Stade

This research aims to evaluate the effectiveness, safety, and tolerability of two doses of remibrutinib compared to placebo in people aged 12 years and older with moderate to severe hidradenitis suppurativa, a chronic skin condition. The study is a phase 3 clinical trial involving participants with a diagnosis lasting at least six months and active symptoms in multiple body areas. The purpose is to determine how well remibrutinib works and how safe and tolerable it is for this condition. The trial lasts a total of 76 weeks and includes several parts: a screening period of up to 4 weeks, a first treatment period of 16 weeks where participants receive either remibrutinib Dose A, Dose B, or placebo in a double-blind manner, followed by a second treatment period lasting 52 weeks during which all participants receive remibrutinib doses. After treatment, there is a 4-week safety follow-up without treatment. Participants stopping treatment early are encouraged to continue in the study and complete the safety follow-up. During the study, participants will be regularly monitored for their response to treatment, including the proportion who achieve a clinical response measure called HiSCR50 at Week 16. Assessments will include physical exams and safety checks throughout the treatment periods and follow-up. The study seeks to gather detailed information on how remibrutinib affects the severity of hidradenitis suppurativa and participants' overall health during and after treatment.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

Researchers are evaluating the patient-reported outcomes, real-world efficacy, and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer receiving treatment according to the approved product guidelines in routine clinical practice in Germany. This prospective, non-interventional, multicenter study includes approximately 800 patients divided equally into HER2-positive and HER2-low/ultralow groups. Patients will also be informed about the use of a digital healthcare application (DiGA). Eligible patients must be receiving T-DXd as part of their routine care, with all diagnostic tests and treatment visits determined by their treating physicians and not by the study protocol. The study observes patients treated with T-DXd in line with the applicable summary of product characteristics. Treatment decisions, including visit frequency and procedures, follow standard clinical practice rather than study-mandated schedules. Participants will be followed to monitor the time from the first dose of T-DXd until the start of the next treatment or death, assessed for up to 60 months. Data collection will include patient-reported outcomes, safety information, and real-world clinical data. The study aims to gather comprehensive information on treatment effects and patient experiences during routine care without altering their treatment plan.

Researchers are evaluating the effectiveness and safety of sacituzumab govitecan-hziy (SG) combined with pembrolizumab compared to the treatment chosen by a doctor, which may be pembrolizumab alone or pembrolizumab with capecitabine. This study focuses on patients with triple negative breast cancer who still have invasive cancer remaining after surgery and pre-surgical treatment. The study is a phase 3, randomized, open-label trial designed to assess outcomes in this patient group. Participants receive sacituzumab govitecan-hziy and pembrolizumab through intravenous infusion as the experimental treatment. The comparison group receives the physician's choice of treatment, which involves either pembrolizumab alone intravenously or pembrolizumab combined with oral capecitabine tablets. Both treatment options follow surgery and prior therapy, targeting residual invasive disease. Throughout the study, participants are monitored up to 60 months to measure invasive disease-free survival, which indicates the time without cancer recurrence or progression. Researchers will track treatment safety and effectiveness through regular assessments. The study involves tissue sample submissions from before and after neoadjuvant therapy and surgery, performance status evaluations, organ function tests, and recovery status from surgery and radiotherapy.

Researchers are evaluating the safety and effectiveness of the Occlutech Atrial Flow Regulator (AFR) device in patients with Heart Failure. This international, multicenter follow-up study aims to identify any unknown side effects and better understand when this device should or should not be used. The study focuses on patients with chronic symptomatic heart failure and monitors their health for up to 36 months after the device implantation. Participants will receive the Occlutech AFR device, which is an interatrial shunt implanted through a minimally invasive transcatheter procedure. The treatment is done according to the device's instructions and routine clinical practice by experienced physicians. The study includes regular follow-up visits and evaluations that last for three years after implantation to assess the device's performance and safety. During the study, participants will have their vital signs checked and undergo laboratory tests, ECGs, echocardiograms, and complete quality of life questionnaires. Researchers will track major adverse cardiovascular and neurological events for one year after implantation as a primary outcome. The study monitors patients closely throughout the follow-up period to evaluate how well the device works and to detect any side effects or complications.