Segrate

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This study is a phase 2 trial lasting about 4 to 5 years, aiming to understand how well these treatments work alone or together for this chronic condition. Participants will receive either eltrekibart alone, mirikizumab alone, a combination of both, or a placebo. The treatments are administered as drugs, and the study includes a screening period of up to 35 days before enrollment. The total participation time for each person is approximately 69 weeks, which includes the screening and treatment periods. During the trial, participants will be closely monitored to assess the percentage who achieve clinical remission by week 12. Researchers will conduct regular evaluations, which may include medical assessments and questionnaires, to track the safety and effects of the treatments. The study emphasizes careful follow-up to ensure participant safety and to gather detailed information about the therapies over the entire study duration.

Researchers are studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.

Researchers are investigating patients affected by aneurysmal subarachnoid hemorrhage (aSAH), a type of hemorrhagic stroke caused by the rupture of a brain aneurysm, leading to bleeding in the space around the brain. Although early treatment has improved survival, many patients still develop long-term disabling neurological problems. The study focuses on delayed ischemic neurological deficit (DIND), a condition that can lead to delayed cerebral ischemia (DCI) and worsened neurological outcomes. There is no established standard for diagnosing or treating DIND, and the trial aims to describe its incidence, diagnostic imaging findings, and different treatment approaches across centers. The study observes patients with aSAH who require intensive care admission. Early aneurysm repair within 24 to 72 hours is standard, using techniques like endovascular coiling or surgical clipping. The trial collects data on clinical neurological exams and instrumental monitoring such as EEG and ultrasound to identify DIND. Various treatments for DIND are evaluated, including blood pressure management, intra-arterial vasodilator drugs, and mechanical angioplasty. The study also considers innovative methods like stent retriever angioplasty. No specific interventions are assigned by the study; it compares existing diagnostic and therapeutic strategies used in different centers. Participants undergo neurological assessments, brain imaging, and continuous monitoring to detect DIND and evaluate neurological outcomes over time. Researchers collect data on mortality and functional status in the short and long term, as well as treatment intensity and usefulness. The primary measure is the incidence of DIND within 12 months. The total duration of participation depends on patient follow-up. This comprehensive monitoring helps understand how different approaches impact patient recovery and complications after aSAH.