Guarda

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating whether adding tucatinib to trastuzumab and mFOLFOX6 works better than the current standard treatments for people with HER2 positive metastatic colorectal cancer. This study focuses on participants whose cancer has spread or cannot be removed by surgery. The trial also monitors side effects that might occur from taking these drug combinations. Participants are randomly assigned to one of two groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every three weeks and mFOLFOX6 chemotherapy every two weeks. The other group receives standard care, which includes mFOLFOX6 alone or combined with bevacizumab or cetuximab given by intravenous infusion. The study treatments continue as per the assigned schedule. During the study, participants undergo regular scans and evaluations to measure progression-free survival and other outcomes up to approximately three years. Researchers also assess overall survival, response rates, duration of response, quality of life, and side effects for up to about six years. Safety monitoring continues for around one year after the last treatment. Participants are closely followed to understand the impact of these treatments on their cancer and well-being.

Researchers are evaluating the efficacy, safety, and tolerability of folate-based liposomes encapsulating methotrexate FBL-MTX administered by subcutaneous injection in patients with moderate-to-severe active rheumatoid arthritis RA. This Phase IIa proof-of-concept study focuses on patients who are either new to disease-modifying antirheumatic drugs DMARD-nave or have had an inadequate response or intolerance to oral methotrexate. The study aims to explore whether the subcutaneous route offers a patient-friendly treatment with comparable efficacy. The study treatment involves administering FBL-MTX by subcutaneous injection with dosing adjusted based on clinical response. DMARD-nave patients start with a 1 mg dose, which can be increased every four weeks over 12 weeks up to a maximum of 2.5 mg every two weeks. Patients with an inadequate response or intolerance to oral methotrexate start at 2.5 mg, with similar dose titration. The treatment period includes eight visits spaced two weeks apart. Participants will be screened within 28 days before treatment to confirm eligibility. During the study, assessments will include disease activity scores such as DAS28-CRP, clinical response criteria ACR20, ACR50, ACR70, and quality-of-life questionnaires over 14 weeks. Safety monitoring includes tracking adverse events and laboratory tests. The total study duration for each participant spans from screening up to week 14 of treatment evaluation.

Researchers are evaluating VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, for preventing recurrence of Clostridioides difficile infection CDI. This Phase 3, randomized, double-blind, placebo-controlled trial aims to assess the safety and rate of CDI recurrence eight weeks after treatment. The study includes participants with either recurrent CDI or primary CDI at high risk of recurrence, comparing VE303 to a placebo. Participants receive either VE303 or placebo capsules three times daily for 14 days, following 10 to 21 days of standard antibiotic treatment for CDI. VE303 capsules contain the active live bacteria, while placebo capsules contain inactive ingredients and look identical. The study is divided into two stages focusing on recurrent CDI and high-risk primary CDI populations. During the trial, participants are monitored for CDI recurrence over eight weeks, with assessments including stool sample testing and symptom tracking. The study evaluates the effectiveness of VE303 in preventing CDI from returning after initial antibiotic treatment, while monitoring participant safety. Total participation time includes the treatment period plus follow-up to week 8.