Marugame

Researchers are evaluating the effectiveness and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation, and some people require systemic treatments beyond topical therapies. This phase 3b/4 study aims to provide data on upadacitinib's impact on AD symptoms in this specific population. The study is conducted in two open-label periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg orally once daily or dupilumab 300mg by subcutaneous injection every two weeks. After two weeks, those on upadacitinib 15mg may have their dose increased to 30mg based on their response. Period 2 lasts 24 weeks, during which participants either continue their assigned dose or switch doses depending on their eczema severity scores. The entire treatment duration is 32 weeks with follow-up for 30 days after treatment ends. Participants will undergo regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The main outcome measured is the number of participants achieving at least a 90% improvement in their eczema severity index by week 8. The study includes a 35-day screening period before treatment begins and monitors safety and efficacy throughout the study duration.

Researchers are evaluating AGN1 LOEP, a local osteo-enhancement procedure, to prevent secondary hip fractures in women with osteoporosis who have recently had a hip fracture repaired. This randomized controlled trial involves up to 2400 postmenopausal women aged 65 to 91 years who have experienced a low-energy fragility hip fracture and are undergoing surgical repair. The study aims to reduce the incidence of new fractures on the opposite hip, which is at risk during recovery. Participants are randomly assigned to one of two groups: the treated group receives standard hip fracture repair plus the AGN1 LOEP treatment on the unfractured opposite hip, while the control group receives only the standard repair without the AGN1 procedure. The AGN1 LOEP treatment involves injecting the implant material at the treatment site immediately after hip surgery. Follow-up visits are scheduled at 6 weeks, 6 months, and then every 6 months for at least 5 years to monitor outcomes. During the study, participants will undergo assessments to track the occurrence of secondary hip fractures and any adverse events, including serious complications. Researchers will collect data at multiple visits to evaluate the procedure's safety and effectiveness over time. The main outcomes measured include the cumulative incidence of new hip fractures and adverse events approximately 30 months after treatment, with long-term follow-up continuing for a minimum of five years.