Clinical trials: sponsored by Sanofi
Glycogen Storage Disease Type II;Pompe's Disease
Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease
Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa.
- Trial name
- COMET (NCT02782741)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 69 sites in United States, Argentina and 23 more
- Volunteers
- 101 people
- Sponsor
- Genzyme, a Sanofi Company
Multiple Myeloma
Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients
Primary Objectives: Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
- Trial name
- Islands (NCT02812706)
- Testing
- Isatuximab SAR650984
- Where
- 13 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Sanofi
Paroxysmal Nocturnal Hemoglobinuria
A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults
Primary objective The tolerability and safety of SAR443809 Secondary The PK parameters of SAR443809 The PD activity of SAR443809 The immunogenicity of SAR443809
- Trial name
- NCT06326814
- Testing
- Humanized anti-Factor Bb monoclonal antibody
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Sanofi
Glycogen Storage Disease, Pompe Disease
Pompe Lactation Sub-Registry
The objective is to determine if alglucosidase alfa is present in breast milk from mothers with Pompe Disease being treated with alglucosidase alfa and to measure breast milk production and composition in women with Pompe Disease…
- Trial name
- NCT00566878
- Testing
- alglucosidase alfa
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Genzyme, a Sanofi Company
Influenza (Healthy Volunteers)
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23
This is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination.
- Trial name
- NCT05568979
- Testing
- Quadrivalent Influenza Vaccine, High-Dose Quadrivalent Influenza Vaccine
- Where
- 15 sites in Finland, Germany
- Volunteers
- 1,001 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Type 2 Diabetes Mellitus (T2DM)
A Study of an Existing Database to Assess the Treatment Persistence to Basal Insulin in Type 2 Diabetes Mellitus Patients in a Structured Patient Education Program in India
The aim of this study is to analyze data from an existing database named SAATH-7 Star, in order to assess the treatment persistence to basal insulin in Type 2 diabetes patients who had been enrolled in the SAATH-7 Star structured…
- Trial name
- PERSISTENT (NCT05628090)
- Where
- France
- Volunteers
- 47,885 people
- Sponsor
- Sanofi
Asthma
Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma
This is a parallel, treatment, Phase 2, double-blind, 2 arm, 12-week Proof of Concept (PoC) study with 2 staggered cohorts (2 arms in each cohort) that is designed to assess the efficacy, safety, and tolerability of rilzabrutinib…
- Trial name
- NCT05104892
- Testing
- Rilzabrutinib
- Where
- 51 sites in Argentina, Bulgaria and 11 more
- Volunteers
- 196 people
- Sponsor
- Sanofi
Fabry Disease
Study Based on Electronic Health RecOrds to Identify Patients at High-risk of Fabry DiseasE (HOPE Fabry)
Primary objective: To estimate the prevalence of patients who are at high-risk for Fabry Disease (FD) in the Cleveland Clinic, Abu Dhabi (CCAD) United Arab Emirates (EMR) database from May 2016 to May 2022, according to the…
- Trial name
- NCT05671770
- Where
- United Arab Emirates
- Volunteers
- 15 people
- Sponsor
- Sanofi
Allogenic Stem Cell Transplantation
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
This is a multicenter, parallel multicohort, phase 2, single-arm study for adjunctive treatment in participants with high-risk myeloid malignancies undergoing allogeneic HSCT.
