Leutershausen

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Researchers are evaluating RAY121, an inhibitor of the classical complement pathway, in a Phase 1b basket trial involving patients with various immunological diseases including antiphospholipid syndrome, bullous pemphigoid, Behets syndrome, dermatomyositis, immune-mediated necrotizing myopathy, and immune thrombocytopenia. This study aims to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of multiple doses of RAY121 in these patient populations. All enrolled patients will receive multiple doses of RAY121 administered by injection. The study is designed as a single-group trial where participants receive the experimental treatment without comparison to placebo or other interventions. Treatment monitoring and assessments will continue up to 32 weeks following the baseline visit to evaluate the effects and behavior of the drug in the body. Participants will be involved in regular assessments including monitoring for adverse events, measurement of drug concentration and activity, complement pathway activity, and antibody formation against RAY121 from baseline through week 32. The study includes safety evaluations and collection of pharmacokinetic and pharmacodynamic data to understand how the drug works and is tolerated over time. The total participation duration may last up to 32 weeks with ongoing monitoring throughout this period.