Peterborough

Researchers are evaluating the effectiveness, how the body processes the drug, and safety of remibrutinib compared to a placebo in adolescents aged 12 to less than 18 years with chronic spontaneous urticaria not well controlled by H1-antihistamines. The study also aims to collect long-term data on the drugs safety, tolerability, and effectiveness after 24 weeks of treatment and monitor safety up to three years after the last dose. The trial includes three periods a 24-week double-blind, randomized core period where two-thirds of participants receive remibrutinib orally twice daily and one-third receive placebo, followed by an optional open-label extension where participants who completed the core period may receive remibrutinib for up to six cycles of 24 weeks or enter a treatment-free observational period for up to one year, with options to switch based on symptoms. A further optional long-term treatment-free follow-up lasts up to three years with limited visits. Participants will have about 10 site visits during the core period and between 3 and 15 visits during the extension depending on symptoms, plus annual follow-up visits and phone calls during the long-term follow-up. Researchers will assess changes in urticaria activity and severity scores at baseline and week 12, monitor drug levels in the blood, track adverse events, and evaluate quality of life. Safety and symptom control are closely monitored throughout all study periods.

Researchers are evaluating whether less frequent dosing of pembrolizumab after six months of standard treatment is safe and effective for patients with advanced non-small cell lung cancer NSCLC. Pembrolizumab, an immunotherapy targeting the PD-1 receptor, has improved outcomes in NSCLC, but current dosing every six weeks for up to two years may result in overtreatment. This UK phase III trial aims to find if reducing dose frequency can maintain effectiveness while improving quality of life and lowering costs. Participants who have received six months of pembrolizumab, with or without chemotherapy, and plan to continue treatment will be randomized to receive pembrolizumab intravenously every six weeks control or every twelve weeks initially. If the 12-week dosing is found to be not less effective, additional groups receiving doses every nine, fifteen, and eighteen weeks will be included. Patients who experience disease progression while on reduced frequency dosing can return to the standard six-week schedule. Throughout the study, participants will be monitored for overall survival at 18 months from randomization, along with other outcomes such as progression-free survival, response rate, duration of response, and adverse events over two years. The study involves regular hospital visits for treatment and assessments, and the results may lead to safer, more convenient treatment options for NSCLC patients. The total participation time varies depending on individual treatment and follow-up schedules.

Researchers are studying whether ziltivekimab can help people living with heart failure and inflammation. The trial focuses on participants with heart failure who have mild to preserved heart function and systemic inflammation. This phase 3 study compares ziltivekimab, a new medicine not yet approved, to an inactive placebo to understand its effects on heart failure symptoms and physical function. Participants will receive either ziltivekimab or a matching placebo administered as a subcutaneous injection once a month for 12 months. Both groups will continue their standard heart failure care alongside the study treatment. The treatment assignment is randomized, meaning participants have an equal chance of receiving the active medicine or placebo, and the study uses a quadruple masking method to keep participants and researchers unaware of the treatment given. During the study, participants will be monitored for changes in heart failure symptoms using tools like the Kansas City Cardiomyopathy Questionnaire and a 6-minute walk test. Researchers will also assess inflammation markers, heart function measures, and quality of life at regular intervals over the 12 months. The study aims to observe the effects of ziltivekimab compared to placebo over this period, with safety and symptom improvement carefully tracked.

Researchers are evaluating camizestrant, an oral selective estrogen receptor degrader, compared to standard endocrine therapy in patients with early-stage ER-positive, HER2-negative breast cancer. This Phase III open-label study focuses on individuals at intermediate or high risk for disease recurrence who have completed locoregional therapy and at least 2 years, up to 5 years, of standard adjuvant endocrine therapy. The goal is to assess if camizestrant improves invasive breast cancer-free survival and other related outcomes. Participants are randomly assigned to receive either camizestrant or continue with standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors such as exemestane, letrozole, anastrozole, or tamoxifen. Treatment duration for both groups is planned for 60 months 5 years. The study allows prior use of CDK46 inhibitors and excludes patients with specific medical conditions or prior use of similar investigational agents. During the study, patients will be regularly monitored for invasive breast cancer-free survival, invasive disease-free survival, distant relapse-free survival, overall survival, and safety measures, including adverse events and changes in laboratory and vital signs. Quality of life assessments related to symptoms like arthralgia, hot flushes, and vaginal dryness will also be conducted. Follow-up for participants will continue for up to 10 years from the last patients randomization.

Researchers are studying the effects of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. The study aims to evaluate how well and how safely eloralintide works in this group. This phase 3 trial is sponsored by Eli Lilly and Company and includes adults with specific weight-related health conditions or a history of unsuccessful weight loss efforts. Participants in this randomized, double-blind study will receive weekly subcutaneous injections of eloralintide at one of four doses or a placebo. The main phase lasts about 75 weeks, during which participants are monitored closely. Those with prediabetes at the start may continue in an extension phase for an additional two years to further assess long-term effects. Throughout the study, participants will undergo various assessments including body weight, body fat mass, waist circumference, blood pressure, blood markers like triglycerides and HbA1c, and quality of life questionnaires. Researchers will track changes from baseline at week 64 and monitor the onset of type 2 diabetes up to week 191. Safety and medication use will also be observed, ensuring comprehensive evaluation over the course of participation.

