Tenri

Researchers are evaluating the safety and effectiveness of nipocalimab compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab. This Phase 2/3 study focuses on delaying disease relapse in this patient group, based on diagnosis criteria from the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021. Participants are adults diagnosed with progressing or relapsing forms of CIDP and with active disease as indicated by specific disability scores. Participants will receive either nipocalimab or a placebo, both administered intravenously. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple stages, including a withdrawal phase to observe the time to first relapse over up to 52 weeks. Nipocalimab dosing details and treatment schedules are managed to compare its effects against placebo in maintaining disease control. During the study, participants will undergo regular assessments to monitor their condition and response to treatment. Researchers will track the time until a relapse event occurs, alongside safety monitoring. Eligibility is confirmed by disability scoring and disease activity evaluations. The study includes ongoing evaluation of participant health and safety, ensuring comprehensive data collection over the treatment and observation periods.

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.