Pasadena

Researchers are conducting a phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate camoteskimab in adults with moderate-to-severe atopic dermatitis. The study includes both treatment-naive participants and those who have had an inadequate response to previous biologic therapies, aiming to assess the effectiveness and safety of camoteskimab for this condition. The study has two parts. In Part 1, lasting 24 weeks, participants are randomly assigned to receive one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, which is an extension period, all participants will receive camoteskimab. This design allows comparison of different doses and the placebo before all receive the active treatment. Participants will undergo regular assessments including evaluation of eczema severity, body surface area affected, and itch intensity using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Researchers will monitor changes from baseline over 24 weeks. Safety and adherence will be closely followed throughout the study, which is planned to continue until April 2028.

Researchers are evaluating the use of Orion17, a dual-layer amniotic membrane allograft, in addition to standard wound care for people over 50 years old with diabetic foot ulcers. The study aims to compare the healing outcomes between those receiving standard wound care alone and those receiving standard care plus the amniotic membrane allograft. The main goal is to determine the rate of complete wound closure after 12 weeks of treatment. Participants will be randomly assigned to one of two groups one receiving standard wound care, which includes surgical cleaning, infection screening, weekly collagen alginate dressings, and off-loading devices and another receiving the same standard care plus weekly applications of the Orion17 amniotic membrane allograft. The treatment period lasts 12 weeks, during which wound healing progress is closely monitored. Throughout the study, participants will visit their doctor weekly for wound assessments and to complete quality of life questionnaires. Researchers will measure outcomes such as incidence and time to complete wound closure, changes in wound size, quality of life improvements, and record any adverse events. Follow-up monitoring continues for six months after treatment to track wound recurrence and other health events, ensuring comprehensive evaluation of the treatments over time.

Researchers are evaluating a new home-based neuromodulatory platform called Computerized Chemosensory-Based Orbitofrontal Networks Training for Pain CBOT-P in adults with chronic low back pain CLBP. This Phase II randomized clinical trial aims to assess the short- and long-term effects of CBOT-P on pain severity, negative mood, cognitive function, and brain structure, comparing it to a sham device. The study focuses on improving pain and related symptoms while monitoring brain changes over six months. Participants will be randomly assigned to use either the CBOT-P device, which delivers olfactory stimulation with beta-caryophyllene BCP, or a sham CBOT device without the active ingredient. Treatment involves daily use of the assigned device for six months. Brain MRI scans will be taken at the start and after six months to evaluate structural changes. Pain, mood, cognitive abilities, sleep, and physical function will be regularly assessed throughout the study. During the trial, participants will complete assessments at baseline, and at months 1, 3, and 6, including patient-reported pain and mood scales, cognitive tests, and wearable sleep monitoring. Weekly mobile health prompts will encourage participants to report their pain, affect, sleep, and function. The study also collects user experiences to refine the product and aims to support future regulatory approval and commercial availability. The total participation time is six months with ongoing safety monitoring.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.