Kirksville

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 remibrutinib in patients with chronic spontaneous urticaria CSU in a prospective, multi-country, non-interventional study. The study focuses on patients where the treatment decision to escalate current second-generation H1-antihistamines sgH1-AHs or switch to remibrutinib was made before enrollment. The goal is to collect real-world data on the effectiveness and safety of remibrutinib across diverse clinical practices, reflecting a broader patient population than typical clinical trials. The study follows an umbrella design allowing adaptations to local treatment guidelines and evidence needs across countries. Patients are grouped into cohorts based on their treatment history and decisions Cohort 1 includes those escalating sgH1-AH treatment due to inadequate control Cohort 2 includes those switching to remibrutinib Cohort 3 covers patients switching to remibrutinib with other prior treatments. Data are collected using tools like the Urticaria Control Test UCT, Urticaria Activity Score over 7 days UAS7, and Dermatology Life Quality Index DLQI. Participants will be monitored for up to 24 months with regular assessments of disease control, quality of life, angioedema activity, treatment patterns, and adverse events. Data will be gathered via electronic patient-reported outcomes and diaries to track symptoms and treatment adherence. The primary outcomes measured are UCT7 and UAS7 scores at 12 weeks after starting remibrutinib, with additional long-term measures to understand treatment effects and patient experiences.

Researchers are evaluating remibrutinib, a new treatment option for patients with Chronic Spontaneous Urticaria CSU, in a prospective, non-interventional study. The study focuses on patients whose treatment plan before joining has already been decided to either increase their current sgH1-AH treatment or switch to remibrutinib. This US sub-study is part of a larger global program called REASSERT, which aims to collect real-world effectiveness and safety data on remibrutinib in typical clinical settings. The study observes patients divided into three groups based on their treatment history and decisions those escalating their current licensed sgH1-AH dose due to inadequate control, those switching to remibrutinib after inadequate control despite licensed or escalated sgH1-AH doses, and those switching to remibrutinib after other treatments in addition to H1-AH. Treatment decisions are made independently of the study. No interventions are assigned by the study, as it is observational. Participants will be followed for up to 24 months, during which researchers will collect data on disease control using UAS7 and UCT7 scores at 12 weeks and throughout the study. Other measures include angioedema activity, use of rescue medications, quality of life questionnaires, healthcare resource use, and adverse events. Patients will provide information electronically, and the study will evaluate treatment patterns, adherence to guidelines, and long-term outcomes.

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.