Vereeniging

Researchers are evaluating SAR448501DR-0201 in adults with select autoimmune rheumatic diseases, including systemic lupus erythematosus SLE and rheumatoid arthritis RA. This open-label, phase 1 study aims to find optimal doses by studying safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial clinical responses. The study is sponsored by Sanofi and involves patients who meet specific disease activity and treatment history criteria. Participants will receive SAR448501 for up to 71 days, with multiple dose levels tested across different cohorts. Following treatment, a 42-week follow-up period will monitor participants, and if needed, visits will continue every 4 weeks until their blood B cells return to near-normal levels. This multi-ascending dose design allows careful observation of effects at increasing doses. Throughout the approximately 13-month participation, individuals will undergo screening, treatment, and extended follow-up. Assessments include monitoring adverse events, pharmacokinetic parameters, anti-drug antibodies, and clinical responses. Safety evaluations cover treatment-emergent adverse events and clinically significant abnormalities up to one year after treatment. Participants will have regular visits and blood tests to track progress and safety.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years with severe uncontrolled asthma. These children are already on medium to high doses of inhaled corticosteroids and at least one other asthma controller medication. The study is a phase 3, randomized, double-blind, placebo-controlled trial aimed at assessing tezepelumabs impact on asthma control and safety in this pediatric population. Participants will be randomly assigned in a 21 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo over a 52-week double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in period. After the treatment phase, there is a 12-week off-treatment follow-up for those not continuing. Additionally, an optional 104-week open-label extension allows eligible participants to receive tezepelumab, followed by another 12-week post-treatment follow-up. Throughout the study, participants will undergo regular assessments including lung function tests, asthma control questionnaires, symptom diaries, and blood tests to measure inflammation and immune response. Researchers will monitor asthma exacerbations, medication use, quality of life, and any side effects. Safety will be tracked during treatment and follow-up periods, with total study involvement potentially lasting over three years for those in the extension phase.