Leutershausen

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early effectiveness of RAY121, a drug that inhibits the classical complement pathway, in adults with various immune system diseases. These diseases include antiphospholipid syndrome, bullous pemphigoid, Behçet's syndrome, dermatomyositis, immune-mediated necrotizing myopathy, and immune thrombocytopenia. This is a Phase 1b basket trial designed to study multiple conditions within one protocol. Participants receive multiple doses of RAY121 administered by injection. The study does not specify different treatment groups or comparators, focusing on the investigational drug alone. The trial includes detailed eligibility criteria for each disease group to ensure appropriate patient selection. The study monitors participants during treatment and may include assessments tailored to each disease's features. During the study, researchers will observe participants from baseline through week 32 to track adverse events and other safety measures. They will assess how the drug is processed and affects the body, including immune responses. Various tests and evaluations related to each disease will be performed to understand the drug's impact and tolerability over time. The total duration of participation includes all scheduled visits and monitoring up to week 32.