Lujan De Cuyo

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are evaluating the clinical benefit of combining Navlimetostat BMS-986504, a selective MTA-cooperative inhibitor of PRMT5, with pembrolizumab and chemotherapy compared to placebo plus pembrolizumab and chemotherapy. This study focuses on participants with first-line metastatic non-small cell lung cancer NSCLC who have a homozygous MTAP deletion. The trial is a randomized Phase 23 study aimed at advancing treatment options for this specific lung cancer group. Participants will receive one of several combinations Navlimetostat plus pembrolizumab and chemotherapy, or placebo plus pembrolizumab and chemotherapy. Chemotherapy drugs involved may include cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on certain days. The study uses a quadruple-masked, parallel design with multiple treatment arms to compare these regimens. During the study, participants will be monitored for progression-free survival and overall survival up to five years. Researchers will assess tumor response, disease control, duration and time to response, and safety through adverse event reporting and laboratory tests. The study includes detailed follow-up to evaluate efficacy and safety outcomes over the long term, with a primary completion date in 2031.

The trial investigates the effects of a combination treatment using Fluticasone Furoate FF, Umeclidinium UMEC, and Vilanterol VI on lung function compared to a combination of FF and VI alone. The study focuses on adolescents aged 12 to 17 years with asthma that is not adequately controlled despite stable maintenance therapy with inhaled corticosteroids and long-acting beta2-agonists. The research aims to assess efficacy, safety, tolerability, and pharmacokinetics over a 24-week period in this age group. Participants receive either the FFUMECVI combination or the FFVI combination, both administered via the ELLIPTA inhaler. The study is randomized, double-blind, and conducted in parallel groups. Treatments are given daily, and the trial lasts for 24 weeks to monitor the effects on lung function and asthma control. During the study, participants undergo lung function tests measuring forced expiratory volume in 1 second FEV1 at the start and after 24 weeks. Additional assessments include asthma control questionnaires at baseline and week 24 to evaluate changes in symptoms. Safety and tolerability are monitored throughout, with the total participation lasting 24 weeks.

Researchers are evaluating the effectiveness, safety, and tolerability of a vaccine designed to reduce Clostridioides difficile C. difficile infections in adults aged 65 years and older. This phase 3 study compares the vaccine to a placebo in a group of older adults who have recent or planned contact with healthcare systems or recent antibiotic use. The purpose is to understand how well the vaccine works to prevent infections and to monitor any side effects or reactions. Participants will receive either the C. difficile vaccine or a placebo shot injected into the upper arm muscle. The study is randomized, double-blinded, and placebo-controlled. The vaccination period includes two doses and participants will be monitored for up to about three and a half years. Follow-up includes three planned clinical visits and three phone visits initially, then yearly clinic visits until the study ends. Participants are asked to report and save stool samples if they experience three or more loose stools in 24 hours to check for possible infection. During the study, researchers will track local and systemic reactions to the vaccine within seven days after each shot, adverse events up to one month after each vaccination, and serious adverse events for up to 18 months after the last dose. The main measurement is the occurrence of medically attended primary C. difficile infections from two weeks after the second vaccination through the surveillance period. Safety monitoring and annual visits will continue until the study is completed, which could be sooner or later depending on infection rates.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.