Buford

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with Cutaneous Lupus Erythematosus, including Subacute and Chronic forms. The study focuses on participants who have active disease and have not responded adequately to conventional treatments. This Phase 2b trial aims to better understand how IMVT-1402 performs compared to a placebo in this patient group. The study includes three treatment periods. In Period 1, participants are randomly assigned to receive either IMVT-1402 Dose 1 or a placebo injection once weekly for 12 weeks. In Period 2, all participants who finished the first period receive IMVT-1402 Dose 1 once weekly for 14 weeks. In Period 3, after completing Period 2, participants are re-randomized to receive either IMVT-1402 Dose 1 or Dose 2 weekly for 26 weeks. All treatments are given as subcutaneous injections. Participants will be involved for about 61 weeks total. Researchers will measure changes in disease severity using the Cutaneous Lupus Erythematosus Disease area and Severity Index (CLASI-A) score from the start to Week 12. Throughout the study, safety and tolerability will be monitored, along with other assessments to track disease activity and participant health.

Researchers are evaluating the safety, efficacy, and pharmacokinetics of ferumoxytol for treating iron deficiency anemia (IDA) in children aged 2 to under 18 years. This Phase 3, randomized, open-label, multicenter study includes male and female pediatric subjects with IDA or those considered at risk for developing IDA. The study excludes children with chronic kidney disease (CKD), who are studied separately. Participants will be randomly assigned in a 2:1 ratio to receive either ferumoxytol or iron sucrose, with age groups stratified as 2 to under 6 years, 6 to under 12 years, and 12 to under 18 years. Ferumoxytol is given as two intravenous doses of 7 mg iron per kilogram (max 510 mg per dose) with the second dose 2 to 8 days after the first. Iron sucrose is given as five intravenous doses of 4 mg iron per kilogram (max 200 mg per dose), starting on Day 1, with subsequent doses at least weekly and up to three times per week. Participants are monitored for at least one hour after each infusion. During the approximately 5-week study period, researchers will assess blood hemoglobin levels, monitor for adverse events, and conduct other safety evaluations. The main measurement is the change in hemoglobin from the start of the study to Week 5. Participants will have ongoing assessments and safety monitoring throughout the study to evaluate treatment effects and tolerability.

This research aims to collect ongoing safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis used by patients with lower extremity pareses. The study follows patients who have been casted for a C-Brace fitting and consent to participate, focusing on documenting their progress and experiences over time with this device. The C-Brace device includes custom thigh, calf, and foot components connected by an ankle joint and sensor system that continuously monitors knee joint movement. This allows the device to adjust resistance and control knee flexion and extension during walking. Participants will receive standard care including baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after final fitting. Participants will undergo assessments such as walking speed tests, mobility and balance evaluations, and balance confidence questionnaires to measure changes from baseline. The study also tracks device-related adverse events, especially falls, to monitor safety over 12 months and beyond. The total follow-up period extends up to 36 months to provide comprehensive data on long-term use.