Newcastle

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease CAD. This observational registry focuses on individuals treated with this specific stent and planned for a short dual antiplatelet therapy DAPT of up to 3 months. The study aims to collect real-world data on clinical outcomes including safety and effectiveness over a 12-month period. Participants in this single-arm registry have undergone percutaneous coronary intervention PCI using the Vivo ISAR stent and will receive standard care short DAPT treatment for no more than 3 months. The study does not affect treatment choices or standard care procedures. After the PCI, eligible patients will be invited to join the registry and followed up at 1 month, 3 months, and 12 months. During the study, researchers will collect baseline medical data and conduct telephonic follow-ups at 30 days, 3 months, and 12 months. These follow-ups will check on medication use, laboratory assessments, adverse events, and any further interventions. The main outcomes measured include ischemic and bleeding events at 12 months, along with secondary outcomes such as mortality, heart attacks, strokes, stent thrombosis, and need for additional vessel treatments. The total participation duration is one year from the PCI procedure.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of AOC 1044, also known as delpacibart zotadirsen, for treating Duchenne Muscular Dystrophy DMD in boys aged 7 to 16 with specific gene mutations suitable for exon 44 skipping. This study is designed as a randomized, double-blind, placebo-controlled trial to assess the impact of this intravenous treatment on muscle function over time. Participants will be randomly assigned to receive either AOC 1044 or a placebo infusion every 6 weeks for 54 weeks, totaling 9 doses during the double-blind treatment period. After this, all participants can join an open-label extension where they receive AOC 1044 every 6 weeks for another 54 weeks, adding 9 more doses. Following the final dose at week 102, participants will have assessments at weeks 108 and 114 to evaluate safety and treatment effects. During the study, participants will undergo various assessments including tests for time to rise velocity, muscle strength, walking and climbing abilities, and quality of life measures. Muscle enzyme levels and global impressions of severity and change from both patients and caregivers will also be monitored. Safety and tolerability will be reviewed regularly by an independent committee. Overall participation lasts over two years, including screening, treatment, extension, and follow-up phases.

Researchers are studying MTX325 as a potential treatment to modify the progression of Parkinsons Disease PD. This Phase 1 trial includes healthy volunteers and patients with mild to moderate, early-stage Parkinsons Disease. The study aims to evaluate safety, tolerability, pharmacokinetics, brain biodistribution, and the effect of food on the drug. Parts 1 to 4 of the study, involving single and multiple ascending doses as well as elderly participants and PET biodistribution, have been completed. Part 5, which assesses multiple doses in PD patients, is currently ongoing. Participants receive MTX325 in different doses as oral capsules or placebo capsules depending on the study part. In some parts, a radiolabelled MTX325 solution is used for PET imaging in healthy volunteers to assess central nervous system penetration and biodistribution. The study uses a randomized, parallel design with several parts examining single ascending doses, multiple ascending doses, elderly subjects, and patients with Parkinsons Disease. PET scans and MRI are used during screening and on dosing days to study brain biodistribution. During the trial, participants undergo safety and tolerability assessments up to 28 days after dosing. Screening includes MRI, PET scans, clinical evaluations, and laboratory tests such as HIV, hepatitis, and drug abuse screening. Participants are monitored for vital signs and adverse events, and cognitive assessments are performed to exclude dementia. The study involves scheduled visits for dosing, imaging, and follow-up to measure safety, drug distribution in the brain, and pharmacokinetics. Participation duration varies by study part, with some completed and others ongoing until late 2027.

Researchers are investigating whether a coronary CT angiography CCTA-guided calcium modification approach can improve the treatment of patients with significant calcified coronary artery disease undergoing percutaneous coronary intervention PCI. This prospective, multicenter, randomized controlled trial compares the CCTA-guided strategy to the current standard of care using intravascular ultrasound IVUS-guided PCI. The study aims to see if the CT-based approach can improve procedural efficiency and stent results while maintaining similar clinical outcomes to IVUS guidance. Participants will be randomly assigned to one of two groups one using CCTA to inform calcium modification and plaque preparation before PCI, and the other using IVUS imaging to guide the procedure. Both groups undergo imaging to evaluate lesion characteristics before the procedure, with IVUS also used after stent placement to confirm correct implantation. The trial includes two main goals showing superiority in minimal stent area by IVUS and demonstrating non-inferiority in 12-month target vessel failure rates. During the study, participants receive imaging and PCI treatments according to their assigned group. Researchers will collect data on procedure time, radiation exposure, contrast volume, and detailed stent measurements. Clinical safety outcomes such as myocardial infarction and stent thrombosis will be monitored up to 12 months, along with patient-reported angina symptoms. Total participant involvement spans the procedure and follow-up assessments to evaluate both imaging and clinical outcomes.

