Payson

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab in adults with moderate to severe chronic spontaneous urticaria (CSU) that is not adequately controlled by second generation H1-antihistamines (sgH1-AHs). This Phase 3b, multi-center, randomized, double-blind, double-dummy study is conducted in the US and focuses on early treatment effects at 4 weeks and earlier. The study includes a screening period of up to 4 weeks, followed by a 12-week core treatment period where about 400 participants are randomly assigned to receive either remibrutinib (25 mg twice daily by mouth) with a placebo injection or dupilumab (a 600 mg loading dose followed by 300 mg every 2 weeks by injection) with a placebo tablet. All participants continue their stable dose of sgH1-AH during this period, with the option to add rescue doses if needed, not exceeding four times the standard dose per day. After the core period, participants may join an optional open-label extension to receive remibrutinib for an additional 12 weeks if the drug is not commercially available. Participants will complete daily diaries and regular assessments to track urticaria symptoms and treatment effects. Researchers will measure changes in the Weekly Urticaria Activity Score (UAS7) from the start to Week 4. Safety follow-up will occur for 12 weeks after treatment ends, with phone calls and site visits as needed, continuing longer if participants join the extension. The total study duration includes screening, treatment, optional extension, and safety follow-up phases.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.