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Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Researchers are evaluating the effectiveness and safety of FBL-MTX, a folate-based liposome encapsulating methotrexate, administered by subcutaneous injection in patients with moderate-to-severe active Rheumatoid Arthritis (RA). This Phase IIa proof-of-concept study aims to explore if this method provides a patient-friendly treatment with at least the same efficacy as existing options, focusing on patients who are either new to disease-modifying antirheumatic drugs (DMARD-nave) or who have not responded well or tolerated oral methotrexate. During the treatment period, participants will attend eight study visits every two weeks. DMARD-nave patients will start with a 1 mg dose of FBL-MTX subcutaneously, with doses adjusted based on clinical response every four weeks, up to a maximum of 2.5 mg every two weeks. Patients with inadequate response or intolerance to oral methotrexate will begin with a 2.5 mg dose, also titrated as needed. This dose-titration follows a treat-to-target strategy to optimize treatment. Participants will be monitored from screening through week 14, with evaluations of disease activity using measures like DAS28-CRP, Clinical Disease Activity Index, and Health Assessment Questionnaires at multiple time points. Researchers will assess how many reach remission or low disease activity, and track responses according to American College of Rheumatology criteria. Safety, tolerability, and quality of life assessments will also be part of the study to understand the overall impact of FBL-MTX treatment over the 14-week period.

Researchers are evaluating VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, to prevent recurrent Clostridioides difficile infection (CDI). This randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the safety and CDI recurrence rate at 8 weeks in participants receiving a 14-day course of VE303 or a matching placebo. The study includes two stages: one focusing on participants with recurrent CDI and the other on those with primary CDI at high risk of recurrence. Participants will receive either VE303 or placebo capsules that look identical and contain no active drug. The treatment lasts for 14 days, starting on the last planned day of standard antibiotic therapy for the qualifying CDI episode or within 2 days after completing antibiotics. Participants must have completed and responded to standard antibiotic treatment before receiving study medication. The study evaluates the effect of VE303 versus placebo on preventing CDI recurrence after antibiotic therapy. During the study, participants will be monitored through clinical evaluations to track CDI recurrence by Week 8, including stool samples tested for CDI. Safety and clinical response will be assessed throughout the study period. Participants are followed to ensure stability after the qualifying CDI episode and to monitor any complications or adverse events. The total participation duration includes treatment and follow-up through Week 8 to measure CDI recurrence rates and safety.