Staudach Egerndach

Researchers are evaluating the optimal doses of the drug E2086 compared to placebo in adults with narcolepsy, a condition characterized by excessive daytime sleepiness EDS. The study focuses on reducing EDS as measured by the Mean Sleep Latency MSL using the first four maintenance of wakefulness tests MWTs. This Phase 2 trial includes participants diagnosed with either narcolepsy type 1 NT1 or type 2 NT2 within the last 10 years. Participants will be randomly assigned to receive either E2086 or a matching placebo tablet taken orally once daily for four weeks at low, middle, and high doses. Each dosing period is separated by a washout period of at least seven days, with a total treatment duration of approximately 14 weeks. This design allows comparison of the effects of different doses of E2086 on narcolepsy symptoms. During the study, participants will undergo assessments to measure changes in sleep latency, cataplexy episodes, and sleepiness scales. Additional safety evaluations include monitoring for adverse events, laboratory tests, vital signs, ECG parameters, and suicidality assessments. Blood samples will be collected to analyze drug concentration levels. The study involves regular monitoring up to Day 113 and aims to assess both efficacy and safety over the course of treatment and follow-up.

This research aims to evaluate the effects of Seladelpar on clinical outcomes in adults with Primary Biliary Cholangitis PBC who also have compensated cirrhosis. The study is a Phase 3 randomized, double-blind, placebo-controlled trial focusing on treatment outcomes for this liver condition. It is sponsored by Gilead Sciences and seeks to understand how Seladelpar may impact disease progression and survival in this specific patient group. Participants will be randomly assigned to receive either Seladelpar or a placebo daily for up to 36 months. Those with CP-A cirrhosis will take 10 mg capsules of Seladelpar, while those with CP-B cirrhosis will take 5 mg capsules. The placebo group will take one capsule daily as well. This long-term treatment period allows researchers to compare outcomes between the two groups effectively. During the study, participants will follow a schedule of assessments to monitor their health and response to the study drug. Researchers will measure outcomes such as event-free survival, overall survival, liver transplant-free survival, and time to hospitalization over 36 months. Safety and laboratory parameters will be regularly evaluated to ensure participant well-being throughout the trial.

Researchers are evaluating AZD9574 as a treatment for adults with advanced solid cancers that have returned or worsened after prior treatments. This phase IIIa study aims to assess the safety, tolerability, how the drug moves through and affects the body, and early signs of effectiveness of AZD9574 alone and combined with other cancer drugs. The study includes several modules focusing on different cancer types and drug combinations, enrolling approximately 695 participants. Participants will receive AZD9574 orally either alone or with other drugs such as temozolomide, trastuzumab deruxtecan, or datopotamab deruxtecan, depending on their cancer type and the study module. The study includes dose escalation phases to find appropriate dosing and dose expansion phases to further evaluate the treatments. Some participants will also be involved in a PET sub-study using intravenous 11CAZ1419 3391. Treatment cycles vary by module, with some lasting up to 12 cycles or longer. During the study, participants will undergo regular assessments including monitoring for adverse events, blood tests, imaging scans like MRI, and performance status evaluations. Researchers will measure changes in tumor size, response rates, progression-free survival, and specific biomarkers related to the cancers studied. Safety and drug levels in the body will be tracked from the first dose through approximately three years of follow-up. Participants may also provide tissue samples and undergo biopsies as part of the study evaluations.