Researchers are evaluating the immune response and safety of the mRNA-1018-H5 vaccine against pandemic influenza in healthy adults aged 18 years and older. The study aims to measure how well the vaccine triggers protective antibodies and to monitor any side effects or reactions. This is a phase 3 randomized trial sponsored by ModernaTX, Inc., focusing on adults without significant health issues or with stable chronic conditions. Participants will be randomly assigned to receive either the mRNA-1018-H5 vaccine or a placebo. Both are given as intramuscular injections on Day 1 and Day 22. The vaccine is a sterile liquid designed for injection. The study includes a blinded design to ensure unbiased safety and immunogenicity assessments. Participants may be monitored for up to 205 days to assess antibody levels and adverse events. During the study, participants will have blood tests to measure antibody responses on Days 22, 43, and 205. Researchers will track local and systemic reactions for 7 days after each injection and any adverse events for up to 205 days. The main outcomes include the percentage of participants achieving protective antibody levels, immune response strength, and safety measures. Participants will be involved in regular visits and evaluations throughout the study period.

Researchers are evaluating nipocalimab compared to placebo in adults with moderate to severe Systemic Lupus Erythematosus SLE, a chronic condition where the immune system attacks healthy tissues causing inflammation in various organs. This Phase 3 study aims to measure how well nipocalimab works using the SLE Responder Index SRI-4 response at Week 52 as the primary outcome. Participants will be randomly assigned to receive either nipocalimab or placebo along with standard care treatments during a 52-week double-blind period. After Week 52, eligible participants from both groups can join an open-label extension where they will receive nipocalimab until Week 156 or until the treatment is stopped. Throughout the study, participants will have regular assessments including physical exams, medical history reviews, vital signs, ECGs, and disease activity scoring. Researchers will track responses such as disease activity, joint pain, fatigue, and flare status at Week 52. Safety monitoring will continue during the extension period, with total participation lasting up to about three years.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart RO7790121 compared to placebo in people with moderately to severely active ulcerative colitis UC. This Phase III, multicenter, double-blind, placebo-controlled study aims to understand how well Afimkibart works and its safety profile in this population. Participants will be randomly assigned to receive either Afimkibart or a placebo. Those in the Afimkibart group will receive the drug first through an intravenous IV infusion followed by a subcutaneous SC injection. The placebo group will receive matching placebo treatments by IV and SC as well. The study treatment period includes these induction therapies, with monitoring continuing up to 30 weeks for safety. During the study, participants will be assessed for clinical remission at 12 weeks, which is the primary outcome. Other evaluations include changes in partial Modified Mayo Score, endoscopic improvement and remission, histologic improvements, bowel urgency, abdominal pain, fatigue, and health-related quality of life. Safety will be monitored by recording adverse events throughout the study. Participants will have visits for these assessments and monitoring over the course of the study duration.

Researchers are evaluating CD388, a long-acting antiviral treatment, to prevent symptomatic influenza infections in adults and adolescents at higher risk for influenza complications. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well CD388 works compared to placebo, as well as its safety and tolerability. Participants are randomly assigned to receive either a single dose of 450 mg CD388 or a matching placebo, both given by three subcutaneous injections. The study is conducted across multiple centers and includes participants aged 12 years and older. The trial compares the incidence of influenza-like illness starting from 7 days after dosing up to 24 weeks later. During the study, participants undergo screening tests including rapid antigen tests for influenza and COVID-19 before dosing. Researchers monitor participants for influenza-like illness, collect blood samples at several visits to measure CD388 levels and immune responses, and record any side effects. The overall participation lasts up to about 24 weeks, during which adherence to study procedures and safety are closely followed.

This research aims to understand the safety and effects of a study medicine called PF-08653944 in adults who are overweight or obese and have type 2 diabetes. Type 2 diabetes is a condition where there is too much sugar in the blood, and being overweight means carrying excess body weight. The study is a phase 3, randomized, placebo-controlled trial sponsored by Pfizer to evaluate this medicines impact on weight loss and diabetes management. Participants will receive the study medicine or a placebo via a shot under the skin in the belly area once every week. About 660 out of 1000 participants will get the study medicine while about 330 out of 1000 will receive a placebo, which looks like the medicine but contains no active drug. The study will last about 21 months and involve approximately 14 in-person visits and 5 phone visits. During the study, participants will be trained to self-inject the medicine at home. Researchers will monitor changes in body weight, blood sugar control HbA1c, waist size, blood pressure, cholesterol levels, and quality of life through various tests and questionnaires at baseline and weeks 64 and 84. Safety will be tracked by recording any side effects or lab abnormalities. The main outcome is the percentage change in body weight from the start of the study to week 64.