San Rafael

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the effectiveness, safety, and how the body processes INM004 in children with Hemolytic Uremic Syndrome caused by infection with Shiga toxin-producing Escherichia coli (STEC-HUS). The study aims to see if adding INM004 to the usual treatment helps improve kidney function and reduce complications, mortality, and hospital stay time. This is a Phase III study focusing on pediatric patients with this condition. Participants will receive either INM004 or a placebo, both given as two intravenous infusions 24 hours apart. INM004 involves doses of Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab´)2 fragments calculated by the child's weight, infused over 50 minutes or 100 minutes for those with a body mass index over 30. The placebo matches the infusion schedule and appearance but contains no active drug. During the study, participants will be closely monitored for kidney function recovery over 28 days and other health outcomes. Assessments include laboratory tests for blood and kidney function, safety evaluations, and pharmacokinetics of INM004. Hospitalization will occur at the participating institution, with informed consent and pregnancy testing as part of the process. The study includes children from 9 months to under 18 years old and lasts through the acute phase recovery period.