Koriyama

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating whether baricitinib can delay the development of clinical stage 3 type 1 diabetes T1D in children and adults at high risk. This phase 3, double-blind, randomized, placebo-controlled study includes participants aged 1 to under 36 years who have early stages of T1D or specific diabetes-related autoantibodies. The study aims to better understand preventing or delaying the onset of clinical diabetes in this at-risk population. Participants will be randomly assigned to receive either baricitinib or a placebo orally. The study lasts up to approximately 5 years, during which participants take the assigned treatment and are monitored regularly. The trial includes a control group receiving placebo to compare with the baricitinib group. The dosing schedule and exact treatment duration depend on the study protocol and participant response. Throughout the study, participants will undergo assessments including monitoring the time to diagnosis of stage 3 T1D, blood tests measuring glucose and C-peptide levels, body measurements, and health surveys. Researchers will track changes in these measures over time, including pharmacokinetics of baricitinib. Safety and response to treatment will be closely observed throughout the study duration to evaluate the effects of the medication.

Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are evaluating the efficacy and safety of empasiprubart in adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP. This Phase 3, randomized, double-blinded, placebo-controlled study compares empasiprubart to placebo to better understand its impact on CIDP symptoms and disease progression. The study has two parts Part A lasts 24 weeks 6 months, where participants receive either empasiprubart or placebo via intravenous infusion. After Part A, all participants enter Part B for 96 weeks 24 months during which everyone receives empasiprubart. Participants who received empasiprubart in Part A will receive a placebo dose once during Part B to maintain the study blind. Participants will have regular assessments including measurements of disability using the adjusted inflammatory neuropathy cause and treatment aINCAT score, grip strength, and other neurological and quality of life scales. Safety is monitored throughout the study. The total participation period spans up to 120 weeks, with evaluations at multiple time points to track changes from baseline and any adverse events.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are studying adults aged 40 years or older who have at least one family member with pulmonary fibrosis, a condition that causes scarring in the lungs and makes breathing difficult. The trial aims to find out if a drug called nerandomilast can slow lung changes in people showing early lung abnormalities on scans. This study is a Phase 3 clinical trial involving participants who have early signs of lung scarring and a family history of pulmonary fibrosis. Participants are randomly assigned to one of two groups one group takes nerandomilast tablets, and the other takes placebo tablets that look the same but contain no medicine. They take a tablet twice daily for about 2 to 3 years. During the study, there is a 60% chance a participant will receive nerandomilast. The trial lasts approximately 2 to 3 years, with more frequent visits every three months during the first two years and then every six months, plus phone calls in the third year. Throughout the study, doctors regularly test lung function and perform chest scans to monitor lung changes and the effects of treatment. Health status and any unwanted effects are also checked. The main outcome measured is the time to worsening of lung abnormalities over the trial period. Participants will be followed closely with lung function tests, imaging, and health assessments to understand the impact of nerandomilast compared to placebo.

Researchers are evaluating the effectiveness and safety of the drug SEP-363856 in adults experiencing acute psychotic episodes related to schizophrenia. This Phase 3 clinical trial uses a randomized, double-blind, placebo-controlled design to compare SEP-363856 against placebo in a parallel-group multicenter setting. The study focuses on participants aged 18 to 65 who are experiencing a recent worsening of schizophrenia symptoms. Participants are assigned to one of three groups receiving either a placebo, 75 mgday of SEP-363856, or 100 mgday of SEP-363856 tablets. The study treatment is given daily, and the trial lasts for six weeks. During this time, efficacy and safety data are collected to assess the impact of SEP-363856 on schizophrenia symptoms. Throughout the study, participants undergo regular assessments including the Positive and Negative Syndrome Scale PANSS and the Clinical Global Impression-Severity CGI-S scale to measure symptom changes from baseline to week 6. Safety is monitored as part of the trial. Participants are followed until the end of the six-week treatment period, with all study visits and procedures conducted during this timeframe.

Researchers are investigating the efficacy and safety of duvakitug in people with moderately to severely active Crohns Disease in a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. The trial includes three sub-studies aiming to evaluate duvakitugs effects compared to placebo during induction treatment phases, focusing on clinical remission and endoscopic response at 12 weeks. Participants receive subcutaneous injections of duvakitug or placebo following the study protocol. The study duration can be up to 35 weeks, including a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 open-label, Sub-Study 2 pivotal induction, or Sub-Study 3 extended induction for non-responders. A 6-week follow-up period applies to participants not entering the maintenance study. Throughout the trial, participants undergo scheduled visits for assessments including clinical remission based on Crohns Disease Activity Index and endoscopic scores. Safety is monitored with reports of adverse events and serum drug levels. Up to 8 to 15 visits are planned depending on the sub-study, with follow-up continuing for 45 days after the last dose for those not moving to maintenance treatment.

Crohns disease is a chronic inflammatory condition affecting the digestive tract and is currently incurable. This research aims to evaluate how safe and effective the drug upadacitinib is for treating moderately to severely active Crohns disease in real-world settings. The study will monitor any adverse events and track changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their own doctors according to approved local guidelines. The study plans to enroll about 240 participants in Japan who have recently started upadacitinib treatment. Treatment will follow routine clinical practice without altering the prescribed approach. Participants will be followed for up to 64 weeks with visits that may occur in person or virtually, aligned with standard care. Researchers will assess outcomes such as the percentage of participants experiencing serious infections related to the drug. There is expected to be no extra burden beyond usual medical care throughout the study period.

Researchers are evaluating a new type of dental implant called a periodontal ligament-integrated implant for adults aged 18 and older who need a single-rooted tooth extracted. This exploratory study aims to assess whether this implant can successfully integrate with the jawbone 24 weeks after placement and if it can restore natural tooth functions such as mobility and sensory feedback while maintaining periodontal health. The implant uses residual periodontal ligament tissue in the extraction socket to promote functional attachment, differing from traditional implants that rely solely on bone integration. Participants will undergo extraction of one single-rooted tooth followed immediately by placement of the investigational implant stabilized with a temporary fixation device. This fixation remains for about nine weeks to allow healing and integration. Afterward, a superstructure is placed for controlled chewing load, and the fixation device is removed once stable integration is confirmed. The study involves multiple follow-up visits over 48 weeks, with ongoing oral care and monitoring. During the study, participants will have dental X-rays, CT scans, and clinical exams to evaluate bone healing, periodontal ligament formation, implant stability, and tooth mobility. Researchers will also measure periodontal pocket depth, pain levels, and assess patient quality of life using oral health questionnaires. Safety and implant performance will be closely monitored, with assessments continuing up to 48 weeks to gather comprehensive data on the implants biological feasibility, mechanical behavior, and clinical safety.