fasted Condition Versus as a Tablet After Food (Part 2)
Part 1: This is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part to determine the relative…
- Trial name
- NCT05797701
- Testing
- SAR443820
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Sanofi
Acquired Thrombotic Thrombocytopenic Purpura
Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
This study was a Phase II, single-blind, randomized, placebo-controlled trial to determine whether anti-vWF Nanobody is safe and effective as adjunctive treatment in patients with aTTP.
- Trial name
- TITAN (NCT01151423)
- Testing
- Caplacizumab
- Where
- 51 sites in United States, Australia and 11 more
- Volunteers
- 75 people
- Sponsor
- Ablynx, a Sanofi company
Unstable Angina, Non ST Segment Elevation Myocardial Infarction (NSTEMI)
Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients.
- Conditions
- Unstable Angina, Non ST Segment Elevation Myocardial Infarction (NSTEMI), Stable Angina (Associated With High Risk PCI)
- Trial name
- NCT01020383
- Testing
- ALX-0081, ReoPro®
- Where
- 39 sites in Austria, Belgium and 5 more
- Volunteers
- 364 people
- Sponsor
- Ablynx, a Sanofi company
Amyotrophic Lateral Sclerosis (Healthy Volunteers)
Single & Multiple Ascending Dose Study of SAR443820 in Healthy Adult Participants
This is a Phase 1, single-center study conducted in 2 parts: Part 1a, single ascending dose (SAD-TDU16519): Double-blind, randomized, placebo-controlled sequential ascending single oral doses including up to 6 cohorts.
- Trial name
- NCT05795907
- Testing
- SAR443820
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Sanofi
Influenza (Healthy Volunteers)
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22
The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the…
- Trial name
- NCT05078060
- Testing
- Quadrivalent Influenza Vaccine, High-Dose Quadrivalent Influenza Vaccine
- Where
- 15 sites in Finland, Germany
- Volunteers
- 1,804 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pompe Disease, Glycogen Storage Disease Type II (GSD II)
Safety and Efficacy Evaluation of Repeat neoGAA Dosing in Late Onset Pompe Disease Patients.
Primary Objective: To evaluate the safety and tolerability of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients.
- Conditions
- Pompe Disease, Glycogen Storage Disease Type II (GSD II), Acid Maltase Deficiency
- Trial name
- NCT01898364
- Testing
- GZ402666
- Where
- 17 sites in United States, Belgium and 5 more
- Volunteers
- 24 people
- Sponsor
- Genzyme, a Sanofi Company
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