Lajeado

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the use of adjuvant chemotherapy in patients with locally advanced cervical cancer who test positive for cell-free human papillomavirus deoxyribonucleic acid (cfHPV-DNA) in their plasma after standard treatment. This Phase 3, randomized, multicenter clinical trial aims to determine if patients with persistent cfHPV-DNA expression after chemoradiotherapy can benefit from additional chemotherapy. The study includes patients with cervical cancer stages IB3 to IVA who have completed standard concomitant chemoradiotherapy.

Researchers are investigating a treatment approach for patients hospitalized with community-acquired pneumonia (CAP), a condition with high rates of illness and death. This phase 3 trial compares therapeutic-dose heparin versus usual care pharmacological thromboprophylaxis to see if it improves patient outcomes. The study focuses on preventing complications caused by blood clots and inflammation that can worsen respiratory and organ function in CAP patients. Previous findings in COVID-19 pneumonia suggest heparin might reduce disease progression and mortality, but its effects in non-COVID-19 CAP are unknown. Participants will receive either therapeutic-dose heparin, preferably a low molecular weight heparin (LMWH) like enoxaparin, dalteparin, or tinzaparin, dosed by patient weight unless contraindicated. Intravenous unfractionated heparin (UFH) may be used instead, especially for those with kidney issues, with dosing adjusted to specific blood clotting targets. The trial is open-label and randomized, with adaptive rules to monitor progress. Usual care pharmacological thromboprophylaxis is the comparator. Treatment and monitoring occur during hospital admission, anticipated to last at least 72 hours after randomization. During the study, patients are assessed for survival at 30 days and monitored for complications related to CAP. Researchers collect clinical data including oxygen use, laboratory tests, and adverse events, tracking safety and effectiveness. The study excludes patients with active COVID-19, recent bleeding, contraindications to anticoagulation, or those receiving critical care interventions. Overall participation depends on hospital stay length and clinical status, with follow-up to evaluate the primary outcome of survival within a month.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.