Bad Bramstedt

Researchers are evaluating depemokimab for adults with uncontrolled Hypereosinophilic Syndrome (HES) who are already receiving standard care treatment. This Phase 3 study is a 52-week, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants must have a confirmed HES diagnosis, be on stable therapy for at least 4 weeks before randomization, have experienced at least two disease flares in the past year, and have a blood eosinophil count of at least 1,000 cells/µL during screening. Historical flares are defined by worsening symptoms or increased eosinophils that require treatment changes. Eligible participants will be randomly assigned in a 2:1 ratio to receive either depemokimab or a matching placebo, while continuing their usual HES therapy. The study medication will be administered alongside standard care to assess the drug’s effect on reducing HES flares over the course of one year. During the study, participants will be monitored regularly for flare frequency, safety, and treatment effects. Researchers will collect data on the number of HES flares up to 52 weeks. Safety assessments and clinical evaluations will be conducted throughout the study to understand how participants respond to the treatment and to monitor any adverse events.

Researchers are evaluating the real-world effects of subcutaneous anifrolumab treatment in adults with systemic lupus erythematosus (SLE) who have not previously used anifrolumab. This non-interventional, prospective, multicenter study aims to assess disease activity, patient quality of life, medication use, flares, and organ damage over a 24-month period in routine clinical care settings. Participants will receive subcutaneous anifrolumab according to European prescribing guidelines, with treatment decisions made independently of the study. This observational study does not involve additional interventions but follows patients receiving this therapy as part of their regular care. During the 24-month observation, participants will undergo clinical evaluations and report outcomes related to disease activity, remission status, quality of life, medication patterns, and organ damage progression. Researchers will measure the proportion of patients achieving remission according to the DORIS criteria at 24 months, alongside monitoring flares and other important clinical outcomes.