Maribor

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are investigating the long-term safety and tolerability of open-label iptacopan in adults with primary IgA nephropathy who have previously completed specific clinical trials (CLNP023X2203 or CLNP023A2301). This extension study is designed to allow participants continued access to iptacopan until certain conditions are met, such as reaching three years from the last patient first visit, loss of treatment benefit, negative benefit-risk profile, initiation of dialysis or kidney transplant, or commercial availability of the drug. The study will also assess the drug's effects on disease progression every six months. Participants who completed the prior trials and meet inclusion criteria may receive oral iptacopan capsules at a dose of 200 mg twice daily. The study is open-label and non-randomized and will continue treatment under this regimen until one of the study-defined stopping points is reached. Supportive care with ACE inhibitors or ARBs is maintained as per clinical guidelines, and vaccination against certain infections is required before enrollment. During the study, participants will be monitored for safety, including serious adverse events, adverse events of special interest, vital sign abnormalities, ECG changes, and laboratory test abnormalities from the first day of treatment until seven days after the last dose. Efficacy assessments occur every six months to evaluate clinical effects on disease progression. The study aims to collect long-term safety and tolerability data while providing ongoing treatment access until the drug becomes commercially available or other stopping criteria apply.

Immunoglobulin A nephropathy (IgAN) is a kidney disease caused by the build-up of immune protein complexes in the kidneys, leading to inflammation and possible kidney damage. This Phase 3 study is evaluating how well mezagitamab, compared to a placebo, reduces protein levels in the urine (proteinuria) in adults with primary IgAN. It also aims to assess the safety and tolerability of mezagitamab and its ability to maintain kidney function over the long term. Participants will be randomly assigned to one of two groups in the main study: two-thirds will receive mezagitamab injections under the skin, and one-third will receive placebo injections that look identical but have no active medicine. Treatment will occur in two 1-year cycles, each including about six months of dosing and six months of observation with monthly check-ups. An open-label group will include a small number of participants with lower proteinuria or kidney filtering issues, including those who previously received mezagitamab in another study; these participants will receive mezagitamab similarly to the main group. During the study, participants will visit the clinic several times for assessments. Researchers will monitor changes in proteinuria from the start through week 36, along with safety and kidney function. They will also perform regular evaluations and check-ups throughout each treatment and observation period to track participants' health and response to treatment.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

This research evaluates the effects of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. The study is a Phase 3 trial aiming to assess the safety and effectiveness of these treatments. Participants must meet specific CIDP diagnostic guidelines and have shown response to IVIg in the past five years. The study is divided into two parts. In Part A, lasting 24 weeks (6 months), participants receive either empasiprubart with a placebo mimicking IVIg, or IVIg with a placebo mimicking empasiprubart. Following this, Part B lasts 96 weeks (24 months), during which all participants receive empasiprubart. Both treatments are given by intravenous infusion. Placebos are used to maintain blinding in the study. Participants will be monitored for changes in their disease symptoms, particularly focusing on improvements measured by a reduction of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (aINCAT) score by week 24. Throughout the study, safety and disease activity will be regularly assessed. The total study duration for participants is up to 120 weeks, including both treatment parts.

Researchers are evaluating the effectiveness and safety of BHV-7000 in adults with refractory focal onset epilepsy, a condition where seizures originate in one area of the brain and do not respond well to current treatments. This Phase 2/3 clinical trial aims to determine whether BHV-7000 can reduce seizure frequency in this population. The study is divided into two parts. In Part A, participants are randomly assigned to receive either 25 mg or 50 mg of BHV-7000, or a matching placebo, taken once daily. After completing Part A, participants move to Part B, where they are randomized to receive 75 mg of BHV-7000 or a matching placebo, also taken once daily. Both parts are randomized and double-blinded to ensure unbiased results. Participants will be monitored from Week 8 to Week 20 of each part for changes in average seizure frequency, serious adverse events, discontinuations due to side effects, and laboratory abnormalities. Researchers will track seizure diaries and assess safety and tolerability throughout the study. The total duration includes both study parts with regular evaluations to measure the drug’s impact and participant safety.

