Veldhoven

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

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 combination of BMS-986504, pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in people with first-line metastatic non-small cell lung cancer who have a homozygous MTAP deletion. The study is a randomized phase 2/3 trial focused on assessing clinical benefits in this specific patient group. Participants will receive either BMS-986504 with pembrolizumab and chemotherapy or placebo with pembrolizumab and chemotherapy. The chemotherapy may include drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on specified days. This treatment is administered as part of the first-line therapy for metastatic disease. During the study, researchers will monitor progression-free survival up to 2 and 5 years using RECIST v1.1 criteria and overall survival up to 5 years. Participants will be assessed regularly for disease progression and survival outcomes. The study includes detailed monitoring to evaluate the effects and safety of the treatment combination over time.

This research aims to evaluate the effects of povorcitinib on reducing itch and improving skin lesions in adults with prurigo nodularis, a chronic skin condition characterized by itchy nodules. The study is a Phase 3 trial designed to assess the safety and efficacy of this treatment compared to a placebo in participants aged 18 to 75 years with a confirmed diagnosis of prurigo nodularis lasting at least three months. Participants will receive either oral povorcitinib tablets or placebo tablets as part of the randomized, double-blind study. Key eligibility includes having significant itch severity and at least 20 pruriginous lesions on multiple body regions. The study monitors the treatment effects over 24 weeks, focusing on improvements in itch intensity and skin lesion severity. During the study, participants will be closely monitored for changes in their itch scores and skin condition. Researchers will assess the proportion of participants achieving specified improvements by Week 24. Safety and tolerability will also be evaluated throughout the trial. Participants will undergo regular assessments including clinical evaluations, laboratory tests, and adherence monitoring to track progress and any side effects over the course of the study.

Researchers are investigating the effects of PKN605, an oral medication, on reducing the burden of atrial fibrillation in adults diagnosed with this heart rhythm disorder. This Phase 2, randomized, placebo-controlled, and double-blinded study aims to evaluate how well PKN605 works, as well as its safety, tolerability, and how the body processes the drug. Participants must have a history of atrial fibrillation or flutter and meet certain clinical criteria for inclusion. The study begins with a screening period lasting up to 90 days to determine eligibility. After this, participants are randomly assigned to receive either PKN605 or a matching placebo. The treatment phase lasts 24 weeks, during which participants visit the clinic about once a month. Atrial fibrillation is closely monitored throughout the study using various ECG devices. Approximately one month after the treatment ends, a final safety follow-up visit is conducted. Participants will be involved in regular clinic visits for assessments, including ECG evaluations to measure atrial fibrillation burden. Researchers will track how much time participants spend in atrial fibrillation using ECG patch monitors over 24 weeks. Safety and tolerability are also monitored throughout the study. The total participation time includes the screening, treatment, and follow-up phases, providing comprehensive data on the effects and safety of PKN605.

Researchers are investigating the role of amniotic fluid (AF) in the development of the intestinal tract and early gut microbial colonization in extremely preterm infants. This study focuses on babies born between 24 and 27 weeks of gestation and aims to understand how changes in AF composition relate to conditions like chorioamnionitis (CAM), fetal growth restriction (FGR), necrotizing enterocolitis (NEC), and sepsis. The study also seeks to identify AF profiles that might help predict neonatal health outcomes and guide future interventions. This multicenter, prospective cohort study will collect about 5 mL of amniotic fluid from obstetric patients delivering extremely preterm infants, either through vaginal delivery or cesarean section. Samples will also be collected from a reference group that includes earlier and later preterm as well as full-term pregnancies. The AF will undergo detailed analysis including microbial profiling and metabolomics. Neonatal fecal samples will also be studied to explore the relationship between AF composition and early gut microbiota. Participants will be closely monitored with collection of AF and neonatal fecal samples. Researchers will assess the composition of AF and its association with neonatal outcomes such as NEC and sepsis, as well as early gut colonization patterns. The study aims to improve understanding of gastrointestinal development in preterm infants and potentially identify high-risk babies. This may help in developing targeted microbiota-based strategies to prevent disease and improve health outcomes in the future.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are investigating bleeding disorders in individuals diagnosed with a bleeding disorder of unknown cause (BDUC) in the Netherlands. This study aims to understand why these individuals experience increased bleeding and how it impacts their daily life and overall health. It also seeks to clarify the underlying mechanisms of bleeding in BDUC, evaluate patient outcomes, and improve healthcare delivery for this group. Participants who have unexplained increased bleeding despite standard coagulation testing will be enrolled at Hemophilia Treatment Centers across the Netherlands. The study includes advanced blood tests such as hemostasis and fibrinolytic testing, platelet function assessments, and genetic analyses. Additionally, targeted therapeutic interventions will be tested in the lab to explore their effects on blood clotting processes. Data collection will extend over a 10-year follow-up period, including clinical evaluations and patient questionnaires. Participants will complete validated questionnaires assessing their bleeding symptoms and health-related quality of life. Researchers will collect clinical data, laboratory results, and patient-reported outcomes to monitor changes over time. The study also aims to develop a care pathway framework by combining clinical data and feedback from patients and physicians to identify opportunities for better diagnosis and treatment management.

Researchers are evaluating the effectiveness of a vaginal cerclage, a minor surgical procedure, in women with twin pregnancies who have a short cervix or cervical dilatation in midpregnancy. The study aims to see if cerclage can reduce the rate of extreme preterm birth before 28 weeks of gestation compared to standard treatment without cerclage. This research addresses a significant concern, as early preterm birth in twins results in high perinatal mortality in the Netherlands. Participants will be randomly assigned to either receive the vaginal cerclage procedure or no cerclage as standard care. The cerclage involves placing an unabsorbable suture around the cervix under anesthesia to strengthen and close it, potentially preventing early cervical changes that lead to preterm birth. This procedure is commonly performed in singleton pregnancies, and the study will determine its impact in twin pregnancies. During the study, women will be monitored for pregnancy outcomes, focusing on the occurrence of extreme preterm birth before 28 weeks. Researchers will assess perinatal complications and overall neonatal health to understand the benefits and risks of cerclage in this setting. The study's findings could influence care practices and improve long-term health for children born from twin pregnancies complicated by cervical issues.