Lutz

Researchers are evaluating the pharmacokinetics and safety of Dupilumab in children and adolescents aged 6 months to less than 18 years with prurigo nodularis, a chronic skin condition characterized by itchy nodules. This Phase 3, multicenter, open-label study aims to better understand how Dupilumab behaves in the body and its safety profile in this young population. Participants will receive Dupilumab administered by subcutaneous injection, with dosing based on their weight and age. The study includes three periods a screening period lasting 2 to 4 weeks, a treatment period of 24 weeks during which Dupilumab is given, and a post-intervention follow-up period of 16 weeks. Each participant will have a total of 6 planned study visits over approximately 42 to 44 weeks. Throughout the study, participants will complete daily symptom diaries and undergo evaluations to measure Dupilumab concentration in the blood from Day 1 to Week 40. The study will also monitor any treatment-emergent or serious adverse events and check for the development of antibodies against Dupilumab. Safety and effectiveness assessments will continue during the follow-up period to ensure comprehensive monitoring of participant health and treatment response.

Researchers are evaluating the effects of etrasimod as a treatment for adults with moderate to severe ulcerative colitis who have not previously taken this medication. This observational study aims to understand how etrasimod impacts disease activity by comparing patients symptoms before and after starting treatment. The study includes patients who are prescribed etrasimod as part of their standard medical care. All participants will receive etrasimod according to regular medical practice without additional experimental treatments. Health questionnaires about ulcerative colitis symptoms will be completed by patients at various times throughout the study using their personal mobile phone, tablet, or computer. The study period lasts 52 weeks, followed by a 28-day safety follow-up after treatment. During the study, patients will attend doctor visits and undergo tests as part of routine care. Researchers will collect patient-reported symptom information through digital questionnaires to assess outcomes such as symptomatic remission and response at multiple time points up to one year. Safety and changes in symptoms like bowel urgency, abdominal pain, and fatigue will also be monitored. The total participation time is just over one year, including follow-up after treatment ends.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo for treating bacterial conjunctivitis in both adults and children. This Phase 3 clinical trial aims to show that fusidic acid 1% is superior to placebo in curing bacterial conjunctivitis and to further confirm its safety when applied topically to the eyes. Participants will be randomly assigned to one of two groups one group will apply one drop of fusidic acid 1% in each eye twice daily for seven days, and the other group will use a placebo eye drop with the same schedule. The doses are ideally spaced about 12 hours apart, but the twice-daily application schedule is prioritized over exact timing. During the study, participants will be assessed for clinical cure and microbial eradication at Day 4 and Day 8 visits. Researchers will monitor safety and treatment effects through these evaluations and by tracking any adverse events. The total participation duration covers at least the seven days of treatment plus follow-up assessments, helping establish both effectiveness and safety profiles for the treatment.

Researchers are evaluating the FebriDx test to determine how well it distinguishes between bacterial and non-bacterial causes in children aged 2 to 11 years who have a fever and suspected acute respiratory infection. This observational study involves febrile pediatric patients presenting to emergency departments, urgent care centers, or primary care offices. The goal is to assess the tests ability to detect a bacterial systemic immune response compared to expert clinical adjudication using a clinical reference algorithm including pathogen detection and immune response measures. The study involves using the FebriDx 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 suspected of acute respiratory infection will undergo the FebriDx test during a single visit. The study is blinded and observational without experimental treatments or placebo groups. Participants will be assessed once at enrollment with the FebriDx test and clinical data collection. Researchers will review clinical signs, symptoms, and results from pathogen detection tests such as bacterial culture or multiplex PCR to adjudicate infection status. Follow-up includes a 7-day period to monitor outcomes. The main outcome measure is the performance of the FebriDx test in identifying bacterial infections on the day of testing.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.