Yahaba

Researchers are evaluating the safety and effectiveness of SAR441566 in adults with moderate to severe Crohn's Disease in this phase 2, multinational, randomized, double-blind, placebo-controlled study. The main goal is to compare different doses of SAR441566 against a placebo to see how well they work in treating Crohn's Disease. The study involves participants who have had a confirmed diagnosis of Crohn's Disease for at least three months and have shown moderate to severe symptoms. Participants will take either SAR441566 tablets or matching placebo tablets orally during the study. The study begins with a 4-week screening period, followed by a 52-week main treatment phase that includes 12 weeks of induction treatment and 40 weeks of maintenance treatment under double-blind conditions. After this, a 2-week follow-up is conducted for those not entering the long-term safety study. Eligible participants may join an open-label phase lasting up to 40 weeks, but the combined time in maintenance and open-label phases will not exceed 40 weeks. During the study, participants will undergo assessments including endoscopy to measure response at week 12. Researchers will monitor symptoms, stool frequency, and abdominal pain scores to evaluate treatment effects. Safety will be tracked throughout the study, including a follow-up after treatment ends. The total study duration for participants can be up to 59 weeks, with careful monitoring to ensure accurate evaluation of SAR441566's impact on Crohn's Disease.

Researchers are evaluating the efficacy and safety of SAR441566, an oral tablet medication, in adults with moderate-to-severe ulcerative colitis (UC). This Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study aims to determine how well different doses of SAR441566 help patients achieve clinical remission, measured by the modified Mayo Score, after 12 weeks of treatment. The study includes a screening period lasting up to 28 days plus an additional 7 days if needed. The main treatment period lasts 52 weeks and consists of a 12-week double-blind induction phase followed by a 40-week maintenance phase, ending with a 2-week follow-up after treatment. Participants receive either SAR441566 or a matching placebo orally as tablets. After the main study, eligible participants not joining a long-term study may enter an open-label treatment period for up to 40 weeks. The main study involves 12 visits, and the open-label phase includes 8 visits. During the study, participants will be monitored through clinical assessments and scoring of disease activity. Researchers will track remission rates at week 12 and evaluate long-term safety and efficacy during the maintenance and open-label periods. The total time involved for participants can be up to 59 weeks, including screening, treatment, follow-up, and optional open-label extension.

Researchers are evaluating an experimental drug called linvoseltamab (REGN5458) for adults with relapsed or refractory multiple myeloma who have had one to four previous treatments and have standard treatment options available. This phase 3 study compares linvoseltamab to a combination of three cancer drugs: elotuzumab, pomalidomide, and dexamethasone (EPd). The study aims to assess the safety and effectiveness of linvoseltamab compared to EPd, including how long participants benefit, tumor response, side effects, survival, and pain improvement. Linvoseltamab is given by intravenous infusion, while the comparison group receives elotuzumab by infusion and pomalidomide capsules and dexamethasone tablets or capsules by mouth or IV. Participants are randomly assigned to receive either linvoseltamab or the EPd combination. The study includes participants who have previously received lenalidomide, a proteasome inhibitor, and in some cases, a CD38 antibody. Treatment continues as per protocol with ongoing monitoring. Participants will undergo regular assessments to evaluate their disease response and side effects. Researchers will monitor progression-free survival for up to approximately five years. Assessments include measuring tumor response, survival, pain levels, and safety. Participants must have measurable disease and adequate organ function, and they will be followed closely to assess how well the treatments work and their safety over time.

Researchers are evaluating the safety and effectiveness of a 14-day intravenous infusion of teplizumab in Japanese participants aged 8 to 34 years who have Stage 2 Type 1 Diabetes. This Phase 2, two-arm study aims to assess teplizumab's ability to delay progression to Stage 3 Type 1 Diabetes. The study also examines the drug's pharmacokinetics, pharmacodynamics, and immunogenicity based on previous clinical data from Western countries. Participants will receive teplizumab through intravenous infusion following a dosing regimen consistent with the FDA-approved schedule for delaying Stage 3 Type 1 Diabetes onset. The study includes a treatment period of 14 days and lasts approximately 756 days in total to monitor long-term safety and effectiveness outcomes. Throughout the study, participants will undergo multiple assessments including monitoring for adverse events, vital signs, ECGs, and laboratory tests. Researchers will measure changes in C-peptide levels and endogenous insulin from baseline up to week 104 to evaluate beta-cell function. The total study duration involves continuous safety monitoring and collection of data to determine the number of participants progressing to Stage 3 Type 1 Diabetes.

Researchers are evaluating the safety and effectiveness of mirvetuximab soravtansine combined with bevacizumab as maintenance therapy in adult women with platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancers that have high folate receptor-alpha (FRα) expression. This Phase 3, multicenter, open-label study focuses on patients who have not progressed after second-line platinum-based chemotherapy plus bevacizumab. Participants must have tumors confirmed as FRα-positive using the Ventana FOLR1 assay. Participants will be assigned to receive either mirvetuximab soravtansine at 6.0 mg/kg adjusted ideal body weight plus bevacizumab at 15 mg/kg every 3 weeks, or bevacizumab alone at 15 mg/kg every 3 weeks. Mirvetuximab soravtansine is an investigational antibody drug conjugate designed to selectively kill cancer cells expressing FRα. The treatment is given as maintenance therapy following prior platinum-based chemotherapy and bevacizumab. During the study, participants will undergo regular assessments to monitor progression-free survival for up to 4 years. Researchers will evaluate disease status and safety through clinical evaluations. Participants will also need to adhere to contraceptive requirements during treatment and for several months after. The study aims to understand how well the treatment combination controls cancer without progression and to assess its safety profile over time.