Clinical trials: sponsored by Sanofi
Chronic Graft Versus Host Disease
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use…
- Trial name
- NCT07771439
- Testing
- Belumosudil, Best available therapy (BAT)
- Where
- 3 sites in Netherlands, Spain
- Volunteers
- 356 people
- Sponsor
- Sanofi
Dermatitis Atopic
Pharmacokinetics, Immunogenicity and Safety of Subcutaneous Dupilumab and Berahyaluronidase Alfa (ALT-B4) Coformulation
This is a Phase 3, open label, randomized, parallel-group, 2-arm study. The purpose of this study is to measure PK, immunogenicity, safety and, tolerability of dupilumab hyaluronidase coformulation compared with dupilumab…
- Trial name
- EXTENSA (NCT07919899)
- Testing
- Dupilumab coformulated with berahyaluronidase alfa, Dupilumab
- Volunteers
- 150 people
- Sponsor
- Sanofi
Yellow Fever Immunization
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and…
- Trial name
- NCT07103148
- Testing
- Yellow fever vaccine (live), Measles, combinations with mumps and rubella, live attenuated
- Where
- 15 sites in Honduras, Mexico and 1 more
- Volunteers
- 2,440 people, healthy volunteers welcome
- Sponsor
- Sanofi
Asthma
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and…
- Trial name
- AIRITY (NCT07556159)
- Testing
- Procedure: Investigational Procedures
- Where
- 83 sites in United States, Canada and 4 more
- Volunteers
- 2,500 people
- Sponsor
- Sanofi
Type 1 Diabetes Mellitus
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on…
- Trial name
- FABULINUS (NCT06111586)
- Testing
- Frexalimab, Insulin
- Where
- 79 sites in United States, Austria and 14 more
- Volunteers
- 197 people
- Sponsor
- Sanofi
Atopic Dermatitis
This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment
The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and…
- Trial name
- ARMADA-AD (NCT07290803)
- Where
- 82 sites in United States, Canada and 7 more
- Volunteers
- 1,000 people
- Sponsor
- Sanofi
Glycogen Storage Disease Type II, Pompe Disease
Pompe Disease Registry Protocol
The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both…
- Trial name
- NCT00231400
- Where
- 282 sites in United States, Argentina and 42 more
- Volunteers
- 2,000 people
- Sponsor
- Genzyme, a Sanofi Company
Hemophilia
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
This is a parallel, Phase 3, two-arm, open-label study to evaluate the efficacy and safety of treatment with fitusiran prophylaxis administered to male pediatric participants (aged 1 to <12 years) who have severe hemophilia A or…
- Trial name
- ATLAS-KIDS (NCT07285460)
- Testing
- Fitusiran, Clotting factor concentrates (CFC) or bypassing agents (BPA), Antithrombin concentrate (ATIIIC)
- Where
- 37 sites in United States, Belgium and 10 more
- Volunteers
- 85 people
- Sponsor
- Sanofi
Hemophilia A or B
A Study to Describe Patient REal-world FitusiRan ExpeRience
This is a real-world, mixed-methods observational study conducted among adolescent (ages 12-17 years) and adult participants diagnosed with hemophilia A or B, with or without Factor VIII (FVIII) or Factor IX (FIX) inhibitors, who…
- Trial name
- PREFER (NCT07895381)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Sanofi
Chronic Graft Versus Host Disease
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.
- Trial name
- NCT07135973
- Testing
- Belumosudil
- Volunteers
- 26 people
- Sponsor
- Sanofi
Ulcerative Colitis
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis…
- Trial name
- SUNSCAPE-1 (NCT07184996)
- Testing
- Duvakitug
- Where
- 240 sites in United States, Argentina and 23 more
- Volunteers
- 980 people
- Sponsor
- Sanofi
Type 1 Diabetes
Early Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF)
The aim of this research is to identify pre-symptomatic Type 1 Diabetes (T1D) in young children and adolescents who have first degree relatives with T1D.
- Trial name
- NCT07038473
- Testing
- Investigational Procedure
- Where
- 7 sites in Kuwait, Saudi Arabia and 1 more
- Volunteers
- 3,500 people, healthy volunteers welcome
- Sponsor
- Sanofi
Crohn's Disease
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely…
- Trial name
- STARSCAPE-1 (NCT07184931)
- Testing
- Duvakitug
- Where
- 461 sites in United States, Argentina and 34 more
- Volunteers
- 980 people
- Sponsor
- Sanofi
Crohn's Disease
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD).
- Trial name
- STARSCAPE-2 (NCT07184944)
- Testing
- Duvakitug
- Where
- 109 sites in United States, Australia and 25 more
- Volunteers
- 751 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
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
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
Meningococcal Infection, Healthy Volunteers
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
The purpose of this study is to describe the safety and immunogenicity of MenACYW conjugate vaccine compared with locally-licensed meningococcal vaccines in healthy infants and toddlers in China.
- Trial name
- NCT07710872
- Testing
- MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA), Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China)
- Where
- 8 sites in China
- Volunteers
- 4,568 people, healthy volunteers welcome
- 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
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