L Aquila

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 in people living with chronic kidney disease, some of whom have type 2 diabetes and are overweight or obese. This Phase 2 study also compares NNC0519-0130 to semaglutide, an already prescribed medicine, and a placebo to see how they may improve kidney function. Participants will be randomly assigned to receive once-weekly subcutaneous injections of NNC0519-0130 with a fixed dose escalation until reaching a maintenance dose, semaglutide with a similar dosing schedule, or a placebo matching NNC0519-0130. The treatment period lasts up to 43 weeks with several dosing schemes and groups. During the study, participants will have their kidney function monitored through urine albumin-to-creatinine ratio changes at weeks 12, 24, and 36. Other assessments include estimated glomerular filtration rate, body weight changes, waist circumference, blood pressure, and glycated hemoglobin levels. Safety will be evaluated by tracking adverse events throughout the trial duration. Participants will be regularly assessed to understand the medicines effects and safety.

This research aims to evaluate the effectiveness and safety of upadacitinib at different doses for adults with moderate to severe atopic dermatitis AD who have not responded well to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation. The study includes approximately 200 adults aged 18 to less than 64 years, all current dupilumab users with a history of inadequate response. The trial is conducted in two periods to compare upadacitinib 15mg to dupilumab 300mg and adjust doses based on clinical response. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg tablets once daily or dupilumab 300mg subcutaneous injections every two weeks for eight weeks. Participants on upadacitinib 15mg may have their dose increased to 30mg after two weeks depending on response. Period 2 lasts 24 weeks, during which participants continue or adjust doses based on their Eczema Area and Severity Index EASI response at Week 8. Participants may remain on their assigned dose or switch doses accordingly. Participants attend regular visits at hospitals or clinics during the 35-day screening, 8-week Period 1, and 24-week Period 2, plus a 30-day follow-up. Assessments include medical exams, blood tests, monitoring for side effects, and questionnaires. Researchers measure outcomes such as the percentage achieving at least a 90% reduction in eczema severity EASI 90 at Week 8. The study monitors treatment effects and safety carefully throughout the 32-week treatment and follow-up period.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Alopecia areata AA is a condition where the immune system attacks hair follicles, causing hair loss mainly on the head and face but possibly on other body parts. This research evaluates the safety, effectiveness, and tolerance of upadacitinib, an approved drug, in adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled, double-blind trial enrolling about 1500 participants worldwide. Participants are randomly assigned to one of three groups receiving different treatments two doses of upadacitinib or placebo. In initial periods, some may switch from placebo to upadacitinib based on their Severity of Alopecia Tool SALT score. Those completing early parts may enter an extension phase receiving upadacitinib for up to 108 weeks. Treatment involves taking oral tablets once daily for up to 160 weeks, with possible re-randomization at Weeks 24 and 52. Throughout the study, participants attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers measure hair loss improvement using SALT scores and record adverse events over approximately 164 weeks. Participants are followed for up to 30 days after their last dose for safety monitoring.

Researchers are evaluating whether adding erythritol powder during non-surgical periodontal treatment deep cleaning can improve gum health in people with advanced periodontitis stage 3 or 4. The study focuses on individuals with deep gum pockets of 4 mm or more and aims to see if erythritol helps with healing, bleeding, plaque levels, and gum attachment compared to standard treatment alone. The trial is randomized and led by the University of LAquila. Participants receive either standard non-surgical periodontal therapy, which involves scaling and root planing with ultrasonic and manual instruments, or the same treatment combined with sub-gingival air polishing using erythritol powder. Each participant undergoes a single treatment session targeting periodontal pockets of at least 4 mm in depth on non-adjacent teeth. During the study, researchers measure the proportion of gum pockets that successfully close at 2 and 4 months after treatment. They also track bleeding, plaque levels, and gum attachment to assess periodontal health. Factors such as age, sex, smoking status, and diabetes are monitored to understand how they may affect treatment response. Participation involves clinical evaluations and periodontal assessments over the study period ending in late 2025.

