Tsfat

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Researchers are evaluating the safety and effectiveness of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. This phase 3 study focuses on participants with advanced or metastatic NSCLC who have specific genetic markers and have progressed after prior therapies. The study aims to assess changes in disease activity and adverse events over time. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. Treatment continues until predefined discontinuation criteria are met. Those who benefit from the study treatment may have the option to continue receiving it through an extension or rollover study. Approximately 698 adults will be enrolled worldwide at about 330 sites. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure progression-free survival and overall survival for up to approximately 39 months. The study includes careful safety monitoring and evaluates the impact of treatment on disease progression and patient well-being.

Researchers are evaluating the effectiveness of TAR-210 compared to a single-agent intravesical chemotherapy in adults with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who have specific fibroblast growth factor receptor (FGFR) mutations or fusions. This phase 3 randomized study aims to compare disease-free survival between these treatments. Eligible participants must have a confirmed diagnosis of intermediate-risk NMIBC with certain risk factors and be willing to undergo multiple cystoscopies and assessments throughout the study. Participants will receive either TAR-210, which is delivered directly into the bladder, or one of the investigator-chosen intravesical chemotherapy drugs, including Gemcitabine or MMC, also administered into the bladder. Prior to randomization, visible tumors must be fully removed, and the absence of disease confirmed. The study includes a main study group and a substudy group with slightly different eligibility criteria based on tumor grade and risk factors. During the study, participants will be closely monitored through cystoscopies and surgical assessments (TURBT) to evaluate cancer recurrence or progression. The primary outcome measure is disease-free survival, tracked from randomization until the first documented cancer recurrence, progression, or death, over approximately four years and two months. Safety and treatment adherence will also be assessed throughout the study period.

Researchers are evaluating the efficacy of claseprubart (DNTH103) compared to placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in this Phase 3 study. The goal is to assess how well claseprubart works in treating this condition, which involves nerve inflammation leading to muscle weakness and sensory problems. The study consists of multiple periods: Part A is an open-label phase lasting up to 13 weeks where all participants receive claseprubart. Those who respond move to Part B, a randomized, double-blind, placebo-controlled phase lasting up to 52 weeks, where participants receive either claseprubart or placebo by infusion or injection. After Part B, eligible participants may join an optional open-label extension for up to 104 weeks. A safety follow-up period of 40 weeks follows the treatment phases. Participants will undergo various assessments including neurological evaluations and disease activity scoring. Researchers will monitor the time from the first dose to disease relapse as the main outcome. Additional safety and efficacy measures will be tracked throughout all study periods. Total participation may last over two years including extension and follow-up phases.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

This research aims to evaluate the safety and effectiveness of an investigational drug called Zelpultide Alfa in reducing the occurrence of Bronchopulmonary Dysplasia (BPD) in extremely premature babies. The study is a randomized, double-blind, placebo-controlled multicenter trial with an adaptive seamless design, combining Phase 2b and Phase 3. It focuses on high-risk preterm neonates born between 22 and 27.6 weeks gestational age who require invasive mechanical ventilation and surfactant treatment. The study is divided into two parts. In Part 1 (Phase 2b), participants are randomly assigned in equal groups to receive either standard care plus Zelpultide Alfa at doses of 4 mg/kg or 6 mg/kg, or standard care plus a placebo (air-sham). Treatment is given via intratracheal administration up to seven times at 24-hour intervals while the babies remain intubated. Based on safety and early efficacy results, one dose will be selected to advance to Part 2 (Phase 3), where participants will be randomized to receive either the selected dose of Zelpultide Alfa plus standard care or placebo plus standard care. During the study, participants will be closely monitored for the development of moderate to severe BPD or death by 36 weeks postmenstrual age. Researchers will assess safety, tolerability, and efficacy through clinical evaluations and standard care procedures. The study includes careful follow-up to evaluate the impact of the drug on lung health in these vulnerable neonates, with the total treatment period covering the time they remain intubated and under mechanical ventilation.

Researchers are investigating new treatments for combined postcapillary and precapillary pulmonary hypertension (Cpc-PH) caused by heart failure with preserved ejection fraction (HFpEF). This extension study focuses on evaluating the long-term safety and tolerance of sotatercept in people who have previously participated in a related sotatercept study for Cpc-PH. The study is part of a Phase 2 trial aiming to understand the effects of sotatercept over an extended period. Participants in this study will receive sotatercept through subcutaneous injections. This extension study is designed for individuals who completed the earlier MK-7962-007 (CADENCE) study without stopping the treatment and can safely join this follow-up trial called MK-7962-007 (HARMONIZE). The study will continue monitoring their health while they receive sotatercept injections. During the study, researchers will track the number of participants who experience adverse events and those who discontinue treatment due to these events, with follow-up lasting up to approximately 187 weeks. This long-term monitoring aims to assess how well patients tolerate sotatercept and to gather detailed safety information over time.