Toluca De Lerdo

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the effectiveness of iberdomide maintenance therapy compared to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in adults with newly diagnosed multiple myeloma. This phase 3 study aims to determine which maintenance treatment better supports patients following their initial transplant and induction therapies. Participants must have responded to prior treatments and undergone ASCT within specified time frames. Participants will receive either iberdomide or lenalidomide at specified doses on scheduled days as maintenance therapy after their ASCT. The study is randomized, multi-center, and open-label, meaning both participants and researchers know which treatment is given. The treatments will be administered following a standard induction therapy including proteasome inhibitors, immunomodulatory drugs, and possibly monoclonal antibodies, with or without consolidation after transplant. Throughout the study, participants will be monitored for progression-free survival for up to 6 years to assess how well the maintenance therapies prevent disease progression. Researchers will also evaluate safety and treatment response according to established myeloma criteria. Regular assessments will include clinical evaluations and monitoring for any signs of disease relapse or adverse effects over the long term.

Researchers are evaluating the safety, effectiveness, and drug levels of Deucravacitinib (BMS-986165) in adolescents aged 12 to less than 18 years with moderate to severe plaque psoriasis. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how this treatment affects this condition in younger patients. Participants must have had stable plaque psoriasis for at least six months and meet specific severity criteria. Participants will receive either Deucravacitinib or a placebo at specified doses on designated days. The study compares the drug to placebo to assess its impact on psoriasis symptoms. No additional details about dosing schedules are provided, but the intervention period includes monitoring drug levels and safety. This design allows researchers to evaluate the treatment in a controlled and blinded manner. Throughout the study, participants will be monitored for improvement in their psoriasis using measures like the Psoriasis Area and Severity Index (PASI) and the static Physicians Global Assessment (sPGA) at week 16. Safety will also be assessed. The primary outcomes include the number of participants achieving at least 75% improvement in PASI and those reaching clear or almost clear skin with a significant reduction in sPGA score. Participants are observed from screening through the intervention period with regular assessments to track efficacy and safety.

Researchers are evaluating adults with advanced small cell lung cancer (SCLC) in this study. The main goal is to see if adding a medicine called obrixtamig to the usual treatment, which includes atezolizumab, carboplatin, and etoposide, helps patients live longer compared to the usual treatment alone. Obrixtamig is an antibody-like drug that may support the immune system in fighting cancer. The study also tests a new medical device designed to measure levels of a tumor marker called DLL3. Participants are randomly assigned to one of two groups. One group receives obrixtamig along with the standard treatment, while the other group gets only the standard treatment. All medicines are given through a vein. Those receiving obrixtamig must stay overnight at the study site after their first two treatments with this medicine. Treatment continues as scheduled, following the same general approach for both groups. During up to three years of participation, patients regularly visit the study site for tumor size assessments and health checks. Researchers monitor side effects and compare the results between the two groups to determine treatment effectiveness. The main outcome measured is overall survival over this period.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with moderate to severe systemic primary Sjogren's disease. This Phase 2b study compares IMVT-1402 to a placebo using a double-blind, randomized, placebo-controlled design. The main goal is to see how the treatment affects disease activity scores over 24 weeks, with participation lasting up to 105 weeks. Participants receive either IMVT-1402 or placebo through weekly subcutaneous injections. The study carefully monitors changes in disease activity, focusing on a clinical score called clinESSDAI. The trial includes a long observation period to track both the treatment's effects and safety over time. During the study, participants undergo evaluations at the start and at week 24 to measure changes in their disease activity. Researchers will also monitor safety and tolerability throughout the entire study period. Participants are assessed for antibody status, salivary flow, and systemic disease activity to understand the impact of the treatment fully.

Researchers are investigating the effects of Nano-Pomegranate Seed Oil (NANO-PSO) compared to a placebo for managing vasomotor symptoms in women experiencing early menopause. Vasomotor syndrome, which includes symptoms like hot flashes, affects about 85% of postmenopausal women. Hormone therapy is the common first-line treatment, but many women cannot use it due to contraindications or side effects such as dryness and insomnia. This study aims to explore NANO-PSO, known for its antioxidant and neuroprotective properties, as a safer alternative for symptom control over six months. The study involves 90 women aged 45 to 55 years with early menopausal symptoms and a Menopause Rating Scale (MRS) score above 15 who have not previously received treatment for menopause symptoms. Participants are randomly assigned to receive either two capsules daily of NANO-PSO—pomegranate seed oil formulated with nanotechnology at 640 mg per capsule—or a matching placebo for 60 days. The total follow-up period is 120 days with evaluations occurring at baseline, three months, and six months. Participants will be closely monitored through clinical visits where vasomotor symptoms are assessed using the Menopause Rating Scale, as well as other measures including FSH hormone levels, the Pittsburgh Sleep Quality Index, and the STRAW+10 staging system. Researchers will track symptom changes and treatment response over time, focusing on safety and effectiveness. The goal is to determine if NANO-PSO offers better control of menopausal symptoms compared to placebo after six months of treatment.