Researchers are investigating ischemic stroke cases in patients who are on oral anticoagulants due to atrial fibrillation or other cardioembolic arrhythmias. This observational study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate the short- and long-term outcomes of different strategies used to prevent recurrent strokes. The study includes both retrospective and prospective data collection from multiple centers worldwide, coordinated by the University of LAquila. The study has two parts ASPERA-R and ASPERA-P. ASPERA-R collects retrospective data over five years, focusing on baseline demographic, clinical, and neuroimaging features of ischemic strokes in patients on oral anticoagulants. ASPERA-P enrolls patients prospectively for two years with follow-up for five years to assess risks of stroke recurrence and safety events under different secondary prevention approaches, such as continuing or changing oral anticoagulation. Participants will have their data collected at several time points, including hospital admission, discharge, and follow-ups at 90 days, 1 year, and 5 years after stroke. Assessments include clinical evaluations, neuroimaging exams, and monitoring for stroke recurrence, bleeding events, heart attacks, and mortality. The study tracks outcomes to better understand risks and to identify features linked to stroke recurrence and safety events, with total participation lasting up to seven years for prospective patients.

Researchers are investigating autoinflammatory diseases AID, which involve recurring inflammatory episodes without infection, cancer, or adaptive immune system problems. This study focuses on both monogenic hereditary periodic syndromes and polygenic or multifactorial AID, including rare conditions like Behets disease, Still disease, Schnitzlers disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, among others. The goal is to gather detailed data to improve understanding and management of these rare diseases through an international collaboration. The study uses the AIDA registry, a secure online platform for collecting demographic, genetic, clinical, laboratory, radiologic, and therapeutic information. Data are gathered retrospectively and prospectively during routine clinical visits scheduled every 3-6 months. Eleven registries focus on different AID conditions, enabling comprehensive data collection to identify clinical patterns, treatment impacts, and long-term outcomes over a period of at least 10 years. Participants provide information during their usual care visits, allowing researchers to track changes in disease activity, organ involvement, inflammatory markers, visual function, pain levels, fatigue, fertility, and socioeconomic factors. The study monitors these outcomes over multiple timepoints up to 120 months. Data privacy is ensured by pseudonymizing patient information. This registry supports multiple clinical studies and aims to enhance knowledge, awareness, and future research on autoinflammatory diseases worldwide.

Researchers are studying automated fetal heart function parameters to see if they differ between healthy babies and those with congenital heart disease. This international multicenter observational study aims to find out if these automated measurements can better predict heart complications like hydrops compared to current cardiovascular scores. The study focuses on pregnancies with and without fetal heart defects to compare cardiac function over time. Participants will have two fetal cardiac function ultrasound scans one between 27 weeks and 29 weeks plus 6 days of pregnancy, and another between 34 weeks and 36 weeks plus 6 days. These scans use both clinical and advanced research ultrasound systems to capture detailed heart measurements, including heart size, valve function, blood flow, and contractility. The study collects images and data securely and follows participants until delivery and hospital discharge. During the study, women will undergo standard pregnancy ultrasounds alongside research scans assessing various heart function parameters. Researchers will analyze these detailed images and functional data to compare healthy and affected fetuses. They will also evaluate if adding automated measures improves prediction of complications like hydrops. Data confidentiality is maintained, and results will be published while protecting patient privacy. The entire pregnancy period is observed, with data collected at two specific gestational windows.

This research aims to compare the effects of a new low glucose peritoneal dialysis solution called XyloCore against standard glucose-based solutions in patients with End-Stage Renal Disease ESRD who are undergoing Continuous Ambulatory Peritoneal Dialysis CAPD. The study is randomized, controlled, and open-label with blinded assessment of the main outcomes, conducted over a 6-month period. It includes patients already using common glucose peritoneal dialysis solutions and Extraneal for their long-dwell exchange. Participants will be randomly assigned to receive either the experimental XyloCore solution or continue with their current glucose peritoneal dialysis solutions. XyloCore is provided in low, medium, or high strengths matched to the glucose concentration of the patients prior prescription, while the control group maintains their usual glucose-based solutions. Both groups will continue using Extraneal for the nocturnal long-dwell exchange. Dialysis prescriptions may be adjusted by investigators to meet a target dialysis adequacy measure KtV > 1.7 per week. Throughout the study, participants will undergo regular assessments including measurement of dialysis adequacy total weekly KtVurea, blood tests such as HbA1c, cholesterol levels, hemoglobin, and insulin, as well as monitoring of kidney function, fluid removal, fatigue, and adverse events. The study includes follow-up visits for up to 6 months, with careful monitoring of safety and treatment effects. The trial is sponsored by Iperboreal Pharma Srl and uses centralized randomization with blinded evaluation of primary endpoints.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.