Penrith

Researchers are evaluating the efficacy and safety of intravenously administered YN001 in adults diagnosed with coronary atherosclerosis who are also receiving background therapy for managing cardiovascular risk factors. This multinational, multicenter, phase 2b clinical trial is randomized, double-blind, and placebo-controlled to compare YN001 with placebo in this patient population. Participants will be randomly assigned to receive one of three doses of YN001 or matching placebo intravenously once weekly for 13 weeks. The doses include 40mg, 20mg, or 0mg placebo. The study consists of up to a 12-week screening and baseline period, a 12-week blinded treatment period, a 30-day safety follow-up, and a long-term follow-up extending to approximately two years after randomization. During the study, participants will undergo various assessments including imaging to measure changes in coronary non-calcified plaque volume, carotid intima-media thickness, and plaque characteristics at multiple time points. Safety and immunogenicity will be monitored alongside pharmacokinetic analyses. The primary outcome focuses on relative change in coronary NCPV at week 13. Participants will be followed for up to 96 weeks to evaluate major adverse cardiac events and long-term safety.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating the effectiveness and safety of a combination treatment including BMS-986489 a fixed dose combination of BMS-986012 and Nivolumab with Carboplatin plus Etoposide compared to Atezolizumab combined with Carboplatin plus Etoposide as a first-line therapy for participants with extensive-stage small cell lung cancer. This is a randomized, double-blind, multicenter phase 3 trial sponsored by Bristol-Myers Squibb. Participants will receive either the experimental combination of BMS-986489 with Carboplatin and Etoposide or the comparator regimen of Atezolizumab with Carboplatin and Etoposide. Doses are given on specified days according to the study protocol. The study examines these treatments as initial therapy for this type of lung cancer. During the trial, participants will be closely monitored for overall survival over a period of up to 5 years. Researchers will also measure other outcomes such as time to clinical decline based on lung cancer symptom scores, response duration, progression-free survival, and the occurrence of adverse events up to 135 days after the last treatment. Regular assessments will include imaging and clinical evaluations to track treatment effects and safety throughout the study.

Researchers are evaluating Pumitamig compared to Durvalumab in adults with unresectable stage III Non-small Cell Lung Cancer NSCLC who have completed concurrent chemoradiation therapy. This phase 3 study aims to assess which treatment better controls cancer progression and improves survival outcomes in this patient population. Participants are randomly assigned to receive either Pumitamig or Durvalumab at specified doses on designated days. Both treatments are administered following at least two cycles of platinum-based concurrent chemoradiotherapy with a radiation dose of at least 54 Gy. The study focuses on patients who have no progressive disease after this initial treatment and have good performance status. Throughout the trial, participants will be monitored for progression-free survival and other outcomes such as overall survival, objective response, disease control rate, and duration of response over several years. Assessments include imaging reviewed by independent central reviewers and investigators according to standardized criteria. The study involves regular evaluations to track cancer status and safety, with follow-up extending up to approximately nine years to understand long-term effects.

Researchers are conducting an international, multicenter, open-label phase III trial to evaluate the addition of adjuvant durvalumab after neoadjuvant chemotherapy combined with durvalumab and surgery in patients with early-stage, operable non-small cell lung cancer NSCLC stages IIB to IIIB. The main goal is to see if giving durvalumab after surgery improves disease-free survival in patients who do not achieve complete pathological response after initial treatment. The treatment plan involves 3 to 4 cycles of neoadjuvant durvalumab combined with platinum-based doublet chemotherapy, followed by surgery to remove the tumor. After surgery, patients with complete R0 or microscopic residual R1 resection are randomly assigned to either receive adjuvant durvalumab given intravenously at 1500 mg every 4 weeks for up to 12 cycles or to be observed without additional treatment. Participants will be monitored regularly for about 60 months after randomization to assess disease-free survival and other outcomes such as overall survival, time to recurrence, and treatment toxicity. Assessments include imaging scans to check for metastatic disease, pathological review after surgery, and ongoing safety evaluations. Participants must attend scheduled visits and follow study procedures throughout the treatment and follow-up periods.

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

This research aims to evaluate whether early use of enteral fludrocortisone can reduce death and dependency six months after aneurysmal subarachnoid haemorrhage aSAH, a severe type of stroke that mainly affects adults aged 45 to 64 and more often women. The condition has a high mortality rate and many survivors face lasting neurological and cognitive problems, impacting their quality of life and ability to work. The study will address the need for better treatment options given the high healthcare costs and poor outcomes associated with aSAH. Participants will be randomly assigned to receive either fludrocortisone or a matched placebo tablet every six hours by mouth for 14 days. Fludrocortisone is a synthetic steroid that helps retain sodium and fluids, potentially preventing hyponatraemia, a common and serious complication of aSAH that can worsen brain swelling and increase the risk of further brain injury. This trial is blinded and controlled to compare the effects of fludrocortisone against placebo in critically ill patients. During the study, participants will be monitored in a critical care setting with regular assessments including neurological evaluations and laboratory tests. The main outcome measured will be the level of disability or recovery at six months using the Modified Rankin Scale. Additional assessments will include quality of life tools specific to subarachnoid haemorrhage. Safety and side effects will be closely observed throughout the study. The total duration of participation includes treatment and follow-up assessments up to six months after randomization.

Researchers are evaluating whether increasing the use of finger-stick point-of-care testing for hepatitis C virus HCV infection improves diagnosis and treatment rates. The study focuses on people at risk for HCV infection, recruited from various settings such as drug treatment clinics, needle and syringe programs, homelessness services, mental health services, prisons, and mobile outreach. This observational cohort study aims to address challenges in HCV elimination caused by reduced treatment uptake and barriers in current diagnostic pathways. Participants will attend a single visit to receive point-of-care HCV testing using finger-stick methods. Testing includes rapid HCV antibody tests, and if positive, further HCV RNA testing is performed to detect active infection. Those with detectable HCV RNA will be linked to standard care for further assessment and treatment outside the study. Participants will complete a self-administered survey during the visit. No treatment is provided as part of this study. During the study, researchers will measure how many participants with active HCV infection start treatment within 12 weeks after testing. They will also evaluate acceptance of testing, prevalence of active infection, treatment initiation timing, treatment completion, and virus clearance rates up to 52 weeks following testing. Data from surveys will be linked to administrative records to assess long-term health outcomes. Participation involves only one study visit for testing and survey completion.