Bad Bramstedt

Researchers are studying depemokimab in adults with uncontrolled Hypereosinophilic Syndrome HES who are already receiving standard treatment. This phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter trial focuses on patients with a confirmed HES diagnosis, a history of at least two flares in the past year, and a high blood eosinophil count. The study aims to evaluate the frequency of HES flares over 52 weeks while maintaining participants on stable therapy. Participants will be randomly assigned in a 21 ratio to receive either depemokimab or a placebo, in addition to their existing standard of care treatment. The study lasts 52 weeks, during which participants continue their usual HES therapy alongside the study drug or placebo. The trial is designed to assess safety and efficacy with careful monitoring throughout. During the study, participants will undergo regular assessments including monitoring of HES flare frequency, time to first flare, and fatigue levels using the Brief Fatigue Inventory. Researchers will track clinical symptoms, blood eosinophil counts, and any adverse events. The total participation time is up to 52 weeks, with ongoing safety evaluations to understand the impact of depemokimab compared to placebo.

Researchers are evaluating real-world clinical and patient-reported outcomes in adults with systemic lupus erythematosus SLE who start treatment with subcutaneous anifrolumab. This non-interventional, multicenter study aims to observe disease activity, treatment goals like remission and low disease activity, quality of life, medication use, flares, and organ damage over two years. The study follows patients who have not previously used anifrolumab either subcutaneously or intravenously. Participants receive anifrolumab via subcutaneous injections as prescribed according to the European summary of product characteristics. This study is single-arm and non-interventional, meaning treatment decisions are made independently by doctors and not assigned by the study. The observation period lasts 24 months to capture long-term disease control, medication patterns, and organ damage development during routine care. During the study, patients will be regularly assessed for disease activity using tools such as the DORIS remission criteria and lupus low disease activity state LLDAS. Researchers will also evaluate patient-reported outcomes like quality of life and fatigue, and record changes in disease activity scores and damage indices. Data on treatment patterns and flare events will be collected throughout the 24 months, with safety and health monitored as part of routine visits.