Empangeni

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effectiveness of different doses of ELV001 in adults with active rheumatoid arthritis who have not responded adequately to methotrexate and tumor necrosis factor inhibitors. This Phase 2 randomized, double-blind, placebo-controlled study plans to enroll about 180 to 220 participants and lasts 32 weeks from screening to the end of the study. The study aims to understand how ELV001 affects disease activity scores and other health measures in this patient group. Participants are divided into four groups receiving either placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. The study includes a 4-week screening period, followed by a 12-week placebo-controlled treatment phase. After week 12, all participants receive ELV001 at 75 mg or 125 mg doses during a treatment extension lasting until week 24. This is followed by a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including disease activity scoring, joint counts, health questionnaires, blood tests, ECGs, and vital sign monitoring up to week 28. The main measurement is the change in disease activity score from baseline to week 12. Safety outcomes such as adverse events and laboratory results will be tracked up to 32 weeks. Participants will be closely monitored for response and side effects during the entire 32-week study duration.

Researchers are evaluating obinutuzumab in adolescents aged 12 to less than 18 years with biopsy-confirmed proliferative lupus nephritis LN in this phase II, randomized, double-blind, placebo-controlled study. The trial also examines the open-label safety and pharmacokinetics of obinutuzumab in younger pediatric participants aged 5 to less than 12 years with LN. The study aims to assess the treatments safety, effectiveness, and behavior in the body. Participants aged 12 to less than 18 will be randomly assigned to receive either obinutuzumab or a placebo by intravenous infusion at specific times Day 1, Day 14, Week 24, Week 26, and Week 52. Dosage depends on body weight, with those weighing 45 kg or more receiving 1000 mg, and lighter participants getting a weight-adjusted dose. Younger children aged 5 to less than 12 will receive open-label obinutuzumab infusions on the same schedule. Additional medications like mycophenolate mofetil, acetaminophen, diphenhydramine, methylprednisolone, and prednisone are used as part of the treatment regimen. Participants will be closely monitored over 76 weeks with evaluations including kidney response, adverse events, blood tests, and quality of life assessments. Researchers will track changes in proteinuria, kidney function, immune markers, and fatigue levels. Safety will be assessed by recording side effects and antibody development. The study includes frequent visits for infusions and assessments, with ongoing follow-up to measure treatment response and safety over time.

Pain relief in children can be difficult in places with limited medical resources due to lack of medicine, equipment, or trained staff. This research aims to test a simple and low-cost method to reduce pain using a kaleidoscope as a distraction during dressing changes for children with partial thickness burns. The study will compare pain levels between children receiving usual care and those who also use the kaleidoscope to see if this method helps reduce pain during these procedures. The trial will randomly assign children aged 7 to 12 with partial thickness burns covering no more than 10% of their body to one of two groups. One group will receive standard care, which may include no pain medication or use of paracetamol or NSAIDs during dressing changes. The other group will receive the same care plus distraction by looking through a kaleidoscope during the dressing change, starting when the procedure begins and continuing until a minute after it ends. Participants will be monitored for changes in pain before, during, and after dressing changes using pain scores. Heart rate and oxygen levels will also be measured at multiple points. Researchers will also assess satisfaction and procedure duration. The study expects to show that this distraction technique is feasible and helpful for pain relief in low-resource environments, potentially improving psychological well-being and recovery in children undergoing painful treatments.

This research aims to compare the effects of two inhalers, budesonidealbuterol metered-dose inhaler BDA MDI and albuterol sulfate metered-dose inhaler AS MDI, both used as needed, in adolescents aged 12 to 17 years with asthma. The study focuses on their impact on the annual rate of severe asthma attacks in participants who have a documented diagnosis of asthma and at least one severe exacerbation in the past year. This is a randomized, double-blind, multicenter Phase IIIb trial. Participants are randomly assigned in equal numbers to receive either BDA MDI 160180 micrograms 2 puffs of 8090 micrograms or AS MDI 180 micrograms 2 puffs of 90 micrograms as needed, alongside their usual maintenance asthma therapy. The study includes a 7 to 28-day screening period, a 52-week treatment period, and a safety follow-up lasting 7 to 14 days after treatment ends. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered at a separate visit after safety follow-up. During the study, participants will be monitored through regular assessments including lung function tests such as peak expiratory flow, evaluation of asthma exacerbations, and safety checks for adverse events. The main outcome measured is the annualized rate of severe asthma exacerbations over the 52-week treatment. Safety follow-up and pharmacokinetic evaluations will further assess drug concentrations and participant well-being. Overall participation lasts from screening through safety monitoring after treatment completion.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.