Clinical trials: sponsored by Sanofi
Clostridium Difficile Infection-associated Diarrhea and Colitis
Efficacy and Safety of Teicoplanin in CDAD
Primary Objective: Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis Secondary Objective: Evaluate…
- Trial name
- NCT04003818
- Testing
- TEICOPLANIN
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Sanofi
Hypercholesterolemia
A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy
Primary Objective: To demonstrate the superiority of the single pill combination (SPC) ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) compared to rosuvastatin 10 mg (R10), in the reduction of low density lipoprotein cholesterol…
- Trial name
- ROZEL (NCT04669041)
- Testing
- Rosuvastatin, SPC ezetimibe/rosuvastatin, Rosuvastatin active capsule
- Where
- 40 sites in China
- Volunteers
- 305 people
- Sponsor
- Sanofi
Hepatic Function Abnormal
Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function
This is a Phase 1, parallel, open-label, 3-arm study to investigate the pharmacokinetic (PK) parameters of amcenestrant in female participants aged 40 to 75 years with mild and moderate hepatic impairment, and in matched…
- Trial name
- NCT05126329
- Testing
- amcenestrant
- Where
- 3 sites in Germany, South Korea
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Sanofi
Meningococcal Immunisation, Healthy Volunteers
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
This study evaluated the immunogenicity and safety of a single dose of MenQuadfi® administered as a booster vaccine in toddlers 12 - 23 months of age in Argentina who had been primed with at least 1 dose of the quadrivalent…
- Trial name
- NCT05929651
- Testing
- MenACYW conjugate vaccine
- Where
- 2 sites in Argentina
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Squamous Cell Carcinoma of Head and Neck
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)
The study was a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older…
- Trial name
- NCT05061420
- Testing
- Pembrolizumab, SAR444245 (Thor-707), Cetuximab
- Where
- 27 sites in United States, Argentina and 9 more
- Volunteers
- 59 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs
Primary Objective: To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs Secondary Objective: To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D…
- Trial name
- SAFEGUARD (NCT04980027)
- Testing
- Insulin glargine (U300)
- Where
- 2 sites in India
- Volunteers
- 228 people
- Sponsor
- Sanofi
Thrombotic Thrombocytopenic Purpura
A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Primary Objective: To evaluate the effect of caplacizumab on prevention of recurrence of aTTP (proportion of participants with a recurrence of aTTP) during the overall study period.
- Trial name
- NCT04074187
- Testing
- Caplacizumab (ALX-0081), Plasma exchange (PE), Corticosteroid treatment (Methylprednisolone or prednisolone)
- Where
- 12 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Sanofi
Overweight, Healthy Subjects
First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects
Primary Objective: To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses Secondary Objectives: To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC…
- Trial name
- NCT04521738
- Testing
- SAR441255
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sanofi
Autologous Haematopoietic Stem Cell Transplant
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Combination With G-CSF in Multiple Myeloma Patients
This is a single-group treatment, phase IV, open label study to assess the mobilization efficacy and safety of plerixafor in combination with G- CSF in male and female participants from 18 to 75 years of age with multiple myeloma…
- Trial name
- NCT05087212
- Testing
- plerixafor + G-CSF
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period
This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to…
- Trial name
- INITIATION (NCT05002933)
- Testing
- Insulin glargine 300 U/ml
- Where
- China
- Volunteers
- 570 people
- Sponsor
- Sanofi
Amyotrophic Lateral Sclerosis
Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Amyotrophic Lateral Sclerosis in a cross-over design
- Trial name
- NCT03757351
- Testing
- DNL747
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 15 people
- Sponsor
- Sanofi
Yellow Fever (Healthy Volunteers)
Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
The primary objectives of the study are: To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit To describe the…
- Trial name
- VYF01 (NCT04142086)
- Testing
- Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine, Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine, Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Autoimmune Haemolytic Anaemia
A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
Primary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin…
- Trial name
- NCT04269551
- Testing
- BIVV020
- Where
- 10 sites in United States, Germany and 4 more
- Volunteers
- 12 people
- Sponsor
- Bioverativ, a Sanofi company
Pertussis Immunisation, Diphtheria Immunisation
Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
Primary Objective: To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV Secondary Objective: To describe the immunogenicity profile…
- Conditions
- Pertussis Immunisation, Diphtheria Immunisation, Polio Immunisation, Hepatitis B Immunisation
- Trial name
- NCT04429295
- Testing
- DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus), DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b), Inactivated Poliomyelitis Vaccine
- Where
- 3 sites in Thailand
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rabies (Healthy Volunteers)
Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adult and Pediatric Population in Thaïland
Primary Objective: To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses [2-2-2]) and Day 42 (to assess the immune response after 4 doses [2-2-2-0-2]) when…
- Trial name
- NCT04478084
- Testing
- Purified vero rabies vaccine - serum free VRVg-2, Purified inactivated rabies vaccine, Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)
- Where
- 3 sites in Thailand
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Healthy Volunteers
A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants
This is a 2-part, Phase 1 study, with 1 arm in Part 1 and a randomized parallel design in Part 2. The purpose of this study is to evaluate the comparability of pharmacokinetics, safety and tolerability of two different…
- Trial name
- NCT05796479
- Testing
- Amlitelimab DP1, Amlitelimab DP2
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sanofi
Rabies (Healthy Volunteers)
Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland
Primary Objective: To describe the immune response induced by VRVg-2 and Verorab vaccines at D14 and D35 when co-administered with Human Rabies Immunoglobulins (HRIG) at D0, according to the Zagreb (2-1-1) IM regimen in healthy…
- Trial name
- NCT04594551
- Testing
- Purified vero rabies vaccine - serum free, Purified inactivated rabies vaccine, Human rabies immunoglobulins
- Where
- 3 sites in Thailand
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Healthy Volunteers
Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in…
- Trial name
- NCT05976386
- Testing
- Dupilumab (SAR231893)
- Where
- United States
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatic Function Abnormal
A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment
In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of…
- Trial name
- NCT05607173
- Testing
- Fexinidazole (HOE239)
- Where
- 2 sites in Bulgaria, France
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Sanofi
Atopic Dermatitis
Dupilumab Skin Barrier Function Study in Atopic Dermatitis
Primary Objective: Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in pre-defined lesional skin in participants with moderate to severe atopic dermatitis…
- Trial name
- BALISTAD (NCT04447417)
- Testing
- Dupilumab SAR231893
- Where
- 2 sites in United States, Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Sanofi
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