Vila Nova De Gaia

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a serious autoimmune condition. This Phase 2 study compares ianalumab against a placebo to better understand its effects on this disease. The study is sponsored by Novartis Pharmaceuticals and aims to assess how ianalumab impacts disease activity and progression. The study includes multiple periods a screening period lasting up to 6 weeks a first treatment period of 52 weeks where participants receive either ianalumab or placebo injections followed by a second open-label treatment period of an additional 52 weeks where all participants receive ianalumab. After treatment, there is a post-treatment follow-up period lasting at least 20 weeks and up to 2 years to monitor long-term effects. Participants will undergo regular assessments including measuring their response using the 35 rCRISS25 scale at Week 52, lung function changes, skin thickness scores, and physical disability indexes. Blood samples will be collected throughout the study to monitor drug levels and antibodies. Safety is closely monitored by recording any adverse events during the entire study duration, which can last up to 208 weeks. The study involves detailed clinical evaluations and laboratory tests to fully assess the impact of ianalumab on this condition.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously completed treatment with the drug nerandomilast. The study aims to understand how well participants tolerate long-term treatment with nerandomilast and whether it helps improve lung function or delays worsening symptoms, hospitalizations, or death. This is a phase 3 open-label extension trial sponsored by Boehringer Ingelheim. Participants will take nerandomilast tablets daily for up to 1 year and 10 months. They may continue their usual treatments for pulmonary fibrosis alongside the study treatment. There is no placebo group, and all participants receive nerandomilast during this extension period. Throughout the study, participants will visit their doctors regularly for health check-ups and lung function tests. Researchers will closely monitor any side effects and changes in lung function, particularly forced vital capacity FVC, over nearly two years. The study will track time until symptom worsening, hospital visits, or death to assess the treatments long-term safety and effects.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are evaluating a new classification system called the Modified Baveno Classification to better understand obstructive sleep apnoea OSA in adults newly diagnosed with this condition. The study aims to monitor long-term improvements in both objective and subjective measures related to OSA, including daytime sleepiness and cardiovascular health. This observational cohort study is led by Wissenschaftliches Institut Bethanien e.V and focuses on patients aged 40 years and older. Participants will be categorized into three groups based on the Baveno classification those for whom OSA-specific treatment is generally not recommended, those for whom treatment should be considered individually, and those for whom treatment is generally recommended. The study does not involve administering treatments but observes the patients over time according to their classification and treatment indications. During the study, participants will be followed for up to 36 months. Researchers will assess changes in daytime sleepiness using the Epworth Sleepiness Scale and monitor office blood pressure. Additional evaluations include cardiovascular events, treatment usage, insomnia severity, sleep length, fatigue, cognitive performance, and overnight oxygen levels. The study tracks these measures throughout the observation period to understand how the classification correlates with patient outcomes and treatment decisions.

Researchers are evaluating the effects of pelacarsen TQJ230, given as a monthly subcutaneous injection, on slowing the progression of calcific aortic valve stenosis in adults aged 50 to under 80 years with elevated Lipoproteina levels. This phase 2, randomized, double-blind, placebo-controlled multicenter trial aims to assess the efficacy, safety, and tolerability of pelacarsen compared to a matching placebo. The study is sponsored by Novartis Pharmaceuticals and focuses on patients with mild to moderate calcific aortic valve stenosis who are optimally treated for cardiovascular risk factors. Participants receive either pelacarsen 80 mg or a placebo via a prefilled syringe injected under the skin once every month. The study includes two groups one receiving the active drug and the other receiving a placebo, both administered in the same way. The trial will last up to 36 months, during which patients will be monitored for changes in aortic valve function and calcium levels. Throughout the study, participants will undergo evaluations including measurement of peak aortic jet velocity and aortic valve calcium scores at 36 months. Additional assessments include changes in Lipoproteina levels at 12 months and monitoring of fibrocalcific thickening of the valve and clinical events over the course of the trial. Safety will be closely monitored to ensure participants well-being during the entire study period.

Researchers are evaluating the safety, tolerability, and effectiveness of two drugs, inebilizumab and blinatumomab, in adults with active and hard-to-treat autoimmune diseases. These diseases include systemic lupus erythematosus SLE with nephritis and rheumatoid arthritis RA. The trial aims to understand how these treatments work in different groups of participants with these conditions through multiple subprotocols. Participants will receive either inebilizumab through intravenous infusions or blinatumomab through subcutaneous injections. Different dosing schedules are used for each drug, including three or four doses for inebilizumab and various low, medium, or high doses for blinatumomab. The study is divided into subprotocols focusing on different patient groups and dosing parts. During the study, participants will be monitored for treatment-emergent adverse events and serious side effects over up to 52 weeks. Researchers will assess kidney response, disease remission, and disease activity scores at various time points. Blood tests, antibody measurements, and disease activity indices will be used to evaluate the participants responses and safety. The study lasts from the first day of treatment through week 52 with ongoing evaluations.

