Heerlen

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Research on personality disorders PDs in older adults is limited despite these disorders being common in this age group and often co-occurring with other mental and physical conditions. Current diagnostic criteria mainly fit younger adults, so this study evaluates new dimensional models for PDs called the Alternative Model for Personality Disorders AMPD and the ICD-11 approach. Researchers aim to assess if these models are appropriate and clinically relevant for older adults by comparing younger and older populations and studying older clinical patients. Participants include younger adults 18-64 and older adults 65 from the general population who complete questionnaires. Older adults in clinical settings with various psychological conditions will also take questionnaires, and a smaller group will undergo clinical interviews. The study uses two main questionnaires the LPFS-BF 2.0 measuring personality functioning, and the PID-5-BFM measuring personality traits. Additional standard tests and clinical ratings will be collected in the clinical population. Participants will complete questionnaires in person, with some clinical participants providing informant reports from family or friends. Researchers will analyze questionnaire results for validity, age-neutrality, and clinical utility. The primary outcomes are scores from the PID-5-BFM and LPFS-BF 2.0 collected about one month after admission, with clinical ratings and additional measures collected during hospitalization and follow-up. The study involves ongoing monitoring to understand PD structure and characteristics in older adults and improve care.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating a potential new medicine called CDR132L to understand its effects on the structure and function of the heart in people living with heart failure. The study focuses on participants with heart failure who have reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This research is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aiming to assess safety and efficacy in this population. Participants will receive an intravenous infusion of either CDR132L or a placebo once every four weeks for 48 weeks. Alongside this, all participants will continue their individually tailored guideline-directed standard of care therapy for heart failure. The studys main phase covers these 48 weeks of treatment, followed by monitoring adverse events up to week 60. During the approximately 60-week study, participants undergo evaluations including echocardiography and blood tests measuring biomarkers like microRNA-132-3p and NT-proBNP. Researchers will track changes in heart structure and function, adverse events, and safety throughout the study. The primary outcome focuses on changes in normalized microRNA-132-3p levels from baseline to week 24, while secondary outcomes include measures of heart volume and biomarkers, plus adverse event counts.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the clinical benefit of combining Navlimetostat BMS-986504, a selective MTA-cooperative inhibitor of PRMT5, with pembrolizumab and chemotherapy compared to placebo plus pembrolizumab and chemotherapy. This study focuses on participants with first-line metastatic non-small cell lung cancer NSCLC who have a homozygous MTAP deletion. The trial is a randomized Phase 23 study aimed at advancing treatment options for this specific lung cancer group. Participants will receive one of several combinations Navlimetostat plus pembrolizumab and chemotherapy, or placebo plus pembrolizumab and chemotherapy. Chemotherapy drugs involved may include cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on certain days. The study uses a quadruple-masked, parallel design with multiple treatment arms to compare these regimens. During the study, participants will be monitored for progression-free survival and overall survival up to five years. Researchers will assess tumor response, disease control, duration and time to response, and safety through adverse event reporting and laboratory tests. The study includes detailed follow-up to evaluate efficacy and safety outcomes over the long term, with a primary completion date in 2031.

Researchers are comparing the effectiveness of two different combinations of immunotherapy drugs with chemotherapy for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has PD-L1 expression of 1% or higher. This phase 3, randomized study focuses on participants who have not previously received systemic treatment for advanced disease. The goal is to determine which combination better improves overall survival and other outcomes in this patient group. Participants will be randomly assigned to receive either Nivolumab plus Relatlimab combined with chemotherapy or Pembrolizumab combined with chemotherapy. The chemotherapy drugs used include Carboplatin, Pemetrexed, or Cisplatin, given in specified doses on scheduled days. Treatment is given as first-line therapy for their cancer, with dosing details managed throughout the study period. During the study, participants will undergo imaging scans like CT or MRI to measure disease status, and blood tests to monitor safety and side effects. The main outcome measured is overall survival over up to five years, along with progression-free survival, response rates, duration of response, and adverse events. Researchers will also assess symptoms related to lung cancer over two years. Participants are monitored regularly to track these outcomes and ensure safety throughout the study duration, which may last several years.

Researchers are evaluating the potential of GB-0895, an investigational drug, as an additional treatment for adolescents and adults with severe asthma that is not well controlled by inhaled corticosteroids and other common asthma medications. This global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of GB-0895 over one year, with an optional extension phase. The study includes participants aged 12 to 80 years with documented severe uncontrolled asthma despite current therapy. Participants will be randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every six months during the 52-week treatment period. The study also includes phases for screening and run-in before treatment, followed by a follow-up period lasting up to 38 weeks after treatment ends. An optional open-label extension allows participants to continue receiving GB-0895 at specified weeks after the initial treatment phase. During the study, participants will attend visits every 1 to 2 months after the first month to monitor health and treatment effects. Assessments include lung function tests, asthma symptom questionnaires, quality of life evaluations, and tracking of asthma exacerbations. Researchers will closely monitor safety and treatment responses through these evaluations and collect data on various health measures to understand the drugs impact on severe asthma over the course of the study.

This research aims to evaluate how the medicine nerandomilast affects lung fibrosis in adults with systemic autoimmune rheumatic diseases who have lung fibrosis. The study includes adults 18 years and older who have not shown improvement in lung function after standard immunosuppressant treatment. Participants have interstitial lung disease related to rheumatic diseases such as rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathy, Sjgrens disease, or mixed connective tissue disease. Participants are randomly divided into two groups one group receives nerandomilast tablets and the other receives placebo tablets that look identical but contain no medicine. Tablets are taken twice daily for at least 26 weeks and up to 1 year. Participants continue their usual immunosuppressant treatments during the study. Participants stay in the study for about 7.5 to 13 months and visit the study site 9 to 10 times. During visits, lung function tests and chest imaging are performed, and participants complete questionnaires about symptoms and quality of life. Researchers compare results between the groups to assess the effects of nerandomilast while monitoring health and any side effects throughout the study.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.