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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.
Actively Recruiting
Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.
Actively Recruiting
Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease CKD and proteinuria, a condition where the kidneys leak protein into the urine. This study aims to evaluate the long-term safety of finerenone when added to standard treatments called ACE inhibitors or angiotensin receptor blockers ARBs, which are commonly used to control blood pressure and protect kidney function. The research also seeks to understand how well finerenone can reduce protein levels in urine and support kidney health over time. Participants will receive finerenone in doses adjusted by age and body weight, taken orally for up to 18 months alongside their usual ACEI or ARB treatment. The study includes patients who previously took part in a related trial and will follow them for about 19 months, including a one-month follow-up after treatment ends. The research involves one group receiving finerenone openly without placebo or comparison groups. During the study, participants will attend at least 8 to 12 visits depending on their treatment start status. At these visits, doctors will measure vital signs like blood pressure, heart rate, weight, and height perform physical exams collect blood and urine samples to monitor kidney function and protein levels and conduct heart tests using electrocardiograms and echocardiography. Participants and their caregivers will also answer questions about medication use, side effects, and overall well-being. Safety will be closely monitored by tracking any medical problems that arise during the trial.
Actively Recruiting
Researchers are evaluating the long-term safety and efficacy of the medicine GSK4527226 in people with early Alzheimers Disease, including those with mild cognitive impairment and mild dementia due to Alzheimers. This study is an open-label extension, meaning all participants will receive the same medicine. Participants must have completed the parent study called study 219867 to join this extension study. In this study, all participants will be given GSK4527226. The study will last up to 112 weeks, during which participants will receive the medicine and be monitored regularly. The open-label extension allows researchers to observe the effects of GSK4527226 over a longer period than in the original study. Participants will have regular assessments including monitoring for treatment-emergent adverse events, serious adverse events, and imaging abnormalities related to amyloid. Cognitive and functional abilities will be evaluated using several tests such as the Clinical Dementia Rating, AD Assessment Scale-Cognitive subscale, Mini-Mental State Exam, and others at multiple time points up to 104 weeks. The study includes safety monitoring and aims to gather detailed information about the medicines effects during long-term use.
Actively Recruiting
Researchers are investigating how well the drug VITRAKVI generic name larotrectinib works and how well patients tolerate it in real-world use for those with TRK fusion cancer. This cancer type involves a genetic change called an NTRK gene fusion that can cause tumors to grow. The study includes adults and children with locally advanced or metastatic solid tumors that have this specific gene fusion, reflecting a variety of common and rare cancers. Patients enrolled in this observational study are those for whom their doctors have decided to treat with larotrectinib. Treatments and medical care follow local standard practices without interference from the study. Participants are grouped based on cancer types like gastrointestinal, head and neck, soft tissue sarcoma, CNS, lung, melanoma, pediatric tumors, and others. Data on treatments, other medications, disease changes, and health symptoms will be collected during routine care. Participants will be observed for 24 to 60 months. Researchers will collect information on treatment side effects up to 30 days after treatment ends and monitor responses, disease control, survival, doses, and developmental milestones for up to 8 years. Medical records, including height, weight, neurological assessments, and Tanner stage will be reviewed as part of this long-term observation.
Actively Recruiting
Researchers are studying bronchiectasis in adults and adolescents aged 12 to under 18 who produce sputum and have experienced flare-ups. The trial aims to evaluate whether the medicine BI 1291583 can help reduce these flare-ups compared to a placebo. Participants are randomly assigned to receive either BI 1291583 or a placebo in a phase III, double-blind study. Participants take one tablet of either BI 1291583 or placebo once daily for up to 1 year and 6 months. The study includes two groups one receiving the active medication and the other receiving placebo tablets that look identical but contain no medicine. The study period lasts up to 1 year and 8 months, during which participants attend up to 10 site visits and receive about 13 phone calls. During the study, participants regularly record their bronchiectasis symptoms in a smartphone diary. Study doctors monitor participants health, note any flare-ups, and check for unwanted effects. Researchers compare the number of flare-ups between the two groups as the primary measure. Secondary measures include time to first flare-up, quality of life changes, lung function changes, and rates of severe flare-ups.