T Bilisi

Researchers are evaluating the ReValve System as a treatment for people with clinically significant mitral regurgitation who are suitable candidates for mitral valve surgery. This study focuses on those with symptomatic mitral regurgitation caused by ischemic or non-ischemic cardiomyopathy. Participants typically have New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV heart failure and a left ventricular ejection fraction of 30% or higher. The study is conducted as a Phase 1 clinical trial to assess the device's technical success and safety. Participants will receive the ReValve System, a device designed to replace the native mitral valve. The treatment involves an implant procedure guided by recent echocardiograms and imaging tests to confirm eligibility. The device aims to manage mitral regurgitation by addressing valve function. The study carefully monitors participants before and after the procedure to ensure appropriate device placement and function. During the study, participants undergo various assessments including echocardiograms, left ventriculography, gated blood pool scans, or cardiac MRI to evaluate heart function. Researchers measure technical success of the procedure as the primary outcome. Participants are closely monitored for safety, including any complications related to the device or procedure. The study duration and follow-up details are tailored to assess both immediate and longer-term effects of the ReValve System.

Researchers are evaluating a medicine called MK-1045 in adults aged 18 to 75 who have systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The study aims to learn about the safety of MK-1045 and how well people tolerate it at different doses. Participants with SLE must have had their diagnosis for at least 6 months and meet specific classification criteria while taking at least one background therapy. Those with RA must also have had their diagnosis for at least 6 months and meet established classification criteria. The study involves giving MK-1045 through an intravenous infusion. This is a Phase 1 dose escalation study, meaning participants receive increasing doses of the medicine to assess safety and how the body processes it. The study monitors participants over multiple parts; the first part observes adverse events up to about 12 weeks, and subsequent parts continue monitoring for up to approximately 52 weeks. Participants may discontinue the study drug if they experience adverse events. During the study, researchers will track adverse events and reasons for stopping the medicine, collect information on how the medicine behaves in the body, and monitor participants’ health throughout. Safety and tolerability are the main outcomes, and the study includes ongoing evaluations for up to a year after starting treatment. Participants will have regular check-ins to assess their condition and any side effects while using MK-1045.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are conducting a Phase I/II, multi-site, open-label study to evaluate the safety, effectiveness, and optimal dosing of the investigational treatments BNT323 combined with BNT327 in adults with advanced breast cancer. This includes those with hormone receptor-positive or negative types, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study aims to understand how these treatments work alone and together in this patient population. The study has two parts: Part 1 involves dose escalation where participants with chemotherapy-pretreated advanced breast cancer receive BNT323 and BNT327 together to find the recommended Phase 2 dose. Part 2 is an expansion phase that tests the safety and effectiveness of the chosen dose, including randomized comparisons of combination therapy at different doses and monotherapies. Participants may be assigned to one of four treatment arms, with dosing administered via intravenous infusion. Participants will be monitored for dose-limiting toxicities during the first 21 days of treatment, as well as adverse events up to 90 days after the last dose. Tumor response will be assessed for up to 36 months. Evaluations include heart function tests, tumor imaging, safety assessments, and tracking of side effects. The study carefully monitors treatment safety, effectiveness, and participant health throughout the trial duration.

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of the study.

Researchers are evaluating plamotamab in adults with moderately to severely active rheumatoid arthritis (RA) to determine its safety, tolerability, how the body processes the drug (pharmacokinetics), how the drug affects the body (pharmacodynamics), and the immune response it may trigger. This Phase 1b open-label study involves about 68 participants assigned to different dose groups to optimize dosing. Participants will receive plamotamab by subcutaneous injection under the skin. The study is a dose-escalation trial where doses are adjusted to find the best balance between effectiveness and safety. This process helps understand how different doses perform in people with active RA. During the study, researchers will monitor participants through assessments including safety evaluations, laboratory tests, and tracking how the drug behaves in the body. They will measure outcomes up to 52 weeks to observe the drug’s effects and any side effects. Participants will be closely followed throughout the treatment period to ensure safety and tolerability.

Researchers are evaluating budoprutug, a humanized IgG1 monoclonal antibody that targets CD19 cells, in adults with active, seropositive Systemic Lupus Erythematosus (SLE) who have not responded adequately to standard treatments. This Phase 1b open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of effectiveness of budoprutug in this population. Participants will receive a single intravenous infusion of budoprutug on the first day of the study in ascending dose groups. The study focuses on how the drug affects B cells and antibody levels in the blood over time after the infusion. During the study, researchers will monitor participants for treatment-emergent adverse events and laboratory abnormalities up to 24 weeks. Vital signs including blood pressure, heart rate, respiratory rate, body temperature, and ECG parameters will be measured to assess safety. The study will track changes from baseline in these measures and collect data on pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy over the 24-week period.