Podhajska

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating multiple investigational compounds in adults with moderate to severe atopic dermatitis (AD) in this multicenter, randomized, double-blind, placebo-controlled Phase II platform study. The study aims to assess the efficacy and safety of these compounds, with the first intervention being GHZ339. Participants will be randomly assigned to receive one of the study treatments. The trial compares different doses of GHZ339 against a matching placebo. Participants will receive assigned treatments during the study period, with dosing details including several dose levels labeled A, B, C, and D for GHZ339. The design allows evaluation of treatment effects on moderate to severe AD symptoms. Participants will be involved in the study from baseline through Week 16, with assessments including the Eczema Area and Severity Index (EASI) score measured to track changes from baseline. Safety and efficacy will be monitored throughout the trial, and all participants must meet specific inclusion criteria including an AD diagnosis for at least one year and moderate to severe disease. The total duration of participation spans at least 16 weeks for outcome measurement.

Researchers are evaluating the safety and effectiveness of a drug called PF-07220060 combined with letrozole compared to other approved treatments (palbociclib, ribociclib, or abemaciclib with letrozole) in adults with breast cancer that is hormone receptor-positive and HER2-negative. This cancer has spread locally or to other parts of the body and has not been treated with systemic anti-cancer therapy for advanced or metastatic disease. The study is a Phase 3, open-label, randomized trial involving multiple centers. Participants will be randomly assigned to receive either PF-07220060 plus letrozole or the investigator's choice of one of the approved CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) combined with letrozole. The treatments are given as drugs with letrozole serving as endocrine therapy. The study compares these treatments in terms of how well they control the cancer and their safety profiles. Participants will visit the study clinic regularly for monitoring during treatment. Researchers will assess how long participants live without their disease worsening or dying from any cause, which is the main outcome measured up to about four years. The study team will monitor each participant's health and response to treatment through these visits to gather information about treatment effects and safety.

Researchers are evaluating a new combination treatment of Sigvotatug Vedotin plus pembrolizumab compared to pembrolizumab alone in adults with non-small cell lung cancer (NSCLC) that has high levels of PD-L1 protein. This study focuses on participants with advanced or metastatic NSCLC (Stage 3 or 4) who have PD-L1 expression in at least 50% of their tumor cells. The purpose is to understand how well the combination works versus pembrolizumab alone as a first treatment option. All participants receive pembrolizumab through an intravenous infusion once every 6 weeks at the study clinic. Half of the participants will also receive Sigvotatug Vedotin as an intravenous infusion every 2 weeks along with pembrolizumab. Participants may continue pembrolizumab treatment for up to about two years, while those receiving Sigvotatug Vedotin can continue until their cancer no longer responds to the treatment. During the study, participants will have regular clinic visits where researchers monitor their health and response to treatment. The main outcomes measured include overall survival up to approximately two years and progression-free survival, which tracks the time until cancer worsens or death. Safety and side effects will be closely observed throughout the study period to understand the treatments' impact.