Santos

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment for reversing anticoagulation in adults treated with Factor Xa inhibitors who need urgent surgery or invasive procedures. This Phase 3 trial aims to assess the safety and effectiveness of TAK-330 in managing direct oral Factor Xa inhibitor-related coagulopathy in this urgent setting. Participants will be randomly assigned to receive either TAK-330 or the standard care 4F-PCC before their surgery. TAK-330 is given as a single intravenous infusion of 25 IU/kg on Day 1, with a possible additional dose if needed. The standard 4F-PCC dosing and infusion speed follow local protocols, with an option for an extra dose not exceeding 50 IU/kg or 5,000 IU during surgery if required. During the study, participants will be hospitalized for surgery and monitored closely. Researchers will assess the effectiveness of stopping bleeding during surgery and follow up with participants by telehealth or phone call 30 days after surgery. The study will track safety and hemostasis to understand the impact of the treatments on bleeding control and patient outcomes.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Researchers are evaluating how well elritercept works compared to epoetin alfa in treating anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who need regular red blood cell (RBC) transfusions. The study aims to see if elritercept can reduce the need for RBC transfusions, improve tiredness without transfusions, lower transfusion burden, and enhance quality of life. It also examines the immune response to elritercept and monitors its safety. Participants receive either elritercept or epoetin alfa as subcutaneous injections. The study is a phase 3, multicenter, randomized trial comparing the efficacy and safety of these two drugs. The treatment period lasts through 24 weeks, with each cycle lasting 28 days. Researchers monitor participants for RBC transfusion independence lasting at least 12 weeks and a significant increase in hemoglobin levels. During the study, participants undergo regular assessments including blood tests to measure hemoglobin and other blood counts. Researchers track transfusion needs and quality of life reports. Safety is carefully monitored throughout the trial. Participants are involved from screening through 24 weeks of treatment, with evaluations to measure the effectiveness of the treatments and any side effects.

Researchers are evaluating the safety and effectiveness of LY4268989 compared to a placebo in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on participants who have had UC for at least 3 months and have specific disease activity scores. The study aims to understand how well LY4268989 works in treating this condition over a long period. Participants will receive either LY4268989 or a placebo, both administered orally. The study includes a treatment period lasting up to approximately 108 weeks, not including the screening phase. Participants are monitored to assess their response to the medication, including whether they achieve clinical remission based on the Modified Mayo Score (mMS). During the study, researchers will conduct various assessments to monitor disease activity and participant safety. They will track the percentage of participants achieving clinical remission at Week 10 and among those who responded at Week 10, the remission status at Week 52. The study involves regular evaluations, including endoscopic confirmation of disease activity and safety monitoring over the entire duration.

Researchers are evaluating the safety and tolerability of an absorbable oxandrolone implant as an additional treatment during rehabilitation after anterior cruciate ligament (ACL) reconstruction surgery. This phase II, randomized, double-blind, placebo-controlled study compares oxandrolone implants to placebo implants in men and women aged 18 to 60 years. Oxandrolone, a steroid with strong muscle-building effects and fewer side effects, may help improve muscle mass, strength, and functional recovery after ACL surgery. The study also monitors the drug's serum and pharmacokinetic profile. Participants receive subdermal implants delivering oxandrolone or placebo. Men receive two 200 mg implants (total 400 mg), while women receive one 200 mg implant. The treatment starts after surgery, and participants continue standard rehabilitation. The study lasts for 24 weeks, during which the safety and potential benefits of the oxandrolone implant are assessed. During the study, participants undergo regular monitoring for serious adverse events related to treatment through spontaneous reports and clinical findings. Researchers evaluate muscle mass, strength, and functional capacity to explore oxandrolone's effectiveness. Safety assessments include laboratory tests and clinical evaluations. The total duration of participation is 24 weeks, during which adherence to rehabilitation and implant effects are closely observed.