Carrollton

Researchers are evaluating a new vaccine called V118C designed to prevent pneumococcal disease, which includes infections caused by the Streptococcus pneumoniae bacteria. This study focuses on toddlers and infants to understand the safety and tolerance of V118C. It is a Phase 1 trial that compares V118C to an existing pneumococcal vaccine called PCV20 in children. The study has two parts: Stage 1 involves toddlers aged 12 to 15 months who have already received three doses of PCV20 during infancy. Stage 2 involves infants around 2 months old who will receive four doses of V118C using a 3+1 schedule (three infant doses plus one toddler dose). Both vaccines are given by intramuscular injection. The study compares safety and immune response between V118C and PCV20. Participants will be monitored for immediate reactions within 30 minutes after vaccination and for local and systemic side effects up to 7 days post-vaccination. Unsolicited adverse events will be tracked up to 28 days, and serious or medically attended events will be assessed for up to 12 months after vaccination. The study aims to collect detailed safety and tolerability information over this period.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimer's Disease. This phase 3 study aims to better understand how these treatments impact agitation symptoms in this population by comparing them to a placebo group. Participants must have a confirmed Alzheimer's diagnosis and meet specific criteria for agitation severity to join the study. Participants will receive either the Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, or a placebo, each given at specified doses on designated days. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison of treatment effects. The treatment period lasts through Week 14, during which dosing schedules are closely followed. Throughout the study, participants will be regularly assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) to measure changes in agitation levels from baseline to Week 14. Caregivers will provide reports on participant status and help ensure medication compliance. Safety and symptom changes will be carefully monitored to evaluate the treatments' effects during this period.

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 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.

Researchers are investigating targeted therapies to treat adults with moderately to severely active Rheumatoid Arthritis (RA), a chronic inflammatory disease that causes pain, stiffness, swelling, and loss of joint function. This Phase 2 study includes three substudies that evaluate different treatments for participants who have not responded well to one or two prior biologic or targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies. The study aims to assess both the effectiveness and safety of these therapies. The study tests three treatment approaches: lutikizumab alone, ravagalimab alone, and a combination of lutikizumab and ravagalimab, each compared against placebo. All treatments are given by subcutaneous injection. About 180 participants will be enrolled across approximately 65 sites worldwide. Participants must be on a stable dose of methotrexate to join the study. The study requires regular visits to hospitals or clinics for treatment and monitoring. During the study, participants will undergo medical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. The main outcomes measured include the percentage of participants achieving a 50% improvement in Rheumatoid Arthritis symptoms by week 12 and the number of participants experiencing adverse events up to about week 22. Participants may have a higher treatment burden than usual care due to the study procedures and visits.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

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 the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years with nonsegmental vitiligo, a condition that causes loss of skin color in patches. The study is a Phase 3 trial focusing on this pediatric population to better understand how well the treatment works and how safe it is for young patients. Participants will be randomly assigned to receive either ruxolitinib cream or a matching vehicle cream, both applied as a thin layer twice daily to the affected skin areas. The treatment is topical and focuses on areas of skin depigmentation, including the face and other body parts. The study measures progress over 24 weeks to determine the proportion of participants who achieve significant improvement in facial vitiligo. Throughout the study, participants will have regular assessments including skin evaluations and safety monitoring. Researchers will track changes in the affected skin areas using the Facial Vitiligo Area Scoring Index. Participants must stop all other vitiligo treatments before starting and during the study. Safety follow-ups will continue after treatment to ensure participant well-being and gather comprehensive data on treatment effects.

Researchers are evaluating how well a medicine called BI 3802876 is tolerated in adults with compensated liver cirrhosis caused by Metabolic Dysfunction-Associated Steatohepatitis (MASH). This Phase IIa study aims to understand how different doses of BI 3802876 are processed by the body and to assess its safety in people with this liver condition. Participants are randomly assigned to one of three dose groups and receive either BI 3802876 or a placebo that looks like the medicine but contains no active drug. There is more than twice the chance of receiving BI 3802876 than placebo. The study medicine is given through an infusion into a vein. The study lasts about six months, during which participants have 12 visits to the study site. At two of these visits, they receive the study medicine. Throughout the study, doctors monitor participants for any health problems and take blood samples to see how the body handles BI 3802876. They compare results between the different groups to evaluate safety. The main outcome measured is the occurrence of any adverse events during the study period of up to 134 days.

Researchers are evaluating the effects of a cellular, acellular, matrix-like product called Amnio-Maxx Dual Layer Amnion Patch compared to the standard care alone on healing chronic diabetic foot ulcers (DFUs). This Phase 4 study focuses on patients with nonhealing DFUs, aiming to assess how well the Amnio-Maxx patch helps close these ulcers and reduce their size over 12 weeks. Participants will receive either the Amnio-Maxx patch plus standard care or standard care alone. Standard care includes cleansing, debridement, wound documentation, and off-loading the affected foot. The study involves a screening period followed by randomization to one of the treatment groups, with treatments applied during visits. The index ulcer must be offloaded and have a clean base before treatment. During the study, participants' ulcers will be monitored for complete closure and percentage area reduction at 12 weeks. Researchers will conduct wound assessments, document healing progress, and ensure adherence to offloading. Safety and effectiveness will be tracked throughout, with participants required to follow protocol guidelines and attend scheduled visits during the study period.