Clinical trials: sponsored by Sanofi
Chronic Inflammatory Demyelinating Polyneuropathy
A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg.
- Trial name
- VITALIZE (NCT06290141)
- Testing
- riliprubart, IVIg
- Where
- 134 sites in United States, Argentina and 22 more
- Volunteers
- 160 people
- Sponsor
- Sanofi
Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).
- Trial name
- RESULT (NCT06500702)
- Testing
- frexalimab, brivekimig, rilzabrutinib
- Where
- 79 sites in United States, Argentina and 20 more
- Volunteers
- 84 people
- Sponsor
- Sanofi
Respiratory Syncytial Virus, Human Metapneumovirus
Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and Older
Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy…
- Conditions
- Respiratory Syncytial Virus, Human Metapneumovirus, Healthy Volunteers
- Trial name
- NCT07810010
- Testing
- Bivalent RSV+HMPV protein vaccine
- Where
- 21 sites in Australia, United Kingdom
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Sanofi
Meningococcal Infection, Healthy Volunteers
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and…
- Trial name
- NCT07135986
- Testing
- MenACYW conjugate vaccine, MenACYW135 polysaccharide vaccine, MenAC conjugate vaccine
- Where
- 4 sites in China
- Volunteers
- 1,602 people, healthy volunteers welcome
- Sponsor
- Sanofi
Juvenile Idiopathic Arthritis
A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this…
- Trial name
- SKYPS (NCT02991469)
- Testing
- Sarilumab SAR153191 (REGN88)
- Where
- 40 sites in Argentina, Canada and 12 more
- Volunteers
- 51 people
- Sponsor
- Sanofi
Acute Myeloid Leukemia
A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies
This was a parallel, Phase 1/Phase 2, randomized, open label, multi-cohort, multi-center study assessing the safety, tolerability and preliminary efficacy of SAR443579 with different agents for treatment in adolescent and/or…
- Trial name
- NCT06508489
- Testing
- SAR443579, venetoclax, azacitidine
- Where
- 7 sites in United States, Australia
- Volunteers
- 7 people
- Sponsor
- Sanofi
Chronic Graft Versus Host Disease
A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically…
- Trial name
- ROCKnrol-1 (NCT06143891)
- Testing
- Belumosudil, Prednisone, Prednisolone
- Where
- 151 sites in United States, Argentina and 22 more
- Volunteers
- 260 people
- Sponsor
- Sanofi
Hidradenitis Suppurativa
A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis…
- Trial name
- CLAROS (NCT07225569)
- Testing
- SAR445399
- Where
- 86 sites in United States, Argentina and 13 more
- Volunteers
- 144 people
- Sponsor
- Sanofi
Ulcerative Colitis
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- SUNSCAPE-2 (NCT07185009)
- Testing
- Duvakitug
- Where
- 171 sites in United States, Argentina and 29 more
- Volunteers
- 751 people
- Sponsor
- Sanofi
Sickle Cell Disease
The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-adaptive, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the efficacy, and safety of…
- Trial name
- LIBRA (NCT06975865)
- Testing
- Rilzabrutinib
- Where
- 63 sites in United States, Belgium and 12 more
- Volunteers
- 192 people
- Sponsor
- Sanofi
COPD (Chronic Obstructive Pulmonary Disease)
The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry
The STRIDE Registry will evaluate the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD.
- Trial name
- STRIDE (NCT07612878)
- Testing
- Cohort 1: Dupilumab, Cohort 2: usual care only
- Where
- 7 sites in United States
- Volunteers
- 350 people
- Sponsor
- Sanofi
Pruritus
Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies…
- Trial name
- NCT05263206
- Testing
- Dupilumab, Fexofenadine (loratadine if not available)
- Where
- 94 sites in United States, Argentina and 11 more
- Volunteers
- 284 people
- Sponsor
- Sanofi
COVID-19
Study of a Recombinant Spike COVID-19 Vaccine With Matrix-M in Older Adults and People at Increased Risk of Severe COVID-19
The purpose of this study is to evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants ≥ 65 years of age and participants 12 through 64 years of age who have at…
- Trial name
- NCT07861542
- Testing
- Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M
- Where
- 20 sites in United States
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Sanofi
Factor VIII Deficiency
Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants…
- Trial name
- SYNOVIIIUS (NCT06941870)
- Testing
- Efanesoctocog alfa
- Where
- 14 sites in United States, Canada and 2 more
- Volunteers
- 35 people
- Sponsor
- Sanofi
Plasma Cell Myeloma
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study.
- Trial name
- NCT05669989
- Testing
- Isatuximab intravenous (IV), Cemiplimab (SAR439684), Dexamethasone
- Where
- 37 sites in United States, Australia and 15 more
- Volunteers
- 70 people
- Sponsor
- Sanofi
Chronic Obstructive Pulmonary Disease
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Evaluate the…
- Trial name
- AERIFY-1 (NCT04701983)
- Testing
- Itepekimab SAR440340
- Where
- 232 sites in United States, Argentina and 19 more
- Volunteers
- 1,127 people
- Sponsor
- Sanofi
Crohn's Disease
A Study to Investigate Efficacy and Safety of Brivekimig in Participants With Crohn's Disease
This is a phase 2, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants…
- Trial name
- CHROMA CD (NCT06958536)
- Testing
- brivekimig
- Where
- 66 sites in United States, Australia and 10 more
- Volunteers
- 99 people
- Sponsor
- Sanofi
RSV Immunization
RSV Immunisation Status in Queensland (Australia)
The primary objective of this study is to determine the nirsevimab immunisation rate in eligible infants (according to Queensland Paediatric Respiratory Syncytial Virus Prevention Program recommendation) in Queensland, Australia.
- Trial name
- NCT07615192
- Testing
- Nirsevimab Respiratory Syncytial Virus monoclonal antibody
- Where
- Australia
- Volunteers
- 1,113 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hidradenitis Suppurativa
Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa.
- Trial name
- BRIGHTEN (NCT07170917)
- Testing
- Brivekimig
- Where
- 85 sites in United States, Australia and 17 more
- Volunteers
- 208 people
- Sponsor
- Sanofi
Respiratory Syncytial Virus Immunization, Human Metapneumovirus Immunization
Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older.
- Conditions
- Respiratory Syncytial Virus Immunization, Human Metapneumovirus Immunization, Healthy Volunteers
- Trial name
- NCT07734649
- Testing
- RSV+HMPV vaccine, Control Vaccine 3, Control Vaccine 4
- Where
- 50 sites in United States
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Sanofi