Tlalnepantla

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

This research aims to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study focuses on participants who meet specific IBS-D criteria related to bowel movement patterns and abdominal pain. It is a Phase 2, randomized, double-blind, placebo-controlled trial lasting approximately 35 weeks. Participants will receive either brenipatide or a placebo, both administered under the skin through subcutaneous injection. The treatments are compared to assess their impact on IBS-D symptoms. The study involves careful monitoring of patients' responses to the medication over the treatment period, with no changes in diet allowed in the four weeks before screening. During the study, participants will track their symptoms daily using an electronic diary, including abdominal pain and stool consistency. Researchers will measure the percentage of days participants have a positive composite response between weeks 9 and 16. Safety and side effects will be monitored throughout the study, ensuring participants are closely observed during the full duration of about 35 weeks.

Gastroesophageal reflux disease (GERD) happens when stomach acid or food repeatedly flows back into the esophagus, causing discomfort like heartburn and pain in the stomach, chest, or throat. This condition can affect people of all ages, including children. This research is focused on children aged 2 to 11 years who have symptomatic nonerosive GERD, which means they experience GERD symptoms without damage to the esophagus. The study aims to assess if different doses of the drug dexlansoprazole, adjusted based on body weight, can help relieve these symptoms in children. Participants in this study will receive daily oral doses of dexlansoprazole capsules in one of three amounts: 15 mg, 30 mg, or 60 mg. Children weighing 30 kilograms or less will be randomly assigned to take either 15 mg or 30 mg, while those weighing more than 30 kilograms will be assigned to 30 mg or 60 mg. The medication is taken once daily at the same time throughout the 12-week treatment period. The study will include up to 70 children across multiple centers worldwide. Children and their caregivers will keep an electronic diary to record any heartburn symptoms during the study. The research team will conduct multiple clinic visits over a period of up to 16 weeks, including up to 4 weeks for screening before treatment and a follow-up phone call 5 to 10 days after the final dose. The main outcome measured is the percentage of days without hurting or burning in the stomach, chest, or throat during the 12 weeks of treatment, alongside monitoring for side effects.

This trial focuses on people aged 55 to 90 who have agitation related to Alzheimer's Disease and previously finished one of two earlier studies. It aims to assess the long-term safety and effectiveness of a combination treatment using xanomeline tartrate/trospium chloride immediate release capsules (KarXT) and xanomeline enteric capsules (KarX-EC) in these participants. The study is a Phase 3 open-label extension, meaning all participants receive the treatment while researchers observe effects over time. Participants receive specified doses of KarXT and KarX-EC on set days as part of the treatment regimen. The study follows those who completed the earlier parent studies CN012-0023 or CN012-0024, continuing to monitor their response to the combined medication over an extended period. Throughout the study, researchers evaluate the number of participants who experience any treatment-emergent adverse events up to about 30 weeks. Caregiver involvement is required, with at least one caregiver having regular contact of about 10 hours per week or more. Safety and tolerability are closely monitored to understand the long-term impact of the treatment in managing agitation associated with Alzheimer's Disease.

This research aims to evaluate how well and how safely rimegepant works when taken during the peri-menstrual period to prevent menstrual migraine attacks in women with this condition. The study focuses on women aged 18 to 45 who have a history of menstrual migraines and regular menstrual cycles. It is a Phase 3 clinical trial comparing rimegepant to a placebo. Participants will receive either rimegepant 75 mg oral disintegrating tablets or matching placebo tablets for 7 days during the peri-menstrual period. In addition, they may use rimegepant or standard care medications as needed for acute migraine treatment. The study is double-blind and parallel group, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment phase. During the study, researchers will monitor the average change from baseline in the number of migraine days occurring per 5-day peri-menstrual period over five menstrual cycles. Participants will be assessed regularly to track migraine frequency, safety, and medication use. The total study duration covers multiple menstrual cycles to observe effects over time and ensure participant safety.

Researchers are evaluating the effectiveness of riliprubart compared to the usual treatment of intravenous immunoglobulin (IVIg) in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who are already receiving maintenance IVIg treatment. This Phase 3 study aims to assess how well riliprubart works and its safety in this population. Participants must meet specific CIDP diagnostic criteria and have a history of responding to IVIg treatment. The study involves administering riliprubart or placebo through intravenous (IV) or subcutaneous (SC) solutions, alongside the usual IVIg treatment. The treatment phase includes a randomized, double-blind comparison of riliprubart versus IVIg, followed by an open-label extension period for continued evaluation. The entire study lasts up to 109 weeks, encompassing screening, treatment, and follow-up phases. Participants will have regular assessments to monitor their response to treatment, including measurements of disability and disease activity scores. Researchers will track the percentage of participants showing a response from baseline to week 24 and those maintaining response through week 48 during the extension. Safety and long-term effects will also be observed throughout the study duration, ensuring comprehensive monitoring of participant health and treatment outcomes.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating the safety and effectiveness of nipocalimab compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab. This Phase 2/3 study focuses on delaying disease relapse in this patient group, based on diagnosis criteria from the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021. Participants are adults diagnosed with progressing or relapsing forms of CIDP and with active disease as indicated by specific disability scores. Participants will receive either nipocalimab or a placebo, both administered intravenously. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple stages, including a withdrawal phase to observe the time to first relapse over up to 52 weeks. Nipocalimab dosing details and treatment schedules are managed to compare its effects against placebo in maintaining disease control. During the study, participants will undergo regular assessments to monitor their condition and response to treatment. Researchers will track the time until a relapse event occurs, alongside safety monitoring. Eligibility is confirmed by disability scoring and disease activity evaluations. The study includes ongoing evaluation of participant health and safety, ensuring comprehensive data collection over the treatment and observation periods.

Researchers are evaluating the safety and effectiveness of LY4268989 when given together with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on adults aged 18 to 80 years who have had UC diagnosed for at least 3 months and have active symptoms confirmed by specific clinical scores and endoscopic evidence. The study aims to assess clinical remission using the Modified Mayo Score at 12 weeks. Participants will receive either LY4268989 by mouth combined with mirikizumab administered first intravenously and then by subcutaneous injection, or mirikizumab alone with a placebo pill. The entire study treatment period will last about 104 weeks, with up to 21 visits planned for monitoring. Treatment schedules and dosing are designed to compare the combination therapy to mirikizumab alone. During the study, participants will undergo regular assessments including clinical evaluations, endoscopy, and monitoring of symptoms and safety. Researchers will track the percentage of participants achieving clinical remission by week 12 using the Modified Mayo Score. Participants will be followed closely throughout the study duration, which totals approximately 118 weeks from start to finish, including treatment and follow-up visits.