Michalovce

Researchers are evaluating the efficacy and safety of empasiprubart in adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP. This Phase 3, randomized, double-blinded, placebo-controlled study compares empasiprubart to placebo to better understand its impact on CIDP symptoms and disease progression. The study has two parts Part A lasts 24 weeks 6 months, where participants receive either empasiprubart or placebo via intravenous infusion. After Part A, all participants enter Part B for 96 weeks 24 months during which everyone receives empasiprubart. Participants who received empasiprubart in Part A will receive a placebo dose once during Part B to maintain the study blind. Participants will have regular assessments including measurements of disability using the adjusted inflammatory neuropathy cause and treatment aINCAT score, grip strength, and other neurological and quality of life scales. Safety is monitored throughout the study. The total participation period spans up to 120 weeks, with evaluations at multiple time points to track changes from baseline and any adverse events.

Researchers are evaluating the efficacy, safety, and tolerability of adding ponsegromab to systemic chemotherapy compared to chemotherapy plus placebo for adults with metastatic pancreatic ductal adenocarcinoma mPDAC who have cachexia, a condition causing significant weight loss and fatigue. This Phase 2b3 randomized, double-blind, multinational study focuses on first-line treatment for this advanced cancer and associated cachexia. Participants will receive standard first-line chemotherapy regimens, either nab-paclitaxel plus gemcitabine or FOLFIRINOX, combined with either ponsegromab at one of two doses or a matching placebo. Study intervention is given subcutaneously every four weeks starting on the same day as the chemotherapy cycle and prior to chemotherapy administration. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants will either continue or switch to that dose while remaining blinded. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind phase. During the study, participants will have tumor assessments approximately every 6 to 8 weeks by independent radiologists. Researchers will measure changes in body weight, anorexia symptoms, physical activity, muscle and fat tissue quality, overall survival, and treatment safety through laboratory tests, adverse event monitoring, and patient questionnaires. The study duration extends through Phase 3 with ongoing monitoring until key survival events occur, with an additional optional sub-study assessing caregiver quality of life.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are evaluating the effects of a study medicine called ibuzatrelvir, alone and in combination with remdesivir, for treating symptomatic COVID-19 in adults who are severely immunocompromised. This Phase 3 clinical trial compares ibuzatrelvir with remdesivir to remdesivir alone to assess safety and effectiveness in non-hospitalized or hospitalized patients who do not require supplemental oxygen. Immunocompromised patients often have difficulty fighting infections and may benefit from extended or combination antiviral treatments. Participants are randomly assigned to one of three groups one receiving both ibuzatrelvir taken orally twice daily and intravenous remdesivir, one receiving ibuzatrelvir with a placebo infusion, and one receiving remdesivir with a placebo pill. Placebos that look like the study medicines are used to keep the groups similar in appearance. This design helps researchers determine if adding ibuzatrelvir improves treatment compared to remdesivir alone. Participants will attend about 10 study visits over 24 weeks, including clinic visits for blood tests, nasal swabs collected both at the clinic and at home, and questionnaires. Researchers will measure outcomes such as symptom improvement, viral levels, COVID-19-related healthcare visits, and safety events. The study carefully monitors participants throughout to understand the treatment effects and safety over time.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.