Taglio Di Torrette

Researchers are evaluating SAR445399 in adults with moderate to severe hidradenitis suppurativa, a chronic skin condition. This Phase 2, multinational, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of two different doses of SAR445399 compared to placebo. The study is sponsored by Sanofi and involves adult participants who have had symptoms for at least six months and meet specific severity criteria. Participants will be randomly assigned to receive one of two SAR445399 dose regimens or a matching placebo. The study involves a 32-week treatment period, which is divided into a 16-week initial double-blind phase followed by a 16-week treatment-blinded extension phase. SAR445399 and placebo are given by injection. The trial includes a total of 16 visits over approximately 46 weeks. During the study, participants will undergo regular assessments to measure skin improvement, pain levels, quality of life, and safety. Researchers will monitor clinical responses using standardized scales such as the Hidradenitis Suppurativa Clinical Response HiSCR and other quality of life questionnaires. Laboratory tests, vital signs, and ECGs will also be performed. Safety will be tracked throughout the treatment and extension periods, with follow-up visits included in the 46-week study duration.

Researchers are evaluating SAR446523, an anti-GPRC5D ADCC-enhanced monoclonal antibody, in adults with relapsed or refractory multiple myeloma who have received multiple prior treatments. This first-in-human, open-label Phase 1 trial aims to assess the safety, antitumor activity, and pharmacokinetics of SAR446523. The study is sponsored by Sanofi and will continue until the last participants last visit, allowing therapy continuation until disease progression, unacceptable side effects, or discontinuation requests. The trial has two parts Part A involves dose escalation to find the maximum tolerated and recommended dose range at several dose levels of SAR446523 given by subcutaneous injection. Part B is a dose optimization phase where participants are randomly assigned to one of two dose regimens determined from Part A data to establish the recommended phase 2 dose. Participants receive SAR446523 subcutaneously in both parts. Participants will undergo safety evaluations, laboratory tests, and assessments for adverse events during treatment lasting up to approximately five years. Researchers will measure dose-limiting toxicities, overall response rates, and other efficacy outcomes such as progression-free survival and duration of response over 24 months after the last participant is enrolled. The study also monitors pharmacokinetics, immunogenicity, and quality of life impact throughout the treatment and follow-up period.