Chieti

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 on kidney function in adults with chronic kidney disease, some of whom may also have type 2 diabetes, and who are living with overweight or obesity. The study compares NNC0519-0130 with semaglutide, an existing medicine, and a placebo, which is a "dummy" treatment. This is a Phase 2 proof-of-concept and dose-finding study aimed at understanding how these treatments may reduce kidney damage. Participants will be randomly assigned to one of three groups receiving either NNC0519-0130, semaglutide, or placebo. All treatments are given by subcutaneous injection once weekly. The study treatment phase lasts up to 36 weeks, with assessments at weeks 12, 24, and 36 to monitor changes in kidney damage by measuring the urinary albumin-to-creatinine ratio. The overall study duration can be up to 43 weeks. During the study, participants will be regularly monitored through laboratory tests and clinical evaluations to assess kidney function and safety. Researchers will measure changes from the start of the study in the urinary albumin-to-creatinine ratio at multiple time points. Participants will also need to have stable doses of certain blood pressure medications before joining. Safety and treatment effects will be assessed throughout the study period.

Researchers are evaluating how well the approved weekly injectable insulin icodec controls blood sugar levels compared to daily injectable basal insulins in adults with type 2 diabetes. This Phase 4 study focuses on people who need to start basal insulin treatment and have had type 2 diabetes for at least 180 days. The goal is to understand the effectiveness of once-weekly insulin icodec against standard daily basal insulins in real-world clinical practice over about 13 months. Participants will receive either insulin icodec once a week or one of the daily basal insulin analogues, such as insulin glargine, insulin detemir, or insulin degludec. Both treatments are given by subcutaneous injection. The choice between weekly or daily insulin is based on current treatment standards for type 2 diabetes. The study lasts approximately 52 weeks, during which participants maintain their assigned insulin regimen. During the study, researchers will monitor changes in participants' blood sugar control using the glycated hemoglobin (HbA1c) test from the start until week 52. Participants will have their HbA1c measured within 90 days before starting the treatment. Safety and any reactions to the insulin will also be tracked. The study aims to assess how well the weekly insulin icodec works compared to daily basal insulins in managing blood sugar over a year.

Researchers are evaluating the safety and effectiveness of the drug baricitinib in children aged 1 year to less than 18 years who have systemic juvenile idiopathic arthritis (sJIA), a type of arthritis that affects the joints and causes inflammation. This Phase 3 study includes two groups of participants: one group receives either baricitinib or tocilizumab, and the other group receives only baricitinib. The study aims to understand how well baricitinib works compared to tocilizumab and to monitor its safety in young patients. Participants in the study are assigned to one of two cohorts. Cohort 1 includes children who have not previously received IL-6 inhibitor therapy and will be treated with either baricitinib, taken by mouth, or tocilizumab, given by subcutaneous injection. Cohort 2 includes children who will receive baricitinib alone. The treatments are administered according to the study plan, and participants are monitored throughout the treatment period. During the study, researchers will assess participants' joint activity and overall response to treatment by measuring the percentage who meet specific improvement criteria after 12 weeks. Participants will undergo regular evaluations including physical exams and safety monitoring. The study also closely watches for any side effects or infections. The total duration of participation includes the treatment period and follow-up assessments to ensure comprehensive evaluation of baricitinib's effects in children with sJIA.

Researchers are evaluating the long-term safety and effectiveness of baricitinib for treating Juvenile Idiopathic Arthritis (JIA) in children and teenagers aged 1 to less than 18 years. This phase 3 study focuses on participants who have previously taken part in baricitinib studies I4V-MC-JAHV or I4V-MC-JAHU. The goal is to monitor how well baricitinib works and how safe it is over an extended period in this young population. Participants will receive baricitinib orally as part of the study treatment. Since all participants have prior exposure to baricitinib in earlier studies, this trial continues to observe their response and any long-term effects. The study does not mention a separate comparator group or additional interventions beyond baricitinib administration. During the study, researchers will track serious adverse events and any permanent discontinuations of baricitinib from the start through week 264. Participants will be regularly monitored for safety and treatment effects throughout this long-term follow-up. This extended observation helps assess the ongoing impact of baricitinib on juvenile arthritis over several years.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating the effectiveness and safety of subcutaneous amlitelimab compared with placebo in people aged 12 years and older who have moderate-to-severe atopic dermatitis (AD) and have not responded well to prior biologic or oral Janus kinase inhibitor (JAKi) therapies. This Phase 3, multinational, randomized, double-blind, placebo-controlled study includes participants who are also using background topical corticosteroids (TCS). The goal is to see how well amlitelimab works in improving AD symptoms in this group. Participants will be randomly assigned to one of three groups receiving either amlitelimab or placebo by subcutaneous injection while continuing their topical treatments, which may include corticosteroids, tacrolimus, or pimecrolimus. The total treatment period lasts up to 36 weeks during a double-blind phase. After the treatment phase, participants can choose to join a long-term safety study. The full study duration is up to 56 weeks for those not entering the safety study and up to 40 weeks for those who do, including screening, treatment, and safety follow-up periods. During the study, participants will attend up to 13 visits (or 12 for those continuing into the long-term safety study) for assessments including the Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD), Eczema Area and Severity Index (EASI), and symptom scoring. Safety monitoring and follow-up visits will track progress, side effects, and treatment response. The primary outcomes focus on improvements in skin clearing and reduction of AD severity at Week 36.

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 safety, tolerability, and effectiveness of XEN1101 as an additional treatment for people with primary generalized tonic-clonic seizures (PGTCS) who have generalized epilepsy and are already taking 1 to 3 anti-seizure medications. This phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants aged 12 years and older and aims to better understand how XEN1101 affects seizure frequency compared to placebo. Participants will be randomly assigned to receive either XEN1101 or a placebo capsule once daily with their evening meal during a 12-week double-blind treatment period. Those aged 18 and older will take a 25 mg dose of XEN1101 or placebo, while those aged 12 to under 18 may receive 15 mg, 25 mg, or placebo. Before this period, participants will have up to 9.5 weeks to record their baseline seizure frequency. After completing the double-blind period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week follow-up phase if they do not enroll in the extension. During the study, participants will keep detailed seizure diaries and maintain stable doses of their anti-seizure medications. Researchers will monitor seizure frequency changes, safety, and tolerability throughout the treatment. The main measurement is the median percent change in monthly primary generalized tonic-clonic seizure frequency from baseline through the 12-week treatment. Safety follow-up and monitoring will continue during the post-treatment follow-up or open-label extension periods, with total participation lasting several months depending on extension enrollment.

Researchers are evaluating the safety and effectiveness of SAR445399 in adults with moderate to severe hidradenitis suppurativa, a chronic skin condition. This multinational, randomized, double-blind, placebo-controlled Phase 2 study aims to compare two doses of SAR445399 against a placebo to find the best dosing. The study involves participants who have had symptoms of hidradenitis suppurativa for at least six months and have lesions in multiple areas of their body. Participants will receive SAR445399 or a placebo as an injection. The treatment period lasts 32 weeks, split into a 16-week initial double-blind phase followed by a 16-week treatment-blinded extension phase. The study includes 16 visits over a total duration of up to 46 weeks per participant, during which doses and responses will be carefully monitored. During the study, researchers will assess how many participants achieve significant clinical improvement in their condition by Week 16, using a measure called HiSCR75. Participants will undergo regular evaluations including physical exams and monitoring for safety. The study tracks efficacy and side effects throughout the treatment and extension periods to understand the impact of SAR445399 on hidradenitis suppurativa over time.