Ferrara

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Researchers are studying mitral and tricuspid regurgitation in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). The goal is to better understand how common these valve problems are, measure their severity using new grading standards, and examine their impact on clinical outcomes. This study aims to improve on current assessment methods that do not fully capture the unique heart function changes seen in ATTR-CM. This prospective registry study involves collecting detailed echocardiographic data on mitral and tricuspid valve leakage, including semi-quantitative and quantitative measurements. The study will develop and apply new grading systems tailored to the restrictive heart condition caused by ATTR-CM. These new standards are designed to better reflect the severity of regurgitation in this specific disease. Participants will undergo a comprehensive baseline echocardiogram within six months of their ATTR-CM diagnosis. Researchers will monitor clinical outcomes, including all-cause mortality, for up to 60 months. The study includes regular follow-up assessments to track valve function and disease progression, aiming to link regurgitation severity with patient prognosis over time.

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are assessing the effectiveness and safety of current standard treatments in people with active systemic lupus erythematosus (SLE), including lupus nephritis, who have not adequately responded to glucocorticoids and at least two immunosuppressant therapies. The study focuses on participants with active disease despite treatment, aiming to better understand outcomes in this group. Participants receive standard care treatments based on product labels, which include glucocorticoids and immunosuppressants, with at least one biologic therapy used for a minimum of three months. The study includes those with lupus nephritis confirmed by recent kidney biopsy showing specific active disease features. Treatment follows usual clinical practice without experimental therapies. During the study, participants will be monitored for disease remission using established lupus criteria at six months. Researchers will collect routine clinical data and track safety and response to treatments. The study requires participants to be at least 16 years old and to provide informed consent. Pregnant women and those involved in other experimental drug trials are excluded. The study involves ongoing clinical follow-up to evaluate outcomes over time.

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 effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease (SSc-ILD). This Phase 2/3 randomized, double-blind study aims to assess how belimumab affects lung function and other disease symptoms such as skin thickening and fatigue, which impact quality of life. Participants will receive either belimumab or placebo administered subcutaneously. The study focuses on those diagnosed with diffuse cutaneous systemic sclerosis and active or progressive disease. Treatment is given under blinded conditions, and participants must be capable of self-administering the medication or have a caregiver to assist. During the study, lung function will be monitored by measuring changes in forced vital capacity (FVC) from baseline to Week 52. Researchers will also assess skin involvement and general symptoms. Safety and tolerability will be closely followed throughout the trial, which includes screening and regular assessments to evaluate treatment effects and participant well-being.

This research aims to evaluate how well Debio 4126 maintains insulin-like growth factor 1 (IGF-1) levels at or below the upper limit of normal in adults with acromegaly who have been previously treated with somatostatin analogs. The study is a Phase 3 randomized trial comparing Debio 4126 to a placebo to assess its efficacy and safety. Acromegaly is a condition characterized by excessive growth hormone, and controlling IGF-1 levels is important for managing the disease. Participants will receive either Debio 4126, which is a 12-week extended-release formulation of octreotide given by intramuscular injection, or a placebo injection of mannitol suspension. The study includes a double-blind period where neither participants nor researchers know who receives the active drug or placebo. There is also an open-label period where all participants may receive Debio 4126. The treatment schedule involves injections every 12 weeks. During the study, participants will be monitored to measure the percentage who maintain IGF-1 levels at or below the upper limit of normal at week 36. Researchers will assess safety and efficacy through various evaluations including laboratory tests and clinical assessments. The study also requires participants to meet certain health criteria before and during the trial to ensure safety and reliable results. The total study timeline includes these treatment and observation periods as defined by the protocol.

Researchers are evaluating the safety and effectiveness of ibrutinib combined with venetoclax (I+V) and ibrutinib alone in people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase 2 study focuses on adjusting the ibrutinib dose either proactively or reactively based on side effects to find the best treatment approach. Participants will receive oral capsules of ibrutinib and, for some groups, oral tablets of venetoclax. The study includes different treatment groups to compare how these regimens work when ibrutinib dosing is modified in response to adverse events. Dosing schedules and adjustments will be closely monitored throughout the study. During the study, participants will undergo regular assessments including scans to measure lymph node size and other tests to track response and safety. Researchers will measure the best overall response rate for up to five years. Safety monitoring and follow-up will continue as needed to evaluate long-term outcomes and treatment tolerability.

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.