Great Yarmouth

This trial investigates whether eptinezumab can reduce the number of migraine days in children and teenagers aged 6 to 17 with episodic migraine. The study focuses on pediatric participants who have had migraine headaches for at least six months, aiming to evaluate the preventive treatment potential of this medication. This is a Phase 3 randomized, double-blind, placebo-controlled study designed to assess both the effectiveness and safety of eptinezumab given intravenously. Participants will receive either eptinezumab or a placebo, both administered as a solution through an infusion. The study includes a screening period where migraine and headache frequency are recorded using an electronic diary. The main measurement is the change from baseline in the average number of monthly migraine days over the first 12 weeks of treatment. During the study, participants and their caregivers will complete headache diaries to track migraine occurrences. Researchers will monitor migraine frequency and evaluate safety throughout the trial. The primary outcome is the difference in migraine days per month compared to the start of the study, assessed over the 12-week treatment period. This study helps understand how well eptinezumab may prevent episodic migraine in the pediatric population.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are evaluating whether eptinezumab can reduce the number of migraine days in young people aged 12 to 17 who have chronic migraine. The study is a Phase 3, randomized, double-blind, placebo-controlled trial designed to compare eptinezumab with a placebo in preventing chronic migraine in adolescents. Participants must have a history of chronic migraine for at least six months as defined by recognized headache disorder guidelines. Participants will receive a single intravenous infusion of either eptinezumab at doses of 100 mg or 300 mg, adjusted by body weight to match adult exposure, or a placebo solution. The study includes a 4-week screening period, followed by a 12-week double-blind treatment period, and then an 8-week safety follow-up. Participants are randomly assigned in a 1:1:1 ratio to one of the three groups. Throughout the study, participants will complete headache diaries to record migraine frequency and characteristics. Researchers will measure the change from baseline in monthly migraine days averaged over the first 12 weeks of treatment to assess efficacy. Safety monitoring continues through the follow-up period, with the total participation lasting approximately 24 weeks from screening through follow-up.

Researchers are assessing the long-term safety of eptinezumab in children and adolescents aged 6 to 17 who have chronic or episodic migraine. This Phase 3 extension study invites participants who completed prior migraine studies (19356A or 19357A) to continue treatment and monitoring. The study focuses on understanding how safe eptinezumab is when used over an extended period in this young population. Participants who completed the initial 12-week lead-in studies will join this open-label extension study. Those who previously received 100 mg or 300 mg doses of eptinezumab will continue with the same weight-adjusted dose. Participants who had placebo will be randomly assigned to receive either 100 mg or 300 mg of eptinezumab, also adjusted for weight. The medication is given as a concentrate for solution for infusion. During the study, researchers will monitor participants from baseline through week 44 to track any treatment-emergent adverse events. Safety assessments will guide ongoing participation, with particular attention to any serious reactions or liver-related test abnormalities encountered in the preceding studies. This extended observation aims to provide comprehensive safety data on eptinezumab use in young patients with migraine.

Researchers are studying an experimental drug called odronextamab in combination with lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. This Phase 3 study has two parts: Part 1 focuses on the safety and tolerability of this drug combination and determining the appropriate odronextamab dose, while Part 2 compares the effectiveness of this combination to the current standard treatment of rituximab plus lenalidomide. The study also explores side effects, drug levels in the blood, antibody development against the study drug, and impacts on quality of life and daily activities. Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide according to the study protocol. Part 1 is not randomized, focusing on safety and dose finding, while Part 2 is randomized and controlled to assess efficacy and safety. Treatments are administered per protocol guidelines during these study phases. During the study, participants undergo regular evaluations including imaging scans to measure disease, blood tests, and monitoring for side effects up to two years. The main outcomes measured include dose-limiting toxicities within 35 days, treatment-emergent adverse events over two years, and progression-free survival over five years. Participants are also monitored for quality of life and ability to perform daily activities throughout the trial duration.

Researchers are evaluating whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

This research aims to understand the genetic factors that contribute to the risk of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR). GCA is a serious inflammatory disease affecting blood vessels, mainly in people over 50, which can cause severe complications like vision loss or stroke if untreated. PMR causes pain and stiffness in the limbs with signs of inflammation. The study involves both patients recently suspected of having GCA and those with confirmed diagnoses from the past. It seeks to provide new insights into disease causes and improve diagnosis and treatment approaches. Participants are observed in a multi-center study collecting clinical and genetic data. The study includes both prospective patients with suspected GCA and retrospective patients with confirmed GCA or PMR diagnoses. Some retrospective participants receiving tocilizumab for recurring or difficult-to-treat GCA are also included in a safety monitoring registry. Data collected include clinical features, imaging, tissue and blood samples, and advanced genetic testing. The study also follows patients over time to assess disease impact, quality of life, and long-term outcomes. During the study, participants provide medical information, biological samples, and complete questionnaires about their symptoms and quality of life. Researchers monitor disease activity and treatment effects, especially among those starting certain immune-modifying drugs. The main measurements focus on genetic susceptibility at the study start, with ongoing evaluation of diagnosis, prognosis, and disease progression. The study is designed to improve understanding and management of GCA and PMR over time.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

This research aims to evaluate whether lowering blood phosphate levels in people with end-stage kidney disease (ESKD) who are on dialysis can reduce the risk of death or major heart-related events compared to maintaining higher phosphate levels. The study also looks at whether lowering phosphate improves physical health, fatigue, quality of life, patient satisfaction, and itching, as well as whether it is cost-effective. Hyperphosphatemia, or high phosphate in the blood, is common in ESKD and linked to higher death risk, but there is no strong trial evidence that lowering phosphate improves important patient outcomes. Participants will be randomly assigned to one of two groups: an intensive phosphate target group aiming to keep serum phosphate at or below 1.50 mmol/L using phosphate-lowering medications, or a liberal phosphate target group aiming for a higher phosphate range of 2.0 to 2.5 mmol/L. In the liberal group, all phosphate-lowering drugs at baseline will be stopped and only restarted if phosphate rises above 2.5 mmol/L. Medication choice and doses will be based on physicians' and participants' decisions to meet target levels. The trial is multinational and will include 3600 adults on dialysis. During the study, researchers will track major outcomes including cardiovascular death or serious heart and artery events over 5 years. They will also assess physical health, quality of life using the EQ5D-5L questionnaire, fatigue, itching, and overall survival. The study involves monitoring serum phosphate levels and medication use, and measuring cost-effectiveness of the treatment strategies. Participants will be followed closely to understand the safety and impact of the phosphate targets on their health and well-being.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.