Hachinohe

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Crohn's disease is a chronic inflammatory condition affecting the digestive tract that currently has no cure. This research aims to evaluate the safety and effectiveness of upadacitinib in treating moderate to severe active Crohn's disease in a real-world setting in Japan. The study will monitor any adverse events and changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their doctors following local approved guidelines. Around 240 participants will be enrolled, and treatment will be according to each participant's usual clinical care. The study is observational and non-interventional, meaning no additional treatments or procedures beyond standard care will be required. Participants will be followed for up to 64 weeks, with study visits conducted either in person or virtually according to standard care practices. Researchers will assess safety by tracking serious infections related to the drug and monitor disease activity throughout the study period. There is expected to be no extra burden on participants beyond their routine care and assessments.

This research observes patients with Paroxysmal Nocturnal Hemoglobinuria who are treated with Fabhalta capsules. It is a multicenter, single-arm, non-interventional study designed to monitor drug use and safety over time. The study uses a central registration and all-case surveillance system to collect data. Participants will be observed for 48 weeks after starting Fabhalta treatment. If treatment stops within this period, any adverse events and use of other medications will be tracked up to 30 days after the last treatment day. There are no additional interventions or comparison groups in this study. During the study, researchers will monitor the occurrence of infections and other adverse events through case report forms. Participants' health and drug usage will be recorded throughout the observation period. The total participation lasts for 48 weeks, focusing on safety and drug use in real-world settings.