Schleswig

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 evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

Researchers are studying severe asthma through the German Asthma Net e.V., which focuses on improving medical care and understanding of this condition. Since there is limited reliable data on how often severe asthma occurs, its characteristics, and treatment patterns, this clinical registry collects detailed information from patients across Germany. The aim is to better characterize severe asthma by gathering data from multiple clinics and practices, helping to optimize diagnosis and treatment over time. Participants in this registry have their sociodemographic details and medical information recorded, including diagnosis, therapy, lung function, laboratory values like IgE and eosinophil granulocytes, asthma symptoms, medication use, smoking status, and additional treatments. This data is collected at a baseline visit and then annually for up to 15 years. Each participant receives a unique study ID to protect privacy, with personal and health data stored securely on separate servers. During the study, patients will be regularly monitored for asthma symptom control, with assessments at baseline, four months, and yearly thereafter for up to 15 years. Researchers will track symptoms, medication use, exacerbations, lung function, and laboratory markers to better understand severe asthma's course and treatment outcomes. This long-term follow-up aims to improve care by providing robust data on severe asthma patients.

Researchers are evaluating the safety and effectiveness of tebentafusp-based treatments in people with advanced non-ocular melanoma. The study compares tebentafusp alone, tebentafusp combined with pembrolizumab, and investigator's choice of therapy including clinical trials, salvage therapy, or best supportive care. This phase 3, multicenter, open-label trial focuses on patients who have previously been treated with anti-PD(L)1 therapy, an approved anti-CTLA4 regimen, and if they have a BRAF mutation, a prior BRAF tyrosine kinase inhibitor treatment. Participants are assigned to one of three groups: Arm A receives tebentafusp monotherapy; Arm B receives tebentafusp combined with pembrolizumab; Arm C receives the investigator's choice of standard care or best supportive care. Treatments are given according to each group’s plan, and tumor tissue samples are collected to support biomarker analyses. The study includes screening and treatment periods, with ongoing monitoring of participants throughout. During the study, participants undergo evaluations including tumor assessments by RECIST 1.1 criteria, performance status scoring, and collection of blood and tissue samples for biomarker research. Researchers track overall survival for up to approximately four years. Safety is closely monitored, and participants must comply with study requirements, including contraception use if applicable. The total duration includes the treatment phase and long-term follow-up to assess outcomes and treatment effects.