Torrejon De Ardoz

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

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.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies in this Phase 3 randomized, placebo-controlled, double-blinded trial. The study includes pregnant women aged 49 or younger between 24 and 36 weeks of gestation with uncomplicated singleton pregnancies and no major fetal abnormalities. Participants must also have documented negative tests for HIV, syphilis, and hepatitis B during this pregnancy. The goal is to learn how the vaccine works and to monitor safety for both mothers and their infants. Participants will receive one injection of either the GBS6 vaccine or a saline placebo. Pregnant women will be followed for up to 14 months, including 6 months after delivery. Their babies will be followed for about 12 months after birth. A subset of infants will also receive routine vaccinations such as diphtheria toxoid-containing vaccines and pneumococcal vaccines according to their country's immunization schedule, with blood samples collected one month after completing primary and toddler booster doses. Mothers will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious or medically attended events up to 6 months postpartum. Infants will be observed for adverse events from birth through at least one year, with serious and medically attended events tracked through 6 months. Researchers will also measure antibody levels in infants at birth to assess the vaccine's potential to protect against early and late onset GBS disease. Mothers will attend at least 3 to 4 study visits, some via telephone, to support ongoing safety and immunogenicity assessments.

Researchers are conducting a Phase 3 study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of ABP 692 with Ocrelizumab (both US and EU versions) in people with relapsing-remitting multiple sclerosis (RRMS). The study aims to show similarity between these treatments by measuring how the drugs behave in the body and their effects on suppressing new active brain lesions over 24 weeks using MRI scans. Participants will receive intravenous infusions of either ABP 692, Ocrelizumab (US), or Ocrelizumab (EU). The study design allows comparison between these three groups to assess how the drugs are processed and how well they control disease activity. Infusions are given according to the study schedules, and the effects are monitored over the following weeks. During the study, participants will have regular assessments including brain MRI scans to count new lesions, blood tests to measure drug levels, and neurological evaluations to track disease status. The main outcomes include drug concentration over time and the number of new brain lesions up to week 24. Safety and clinical effects will also be observed throughout the study period, which includes screening and follow-up visits.

Researchers are evaluating the safety and effectiveness of Tumor Treating Fields (TTFields) delivered by the NovoTTF-200T device combined with pembrolizumab and platinum-based chemotherapy for patients with metastatic non-small cell lung cancer (NSCLC) that has spread to other parts of the body. This Phase 3 randomized study aims to compare overall survival and progression-free survival between patients receiving this combination treatment and those receiving pembrolizumab with platinum-based chemotherapy alone. Additional analysis will examine outcomes based on lung cancer subtype and PD-L1 expression levels. The NovoTTF-200T is a portable, battery-operated device designed for continuous home use that emits electric fields to disrupt cancer cell division. Participants will receive this device alongside pembrolizumab, an immune checkpoint inhibitor, and standard platinum-based chemotherapy. The study will stratify patients by cancer histology, PD-L1 expression, and previous immunotherapy treatment. Treatments will be given according to the study protocol at approximately 130 sites globally. Participants will be monitored for up to six years to assess overall survival and progression-free survival using standardized criteria. The study includes regular evaluations of tumor response, safety, and other clinical outcomes. Participants must have good performance status and adequate organ function to join. The research team will collect data on cancer progression and survival to better understand the potential benefits and risks of adding TTFields to standard therapies for metastatic NSCLC.

This trial focuses on adult patients aged 18 to 60 years with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph-negative ALL). The study evaluates treatment approaches based on measurable residual disease (MRD) and genetic analysis done at the start. The goal is to determine the best continuation therapy after initial consolidation treatment to improve overall survival over three years. Participants first receive a uniform four-drug induction chemotherapy including vincristine, prednisone, pegylated asparaginase, and daunorubicin. Patients who do not respond adequately receive a second induction with fludarabine, Ara-C, G-CSF, and idarubicin (FLAG-IDA). Those with good MRD clearance proceed through early consolidation, delayed intensification, reinduction, and maintenance phases with pediatric-type chemotherapy drugs. Patients with less favorable MRD or genetic profiles may receive early or delayed allogeneic hematopoietic stem cell transplantation (alloHSCT). Throughout the study, participants undergo regular monitoring of disease status and response to therapy. Researchers assess overall survival at three years as the primary outcome. Patients' health status, treatment adherence, and side effects are closely followed. The study aims to personalize treatment plans based on MRD and genetics to optimize outcomes for adults with Ph-negative ALL.

Preeclampsia (PE) is a serious pregnancy complication that can have severe effects on both mother and baby. Early detection is important to reduce risks and improve outcomes. Current screening methods often focus on placental biomarkers and maternal factors but have limited sensitivity, especially in the first trimester. Recent research using cell free RNA (cf-RNA) has led to the development of the MaiRa Preeclampsia Test, which shows promise in predicting both early- and late-onset preeclampsia during pregnancy. This study is a multicenter, prospective observational trial designed to validate the MaiRa Preeclampsia Test in predicting early-onset and late-onset preeclampsia during the first and second trimesters. The study will recruit 7,473 pregnant women from 12 hospitals in Spain and will collect maternal blood samples at three points during pregnancy: 9-14 weeks, 15-26 weeks, and at or after 27 weeks. These samples will be analyzed with the MaiRa Test and correlated with pregnancy outcomes. Participants will have their blood drawn during three visits in pregnancy, and clinical data will also be recorded in an electronic system. The study will monitor data quality continuously. Researchers will evaluate the test's accuracy by measuring sensitivity, specificity, predictive values, and other statistical outcomes. The study will last 30 months, including recruitment, sample analysis, follow-up, and reporting.