Clinical trials: completed, sponsored by 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
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
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
Allergic Fungal Rhinosinusitis
Dupilumab in Allergic Fungal Rhinosinusitis (AFRS)
Primary Objective: To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) Secondary Objectives: To evaluate the efficacy of treatment with…
- Trial name
- AIMS (NCT04684524)
- Testing
- Dupilumab SAR231893
- Where
- 47 sites in United States, Argentina and 7 more
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Sanofi
Chronic Obstructive Pulmonary Disease
Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
This study was an exploratory, two-part, 12-week, Phase 2a study evaluated the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years.
- Trial name
- AERIFY-3 (NCT05326412)
- Testing
- Itepekimab SAR440340
- Where
- 23 sites in United States, Belgium and 5 more
- Volunteers
- 49 people
- Sponsor
- Sanofi
Chronic Spontaneous Urticaria
Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine
The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e.
- Trial name
- RILECSU (NCT05107115)
- Testing
- rilzabrutinib
- Where
- 128 sites in Argentina, Canada and 11 more
- Volunteers
- 160 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis
Dupilumab in CRSsNP
Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: To evaluate the…
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis, Chronic Sinusitis, Sinus Disorder
- Trial name
- Liberty CRSsNP (NCT04678856)
- Testing
- Dupilumab SAR231893
- Where
- 58 sites in United States, Argentina and 11 more
- Volunteers
- 71 people
- Sponsor
- Sanofi
Atopic Dermatitis
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18…
- Trial name
- NCT05018806
- Testing
- Rilzabrutinib
- Where
- 31 sites in United States, Canada and 5 more
- Volunteers
- 124 people
- Sponsor
- Sanofi
Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment
The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib
- Trial name
- NCT01298323
- Testing
- Patient outreach, Vandetanib
- Where
- 66 sites in Australia, Austria and 18 more
- Volunteers
- 205 people
- Sponsor
- Sanofi
Acid Sphingomyelinase Deficiency
A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in France
This was an open-label study to evaluate safety and tolerability and provide enzyme replacement therapy (ERT) with olipudase alfa to patients with acid sphingomyelinase deficiency (ASMD) who completed the DFI12712 or the LTS13632…
- Trial name
- NCT06949358
- Testing
- Olipudase alfa
- Where
- 2 sites in France
- Volunteers
- 3 people
- Sponsor
- Sanofi
Asthma
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
This was a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment.
- Trial name
- TIDE-asthma (NCT05421598)
- Testing
- Amlitelimab
- Where
- 113 sites in United States, Argentina and 12 more
- Volunteers
- 437 people
- Sponsor
- Sanofi
Plasma Cell Myeloma
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of…
- Trial name
- IKEMA (NCT03275285)
- Testing
- isatuximab SAR650984, carfilzomib, dexamethasone
- Where
- 70 sites in United States, Australia and 14 more
- Volunteers
- 302 people
- Sponsor
- Sanofi
Cystic Fibrosis
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis
This Phase 1/2, first-in-human study evaluated the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of adult subjects with cystic fibrosis (CF).
- Trial name
- RESTORE-CF (NCT03375047)
- Testing
- MRT5005, Normal saline
- Where
- 16 sites in United States
- Volunteers
- 42 people
- Sponsor
- Sanofi
Hidradenitis Suppurativa
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.
- Trial name
- HS OBTAIN (NCT05849922)
- Testing
- SAR442970
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 86 people
- Sponsor
- Sanofi
Thrombotic Thrombocytopenic Purpura
Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura
This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary…
- Trial name
- MAYARI (NCT05468320)
- Testing
- Caplacizumab, Corticosteroids, anti-CD20 antibody
- Where
- 27 sites in United States, Belgium and 9 more
- Volunteers
- 51 people
- Sponsor
- Sanofi
Chronic Spontaneous Urticaria
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)
This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of…
- Trial name
- NCT05526521
- Testing
- Dupilumab
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Sanofi
Asthma
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- Trial name
- NCT03560466
- Testing
- Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies
- Where
- 81 sites in United States, Argentina and 16 more
- Volunteers
- 378 people
- Sponsor
- Sanofi
Psoriasis
A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis
This was a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It was designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male…
- Trial name
- SPECIFI-PSO (NCT06073119)
- Testing
- SAR441566
- Where
- 51 sites in United States, Argentina and 15 more
- Volunteers
- 221 people
- Sponsor
- Sanofi
Relapsing Multiple Sclerosis
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
Primary Objective: To determine the long-term safety and tolerability of SAR442168 in RMS participants Secondary Objective: To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods
- Trial name
- NCT03996291
- Testing
- Tolebrutinib
- Where
- 37 sites in United States, Canada and 7 more
- Volunteers
- 125 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps, Asthma
EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients
Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives To evaluate the efficacy of dupilumab in improving chronic…
- Trial name
- EVEREST (NCT04998604)
- Testing
- Dupilumab, Omalizumab
- Where
- 87 sites in United States, Belgium and 15 more
- Volunteers
- 360 people
- Sponsor
- Sanofi