Clinical trials: sponsored by Sanofi
Plasma Cell Myeloma Refractory
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy.
- Trial name
- NCT04643002
- Testing
- Isatuximab, Dexamethasone, Pomalidomide
- Where
- 25 sites in United States, Australia and 7 more
- Volunteers
- 258 people
- Sponsor
- Sanofi
Fabry Disease
A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease
This is a 12-month, parallel treatment, Phase 3, double-blind, randomized, placebo-controlled study to evaluate the effect of venglustat on neuropathic and abdominal pain symptoms of Fabry disease in participants ≥16 years of age…
- Trial name
- PERIDOT (NCT05206773)
- Testing
- Venglustat (GZ402671)
- Where
- 50 sites in United States, Argentina and 19 more
- Volunteers
- 122 people
- Sponsor
- Sanofi
Dermatitis Atopic
Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis.
- Trial name
- RIVER-AD (NCT05492578)
- Testing
- Amlitelimab, Topical corticosteroids, Topical calcineurin inhibitors
- Where
- 392 sites in United States, Argentina and 27 more
- Volunteers
- 1,856 people
- Sponsor
- Sanofi
Rheumatoid Arthritis
Phase 1b/2 Study of IV Sarilumab in Adult With RA
This is a Phase 1/Phase 2 study with: 5-arms design for Part A; and a single arm for Part B. The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral…
- Trial name
- OPALS (NCT07704580)
- Testing
- Sarilumab, SAR153191 SC, Sarilumab, SAR153191 IV
- Where
- 12 sites in United States
- Volunteers
- 140 people
- Sponsor
- Sanofi
Prurigo Nodularis
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: Screening period: 2 to 4 weeks. Treatment period: 24 weeks. Post-intervention follow-up period: 16 weeks.
- Trial name
- NCT06293053
- Testing
- Dupilumab
- Where
- 15 sites in United States
- Volunteers
- 18 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: Primary population (former smokers cohort): Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with…
- Trial name
- AERIFY-2 (NCT04751487)
- Testing
- Itepekimab SAR440340
- Where
- 238 sites in United States, Argentina and 27 more
- Volunteers
- 1,234 people
- Sponsor
- Sanofi
Fabry Disease
Agalsidase Beta Long-Term Treatment Outcome for Fabry Disease Patients With IVS4 Mutation in Taiwan
This is a national, multicenter, observational, cohort study designed to assess clinical outcomes upon agalsidase beta treatment, to characterize the clinical manifestations, and to collect the natural history on male and female…
- Trial name
- NCT06052800
- Where
- 5 sites in Taiwan
- Volunteers
- 78 people
- Sponsor
- Sanofi
Meningococcal Immunisation, Healthy Volunteers
Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers
This study was conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age.
- Trial name
- NCT06284915
- Testing
- MenACYW conjugate vaccine
- Where
- 45 sites in Czechia, Denmark and 4 more
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Bronchiectasis
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis
ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups.
- Trial name
- NCT06280391
- Testing
- Itepekimab (SAR440340)
- Where
- 117 sites in United States, Argentina and 18 more
- Volunteers
- 314 people
- Sponsor
- Sanofi
Immune Thrombocytopenia
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
This was a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in…
- Trial name
- LUNA 3 (NCT04562766)
- Testing
- Rilzabrutinib
- Where
- 155 sites in United States, Argentina and 24 more
- Volunteers
- 232 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Pneumococcal Immunization, Healthy Volunteers
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies"…
- Trial name
- NCT07348692
- Testing
- PCV21 vaccine, 20vPCV licensed vaccine
- Where
- 25 sites in United States, Honduras and 2 more
- Volunteers
- 2,195 people, healthy volunteers welcome
- Sponsor
- Sanofi
RSV Immunization
Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12…
- Trial name
- CORAL (NCT06397768)
- Testing
- RSVt vaccine, Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine, Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
- Where
- 72 sites in United States, Mexico and 1 more
- Volunteers
- 2,226 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Asthma
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each…
- Trial name
- RIVER-ASTHMA (NCT06033833)
- Testing
- Amlitelimab
- Where
- 68 sites in United States, Argentina and 12 more
- Volunteers
- 335 people
- Sponsor
- Sanofi
Prurigo Nodularis
Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study
This study is a prospective, multinational, observational investigation designed to elucidate the real-world effectiveness and treatment patterns of dupilumab therapy in adult patients diagnosed with prurigo nodularis (PN).
- Trial name
- GLOBOSPIN (NCT05991323)
- Testing
- Dupilumab
- Where
- 49 sites in United States, Canada and 4 more
- Volunteers
- 110 people
- Sponsor
- Sanofi
Hemophilia
Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX
Primary Objective: To characterize the long-term safety and tolerability of fitusiran Secondary Objectives: To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of: Bleeding episodes…
- Trial name
- ATLAS-OLE (NCT03754790)
- Testing
- Fitusiran
- Where
- 79 sites in United States, Australia and 18 more
- Volunteers
- 281 people
- Sponsor
- Genzyme, a Sanofi Company
Eosinophilic Oesophagitis
A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5…
- Trial name
- NCT06101095
- Testing
- Dupilumab
- Where
- 30 sites in United States, Brazil and 3 more
- Volunteers
- 69 people
- Sponsor
- Sanofi
Hemophilia A
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A
This is a prospective, observational, multi-center longitudinal cohort study to describe the real-world effectiveness, safety and treatment usage of efanesoctocog alfa in patients with hemophilia A treated per standard of care in…
- Trial name
- NCT05911763
- Testing
- Efanesoctocog Alfa BIVV001
- Where
- 28 sites in United States
- Volunteers
- 200 people
- Sponsor
- Sanofi
Neoplasm Malignant
First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL
Primary Objective: To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma…
- Trial name
- NCT04401020
- Testing
- SAR442257
- Where
- 16 sites in United States, Czechia and 3 more
- Volunteers
- 47 people
- Sponsor
- Sanofi
Diabetes Mellitus, Type 1
Teplizumab in Pediatric Stage 2 Type 1 Diabetes
The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are <8 years of age.
- Trial name
- PETITE-T1D (NCT05757713)
- Testing
- teplizumab
- Where
- 10 sites in United States
- Volunteers
- 23 people
- Sponsor
- Sanofi
Cancer, Neoplasm
Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors
The study enrolled advanced cancer participants with unresectable or metastatic disease who were refractory to or were not candidates for standard approved therapy.
- Trial name
- NCT04717375
- Testing
- SAR444881, Pembrolizumab, Cetuximab
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Sanofi
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