Researchers are evaluating the accuracy and safety of the new Syai Tag system for continuous glucose monitoring in patients admitted to the intensive internal care unit. This study focuses on people with diabetes and other critical illnesses who need close blood sugar monitoring to prevent complications. The trial involves patients in intensive care who require blood sugar monitoring during their stay, with the aim to compare the new continuous glucose monitoring sensors against routine blood sugar tests. Participants will have two small Syai Tag sensors placed on their upper arms to continuously measure their blood sugar levels. These sensor readings will not be visible to medical staff. At the same time, healthcare professionals will carry out routine blood sugar measurements using arterial blood samples. The study will include at least 100 patients and monitor glucose levels from admission up to 14 days or until discharge. The procedure is safe, painless, and patients will continue to receive the usual standard of care. During the study, researchers will track the percentage of time the sensors function properly while in the ICU and compare the glucose values from the sensors to arterial blood gas glucose measurements. Participants will be monitored closely during their ICU stay, which is expected to last more than 24 hours. The study focuses on safety and accuracy while ensuring participants' care remains consistent throughout the trial.

Shock is a life-threatening condition that can cause multiple organ failure and death, characterized by low blood pressure managed with drugs called vasopressors. Common vasopressors include noradrenaline, vasopressin, and angiotensin II, which naturally helps maintain blood pressure. In shock patients, angiotensin II levels are low and renin levels are high, and renin may serve as a marker of shock severity. This research aims to explore how renin levels before and after angiotensin II treatment relate to patient outcomes and to identify which patients might benefit most from synthetic angiotensin II. Patients with distributive shock who are not reaching target blood pressure despite high doses of noradrenaline and vasopressin will receive an angiotensin II infusion starting at 20 ng/kg/min, adjusted up to 40 ng/kg/min if needed. Blood samples to measure renin will be taken before and 6 hours after starting angiotensin II. The study will assess organ failure free days and ICU free days over 30 days, along with vasopressor needs, dialysis, mechanical ventilation, and renin trends. Participants will be monitored closely for their response to treatment, with data collected on organ failure and ICU stay length. The study includes patients predicted to survive more than 24 hours with no treatment limitations. Safety and clinical outcomes will be tracked to understand the relation between renin levels and treatment effects. The total participation duration aligns with the early critical period of shock management and response to angiotensin II therapy.

Sudden cardiac arrest is a major cause of death in Europe, and the recommended treatment includes cardiopulmonary resuscitation (CPR) and defibrillation with an automated external defibrillator (AED). Successful survival depends on a chain of care that spans resuscitation and post-resuscitation treatment. This study aims to assess whether changes in brain oxygen levels, measured using cerebral oximetry, can be detected with simple tests and whether these changes align with other methods used to evaluate brain damage and neurological outcomes in patients after a primary out-of-hospital cardiac arrest. Patients will undergo two tests to monitor cerebral oxygen saturation. The first test involves a controlled infusion of a drug that raises blood pressure to increase blood flow to the brain. This infusion will be given immediately after admission and stabilization, and then repeated at 6, 12, 24, 48, and 72 hours after admission. The second test involves passively elevating the lower limbs to temporarily increase heart output and brain blood flow, performed at the same times as the infusion. Throughout hospitalization, a device will continuously monitor brain oxygen levels using near-infrared spectroscopy (NIRS). Participants will be closely monitored with cerebral oxygen saturation readings taken from enrollment until two days after admission. Researchers will also evaluate other clinical, electrophysiological, imaging, and biological assessments to compare with cerebral oxygen changes. The study will not use the test results to influence treatment decisions or predict patient outcomes. The goal is to demonstrate that these simple tests can provide meaningful data that correspond with other brain damage evaluations in this patient group.