Klaipeda

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 evaluating the effect and safety of efgartigimod PH20 SC compared to placebo in adults diagnosed with systemic sclerosis (SSc). This phase 2 randomized, double-blinded, placebo-controlled study aims to understand how this treatment impacts skin involvement measured by the modified Rodnan Skin Score (mRSS) in affected individuals. The study includes participants with diffuse or limited SSc who meet specific classification criteria and antibody test requirements. Participants will be randomly assigned in a 2:1 ratio to receive either subcutaneous efgartigimod PH20 SC via prefilled syringe or a matching placebo. The study consists of a screening period, followed by a treatment period lasting up to 48 weeks, and then a safety follow-up phase. The total duration of participation may be approximately 15 months. During the study, participants will have regular evaluations including assessments of skin thickness using the mRSS to measure changes from baseline at week 24. Researchers will monitor safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity throughout the trial. Additional assessments may include disability and patient global assessment scores, antibody testing, and skin evaluations at injection sites.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are evaluating the safety, efficacy, and pharmacokinetics of ferumoxytol for treating iron deficiency anemia (IDA) in children aged 2 to under 18 years. This Phase 3, randomized, open-label, multicenter study includes male and female pediatric subjects with IDA or those considered at risk for developing IDA. The study excludes children with chronic kidney disease (CKD), who are studied separately. Participants will be randomly assigned in a 2:1 ratio to receive either ferumoxytol or iron sucrose, with age groups stratified as 2 to under 6 years, 6 to under 12 years, and 12 to under 18 years. Ferumoxytol is given as two intravenous doses of 7 mg iron per kilogram (max 510 mg per dose) with the second dose 2 to 8 days after the first. Iron sucrose is given as five intravenous doses of 4 mg iron per kilogram (max 200 mg per dose), starting on Day 1, with subsequent doses at least weekly and up to three times per week. Participants are monitored for at least one hour after each infusion. During the approximately 5-week study period, researchers will assess blood hemoglobin levels, monitor for adverse events, and conduct other safety evaluations. The main measurement is the change in hemoglobin from the start of the study to Week 5. Participants will have ongoing assessments and safety monitoring throughout the study to evaluate treatment effects and tolerability.

This is a Phase 3, randomized, open-label, multicenter, study of the safety (compared to iron sucrose), efficacy, and PK/PD of ferumoxytol (7.0 mg Fe/kg x 2 \[max 510 mg/dose\]) in pediatric subjects with iron deficiency anemia (IDA) and CKD. There will be a total of approximately 125 subjects randomized to treatment in a 2:1 ratio to either ferumoxytol or iron sucrose. Total subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period. Subjects receive the following: • Two IV infusions of ferumoxytol 7.0 mg Fe/kg (max 510 mg/dose), the first administered on Day 1 and the second 2-8 days later OR • Iron sucrose (Venofer®): For Hemodialysis Dependent (HDD) patients: 2 mg Fe/kg, administered on consecutive dialysis sessions, for 10 doses (max 100mg/dose with a total max treatment course of 1000mg) For Non-hemodialysis Dependent (NDD) or Peritoneal Dialysis De pendent(PDD) patients: 4 mg Fe/kg, administered up to 3 times/week, for 5 doses (max 200mg/dose with a total max treatment course of 1000mg).

Researchers are evaluating barzolvolimab in a Phase 3, randomized, double-blind, placebo-controlled study for adults with cold induced urticaria or symptomatic dermographism who continue to have symptoms despite using H1-antihistamines. The study aims to assess the safety and activity of barzolvolimab compared to a placebo in these participants. Participants must have a diagnosis of these conditions for at least 3 months and meet specific diagnostic criteria related to provocation testing and symptom severity. The study includes a screening period of up to 4 weeks, followed by a 24-week treatment period where participants receive either barzolvolimab or placebo by subcutaneous injection. Those on barzolvolimab receive a 450mg dose at the start and then 150mg every 4 weeks. After this, there is a 28-week treatment phase where all participants receive 300mg barzolvolimab every 8 weeks. Finally, a 16-week follow-up period observes all participants without treatment. During the study, participants will complete daily symptom electronic diaries and attend regular study visits. Researchers will monitor safety through blood counts, liver function tests, and provocation testing to measure response. The main outcome measured is the complete response to provocation testing at Week 12 from the first dose. The total study duration includes screening, treatment, and follow-up phases to evaluate long-term safety and effectiveness.

Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria, a condition where the kidneys leak protein into the urine. The study aims to understand the safety of a treatment called finerenone when used together with standard medicines called ACE inhibitors or angiotensin receptor blockers (ARBs). These medicines help control kidney function and blood pressure by targeting a system called the renin-angiotensin-aldosterone system (RAAS), which is often overactive in CKD. Finerenone may help control this system more effectively alongside ACEI or ARB. Participants will receive finerenone in doses adjusted by age and body weight for up to 18 months. The study is open-label and single-arm, meaning all participants receive the treatment. Some participants already took finerenone in a previous study and will continue, while others will start anew. The treatment period lasts about 540 days with a 1-month follow-up after the last dose. Visits are planned at least 12 times for new finerenone users and 8 times for continuing users. During visits, participants will have their blood pressure, heart rate, temperature, height, and weight measured. Blood and urine samples will be collected to monitor kidney function and protein levels. Heart function will be checked using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use, side effects, and well-being. Researchers will track any medical problems during the study and check health about 30 days after treatment ends. The main focus is safety, including monitoring adverse events, potassium levels, and blood pressure changes over about 19 months.

Researchers are investigating a new treatment approach for children aged 6 months to less than 18 years who have chronic kidney disease (CKD) and proteinuria, a condition where the kidneys leak protein into the urine. CKD causes the kidneys to work less effectively, leading to waste buildup and high blood pressure. Current treatments include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB), which help regulate a system involved in blood pressure and kidney function. However, these treatments do not work for all patients. This study is focused on seeing if adding finerenone to ACEI or ARB can better control this system and improve kidney function. Participants will receive either finerenone or a placebo for about 180 days, alongside their usual ACEI or ARB medication. The study will adjust finerenone doses based on age and body weight. Before starting treatment, participants will attend up to two screening visits within 104 days to check eligibility. During the treatment phase, participants will make at least seven visits to the study site for ongoing care and monitoring. Throughout the study, doctors will measure participants' blood pressure, heart rate, temperature, height, and weight. They will collect blood and urine samples to monitor kidney function and protein levels. Heart health will be checked using electrocardiograms and echocardiography. Participants or their parents will answer questions about medication use, side effects, and how they feel. Researchers will track any medical problems that occur during the study and will follow up about 30 days after treatment ends. The main goal is to see how much the protein in urine changes from the start to day 180.

Researchers are conducting a Phase 3 study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of ABP 692 with Ocrelizumab (both US and EU versions) in people with relapsing-remitting multiple sclerosis (RRMS). The study aims to show similarity between these treatments by measuring how the drugs behave in the body and their effects on suppressing new active brain lesions over 24 weeks using MRI scans. Participants will receive intravenous infusions of either ABP 692, Ocrelizumab (US), or Ocrelizumab (EU). The study design allows comparison between these three groups to assess how the drugs are processed and how well they control disease activity. Infusions are given according to the study schedules, and the effects are monitored over the following weeks. During the study, participants will have regular assessments including brain MRI scans to count new lesions, blood tests to measure drug levels, and neurological evaluations to track disease status. The main outcomes include drug concentration over time and the number of new brain lesions up to week 24. Safety and clinical effects will also be observed throughout the study period, which includes screening and follow-up visits.