Toyonaka

Parkinson's disease (PD) is a neurological disorder that affects the brain and causes symptoms like tremors, stiffness, and slow movements. This research aims to evaluate how safe and effective ABBV-951 is when used to treat adults with advanced Parkinson's disease in a real-world setting. ABBV-951 is an approved medication in Japan, and the study will involve about 250 adult participants aged 15 years and older who have been diagnosed with PD and prescribed ABBV-951 by their doctors. Participants will receive ABBV-951 as directed by their physicians over a period of 52 weeks. The study will observe and record any changes in disease activity as well as any adverse events that occur, including monitoring the percentage of participants experiencing infusion site infections during this time. The treatment and follow-up will be conducted either in-person or through virtual visits according to standard care practices. During the study, participants will have regular visits and assessments, which may be conducted on-site or virtually, ensuring minimal additional burden. Researchers will collect data on safety and effectiveness throughout the 52-week period. The study is designed to monitor participants closely while allowing treatment as usual, supporting ongoing evaluation of ABBV-951 in managing advanced Parkinson's disease.

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.

Researchers are evaluating the safety and effectiveness of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease (PAD), a condition causing pain and difficulty walking due to narrowed arteries. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how orforglipron affects walking ability and overall safety in people with this condition. Participants will be involved in the study for about 58 weeks. Participants will receive either orforglipron or a placebo, both administered orally once daily. The study includes a comparison between these two groups to assess the impact of orforglipron on walking distance and other health outcomes over the course of the trial. During the study, researchers will measure changes in the maximum distance participants can walk compared to their baseline, particularly at the start and after 52 weeks of treatment. Participants will be monitored for safety and any side effects throughout the study. The total duration of participation is approximately 58 weeks, allowing for thorough evaluation of the treatment's effects and safety.

Researchers are evaluating NS-089/NCNP-02, a drug given by weekly intravenous infusion, in ambulatory boys aged 4 to under 15 years with Duchenne Muscular Dystrophy (DMD) caused by mutations that can be treated by skipping exon 44. This Phase 2, open-label, multi-center study aims to assess the drug's safety, tolerability, effectiveness, and how the body processes it in this specific group of participants. The study has two parts. Part 1 involves six boys (Cohort 1) who receive three dose levels of NS-089/NCNP-02 weekly over 4 weeks each. Part 2 includes Cohort 1 and an additional 14 boys (Cohort 2) who receive the selected maximum tolerated dose (MTD) weekly for 24 weeks. The treatment is given by intravenous infusion, and dosing is adjusted based on Part 1 results. Participants will be monitored through various assessments including blood and urine tests to study pharmacokinetics, muscle biopsies to measure changes in dystrophin protein, and safety evaluations for adverse events. These measurements are taken at baseline, during dosing, and at follow-up times up to 24 weeks, with additional phone follow-ups to monitor ongoing safety.