Palmdale

Researchers are evaluating the long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

Researchers are evaluating the safety and effectiveness of adding a human placental allograft called BioREtainAmnion Chorion (BR-AC) to standard care for treating non-healing, non-infected venous leg ulcers (VLUs) with confirmed venous reflux and adequate arterial blood flow. The study includes patients with VLUs between 2 cm and 20 cm in area that have lasted between 4 weeks and 52 weeks. It aims to find out if weekly applications of BR-AC plus standard care lead to more wounds fully healing within 12 weeks compared to standard care alone. Participants first undergo a two-week run-in period with standardized care including compression therapy to exclude those whose wounds are likely to heal quickly without BR-AC. Eligible subjects are then randomly assigned to receive either standard care alone or standard care plus weekly BR-AC applications. Standard care involves sharp wound cleaning, moist wound dressings, and compression with the UrgoK2dual compression system. If wounds do not fully heal after 12 weeks on standard care alone, participants can crossover to receive BR-AC treatment for an additional 12 weeks. Throughout the study, weekly visits monitor wound healing progress using an electronic device to measure wound size accurately. Participants who achieve complete wound closure enter a four-week follow-up with visits every two weeks to assess the durability of healing. The main goal is to determine whether BR-AC combined with standard care improves the chance of full wound closure within 12 weeks compared to standard care by itself.

Researchers are investigating the safety, effectiveness, and immune response of an Acne mRNA vaccine in adults aged 18 to 45 years who have moderate to severe acne. This Phase I/II trial aims to find the best vaccine dose and regimen by studying up to three intramuscular injections at four different dose levels. Acne is a widespread inflammatory skin condition with significant global impact, and current treatments have changed little in the past 30 years, highlighting the need for new options. The study includes a Core Study and an optional Long-Term Extension (LTE). The Core Study has two groups testing two doses (Cohorts A) and two groups testing three doses (Cohorts B). Participants in Sentinel Cohorts A and B and Main Cohort A may join a 30-month follow-up after their last Core Study visit to evaluate long-term vaccine effects. Those in Main Cohort B can enter a separate LTE study. The vaccine and placebo are given as liquid injections into the muscle. Participants will be monitored closely through various safety assessments, including tracking adverse events shortly after each dose and for several months afterward. Researchers will measure changes in acne lesions at two months post-treatment and follow participants for up to 38 or 40 months in the LTE. Evaluations include medical exams, lab tests, and questionnaires to understand safety, immune response, and how well the vaccine works over time.

Researchers are evaluating how telehealth self-management coaching sessions affect the quality of life for people who have metastatic pancreatic adenocarcinoma and their family caregivers. Patients with this type of pancreatic cancer often face many symptoms from the disease and its treatment, which can lower their quality of life. Both patients and their families often lack supportive programs that help manage physical symptoms and emotional, social, and spiritual well-being during treatment. Participants will either attend telehealth coaching sessions focused on self-management or receive the usual standard of care. The coaching sessions aim to support patients and caregivers in managing symptoms and improving overall quality of life through regular remote counseling. Additional questionnaires and interviews may be conducted as part of ancillary studies. During the study, participants will complete questionnaires to report their quality of life at the start and three months after randomization. The study will monitor how the telehealth sessions impact patients and caregivers over time. The total duration includes these assessments and ongoing support during the study period.

Researchers are evaluating the safety and effectiveness of MANP (modified atrial natriuretic peptide) given by subcutaneous injection to reduce daytime systolic blood pressure in adults with difficult to control or resistant hypertension. This Phase 2 study compares MANP to a placebo in participants who are taking three or more antihypertensive medications with different mechanisms of action. The study focuses on people aged 18 to 80 years who have high blood pressure despite treatment. Participants will receive daily injections of either MANP or a placebo for 42 days. This dose-titration study monitors the response to the treatment over this period. The placebo used is a matched vehicle without the active ingredient. The study aims to observe changes in blood pressure and evaluate potential side effects during and after treatment. During the study, participants will have their blood pressure measured using 24-hour ambulatory blood pressure monitoring to assess changes from baseline. Researchers will also monitor and record any adverse events, serious adverse events, and treatment-emergent adverse events for up to four weeks after the treatment ends, which totals approximately 10 weeks of follow-up. These assessments help determine the safety and efficacy of MANP in this population.