This is a Phase 3, open-label, follow-up study to evaluate the long-term safety,
tolerability, and efficacy of sotatercept when added to background PAH therapy for the treatment of PAH. Participants enrolled in this study are from the following parent studies: PULSAR, SPECTRA, STELLAR, HYPERION, and ZENITH. Participants eligible to enroll in this study will have participated in and completed the requirements of the MK-7962-004 study (Amendment 07 or later). In this study, participants will receive open-label sotatercept . The duration of participation for each participant will vary based on their enrollment date, but it is anticipated to be up to 3 years.
The main reason for this research study is for researchers to evaluate the relationship between congenital heart disease and development. Currently, there is not enough long-term information available to researchers to predict a child's development if they have been diagnosed with Ductal Dependent Pulmonary Blood Flow (DDPBF), a type of congenital heart disease.
This is an open-label, long-term study assessing the safety and efficacy of abrocitinib in participants aged 2 years and older with moderate-to-severe AD. It includes an extension cohort and a de novo cohort to meet regulatory requirements for a minimum of 300 participants exposed to 52 weeks of abrocitinib. Extension cohort participants must have completed 16 weeks of treatment in parent studies B7451023 or B7451030 and remain eligible. De novo cohort participants must be aged 6 to under 12 years at enrollment and not have participated in previous abrocitinib studies. Enrollment for the de novo cohort will begin after enrollment in Study B7451023 is complete. The study will have two periods lasting up to 2 years or until commercial availability, whichever comes first. All participants will receive abrocitinib oral suspension.
This study is for patients who have been diagnosed with prostate cancer that is prostate-specific membrane antigen (PSMA)-positive and has spread despite treatment with another androgen receptor pathway inhibitor (ARPI). This study is testing an investigational drug called AAA817. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In this study, participants will be randomly assigned (like flipping a coin) to receive AAA817 alone, AAA817 with an androgen receptor pathway inhibitor (ARPI), or standard of care treatment. The primary purpose of this study is to determine whether AAA817, given alone or in combination with an ARPI, is safe and effective compared to standard of care treatments. This drug is given to participants as a radioligand therapy infusion. Participants in this study can expect to be in the study for up to 6.1 years, including two visits before starting treatment, visits every 4 weeks during treatment, and visits every 12 weeks during long-term follow-up for up to 5 years after treatment ends.. There will be a total of 9 patients enrolled locally.
This Phase III trial aims to investigate the efficacy and safety of survodutide (BI 456906) once weekly versus placebo on defined as resolution of steatohepatitis, reduction of liver fibrosis in liver biopsy and long-term improvement in clinical liver outcomes observed in trial participants with MASH and fibrosis stage F2-F3.