Clinical trials: sponsored by Sanofi
Dermatitis Atopic
Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis
Primary Objective: Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus.
- Trial name
- DIFFEREN-STAD (NCT04823130)
- Testing
- Dupilumab (SAR231893)
- Where
- 3 sites in United States, Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteers
Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
- Trial name
- NCT05845996
- Testing
- SAR441344, Keyhole limpet hemocyanin
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Sanofi
Rheumatoid Arthritis
A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566
This is a single center randomized parallel-group partially-blinded, 4-arm Phase 1 study to evaluate the phototoxic potential of two dose levels of SAR441566 treatment compared to placebo and the active comparator, ciprofloxacin…
- Trial name
- NCT05844735
- Testing
- SAR441566, Ciprofloxacin
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Sanofi
Solid Tumor
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors
This is a Phase1, open-label, sequential dose-escalation and dose-expansion study of KD033 (SAR445710) in adult participants with advanced or metastatic solid tumors.
- Trial name
- NCT04242147
- Testing
- KD033 (SAR445710)
- Where
- 5 sites in United States
- Volunteers
- 45 people
- Sponsor
- Kadmon, a Sanofi Company
Healthy Volunteer
Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants
This phase 1 study will assess the safety and tolerability, and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of SAR444336 in healthy subjects following single- and repeated-dose administrations as a…
- Trial name
- NCT05876767
- Testing
- SAR444336
- Where
- 2 sites in Netherlands
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Sanofi
Breast Cancer
Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who…
- Trial name
- AMEERA-6 (NCT05128773)
- Testing
- Amcenestrant, Tamoxifen
- Where
- 2 sites in Chile, China
- Volunteers
- 3 people
- Sponsor
- Sanofi
Meningococcal Immunisation (Healthy Volunteers)
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers
Primary Objective: To demonstrate: the non-inferiority of the seroprotection rate (antibody titers greater than or equal to [>=] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or Nimenrix® as…
- Trial name
- NCT03890367
- Testing
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine, Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine, Meningococcal group C polysaccharide Conjugate vaccine adsorbed
- Where
- 29 sites in Denmark, Finland and 1 more
- Volunteers
- 707 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Immunisation (Healthy Volunteers)
Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)
Primary Objective: To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus…
- Trial name
- NCT04084769
- Testing
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine, Meningococcal Group B vaccine (Trumenba®), Meningococcal group B vaccine (Bexsero®)
- Where
- 30 sites in United States, Puerto Rico
- Volunteers
- 570 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Immunisation (Healthy Volunteers)
Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
Primary Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W)…
- Trial name
- NCT04368429
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine), Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- 4 sites in Japan
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Sanofi
Influenza Immunization, Healthy Volunteers
Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older
This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM…
- Trial name
- NCT05426174
- Testing
- mRNA NA vaccine, High Dose Quadrivalent Influenza Vaccine
- Where
- 6 sites in United States
- Volunteers
- 233 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Atopic Dermatitis, Dermatitis Atopic
Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China
This is a 16-week, open label, exploratory study designed to investigate dupilumab's effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping.
- Trial name
- BALISTAD-CN (NCT05624112)
- Testing
- Dupilumab
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Sanofi
Cold Agglutinin Disease
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
This was a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT number: NCT03347396) or CADENZA (NCT number…
- Trial name
- NCT05132127
- Testing
- sutimlimab
- Where
- 5 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Sanofi
Neoplasm Malignant, Breast Cancer
Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
Primary Objectives: Part 1 (Dose Escalation) To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for…
- Conditions
- Neoplasm Malignant, Breast Cancer, Lung Neoplasm Malignant, Gastric Cancer
- Trial name
- NCT05013554
- Testing
- SAR443216 IV, SAR443216 SC
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 44 people
- Sponsor
- Sanofi
Hepatic Function Abnormal
A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function
This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat.
- Trial name
- NCT05718258
- Testing
- Venglustat (GZ402671)
- Where
- 6 sites in United States, Germany
- Volunteers
- 26 people
- Sponsor
- Sanofi
Gaucher's Disease
Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ
Primary Objective To evaluate the efficacy on hematologic manifestations of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ To evaluate the safety profile of imiglucerase in maximum dose in…
- Trial name
- SEED (NCT04656600)
- Testing
- Cerezyme® / Imiglucerase
- Where
- 5 sites in China
- Volunteers
- 12 people
- Sponsor
- Sanofi
Dermatitis Atopic
Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis
Primary Objective: Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric participants with moderate to severe atopic…
- Trial name
- PELISTAD (NCT04718870)
- Testing
- Dupilumab SAR231893
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Sanofi
Multiple Myeloma
Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
Primary Objectives: To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) To assess the safety and tolerability (including local injection site tolerability) of…
- Trial name
- NCT04045795
- Testing
- isatuximab SAR650984 IV, pomalidomide, dexamethasone
- Where
- 14 sites in United States, Australia and 4 more
- Volunteers
- 56 people
- Sponsor
- Sanofi
Influenza Immunization, Healthy Volunteers
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (>=) 65…
- Trial name
- NCT05050318
- Testing
- Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation, Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization, Healthy Volunteers
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older
Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4…
- Trial name
- NCT04024228
- Testing
- Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD), High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation
- Where
- 17 sites in Belgium, France and 4 more
- Volunteers
- 1,539 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Atopic Dermatitis
Dupilumab in Japanese Patients With Atopic Dermatitis
Primary Objective: To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) Secondary Objective: To evaluate the efficacy of dupilumab administered concomitantly with TCS.
- Trial name
- NCT04678882
- Testing
- Dupilumab SAR231893
- Where
- 19 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Sanofi
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