Researchers are investigating NUC-7738, a nucleotide analogue, in patients with advanced solid tumours and lymphoma through a Phase III dose-escalation and expansion study. The study aims to assess the safety, tolerability, and appropriate dosing schedule of NUC-7738 given alone or combined with pembrolizumab. The trial includes patients with various advanced cancers, including cutaneous melanoma and lymphoma, to explore treatment effects and clinical activity of these therapies. Participants receive NUC-7738 intravenously on either a weekly or fortnightly schedule. In combination cohorts, pembrolizumab is administered intravenously every three weeks alongside NUC-7738. Phase I focuses on dose escalation and safety across two dosing schedules, while Phase II involves dose confirmation and expansion in additional patients, including specific cohorts for melanoma and lymphoma. Biopsies are required for most patients to monitor tumour response. During the study, participants undergo regular assessments including tumour size evaluation every 8 weeks, laboratory tests, physical exams, vital signs monitoring, and electrocardiograms up to 22 months. Researchers will track adverse events, dose-limiting toxicities, pharmacokinetics, and clinical responses such as objective response rate and disease control rate. The study continues safety monitoring until 30 days after the last dose, with detailed pharmacokinetic sampling during early cycles.

Researchers are studying the effects of filgotinib in children and adolescents aged 8 to less than 18 years who have moderately to severely active ulcerative colitis UC. The study aims to evaluate how well filgotinib works, its safety, how well it is tolerated, and how the body processes the drug in this young population. About 80 participants will be enrolled, including at least 8 children aged 8 to less than 12 years. Participants will take filgotinib once daily in the morning, either with or without food, using age-appropriate tablets. Doses are designed to match the systemic exposure seen in adults treated with 200 mg daily. Participants will take the medication at home except for on-site dosing at Weeks 4, 10, and 22. Those not reaching remission or response by Week 10 will continue induction treatment until Week 22, after which lack of remission will lead to discontinuation. During the study, participants will be monitored regularly to assess the drugs effectiveness and safety. The primary measure is remission at Week 10, with further assessments continuing through Week 58 and Week 62 to evaluate longer-term safety and tolerability. The total study duration extends to the primary completion date in June 2028.

Researchers are observing the use of the drug elafibranor in people with Primary Biliary Cholangitis PBC, a rare progressive liver disease that damages bile ducts and can lead to liver scarring. The study aims to collect real-world information on how effective, safe, and tolerable elafibranor is for participants receiving this treatment. The total participation lasts about 5 years for each person. Participants in the study are those who have been diagnosed with PBC and are either starting or currently receiving treatment with the commercialized drug elafibranor. The study does not intervene with treatment but monitors participants as they use the drug in routine care. Data is collected during regular physician follow-up visits over the 60-month period. During the study, researchers will assess response to treatment at 6 months and continue monitoring various health measures such as liver function tests, symptom scales for itching and fatigue, quality of life questionnaires, and liver stiffness. They will also track adverse events, treatment satisfaction, and adherence throughout the study. Follow-up is based on routine medical visits, with no extra visits required specifically for the study.

Researchers are evaluating LY3457263 compared with a placebo in adults with type 2 diabetes who have not reached their hemoglobin A1c HbA1c goal despite being on stable doses of semaglutide or tirzepatide. This Phase 2, double-blind study focuses on measuring changes in HbA1c levels. Participation in the trial lasts about nine months, aiming to provide insights into treatment effects in this specific patient group. Participants will be randomly assigned to receive one of three doses of LY3457263 or a placebo, all given by subcutaneous injection once weekly. The study uses a parallel-group design where each participant receives only one assigned treatment. The trial compares these treatments over a 24-week period to assess their impact on blood sugar control and body weight. During the study, participants will undergo regular assessments including blood tests to measure HbA1c and fasting serum glucose, as well as body weight measurements. These evaluations occur at baseline and at 24 weeks. The study team will monitor participants health and treatment effects throughout the trial, which is expected to last about nine months in total.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.