Colchester

Researchers are evaluating the effects of guselkumab, a medication targeting the IL-23 pathway, in children aged 2 to 17 years with moderately to severely active Crohn's Disease. This Phase 3 study aims to assess both clinical and endoscopic improvement by the end of one year of treatment, focusing on participants who responded to guselkumab after 12 weeks. Participants receive guselkumab either as an injection under the skin or through an intravenous infusion. The study measures effectiveness at Week 52, following initial response at Week 12, to determine remission rates and healing observed via endoscopy. Throughout the study, children will be closely monitored with clinical assessments, endoscopic exams, and evaluation of disease activity scores. Researchers will track safety and treatment response over the 52-week period to understand guselkumab's role in managing pediatric Crohn's Disease.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

Researchers are establishing the American Lung Association (ALA) Lung Health Cohort to study lung health in young adults aged 25 to 35 who do not have severe lung disease. This large, multi-center study aims to define what constitutes ideal lung health and identify early markers of chronic lung disease by examining relationships between environmental exposures, physical activity, biomarkers, and respiratory gene expression. The study begins with a baseline assessment of lung function and other health measures, followed by regular remote follow-ups via text, email, mail, or phone over about 4.5 years. If additional funding is secured, the study may extend beyond 5 years to monitor long-term lung health changes. Recruitment is carried out nationally with support from the American Lung Association. Participants will undergo lung function tests including measurements of forced expiratory volume and forced vital capacity at baseline. They will also provide contact information for proxies to help with follow-up. Researchers will collect data on lung health, exposures, and physical fitness through questionnaires and remote contacts. Safety and compliance will be monitored throughout the study, which aims to help develop early interventions for lung disease.

Researchers are evaluating the drug omalizumab in people aged 40 and older who have Chronic Obstructive Pulmonary Disease (COPD) and allergies to common indoor allergens like pet dander, cockroaches, or dust mites. This Phase 2 clinical trial aims to determine if omalizumab can help reduce COPD flare-ups in individuals exposed and sensitized to these allergens in their homes. Participants will receive either omalizumab or a placebo as a subcutaneous injection under the skin in the arm or leg. The dose and frequency of injections, either monthly (12 doses) or twice monthly (24 doses), will be based on the participant's weight and blood test results. All injections are administered at the clinic, and participants are monitored for any side effects after each dose. Each participant will be involved in the study for about 16 months, including 1 to 3 months of screening, 12 months of receiving the study drug at the clinic, and a follow-up call one month after their final clinic visit. Researchers will measure the rate of COPD exacerbations over 12 months, along with other health assessments and monitoring to track safety and treatment effects.

Researchers are investigating the pharmacokinetics, safety, tolerability, and efficacy of a triple combination drug therapy called VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in children aged 1 to 11 years with cystic fibrosis who have at least one triple combination responsive mutation in the CFTR gene. This Phase 3 study focuses on participants with stable cystic fibrosis to better understand how this treatment behaves in the body and its safety profile. The treatment involves a fixed-dose oral combination of VX-121/TEZ/D-IVA. The study includes a monitoring period from Day 1 to Day 22 for plasma concentration levels of the drugs and their metabolites. Safety and tolerability are assessed by tracking adverse events and serious adverse events from Day 1 up to Day 50 in Part A, and from Day 1 up to Week 28 in Part B. Participants will undergo regular assessments to measure drug levels in the blood and monitor for any side effects or adverse reactions. The study collects data on safety, tolerability, and drug concentration during the treatment and follow-up periods to evaluate how well participants tolerate the therapy and how the drug is processed over time. The total participation duration includes monitoring up to 28 weeks to capture longer-term safety outcomes.

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) a drug called VX-828 alone and in combination with other medications (Tezacaftor, VX-118, or Deutivacaftor) in healthy adults and participants with cystic fibrosis (CF). The study is a Phase 1 trial focused on understanding these effects in both healthy individuals and those with CF, particularly those with specific genetic mutations affecting treatment response. The study involves several parts where participants receive different treatments: VX-828 alone, VX-828 combined with Tezacaftor and VX-118, or VX-828 combined with Deutivacaftor with or without Tezacaftor. These medications are given orally as suspensions or tablets. Some parts include a comparison with placebo treatments. The study also measures drug levels in the blood and how these levels change when combined with other drugs like Itraconazole or Midazolam. Participants will be monitored closely from the time they consent to the study through various follow-up periods up to 111 days depending on the study part. Researchers will track any side effects, serious adverse events, and measure drug concentrations in the blood. The study includes physical exams, laboratory tests, and safety assessments to evaluate how well participants tolerate the treatments and to gather detailed data on the drug’s behavior in the body.

Researchers are conducting a Phase 2, randomized, double-blind, placebo-controlled trial to study adults aged 40 to 80 years with an acute exacerbation of chronic obstructive pulmonary disease (COPD) who also have type 2 inflammation. The study aims to compare the effects of adding rademikibart to standard therapy versus standard therapy alone in an urgent healthcare setting. Participants have a history of COPD with at least one previous exacerbation and meet specific blood eosinophil or FeNO levels indicating type 2 inflammation. Participants will receive either 600 mg of rademikibart or a matching placebo, both administered as a 4 mL subcutaneous injection. This treatment is given in addition to their usual standard care, which includes systemic corticosteroids. The study follows a parallel-group design where participants are randomly assigned to one of the two treatment groups, and neither the participants nor the researchers know which treatment is given. During the study, participants will undergo assessments to monitor their response to treatment and safety. The primary outcome being measured is the rate of treatment failure within 28 days. Researchers will also evaluate various health parameters and monitor for any side effects. The total participation duration and follow-up procedures are designed to ensure thorough evaluation of the treatment's impact on acute COPD exacerbations with type 2 inflammation.

Researchers are studying the effects of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and problems with smell (olfactory dysfunction) in young children with cystic fibrosis. The study is observational and follows children aged 2 to 8 years over two years. It includes two groups: children receiving highly effective modulator therapy (HEMT) and those not receiving this treatment. The goal is to understand if early use of HEMT improves sinus health and sense of smell in these children. Children in the HEMT group will have assessments before starting treatment, then again at one year and two years after starting HEMT. The control group, not receiving HEMT, will have similar evaluations at the same time points to observe how CRS and olfactory problems progress without the treatment. The modulators studied include ivacaftor and elexacaftor/tezacaftor/ivacaftor, prescribed according to the treating doctor’s decision. Participants will undergo sinus MRI scans to measure sinus opacification and olfactory bulb volume at baseline, 1 year, and 2 years. They will also complete objective smell tests and quality of life surveys during these visits. The study carefully tracks how sinus disease and olfactory function change over time with or without HEMT, aiming to improve understanding of these conditions in young children with cystic fibrosis.