New Baltimore

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

Alopecia areata AA is a condition where the immune system attacks hair follicles, causing hair loss mainly on the head and face but possibly on other body parts. This research evaluates the safety, effectiveness, and tolerance of upadacitinib, an approved drug, in adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled, double-blind trial enrolling about 1500 participants worldwide. Participants are randomly assigned to one of three groups receiving different treatments two doses of upadacitinib or placebo. In initial periods, some may switch from placebo to upadacitinib based on their Severity of Alopecia Tool SALT score. Those completing early parts may enter an extension phase receiving upadacitinib for up to 108 weeks. Treatment involves taking oral tablets once daily for up to 160 weeks, with possible re-randomization at Weeks 24 and 52. Throughout the study, participants attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers measure hair loss improvement using SALT scores and record adverse events over approximately 164 weeks. Participants are followed for up to 30 days after their last dose for safety monitoring.

The Vanguard Study is exploring the use of blood tests called multi-cancer detection MCD tests to screen for multiple cancers at once in adults aged 45 to 75 without cancer. The study aims to understand how these tests perform as cancer screening tools and how patients and doctors respond to test results. It also seeks to assess the feasibility of recruiting participants and collecting necessary data for a future larger trial. Participants are randomly assigned to one of three groups two groups receive different MCD tests Shield or Avantect with blood samples collected at enrollment and after one year, while a control group undergoes blood collection without MCD testing. Some sites provide test results to participants, and those with abnormal results are advised to follow up with their clinicians. After the one-year intervention period, all participants are monitored passively for up to 10 years. Throughout the study, participants complete questionnaires and provide blood samples as scheduled. Researchers collect medical record information and track follow-up adherence, test result return times, and diagnostic outcomes for abnormal results. The study measures feasibility outcomes, cancer detection accuracy, participant anxiety, and other effects related to the screening process. Participant follow-up and data collection may continue for up to 10 years after the intervention period ends.