NASDAQ — Healthcare: Manufacturing, Drug Manufacturers - General: Pharmaceutical Preparations
www.sanofi.comA Phase 4 pragmatic, randomized trial comparing high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose (QIV-SD) in older adults is expected to complete on August 31, 2025. Sponsored by Herlev and Gentofte Hospital with Sanofi involvement, the study aims to enroll 339,700 participants across Denmark, assessing vaccine effectiveness and patient-reported outcomes over three influenza seasons. The trial's results may impact the competitive landscape for influenza vaccines targeting older populations.
trial completionSanofi is conducting a Phase 2 clinical trial evaluating SAR447537 (INBRX-101), a recombinant protein therapy, against plasma-derived alpha1-proteinase inhibitor (A1PI) augmentation therapy in adults with alpha-1 antitrypsin deficiency (AATD) emphysema. The trial, which enrolled 99 participants, is expected to complete on October 30, 2025. SAR447537 is being developed as a potential alternative to plasma-derived A1PI for AATD-related emphysema, a rare genetic lung disorder.
trial completionSanofi is conducting a Phase 3, randomized, double-blind, placebo-controlled trial evaluating subcutaneous amlitelimab monotherapy in patients aged 12 and older with moderate-to-severe atopic dermatitis inadequately controlled by topical therapies. The study, with an enrollment of 601 participants, is expected to complete on November 11, 2025. Amlitelimab is a monoclonal antibody targeting OX40L, under development for inflammatory skin diseases. Trial results will inform potential regulatory submissions and future commercialization.
trial completionSanofi is expected to complete its Phase 3 clinical trial of amlitelimab, a subcutaneous monoclonal antibody therapy, for moderate-to-severe atopic dermatitis on December 11, 2025. The multinational, randomized, double-blind, placebo-controlled study (NCT06224348) evaluates efficacy and safety in patients aged 12 and older with inadequate response to topical treatments. Amlitelimab is being developed as a potential first-in-class therapy targeting OX40-Ligand for inflammatory skin diseases.
trial completionSanofi is conducting a clinical trial evaluating the safety of its Tdap5 vaccine, which contains five acellular pertussis components, when administered during pregnancy. The study, with an enrollment of 365,000 participants, is expected to complete on December 31, 2025. Tdap5 is a combination vaccine designed to protect against tetanus, diphtheria, and pertussis. The trial's results may inform future recommendations for maternal immunization strategies.
trial completionSanofi is conducting a multinational, non-interventional observational study of Isatuximab in patients with relapsed and/or refractory multiple myeloma (RRMM). The trial, with an enrollment of 586 participants, is expected to complete on February 23, 2026. Isatuximab is a monoclonal antibody targeting CD38, used in the treatment of multiple myeloma. The study aims to gather real-world data on the drug's use and outcomes in RRMM patients.
trial completionSanofi is conducting a Phase 1 first-in-human clinical trial of SAR442257 in patients with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory non-Hodgkin lymphoma (RR-NHL). The study, which began in July 2020 and is no longer recruiting, is expected to complete on March 17, 2026. SAR442257 is an investigational therapy targeting hematologic malignancies. The trial aims to assess safety, pharmacokinetics, and preliminary efficacy in a cohort of 47 participants.
trial completionA Phase 4 clinical trial evaluating dupilumab for the treatment of Eosinophilic Esophagitis (EoE) with severe strictures is expected to complete on April 1, 2026. The study, sponsored by the University of North Carolina, Chapel Hill, is currently recruiting participants. Dupilumab, a monoclonal antibody marketed by Sanofi and Regeneron, is already FDA-approved for EoE. The trial aims to further assess efficacy and safety in patients with severe esophageal narrowing.
trial completionSanofi is conducting a post-marketing surveillance study in South Korea to assess the safety of its DTaP-IPV-HB-PRP~T combination vaccine, with trial completion expected on April 13, 2026. The study, involving 690 participants, is designed to monitor adverse events following immunization. DTaP-IPV-HB-PRP~T is a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio, hepatitis B, and Haemophilus influenzae type b, and is categorized as a pediatric vaccine product. The study is currently recruiting participants.
trial completionA randomized controlled trial sponsored by Amsterdam UMC, with Sanofi (SNY) as a collaborator, is expected to complete on September 1, 2026. The study investigates interventions to prevent cognitive decline and early unemployment in people with multiple sclerosis (MS). The trial enrolls 270 participants and compares exercise/lifestyle coaching, work coaching, and enhanced usual care. Primary outcome is quality of life improvement, with secondary endpoints including cognitive, psychological, and cost-effectiveness measures. Results may inform future MS care strategies.
trial completion