Springville

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Researchers are evaluating the adaptation and implementation of an innovative clinical decision support CDS tool called ePNa, originally validated in emergency departments, for use in urgent care clinics to improve pneumonia diagnosis and treatment. This study aims to combine ePNa with Stanfords CheXED artificial intelligence model to classify chest images quickly and accurately. The goal is to enhance pneumonia care in ambulatory settings where high patient volumes may benefit from updated and efficient diagnostic tools, especially as COVID-19 evolves. The study involves adapting ePNa for use in urgent care clinics by modifying it to work with the more limited patient data available in these settings and incorporating a chest imaging prompt. The combined ePNa-CheXED tool will be piloted among super user clinicians during clinic shifts. One of two clusters of urgent care clinics will receive the adapted tool, while the other will serve as usual care control. Additionally, a physician survey will assess clinicians experiences with ePNa-CheXED six months after implementation. Participants will be patients aged 12 and older diagnosed with pneumonia, confirmed by radiographic imaging. Physicians and advanced practice clinicians in selected urgent care clinics will also participate by completing surveys. The study will monitor outcomes including the accuracy of pneumonia diagnosis, changes in transfer rates to emergency departments, unplanned subsequent ED visits or hospitalizations, and overall healthcare resource use. The study will continue for up to three years, with ongoing evaluation of ePNa use and impact in the urgent care clinical environment.

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.

This research aims to assess the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have severe alopecia areata, characterized by 50% or greater scalp hair loss. The study includes a double-blind, randomized, placebo-controlled treatment phase followed by an open-label extension. The goal is to better understand how well deuruxolitinib works and how safe it is for this age group with significant hair loss. Participants will be randomly assigned to receive either deuruxolitinib tablets or matching placebo tablets taken orally twice daily for 24 weeks during the initial treatment period. Following this, all participants will have the opportunity to receive deuruxolitinib for an additional 52 weeks in an open-label extension phase. This design allows comparison of the drug to placebo and longer-term evaluation of the drugs effects. Throughout the study, participants will have regular assessments of their hair loss using the Severity of Alopecia Tool SALT at multiple time points up to week 24 and beyond. Safety will be closely monitored by tracking side effects, vital signs, heart tests, lab results, and physical exams. Additional measurements include patient and clinician impressions of improvement, quality of life, and mental health assessments. The total study duration can extend up to 76 weeks of treatment plus safety follow-up to fully evaluate outcomes and tolerability.

Researchers are conducting a prospective non-interventional study to better understand the needs and experiences of adolescent and adult patients with atopic dermatitis AD who start or switch any systemic treatment. The study aims to assess patient journeys and evaluate the safety and clinical outcomes of systemic AD treatments in real-world settings across multiple countries and geographical regions. Patient-specific factors such as age, skin color, flare triggers, previous treatment responses, comorbid conditions, and lesion characteristics will be studied to gain a broad understanding of treatment impact. Participants in this observational study will be those who initiate or switch systemic treatments for AD, including biologics, oral Janus kinase JAK inhibitors, cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil, based on country-specific prescribing information and standard of care. Treatments will be prescribed by investigators according to usual medical judgment, without any experimental intervention from the study. This study will follow participants for up to five years to observe treatment patterns and outcomes. During the study, participants will have their treatment utilization, treatment duration, switching, dose modifications, and reasons for changes recorded. Researchers will also measure changes in the severity and extent of AD using tools like the Eczema Area and Severity Index EASI, Body Surface Area BSA, Investigators Global Assessment, and patient-reported outcomes such as itch, skin pain, sleep disturbance, and overall disease control. Other assessments include quality of life, work productivity, comorbid conditions, and adverse events. The study will provide long-term observational data over a period of up to 60 months.