Lutz

Researchers are evaluating the pharmacokinetics and safety of dupilumab in children aged 6 months to under 18 years who have prurigo nodularis, a skin condition characterized by itchy nodules. This Phase 3, multicenter, open-label study aims to understand how the drug behaves in the body and monitor its safety in this young population. The study involves three main periods: a 2 to 4 week screening phase, a 24-week treatment phase where participants receive dupilumab as a subcutaneous injection, and a 16-week post-treatment follow-up phase. Each participant will attend a total of six study visits throughout the approximately 42 to 44 week duration. Dupilumab is given as an injection solution under the skin to assess its effects and safety in managing prurigo nodularis. Participants will undergo regular assessments including blood tests to measure dupilumab levels in the serum from Day 1 to Week 40. They and their caregivers will complete daily electronic symptom diaries to track itch severity and other symptoms. Safety and treatment response will be closely monitored throughout the study and during the follow-up period to gather comprehensive information on the drug's behavior and tolerability in children with prurigo nodularis.

Researchers are evaluating the effects of etrasimod in adults with moderate to severe ulcerative colitis. This observational study includes patients prescribed etrasimod as their best treatment option by their physician, who have not used etrasimod before. The study aims to understand how etrasimod impacts disease activity over time in a real-world setting. All participants will receive etrasimod as part of their usual medical care. Treatment and doctor visits will follow standard care practices. In addition, patients will complete health questionnaires about their ulcerative colitis symptoms at various times during the study using a mobile phone, tablet, or computer. The study lasts for 52 weeks, followed by a 28-day safety follow-up period. During the study, researchers will collect symptom questionnaires and monitor patients' health to assess symptomatic remission after 12 weeks and overall effects of etrasimod. Disease activity before starting treatment will be compared with outcomes throughout the study. Patients will be observed for safety and treatment effectiveness during their participation.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo in treating bacterial conjunctivitis in both adults and children. This Phase 3 study aims to show that fusidic acid 1% is superior to placebo for this eye infection, while also establishing its safety when applied directly to the eye. Participants will receive either fusidic acid 1% or a placebo ophthalmic solution as part of a randomized, masked treatment. The study is conducted across multiple centers and includes careful monitoring of treatment effects. The main measure of success is clinical cure assessed on Day 4 after starting treatment. During the study, participants will be closely observed for signs of improvement and safety. They must avoid other ocular treatments, cosmetics, and contact lenses during participation. Researchers will confirm bacterial conjunctivitis through clinical signs and tests to exclude viral causes. The total duration and follow-up procedures are designed to thoroughly evaluate treatment outcomes and safety.

Researchers are evaluating the performance of the FebriDx4 test in distinguishing bacterial from non-bacterial causes among children aged 2 to 11 years who have a fever and suspected acute respiratory tract infection. This study is prospective, multi-center, observational, and blinded, focusing on pediatric patients presenting to emergency departments, urgent care centers, or primary care offices. The goal is to assess the test's ability to detect a bacterial-associated immune response compared to a clinical reference algorithm determined by pediatric experts. The study involves the use of the FebriDx4 device, a rapid lateral flow immunoassay that detects elevated levels of host response proteins Myxovirus resistance protein A (MxA) and C-reactive protein (CRP) from a fingerstick blood sample. Children with suspected acute respiratory infections will undergo testing with this device during their visit. No other interventions or treatment groups are described. Participants will be assessed for clinical signs, symptoms, and immune response indicators through the FebriDx4 test and standard pathogen detection methods such as bacterial culture and multiplex PCR. The primary outcome is how well the FebriDx4 test performs in identifying bacterial infection on the day of testing. The study requires informed consent and includes follow-up procedures and expert adjudication of infection status. The total participation duration includes the testing day and a 7-day follow-up period.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.