Orlova 4

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 the effectiveness and safety of milsaperidone compared to a placebo when added to standard treatment in adults with Major Depressive Disorder (MDD). This Phase 3 study specifically focuses on patients who have not responded adequately to their current antidepressant therapy. The goal is to understand how milsaperidone might improve depression symptoms as an additional treatment option. Participants will receive either oral milsaperidone or an oral placebo alongside their existing antidepressant medications. The study is conducted in a randomized, double-blind, placebo-controlled, multicenter design, meaning neither participants nor researchers know who receives the actual drug or placebo during the trial. This setup helps ensure objective assessment of milsaperidone's effects. During the 6-week study period, researchers will monitor changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Assessments will include evaluating symptom improvements and safety measures to track any side effects. Participants will be followed closely to ensure adherence and to gather comprehensive data on the treatment's impact.

Researchers are investigating the effects of quizartinib compared to a placebo, both combined with chemotherapy, in adults newly diagnosed with FLT3-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). This phase 3 clinical trial focuses on overall survival as the primary outcome and involves testing participants for FLT3-ITD mutation status at a central laboratory using a validated assay. Participants will receive either quizartinib or placebo at a dose of 60 mg taken orally once daily. Both groups will also receive standard induction and consolidation chemotherapy using cytarabine and an anthracycline (daunorubicin or idarubicin). After chemotherapy, quizartinib or placebo will be administered as maintenance therapy for up to 36 cycles. During the study, participants will be monitored for overall survival up to approximately 42 months from when the first patient is randomized to reach the target number of deaths. The study involves regular assessments including treatment monitoring and safety evaluations throughout the induction, consolidation, and maintenance phases to evaluate the effect of quizartinib in this patient population.