Vereeniging

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating SAR448501/DR-0201, a bispecific antibody, in adult patients with specific autoimmune rheumatic diseases, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). This phase 1, open-label study aims to find optimal dose(s) by assessing safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical response. The study involves adults aged 18 to 75 years who meet specific disease activity and treatment history criteria. Participants receive multiple ascending doses of SAR448501 during a 71-day treatment period. The study includes a screening period of up to 28 days before treatment and a 42-week follow-up period after treatment. If needed, participants continue visits every 4 weeks after the study ends until their peripheral blood B cells return to at least 80% of the lower limit of normal or their baseline level. Throughout the study, participants undergo assessments for treatment-emergent adverse events and clinically significant abnormalities from baseline to week 52. Researchers monitor safety and activity through clinical evaluations, including disease activity scores and laboratory tests. The total participation time is approximately 13 months, covering screening, treatment, and follow-up phases.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years who have severe uncontrolled asthma. These children must be on medium to high doses of inhaled corticosteroids along with at least one other asthma controller medication, with or without oral corticosteroids. This phase 3, multicenter, double-blind, placebo-controlled study aims to better understand how tezepelumab affects asthma control in this pediatric population. Participants will be randomly assigned in a 2:1 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo for 52 weeks during the double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in phase. After the treatment period, a 12-week follow-up phase occurs without treatment. Eligible participants can then join an optional open-label extension, receiving tezepelumab for an additional 104 weeks followed by another 12-week post-treatment follow-up. Throughout the study, participants will have regular assessments including lung function tests, asthma control questionnaires, and monitoring for asthma exacerbations. Researchers will measure the annualized rate of severe asthma flare-ups from the start of treatment to week 52. Safety and treatment adherence will also be closely monitored during all study phases, with total participation potentially extending over two years for those in the extension period.