Mitaka

Researchers are studying the long-term safety and effects of the medicine ritlecitinib for children with severe alopecia areata, a condition causing significant hair loss. This Phase 3 extension study involves participants who completed previous ritlecitinib studies and aims to assess long-term safety, effectiveness, and patient quality of life over up to 3 years. The study focuses on children aged 6 to 14 years who have experienced severe hair loss and have met specific prior study criteria. All participants receive ritlecitinib capsules taken once daily at home. Those who had higher or lower doses in a previous study continue the same dose, while those who previously received placebo or came from a different parent study are randomly assigned to a higher or lower dose. The study lasts up to 3 years and includes 17 clinic visits plus monthly phone calls to monitor treatment and health. During the study, participants are regularly evaluated for safety and treatment response using hair loss assessments and patient-reported measures of anxiety, depression, behavior, and skin-related quality of life. Safety monitoring tracks side effects and serious events from the start of consent through at least 28 days after the last dose. Participants are checked multiple times to decide whether to continue treatment, ensuring close observation throughout the trial.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating the safety and effectiveness of baricitinib, a medication taken by mouth, for treating severe or very severe alopecia areata, a type of hair loss, in children aged 6 to less than 18 years. This Phase 3 study involves children and adolescents who have had alopecia areata for at least one year and are experiencing a current episode lasting at least six months with significant hair loss. The study aims to see how well baricitinib works compared to a placebo. The study is divided into four distinct periods: a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive either baricitinib or placebo, an approximately 2-year long-term extension period for continued treatment, and a 4-week post-treatment follow-up period to monitor participants after stopping the medication. Both baricitinib and placebo are administered orally. Participants will undergo various assessments throughout the study, including measuring the severity of hair loss using the Severity of Alopecia Tool (SALT) score. The main outcome is the percentage of participants achieving a SALT score of 20 or less after 36 weeks of treatment. Safety and pharmacokinetics of baricitinib will also be monitored during the study. The total participation may last over two years, including treatment and follow-up phases.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This study is a phase 2 trial lasting about 4 to 5 years, aiming to understand how well these treatments work alone or together for this chronic condition. Participants will receive either eltrekibart alone, mirikizumab alone, a combination of both, or a placebo. The treatments are administered as drugs, and the study includes a screening period of up to 35 days before enrollment. The total participation time for each person is approximately 69 weeks, which includes the screening and treatment periods. During the trial, participants will be closely monitored to assess the percentage who achieve clinical remission by week 12. Researchers will conduct regular evaluations, which may include medical assessments and questionnaires, to track the safety and effects of the treatments. The study emphasizes careful follow-up to ensure participant safety and to gather detailed information about the therapies over the entire study duration.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the safety and effects of the medicine ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years. Alopecia areata is a condition that causes significant hair loss. This study aims to compare how well ritlecitinib works for hair regrowth compared to a placebo, along with assessing its safety and impact on patient quality of life. The study includes three groups: one receiving a higher dose of ritlecitinib, one receiving a lower dose, and one receiving a placebo. All treatments are given as oral capsules taken once daily at home for 24 weeks. Participants eligible for the study have at least 50% scalp hair loss and specific vaccination or virus exposure history. After the 24-week treatment, participants may join a long-term extension study or complete a 4-week follow-up if not eligible. Participants will attend 8 clinic visits during the 6-month study and receive about 8 phone calls for monitoring. Assessments include measuring scalp hair loss using the Severity of Alopecia Tool (SALT), evaluations of eyebrows and eyelashes, patient-reported outcomes on anxiety, depression, and quality of life, and pharmacokinetic sampling. Safety monitoring is ongoing to watch for potential risks associated with ritlecitinib.

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.