Clinical trials: sponsored by Sanofi
Alport Syndrome
Study of Lademirsen (SAR339375) in Patients With Alport Syndrome
Primary Objectives: To assess the efficacy of lademirsen (SAR339375) in reducing the decline in renal function. To assess the safety and tolerability of lademirsen (SAR339375) in participants with Alport syndrome.
- Trial name
- HERA (NCT02855268)
- Testing
- lademirsen (SAR339375)
- Where
- 23 sites in United States, Australia and 5 more
- Volunteers
- 43 people
- Sponsor
- Genzyme, a Sanofi Company
Atopic Dermatitis
Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis
This was a Ph2a study that consists of a double-blind, intra-patient placebo-controlled treatment period and an open-label uncontrolled treatment period with objective to evaluate the safety, tolerability, PK and preliminary…
- Trial name
- NCT04992546
- Testing
- PRN473 (SAR444727)
- Where
- 12 sites in United States, Canada
- Volunteers
- 39 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Cold Urticaria
Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)
Primary Objective: To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use of an H1-antihistamine…
- Trial name
- NCT04681729
- Testing
- Dupilumab SAR231893, Non sedating H1-antihistamine
- Where
- 33 sites in United States, Argentina and 3 more
- Volunteers
- 82 people
- Sponsor
- Sanofi
Carcinoma, Non Small Cell Lung
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic…
- Trial name
- VITAL (NCT00532155)
- Testing
- Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), Docetaxel (Taxotere®), Dexamethasone (pre- and post-medication for docetaxel)
- Where
- 32 sites in United States, Argentina and 30 more
- Volunteers
- 913 people
- Sponsor
- Sanofi
Metastatic Neoplasm
A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Primary Objectives: Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in…
- Trial name
- NCT03871348
- Testing
- SAR441000, Cemiplimab REGN2810
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 77 people
- Sponsor
- Sanofi
Asthma
First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants
This is a 3-part, parallel group treatment, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics after sequential single and multiple ascending doses of SAR443765 in…
- Trial name
- NCT05366764
- Testing
- SAR443765, Salbutamol or levosalbutamol
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sanofi
Immune Thrombocytopenia (ITP)
A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)
Primary Objective: To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: To assess the safety and tolerability of…
- Trial name
- NCT04669600
- Testing
- SAR445088 (BIVV020)
- Where
- 9 sites in United States, Czechia and 4 more
- Volunteers
- 12 people
- Sponsor
- Bioverativ, a Sanofi company
Seasonal Allergic Rhinitis
A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis
This study is a proof-of-concept study to demonstrate if a daily dose of a 2-days pre-treatment of Fexofenadine 180mg is effective in alleviating the AR symptoms and to assess the additional benefit to the patient in terms of…
- Trial name
- FEXPRESAR (NCT05692154)
- Testing
- Fexofenadine
- Where
- Canada
- Volunteers
- 95 people
- Sponsor
- Opella Healthcare Group SAS, a Sanofi Company
Myasthenia Gravis
Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis
This was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tolebrutinib compared with placebo in adult participants aged 18 to 85 years old with moderate-to-severe…
- Trial name
- URSA (NCT05132569)
- Testing
- Tolebrutininb
- Where
- 22 sites in United States, Canada and 7 more
- Volunteers
- 6 people
- Sponsor
- Sanofi
Asthma
The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
Primary Objective: To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: To evaluate the effect of dupilumab at Week 24 on…
- Trial name
- VESTIGE (NCT04400318)
- Testing
- Dupilumab
- Where
- 65 sites in United States, Bulgaria and 11 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Primary Objective: Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic…
- Trial name
- ISAKIDS (NCT03860844)
- Testing
- Isatuximab, Dexamethasone or equivalent, Fludarabine
- Where
- 41 sites in United States, Argentina and 14 more
- Volunteers
- 67 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus
The purpose of the study was to demonstrate if iGlarLixi (Soliqua 100/33) would improve glycemic control (as measured by Time in Range) and glycemic variability in participants with very uncontrolled (HbA1c ≥ 9%) type 2 Diabetes…
- Trial name
- Soli-CGM (NCT05114590)
- Testing
- Insulin glargine/Lixisenatide
- Where
- 18 sites in United States
- Volunteers
- 124 people
- Sponsor
- Sanofi
Influenza Immunization
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile…
- Trial name
- NCT05513053
- Testing
- Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
- Where
- 35 sites in United States, Czechia and 2 more
- Volunteers
- 1,308 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the…
- Trial name
- NCT05513391
- Testing
- Recombinant influenza vaccine (RIV4), Quadrivalent influenza vaccine (IIV4)
- Where
- 31 sites in United States, Poland and 1 more
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Low Back Pain
Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain
Primary Objective: To assess the efficacy of the infrared therapy patch (ITP) FIRTECH for treating participants suffering from mild to moderate acute low back pain.
- Trial name
- IRPATCH (NCT05137041)
- Testing
- ITP FIRTECH
- Where
- 7 sites in Germany, Italy
- Volunteers
- 221 people
- Sponsor
- Sanofi
Respiratory Syncytial Virus Infection
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
The primary objectives of the study were: To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus.
- Trial name
- VAD00001 (NCT04491877)
- Testing
- RSV vaccine formulation 1, RSV vaccine formulation 2
- Where
- 29 sites in United States, Chile and 1 more
- Volunteers
- 259 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Type 2 Diabetes Mellitus, Renal Impairment
Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
The TRENT trial is designed to confirm the efficacy and safety of Gla-300 compared with IDeg-100 in insulin-naïve patient (participants who have not tried insulin) with Type 2 Diabetes Mellitus (T2DM) and renal impairment.
- Trial name
- TRENT (NCT05552859)
- Testing
- Insulin glargine 300 U/mL, Insulin degludec 100 U/mL
- Where
- 68 sites in United States, Czechia and 3 more
- Volunteers
- 62 people
- Sponsor
- Sanofi
Pneumococcal Immunization
Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.
Primary Objectives: Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination Assessed the safety profile of the 3 SP0202 formulations…
- Trial name
- NCT04583618
- Testing
- Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb, Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI, Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII
- Where
- 17 sites in United States
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Sanofi
Pneumococcal Immunisation, Diphtheria Immunisation
Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Primary objectives: To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection).
- Conditions
- Pneumococcal Immunisation, Diphtheria Immunisation, Tetanus Immunisation, Pertussis Immunisation
- Trial name
- NCT04398706
- Testing
- Pneumococcal Conjugate Vaccine formulation 1, Pneumococcal Conjugate Vaccine formulation 2, Pneumococcal Conjugate Vaccine formulation 3
- Where
- 57 sites in United States, Canada and 2 more
- Volunteers
- 852 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Autoimmune Disorder, Healthy Volunteers
A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and…
- Trial name
- NCT06342700
- Testing
- Rilzabrutinib crystalline form, Rilzabrutinib amorphous form
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sanofi
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