Palmdale

Researchers are evaluating the long-term safety of Deucravacitinib compared to Ustekinumab in adults with moderate-to-severe plaque psoriasis. This Phase 3b4 study focuses on cardiovascular events and other health outcomes over an extended period, aiming to understand how these treatments impact patients with psoriasis who have cardiovascular risk factors. The study is led by Bristol-Myers Squibb and involves random assignment of participants to either treatment. Participants receive either Deucravacitinib or Ustekinumab at specified doses on scheduled days. The study is open-label, meaning both participants and researchers know which treatment is being given. This trial runs for up to 5 years, during which patients are monitored for cardiovascular safety and other health events related to their psoriasis treatment. Throughout the study, participants undergo regular assessments to track major cardiovascular events like heart attacks, strokes, and hospitalizations, as well as monitoring for infections, cancer, and treatment side effects. Researchers collect data on liver function and lipid levels up to 60 days after the last dose. The long-term follow-up helps evaluate safety and health outcomes over several years, with study activities continuing until early 2031.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating an investigational drug called RAP-219 in adults with focal seizures. The study aims to determine whether RAP-219 is safe and effective in reducing the frequency of focal seizures. This clinical trial is a Phase 3, randomized, double-blind, placebo-controlled study involving adult participants aged 18 to 75 years with focal epilepsy lasting at least 24 months. Participants are randomly assigned to one of three groups receiving either a high dose or medium dose of RAP-219 tablets or a matching placebo, all taken orally once daily. Following the 14-week double-blind treatment period, participants may join an open-label extension study to assess long-term safety or enter an 8-week post-treatment follow-up period. During the study, participants will keep daily seizure records using an electronic diary and undergo brain imaging and EEG assessments consistent with focal epilepsy diagnosis. Researchers will measure the median percent change in seizure frequency from baseline to the end of treatment, along with responder rates and seizure-free intervals. Safety and treatment effects are monitored throughout, with total participation lasting through treatment and follow-up periods.

Researchers are studying an Acne mRNA vaccine candidate to evaluate its safety, effectiveness, and immune response in adults aged 18 to 45 years with moderate to severe acne. This first-in-human Phase III trial aims to find the best vaccine dose and regimen by testing four different doses and comparing two versus three injections. Acne is a common inflammatory skin disease, and current treatments have not changed much in 30 years, so new options are needed. The trial includes a Core Study with four cohorts two cohorts receive two doses Sentinel Cohort A and Main Cohort A and two cohorts receive three doses Sentinel Cohort B and Main Cohort B. The vaccine or placebo is given by intramuscular injection. After completing the Core Study, some participants will join a Long-Term Extension LTE follow-up lasting up to 30 months to assess lasting effects. Participants in the Main Cohort B may join a separate LTE study. During the study, participants will have medical exams, blood tests, and acne lesion counts. Researchers will monitor adverse events shortly after each injection and for up to 6 or 9 months after. They will measure changes in inflammatory and non-inflammatory acne lesions and antibody levels. Safety assessments include monitoring serious and unexpected reactions. Follow-up visits will continue for months after the last dose to observe long-term safety and immune response.

Researchers are evaluating telehealth self-management coaching sessions to improve quality of life for people who have survived pancreatic cancer and their family caregivers. Pancreatic cancer and its treatments often cause many symptoms that can negatively affect well-being, and there are few quality of life programs available to support patients and their families during treatment. This trial aims to see if telehealth coaching can help manage physical symptoms and support emotional, social, and spiritual well-being for both patients and caregivers. Participants in the study are divided into two groups. One group attends telehealth coaching sessions lasting 40 to 60 minutes every two weeks for a total of 6 sessions over 3 months. The other group receives the usual standard of care without additional coaching. Both patients and their family caregivers take part in the intervention sessions and assessments. During the study, researchers collect information on patient-reported quality of life at the start and after 3 months. They also track symptom severity, psychological distress, caregiver burden, and overall survival over 6 months. Participants complete questionnaires and interviews at various time points, and the study monitors enrollment, completion rates, and participant experiences. The total participation time may extend up to 6 months to gather follow-up data and evaluate the impact of the coaching sessions.

Researchers are studying a treatment called MANP modified atrial natriuretic peptide for people with difficult to control or resistant hypertension. This Phase 2 study compares the safety and effects of daily MANP injections to a placebo in reducing daytime systolic blood pressure over 42 days. Participants are adults aged 18 to 80 who are already taking three or more blood pressure medications. Participants will be randomly assigned to receive either MANP or a placebo injection once daily for 42 days. The MANP is given as a subcutaneous injection. The study is double-blind, meaning neither participants nor researchers know who receives the active treatment or placebo until the study ends. A subset of participants with slightly reduced kidney function may also be included, but not exceeding 10% of total enrollment. During the study, participants will have their blood pressure monitored closely using 24-hour ambulatory blood pressure devices and clinic measurements. Safety will be assessed through reports of side effects and serious adverse events up to 4 weeks after treatment ends. Blood samples will be taken for pharmacokinetic and antibody testing. The total study duration includes about 42 days of treatment plus 4 weeks of safety follow-up.