- Trial name
- NCT05726682
- Testing
- SAR445419
- Sponsor
- Sanofi
Glycogen Storage Disease Type II Pompe Disease
Avalglucosidase Alfa Extension Study
Primary Objective: Long-term safety and pharmacokinetics (PK) of avalglucosidase alfa Secondary Objective: Long-term effect of avalglucosidase alfa on pharmacodynamic variables
- Trial name
- NEO-EXT (NCT02032524)
- Testing
- Avalglucosidase Alfa
- Where
- 17 sites in United States, Belgium and 5 more
- Volunteers
- 19 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Obstructive Pulmonary Disease
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by Annualized rate of acute moderate and severe COPD…
- Trial name
- BOREAS (NCT03930732)
- Testing
- Dupilumab SAR231893, Inhaled Corticosteroid, Inhaled Long-Acting Beta Agonist
- Where
- 275 sites in United States, Argentina and 22 more
- Volunteers
- 939 people
- Sponsor
- Sanofi
Mucopolysaccharidosis I, Hurler's Syndrome
A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants
The purpose of this study is to determine if laronidase is present in the breast milk of post-partum women receiving Aldurazyme® (laronidase) and the effects of Aldurazyme (laronidase) on the growth, development, and immunologic…
- Conditions
- Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie
- Trial name
- NCT00418821
- Testing
- Laronidase
- Where
- Italy
- Volunteers
- 2 people
- Sponsor
- Genzyme, a Sanofi Company
Pompe Disease, Mucopolysaccharidosis Type I (MPS I)
A Study to Assess the Safety of Myozyme® and of Aldurazyme® in Male and Female Participants of Any Age Group With Pompe Disease or With Mucopolysaccharidosis Type I (MPS I) in a Home-care Setting
Primary objective: To obtain data pertaining to the safety and tolerability of alglucosidase alfa and laronidase treatments administered in a home-care infusion setting.
- Trial name
- HomERT (NCT05073783)
- Where
- Italy
- Volunteers
- 57 people
- Sponsor
- Sanofi
Plasma Cell Myeloma
Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation
Primary Objectives: VCDI cohort: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone…
- Trial name
- NCT02513186
- Testing
- lenalidomide, bortezomib, cyclophosphamide
- Where
- 12 sites in France, Germany and 2 more
- Volunteers
- 90 people
- Sponsor
- Sanofi
Acne Vulgaris, Acne
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
Acne vulgaris, or acne, is one of the most prevalent diseases worldwide, with skin conditions being one of the top causes of years lived with disability and non-fatal disease burden.
- Trial name
- OREA (NCT05131373)
- Testing
- ORG101 - Experimental 1
- Where
- 6 sites in Germany
- Volunteers
- 38 people
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue Virus Infection
Observational Study to Evaluate the Safety of CYD Tetravalent Dengue Vaccine (CYD-TDV) in Pregnant Women and Their Offsprings Inadvertently Exposed During Pregnancy
Primary Objective: To evaluate the safety of CYD-TDV in pregnant women and their offsprings inadvertently exposed during pregnancy or up to 30 days preceding their last menstrual period (LMP) with regards to maternal, pregnancy…
- Trial name
- NCT04023708
- Testing
- CYD-TDV Dengue Vaccine
- Where
- Brazil
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Gaucher's Disease
A Study to Evaluate Pharmacokinetic Parameters of Eliglustat in Healthy Volunteers Who Are CYP2D6 Extensive or Poor Metabolizers
The primary objective of the study is to evaluate dose proportionality and pharmacokinetics for three different dose levels of eliglustat after single and repeated administration.
- Trial name
- NCT06188325
- Testing
- Eliglustat
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Sanofi
Atrial Fibrillation
Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation
A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional…
- Trial name
- NCT05279833
- Testing
- dronedarone, sotalol
- Where
- France
- Volunteers
- 87,810 people
- Sponsor
- Sanofi
Gaucher's Disease
A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth
A study to assess the absorption of eliglustat through the mouth in healthy subjects and the safety of any systemic exposure resulting from oral surface absorption of eliglustat in healthy subjects.
- Trial name
- Acronym (NCT06193304)
- Testing
- Eliglustat
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanofi
Atopic Dermatitis
Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis
Primary Objective: To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT03912259
- Testing
- Dupilumab, Emollient (moisturizer)
- Where
- 27 sites in China
- Volunteers
- 165 people
- Sponsor
- Sanofi
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