Lower Hutt

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the safety, effectiveness, and how the body processes EP-104GI, an extended-release fluticasone propionate formulation, in adults with eosinophilic esophagitis (EoE). This Phase 1b/2 trial aims to understand how EP-104GI affects the disease by assessing symptoms, tissue changes, and local effects within the esophagus. Approximately 160 adults aged 18 to 75 will participate, including dose escalation groups and a randomized dose optimization phase comparing two doses of EP-104GI to a matching vehicle control. Participants will receive EP-104GI or vehicle control through an injection during an esophagogastroduodenoscopy (EGD) procedure at the start of the study. Dose escalation involves small groups receiving increasing doses to evaluate safety over 52 weeks. The dose optimization phase will randomly assign about 120 participants to either of two EP-104GI doses or vehicle control, with some eligible to switch to EP-104GI after 24 weeks. The study includes up to 10 visits over about a year, with some participants in an extended pharmacokinetics sub-study having up to 4 more visits over 108 weeks. Throughout the study, participants will undergo several EGDs with esophageal biopsies at specified times, provide blood and urine samples for lab tests and drug level measurements, and complete questionnaires about swallowing symptoms. Researchers will monitor adverse events, physical exams, body weight, and cortisol levels. The main outcomes include safety, drug levels, and changes in esophageal tissue inflammation and disease activity, with careful safety monitoring during the entire participation period.

Researchers are collecting prospective data on about 200 patients who undergo alloplastic total temporomandibular joint (TMJ) replacement, a treatment for TMJ disorders. The study aims to understand clinical indications, treatment patterns, outcomes, and quality of life changes after TMJ replacement. It also seeks to identify factors that predict better results and to document reasons why some patients refuse this surgery. The study follows patients for up to 5 years after their TMJ replacement surgery, with data collected at several time points: 10 days, 3 months, 6 months, 12 months, 24 months, and 60 months post-surgery. Information gathered includes the underlying disease, treatment details, functional outcomes, patient-reported outcomes, and any complications related to the procedure. Participating sites are also asked to register patients who decline the TMJ replacement. During the study, patients provide informed consent and are monitored over time with assessments focusing on pain, jaw movement, occlusion, and quality of life. Researchers track adverse events and collect data to understand long-term results and patient experiences. This registry design allows for comprehensive observation of patients from before surgery through 5 years of follow-up.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are investigating the effects and safety of different doses of EVO756 in adults with moderate to severe atopic dermatitis, a chronic skin condition. This is a phase 2b randomized, double-blind, placebo-controlled trial designed to assess how well EVO756 works and whether it is safe for this population. Participants will receive one of three doses of EVO756 or a placebo. The study compares these groups to evaluate the dose range. Details about dosing schedules or administration methods are not provided, but the trial includes a placebo control to measure treatment effects accurately. During the study, researchers will monitor changes in the Eczema Area and Severity Index (EASI) over 12 weeks to assess improvement. Participants will undergo assessments including clinical evaluations to track skin condition severity, and safety will be monitored through laboratory tests, physical exams, vital signs, and ECGs. The study focuses on measuring the percentage change in EASI from the start to week 12.

Researchers are investigating treatments for bloodstream infections caused by the bacterium Staphylococcus aureus, which can be deadly within three months of infection. This international, multi-center Phase 4 adaptive platform trial evaluates multiple treatment options simultaneously to identify those that reduce death rates within 90 days of infection. The trial adapts over time by assigning more patients to better-performing treatments, removing less effective ones, and adding new options, aiming to find the best combination of therapies for patients with this serious infection. Participants receive various antibiotic treatments such as Cefazolin, Penicillin, Clindamycin, Vancomycin or Daptomycin, as well as strategies like early switching to oral antibiotics. The trial also includes whole body FDG PET/CT imaging using standardized protocols to support diagnosis and treatment decisions. Patients are randomly assigned to different concurrent treatment options currently used in routine care, with ongoing adjustments based on accumulating results. During the study, participants undergo regular evaluations including blood culture monitoring to confirm infection clearance, clinical assessments, and imaging when applicable. Researchers track all-cause mortality up to 90 days after enrollment as the primary outcome. The trial infrastructure supports additional sub-studies, with patient safety and treatment effectiveness closely monitored throughout the trial period.

Researchers are evaluating whether an early three-day course of oral dexamethasone can improve recovery and wellbeing in children aged 4 to 17 years with Sydenham's chorea, a movement disorder caused by inflammation in the brain after a Group A streptococcus infection. This condition affects children's movements, mood, and concentration, and can take months to fully recover from. The study is a randomized, double-blinded, placebo-controlled phase 3 trial conducted in New Zealand and Australia, focusing on reducing symptoms and improving mental health outcomes. Participants will be randomly assigned to receive either oral dexamethasone suspension at a dose of 20mg/m2/day (up to 24mg/day) divided into three doses daily for three days, or matching placebo capsules taken three times daily for the same duration. The study compares the effects of this short steroid course against placebo to determine safety and effectiveness in treating Sydenham's chorea. The trial plans to enroll 80 children from multiple hospital sites. During the study, children's chorea severity and psychiatric symptoms will be assessed at one, three, and twelve months using standardized rating scales and questionnaires. Safety checks for adverse events related to dexamethasone will occur on days three, seven, and at one month. Additional outcomes include relapse rates, hospital length of stay, and treatment failures. The total follow-up period spans a year to monitor both physical and mental recovery.