Springville

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Researchers are evaluating a clinical decision support (CDS) tool called ePNa, originally designed for emergency departments, to improve pneumonia diagnosis and treatment in urgent care clinics in Utah. This study focuses on adapting ePNa for use in urgent care centers (UCCs), where pneumonia patients are frequently seen, and combining it with Stanford's CheXED artificial intelligence model to enhance chest image analysis. The goal is to implement and test this adapted tool to support clinicians in making accurate and timely pneumonia care decisions, especially as diagnostic and treatment methods evolve during the COVID-19 pandemic. The study involves adapting ePNa to fit the data limitations and workflow of urgent care clinics, incorporating AI-based chest image classification that provides results in less than one second. The adapted tool will be piloted with selected "super user" clinicians and then deployed to one of two randomly chosen UCC clusters, while the other cluster continues usual care. The implementation process will follow the CFIR framework for best practices in integrating new clinical tools, including identifying barriers and facilitators through focus groups, interviews, and workflow observation. Participants include pneumonia patients aged 12 years and older with specific diagnostic codes, and clinicians working in the selected urgent care clinics. The study will collect data on pneumonia diagnosis accuracy, patient transfers to emergency departments, and safety outcomes like unplanned hospital visits and mortality within 30 days. Physician surveys will assess user experience with ePNa. The study is planned to last up to three years, with ongoing monitoring of how ePNa impacts urgent care clinical environments.

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 the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have severe alopecia areata with 50% or more scalp hair loss. This Phase 3 study includes participants with a current alopecia areata episode lasting between 6 months and 10 years. The goal is to assess how well deuruxolitinib works compared to a placebo in improving hair regrowth and to monitor its safety in this age group. Participants will be randomly assigned to receive either oral deuruxolitinib tablets at a dose of 8 mg or matching placebo tablets during a 24-week double-blind treatment period. After this period, all participants can join an open-label extension lasting 52 weeks, during which they will receive deuruxolitinib. This design allows researchers to evaluate the drug's effects over both the initial treatment and a longer-term period. Throughout the study, participants will undergo evaluations including measuring scalp hair loss using the Severity of Alopecia Tool (SALT) score, monitoring for adverse events, checking vital signs, conducting electrocardiograms, lab tests, and physical exams. The main outcome is the percentage of subjects achieving a SALT score of 20 or less at week 24. Safety and tolerability will also be assessed throughout the 24 weeks. Participants are expected to comply with study visits and procedures during the entire study duration.