Setagaya City

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are evaluating the safety and effectiveness of brenipatide compared to a placebo for adults with moderate-to-severe Alcohol Use Disorder (AUD). This phase 3 study aims to better understand if brenipatide can help reduce drinking in this population. Participants will be followed for about 56 weeks to gather comprehensive information. Participants will receive either brenipatide (LY3537031) or a placebo, both given by subcutaneous injection. The study involves a randomized, double-blind design, meaning neither the participants nor the researchers know who receives which treatment during the trial. This method helps provide reliable results about the effects and safety of brenipatide. During the study, participants will attend scheduled visits, self-inject the study drug, and complete electronic and paper diaries as well as questionnaires. Researchers will monitor changes in drinking patterns using the Timeline Followback Method for up to 56 weeks. Safety monitoring and regular assessments will be performed throughout the study to track participants' health and adherence.

Crohn's Disease (CD) is a gastrointestinal condition that can cause chronic diarrhea, abdominal pain, weight loss, and fever. This study is evaluating the pharmacokinetics, effectiveness, and safety of risankizumab in children aged 2 to less than 18 years with moderately to severely active CD who have not responded well or are intolerant to other treatments. Risankizumab is already approved for adults with certain inflammatory conditions and is being studied here for pediatric CD in a Phase 3 trial. The study includes three groups (cohorts) based on age ranges: 6 to less than 18 years, 2 to less than 6 years, and 2 to less than 18 years. Participants start with an open-label induction period where they receive intravenous risankizumab over 12 weeks. Next, in a double-blind maintenance period lasting 52 weeks, they receive subcutaneous risankizumab at one of two doses. Following this, there is an open-label extension phase of 208 weeks with ongoing subcutaneous risankizumab treatment. Participants will visit hospitals or clinics regularly for medical assessments including blood tests, monitoring for side effects, and questionnaires to evaluate treatment effects. The study will measure outcomes such as clinical remission rates and endoscopic response at 64 weeks. Safety and how the drug moves through the body will also be tracked for up to about 64 weeks, with a follow-up period of approximately 140 days. The total involvement may involve higher treatment burden compared to usual care.

Researchers are evaluating the effectiveness and safety of KarXT in Japanese adults aged 18 to 65 who are experiencing acute psychotic episodes due to schizophrenia. The study focuses on adults diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) and confirmed by a psychiatric interview. Participants must have a specific range of symptom severity measured by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scale. Participants are randomly assigned to receive either KarXT or a placebo during a 5-week double-blind phase where neither the participants nor the researchers know which treatment is given. After this, there is a 52-week open-label extension where all participants receive KarXT. The doses are specified and administered on set days throughout the study. Throughout the study, researchers monitor changes in schizophrenia symptoms using the PANSS score at week 5 and track any treatment-emergent adverse events up to week 52 during the open-label extension. The study involves regular assessments to ensure safety and effectiveness over both the short and long term, with total participation lasting up to 57 weeks.

Crohn's disease is a long-term condition causing severe inflammation in the digestive tract, mainly affecting the bowels. This research evaluates the safety and effectiveness of oral Upadacitinib in treating children and adolescents aged 2 to 18 years with moderate to severely active Crohn's Disease who have not responded well to corticosteroids, immunosuppressants, or biologic treatments. The study is a Phase 3 trial involving approximately 110 pediatric participants worldwide and aims to understand how well Upadacitinib works and its safety in this younger population. The study includes two main periods: Period 1 has two phases—a 12-week open-label induction phase where all participants receive a specific dose of Upadacitinib based on body weight, followed by a 52-week double-blind maintenance phase where participants receive one of two doses without knowing which one. Period 2 is a 156-week open-label extension where participants continue treatment and monitoring. Upadacitinib is given either as oral tablets once daily or oral solution twice daily, taken at about the same time each day with or without food. Participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires about their health. Researchers will measure treatment response using the Pediatric Crohn's Disease Activity Index and endoscopic evaluations, as well as monitor adverse events up to 156 weeks. Safety follow-up will continue for 30 days after treatment ends to ensure participant well-being throughout and after the study.

This research aims to assess the safety, tolerability, effectiveness, pharmacokinetics, and pharmacodynamics of recombinant human heparan N-sulfatase (rhHNS, GC1130A) in patients diagnosed with Sanfilippo Syndrome Type A (MPS IIIA). The study focuses on patients aged between 12 months and 18 years who have this genetic condition affecting the central nervous system. Participants will receive the investigational drug GC1130A through an intracerebroventricular (ICV) injection, delivered via a specialized access device implanted in the brain. This open-label, phase 1 study uses ascending doses to evaluate how the drug performs and is processed in the body. During the study, researchers will closely monitor participants for any adverse events over a period of up to 108 weeks. Assessments will include evaluations of safety, drug tolerance, and biological effects. This long-term monitoring aims to gather detailed information on how the treatment impacts patients with MPS IIIA.