Mibu

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 the effectiveness and safety of subcutaneous amlitelimab compared with placebo in people aged 12 years and older who have moderate-to-severe atopic dermatitis (AD) and have not responded well to prior biologic or oral Janus kinase inhibitor (JAKi) therapies. This Phase 3, multinational, randomized, double-blind, placebo-controlled study includes participants who are also using background topical corticosteroids (TCS). The goal is to see how well amlitelimab works in improving AD symptoms in this group. Participants will be randomly assigned to one of three groups receiving either amlitelimab or placebo by subcutaneous injection while continuing their topical treatments, which may include corticosteroids, tacrolimus, or pimecrolimus. The total treatment period lasts up to 36 weeks during a double-blind phase. After the treatment phase, participants can choose to join a long-term safety study. The full study duration is up to 56 weeks for those not entering the safety study and up to 40 weeks for those who do, including screening, treatment, and safety follow-up periods. During the study, participants will attend up to 13 visits (or 12 for those continuing into the long-term safety study) for assessments including the Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD), Eczema Area and Severity Index (EASI), and symptom scoring. Safety monitoring and follow-up visits will track progress, side effects, and treatment response. The primary outcomes focus on improvements in skin clearing and reduction of AD severity at Week 36.

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 treatments for newly diagnosed ANCA-associated vasculitis, a serious disease involving inflammation of small to medium blood vessels. This phase 4 trial compares whether avacopan combined with short-term reduced-dose glucocorticoids and rituximab works as well as a longer 20-week reduced-dose glucocorticoid and rituximab treatment for achieving remission. The study also examines if avacopan lowers relapse rates compared to rituximab maintenance therapy and assesses the long-term safety of avacopan. Participants will be randomly assigned to one of two treatment groups. One group receives avacopan with short-term (up to 4 weeks) reduced-dose prednisolone and rituximab given at the start. The other group receives reduced-dose prednisolone for up to 20 weeks combined with rituximab administered at weeks 0, 26, 52, and 78. The study is open-label and will follow patients for up to 104 weeks to compare remission, relapse, and safety outcomes. Patients will be evaluated at multiple time points from baseline through week 104. Assessments include disease status (remission or relapse), disease activity scores, damage indexes, and adverse events. The main outcome is the proportion of patients achieving remission at 26 weeks. Researchers will monitor long-term safety and relapse rates over two years to better understand the benefits and risks of these treatment approaches.

Researchers are evaluating the overall survival of women with stage I epithelial ovarian cancer following comprehensive staging surgery. This phase III trial compares the effects of adjuvant chemotherapy versus observation without chemotherapy in this patient group. Patients are randomly assigned based on histologic type, enrollment facility, and clinical staging according to the FIGO system. Participants are divided into two groups. Group A receives adjuvant chemotherapy, which includes either Paclitaxel plus Carboplatin or Docetaxel plus Carboplatin, administered every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. Group B undergoes observation only, with no chemotherapy given. The study treatment starts within eight weeks after comprehensive staging surgery. During the study, participants undergo regular assessments to monitor survival status up to 60 months from randomization. Researchers collect data including clinical evaluations, imaging, and laboratory tests as needed. Safety is closely monitored, and participants provide informed consent before enrollment. The trial aims to determine whether adjuvant chemotherapy improves survival compared to observation alone in this patient population.

Multiple myeloma is a disease where abnormal plasma cells grow in the bone marrow. This study is focused on adults with relapsed or refractory multiple myeloma and aims to evaluate the side effects and changes in disease activity when using the investigational drug etentamig combined with a cereblon E3 ligase modulatory drug (CELMoD) called iberdomide. The study includes patients who have measurable disease and will assess both safety and disease response. Participants will receive intravenous (IV) etentamig and oral iberdomide in varying doses to find a tolerable combination. The study has two phases: in phase 1, doses will escalate to determine safety over about 56 days, and in phase 2, participants will receive one of two doses for up to approximately 129 months. Treatments are given regularly at approved hospitals or clinics. During the study, participants will have frequent medical visits including assessments, blood tests, questionnaires, and monitoring for side effects. The study will track adverse events and disease changes throughout the treatment period. About 135 adult participants will take part, with ongoing evaluation to understand the safety and impact of these treatments over time.

Ulcerative colitis (UC) is an inflammatory bowel disease that causes inflammation and bleeding in the lining of the rectum and colon. This research aims to evaluate the change in disease activity in adult participants with moderate to severe UC receiving risankizumab treatment in real-world clinical settings across Japan. The study focuses on assessing clinical remission using the Partial Adapted Mayo Score at Week 52. Participants prescribed risankizumab by their physicians according to local guidelines will receive their treatment as part of their routine clinical care. Approximately 200 participants will be enrolled at about 30 sites in Japan. The study will follow participants for up to 156 weeks, during which they will continue their usual treatment and clinical visits without additional interventions imposed by the study. During the study, participants will attend regular visits at hospitals or clinics as part of their routine care. They will provide patient-reported outcome data using a smart device and continue this data collection even if they stop risankizumab treatment. Researchers will monitor disease activity, clinical remission at one year, and other health outcomes. Participation involves voluntary consent and adherence to study requirements, with no expected extra burden beyond usual care.