Palermo

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are evaluating a chemo-free combination of rituximab and golcadomide (CC-99282) as a front-line treatment for older, frail patients newly diagnosed with diffuse large B-cell non-Hodgkin lymphoma (DLBCL). This phase II, multicenter study focuses on patients aged 80 or older who are considered frail based on a simplified geriatric assessment (sGA) and are not eligible for standard anthracycline-based chemotherapy. The study aims to assess the effectiveness of this treatment approach in this vulnerable population. Participants will receive an induction phase of up to six 28-day cycles consisting of golcadomide, rituximab, and dexamethasone only during the first cycle. Response to treatment will be evaluated after four and six cycles to identify patients who are responding. Those achieving at least a partial response will continue as planned, while non-responders will stop protocol treatment and switch to alternative regimens. After induction, involved site radiotherapy is permitted for PET-positive disease. Patients with at least partial response at the end of induction may then enter a consolidation phase with up to six additional 28-day cycles of golcadomide. Interim response checks during consolidation will identify disease progression, leading to treatment discontinuation if needed. Throughout the study, participants will undergo assessments including PET/CT or CT scans to evaluate disease and sarcopenia at baseline and end of treatment. Quality of life will be measured at study entry, during treatment, and follow-up. Follow-up visits will occur every three months for the first year and every six months in the second year, with a total follow-up duration of 24 months. Progression-free survival at 24 months is the primary outcome. Patients with disease progression will be considered treatment failures and followed for survival until study completion.

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are conducting a 10-year global, multi-center observational study to better understand the safety of pegvaliase, a treatment for phenylketonuria (PKU). The study focuses on assessing hypersensitivity reactions, long-term safety, tolerability, and the effectiveness of additional risk minimization measures in European Union participants. Both new users starting pegvaliase within 30 days of enrollment and those who have previously begun treatment are eligible. The study involves monitoring subjects receiving pegvaliase through their usual clinical care without any experimental treatments or procedures. Physicians will provide medical history, treatment details for blood phenylalanine levels, and information on safety concerns such as hypersensitivity reactions, anaphylaxis, and serum sickness. Follow-up typically occurs monthly during early treatment phases and every six months during maintenance. Participants will be observed over a maximum of 10 years to track protocol-defined safety events related to pegvaliase use. Data collection relies on routine clinical visits, and an Independent Adjudication Committee will review significant safety events. This long-term monitoring aims to provide a comprehensive safety profile of pegvaliase in real-world settings.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Researchers are evaluating the effects of iptacopan compared with a placebo in adults aged 18 to 85 years who have generalized Myasthenia Gravis positive for acetylcholine receptor antibodies (AChR+ gMG). This Phase III, randomized, double-blind, placebo-controlled, multicenter study aims to assess the efficacy, safety, and tolerability of iptacopan while participants continue their stable standard of care treatments. The study includes participants with moderate to severe gMG symptoms and positive diagnostic criteria. Participants will be randomly assigned in a 1:1 ratio to receive either iptacopan or a matching placebo in the form of hard gelatin capsules for six months (180 days). During this time, they will continue their stable standard of care treatments. After the double-blind treatment period, a maximum 60-month open-label extension phase is offered. Safety follow-up assessments will occur one week and one month after the last dose of study treatment. During the study, participants will be evaluated for changes in their Myasthenia Gravis Activity of Daily Living (MG-ADL) total score from baseline to month 6. Researchers will monitor safety and tolerability throughout the treatment and extension periods. Vaccination status, infection monitoring, and regular clinical assessments will be part of participant evaluations to ensure safety and track disease symptoms over time.

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are evaluating the use of benralizumab in adults with severe eosinophilic asthma to understand its effectiveness in achieving partial and complete clinical remission. This multicenter, observational, prospective study called the ATHENA study aims to add real-world evidence on benralizumab's role in clinical practice. The study also seeks to explore the immunological effects of benralizumab to better understand asthma biology and to collect long-term safety data. Participants will receive benralizumab, administered as a 30mg subcutaneous injection following the approved prescribing information. The study focuses on patients who have either recently started benralizumab treatment within 7 days before enrollment or plan to start within 7 days after enrollment. Treatment and monitoring will follow routine clinical practice without additional interventions. During the study, researchers will track the number and percentage of patients who achieve clinical remission according to the SANI definition over 24 months. Participants will be closely monitored for treatment effectiveness, immunological changes, and safety outcomes throughout this period. The study involves collecting relevant clinical data and ensuring participants adhere to treatment and follow-up visits as per standard care.