Clinical trials: sponsored by Sanofi
Hemophilia
Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B
Primary Objective: To confirm appropriate dose levels of fitusiran when administered to male pediatric participants (ages 1 to <12 years of age) with severe hemophilia A or B Secondary Objectives: To characterize the safety and…
- Trial name
- ATLAS-PEDS (NCT03974113)
- Testing
- Fitusiran
- Where
- 16 sites in United States, Canada and 4 more
- Volunteers
- 32 people
- Sponsor
- Genzyme, a Sanofi Company
Atopic Dermatitis
French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)
The objective of the study is to describe the therapeutic management of patients more than or equal to 18 years old eligible for systemic therapy or treated by systemic therapy for atopic dermatitis (AD).
- Trial name
- FRAME (NCT06837454)
- Where
- 61 sites in France
- Volunteers
- 600 people
- Sponsor
- Sanofi
Multiple Sclerosis
Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI…
- Trial name
- NCT04879628
- Testing
- SAR441344 IV, SAR441344 SC, MRI contrast-enhancing preparations
- Where
- 37 sites in United States, Bulgaria and 8 more
- Volunteers
- 129 people
- Sponsor
- Sanofi
Hemophilia A
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
This is a national, multicenter, retrospective/prospective, observational study in Taiwan designed to assess effectiveness, safety, and usage of efanesoctocog alfa prophylaxis treatment in hemophilia A participants.
- Trial name
- PROTECT-ALT (NCT06684314)
- Testing
- Efanesoctocog alfa
- Where
- 10 sites in Taiwan
- Volunteers
- 79 people
- Sponsor
- Sanofi
Atopic Dermatitis
Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis
This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control.
- Trial name
- PROTYPE2 (NCT06039241)
- Where
- 55 sites in Germany
- Volunteers
- 572 people
- Sponsor
- Sanofi
Hemophilia A
A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab
This is an exploratory, single group, Phase 4, study to assess treatment with fitusiran prophylaxis after switching from emicizumab prophylaxis.
- Trial name
- NCT06145373
- Testing
- Fitusiran (SAR439774), Clotting factor concentrates (CFC) or bypassing agents (BPA), Antithrombin concentrate (ATIIIC)
- Where
- 3 sites in United States, Taiwan
- Volunteers
- 20 people
- Sponsor
- Sanofi
Systemic Lupus Erythematosus
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18…
- Trial name
- APATURA (NCT05039840)
- Testing
- SAR441344 IV, SAR441344 SC
- Where
- 73 sites in United States, Argentina and 14 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Chronic Graft Versus Host Disease
A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)
This is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to <18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for…
- Trial name
- schoolROCK (NCT07116031)
- Testing
- Belumosudil
- Where
- 35 sites in United States, Belgium and 11 more
- Volunteers
- 37 people
- Sponsor
- Sanofi
Asthma
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with…
- Trial name
- AIRLYMPUS (NCT06676319)
- Testing
- Lunsekimig, Short-Acting Beta Agonists (SABA), Fluticasone/Salmeterol
- Where
- 221 sites in United States, Argentina and 20 more
- Volunteers
- 556 people
- Sponsor
- Sanofi
Asthma
Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma
This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies.
- Trial name
- AIRPHRODITE (NCT06609239)
- Testing
- Lunsekimig
- Where
- 150 sites in United States, Argentina and 18 more
- Volunteers
- 900 people
- Sponsor
- Sanofi
Myotonic Dystrophy
A Study to Investigate the Safety, Tolerability, and Efficacy of SAR446268, an Adeno-associated Viral Vector-mediated Gene Therapy in Participants Aged 10 to 55 Years of Age With Non-congenital Myotonic Dystrophy Type 1
This is a Phase 1/Phase 2 open-label single arm, multicenter, and multinational study with SAR446268 for treatment of male and female participants 10 to 55 years old with non-congenital myotonic dystrophy (DM) type 1 (DM1).
- Trial name
- BrAAVe (NCT06844214)
- Testing
- SAR446268
- Where
- 10 sites in United States, Argentina and 4 more
- Volunteers
- 32 people
- Sponsor
- Sanofi
Chronic Obstructive Pulmonary Disease COPD
Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes
The OBS19236 is a retrospective and prospective, non-interventional observational study in COPD patients treated with dupilumab as part of routine clinical care.
- Trial name
- AURORA (NCT07380711)
- Where
- 28 sites in France
- Volunteers
- 500 people
- Sponsor
- Sanofi
Acne
Safety of the Acne mRNA Vaccine in Adolescents 12 to 17 Years of Age With Moderate to Severe Acne
The purpose of this study is to assess the safety profile of intramuscular injections of the Acne mRNA vaccine at 3 dose levels compared with placebo in 12 to 17 years old participants with moderate to severe acne.
- Trial name
- NCT07756957
- Testing
- Acne mRNA (messenger ribonucleic acid) vaccine
- Volunteers
- 410 people
- Sponsor
- Sanofi
Chronic Obstructive Pulmonary Disease
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments.
- Trial name
- AERIFY-4 (NCT06208306)
- Testing
- Itepekimab (SAR440340)
- Where
- 223 sites in United States, Argentina and 30 more
- Volunteers
- 669 people
- Sponsor
- Sanofi
Eosinophilic Esophagitis
A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany
This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with…
- Trial name
- ProMEAL (NCT06695897)
- Testing
- Dupilumab
- Where
- 15 sites in Germany
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sanofi
Niemann-Pick Diseases, Acid Sphingomyelinase Deficiency
A Real-world Long-term Safety and Immunogenicity Study of Olipudase Alfa Therapy in Pediatric Patients Less Than 2 Years of Age With Acid Sphingomyelinase Deficiency (ASMD)
US, multicenter, cohort, open label observational study with primary data collection. Ancillary protocol-specified procedures to address the study objectives (eg, assessment of ADA) may be considered outside the standard of care…
- Trial name
- NCT06192576
- Testing
- Olipudase alfa
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- 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)
- Volunteers
- 356 people
- Sponsor
- Sanofi
Healthy Volunteers, Influenza
Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness.
- Trial name
- NCT07779408
- Testing
- Flu H5 egg pandemic low dose vaccine, with adjuvant, Flu H5 Egg Pandemic medium dose vaccine, with adjuvant, Flu H5 Egg Pandemic high dose vaccine, with adjuvant
- Where
- 16 sites in United States
- Volunteers
- 640 people, healthy volunteers welcome
- Sponsor
- Sanofi
Lichen Simplex Chronicus
A Study to Investigate Improvement in Pruritus of Lichen Simplex Chronicus With Dupilumab Injections Compared With Placebo in Male and Female Participants Aged at Least 18 Years (STYLE 1)
This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged…
- Trial name
- NCT06687967
- Testing
- Dupilumab
- Where
- 63 sites in United States, Argentina and 15 more
- Volunteers
- 142 people
- Sponsor
- Sanofi
Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
Impact of Alirocumab on Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events
To estimate ischemic event rates in individuals with established atherosclerotic cardiovascular disease (ASCVD) and no prior acute ischemic events, comparing alirocumab with no Proprotein Convertase Subtilisin/Kexin type 9…
- Trial name
- OPTIMUS-EPIC (NCT07734753)
- Testing
- Alirocumab, Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)
- Where
- Netherlands
- Volunteers
- 4,006 people
- Sponsor
- Sanofi
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