Kirksville

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 remibrutinib, a new treatment option, in patients with chronic spontaneous urticaria (CSU) who have inadequate control with their current antihistamine therapies. This prospective, multi-country, non-interventional study aims to collect real-world data on the effectiveness and safety of remibrutinib across a broad clinical population. The study is part of the REASSERT global program and accommodates country-specific protocols to address local treatment guidelines and practices. Participants are grouped based on their current treatment and decision to escalate or switch their therapy to remibrutinib or higher doses of sgH1-AHs. The study observes patients who either escalate their current antihistamine treatment or switch to remibrutinib according to local labeling. Enrollment only occurs before starting the next treatment step to capture baseline clinical status. Some countries may modify the protocol to comply with local regulations, such as prohibiting prospective monitoring of off-label antihistamines. During the 24-month follow-up, participants regularly complete assessments including the Urticaria Control Test (UCT), Urticaria Activity Score over 7 days (UAS7), and the Dermatology Life Quality Index (DLQI). Data from all participating countries will be pooled for global analysis. Researchers will monitor effectiveness and safety outcomes, including UCT7 and UAS7 scores at 12 weeks after starting remibrutinib treatment, while participants provide electronic diaries and patient-reported outcome data throughout the study.

Researchers are conducting a prospective, non-interventional study focused on patients with chronic spontaneous urticaria (CSU). The study evaluates the real-world effectiveness and safety of remibrutinib, a new treatment option, in clinical practice. It involves patients who have already had the decision made to either increase their current second-generation H1-antihistamines (sgH1-AHs) treatment or switch/escalate their treatment to remibrutinib. This US sub-study is part of a larger global program called REASSERT, which collects data from multiple countries to support evidence needs for this condition. Participants are grouped based on their treatment history and decisions made prior to enrollment. One group includes patients with inadequate control of CSU despite standard doses of sgH1-AHs who will escalate this treatment. Another group includes patients switching to remibrutinib after inadequate control on licensed or escalated doses of sgH1-AHs. A third group includes those who have received other treatments besides H1-AHs and are switching to remibrutinib. Importantly, patients must not have started their next treatment step before enrollment, ensuring baseline data reflects their clinical status before starting the new or escalated treatment. During the 24-month follow-up, researchers will collect data including patient-reported outcomes recorded electronically to monitor treatment effectiveness and safety. The primary outcome measure is the Urticaria Activity Score over 7 days (UAS7) assessed 12 weeks after starting remibrutinib. The study also requires patients to provide informed consent and be willing to complete the full follow-up period. Monitoring includes real-world data collection without intervention by the study team, reflecting routine clinical practice.

Researchers are conducting a prospective non-interventional study to better understand the needs and treatment experiences of adolescents and adults with atopic dermatitis (AD). The study aims to assess safety and clinical outcomes of systemic AD treatments in real-world settings while exploring patient-specific factors such as age, skin color, flare triggers, previous treatment responses, comorbidities, and lesion characteristics. This study will take place across 10 countries in 4 geographic regions and will follow participants for 5 years. Participants who have a confirmed diagnosis of AD and are at least 12 years old will be included if they are prescribed and scheduled to start any systemic treatment for AD, including biologics, oral Janus kinase inhibitors, cyclosporine, and other immunosuppressants. The study involves monitoring patients who initiate or switch systemic treatments to evaluate treatment patterns over time. During the study, researchers will track a range of outcomes from baseline through up to 60 months, including the number of participants using AD treatments, treatment duration, treatment changes, and reasons for starting, interrupting, switching, or stopping treatments. Disease severity and control will be measured by tools like the Eczema Area and Severity Index and atopic dermatitis control tests. Patient-reported outcomes such as itch, skin pain, sleep disturbance, and overall severity impressions will also be assessed. The long follow-up allows for observing remission and the evolving treatment journey in diverse patients.