Researchers are evaluating the efficacy, safety, and tolerability of iptacopan in adults aged 18 to 85 years with generalized Myasthenia Gravis who are positive for AChR antibodies and are on stable standard-of-care treatment. This randomized, double-blind, placebo-controlled, multicenter Phase III study aims to compare iptacopan with placebo over six months, followed by a long-term open-label extension to further assess treatment effects and safety. Participants will be randomly assigned in equal groups to receive either oral iptacopan or a matching placebo daily for six months while continuing their standard care. After this double-blind phase, all participants are offered open-label iptacopan treatment for up to 60 months. Safety follow-up assessments occur 7 and 30 days after the last study treatment dose. During the study, participants will attend regular visits to assess changes in their Myasthenia Gravis symptoms using several scales, including the MG-ADL score, QMG, MGC, and quality of life questionnaires. Researchers will monitor adverse events and corticosteroid use throughout both the core and extension phases. The total study participation can last up to about five years, including the initial treatment, extension, and follow-up periods.

Researchers are evaluating the effect and safety of different doses of the medicine NNC0662-0419 in adults living with type 2 diabetes. This phase 2 clinical trial compares NNC0662-0419 with placebo and an approved diabetes medication called semaglutide. The goal is to find out if NNC0662-0419 is effective and safe for lowering blood sugar in people with type 2 diabetes. Participants will receive one of three treatments NNC0662-0419, semaglutide, or placebo. All treatments are given once weekly by injection under the skin. NNC0662-0419 will be given in increasing doses during the study. Semaglutide and placebo will also be given by weekly injections to match the other groups. Treatment assignment is random and participants will not know which treatment they receive. During the study, participants will be monitored regularly for changes in blood sugar levels measured by glycated hemoglobin HbA1c at weeks 16, 28, and 40. Additional assessments include body weight, fasting glucose, cholesterol levels, kidney function, waist size, inflammatory markers, and safety through adverse event tracking. The study lasts about 40 weeks of treatment with follow-up to week 44 to evaluate effects and safety.

Researchers are evaluating the effects of CagriSema, cagrilintide, and semaglutide on weight loss in children and adolescents with excess body weight. This phase 3 study aims to compare these treatments against a placebo to see how well they help manage overweight or obesity in this younger population. The study is sponsored by Novo Nordisk AS and involves participants aged 8 to under 18 years who meet specific BMI and health criteria. Participants are randomly assigned to receive one of four treatments CagriSema a combination of cagrilintide and semaglutide, cagrilintide alone, semaglutide alone, or a placebo. All treatments are given as once-weekly injections under the skin, starting with a dose escalation period of up to 16 weeks, followed by maintenance dosing for 52 weeks in the main study. Those in the extension study continue with CagriSema or cagrilintide for up to 156 weeks, while participants who received semaglutide do not enter the extension phase. During the study, participants will have their body mass index BMI and body weight monitored regularly, with the primary outcome measured as the relative change in BMI from the start to week 68. Additional assessments include changes in body composition through scans like DXA and MRI, metabolic markers, blood pressure, and quality of life questionnaires. Safety is closely monitored throughout, with the total participation lasting about 1 year and 6 months for the main study and up to nearly 5 years if including the extension phase.

Researchers are evaluating how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes T2D, lose weight. The purpose of this clinical study is to find out how safe and effective CagriSema is for body weight loss compared to semaglutide, a medicine already prescribed by doctors. This is a Phase 3 randomized trial lasting about 83 weeks. Participants will be randomly assigned to receive either one of two doses of CagriSema or semaglutide, all given once weekly by injection under the skin during a 72-week treatment period. CagriSema is a new medicine being tested, while semaglutide serves as an active comparator. The study compares these treatments for their effects on weight loss and related health measures. During the study, participants will have regular assessments including body weight, body mass index BMI, waist circumference, cholesterol levels, and blood sugar control measured by HbA1c. Researchers will also monitor physical function and quality of life through questionnaires. Safety is tracked by recording any adverse events up to 80 weeks. The main outcome is the change in body weight from the start of treatment to the end of the 72-week period.