Port De Sagunt

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.

This research aims to evaluate the effectiveness and safety of iptacopan (LNP023) compared to placebo and standard care in patients aged 12 to 60 years with native complement 3 glomerulopathy (C3G). The study is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial that includes both adult and adolescent participants. It focuses on measuring reductions in urine protein levels (UPCR), improvements in kidney function (eGFR), and kidney tissue changes seen in biopsies to support the benefits of iptacopan. Participants will receive either iptacopan tablets or placebo twice daily, with adults taking 200 mg b.i.d. and adolescents taking two 100 mg tablets b.i.d. The study includes a double-blind treatment phase lasting 6 months, followed by continued evaluation up to 12 months. Kidney biopsies will be performed in adult participants to assess microscopic kidney improvements that correspond to treatment effects. Throughout the study, participants will undergo urine collections to measure UPCR, blood tests to assess kidney function and complement levels, and safety monitoring. Researchers will compare changes in UPCR and eGFR at multiple time points, including baseline, 6 months, and 12 months, to assess treatment impact. Vaccinations and stable use of certain medications are required prior to treatment. The total participation duration includes screening and treatment periods with ongoing safety assessments.

Researchers are investigating the effectiveness, safety, and tolerability of iptacopan (LNP023) alongside standard care in adults with active lupus nephritis Class III-IV, with or without Class V. This Phase 2 trial aims to assess how well iptacopan works in this condition by comparing it with placebo combined with standard treatments. The study is carefully designed to explore different doses and their impact on kidney health in participants with biopsy-confirmed active lupus nephritis. Participants receive either iptacopan or placebo along with their usual care, including corticosteroids and immunosuppressive drugs like MMF or MPS, for 52 weeks. The study is divided into two parts, both lasting 52 weeks, during which participants take the assigned medications. The treatment is given in a double-blind manner, meaning neither the participants nor the researchers know who is receiving the active drug or placebo. Throughout the study, researchers monitor kidney function and disease activity, focusing on the proportion of patients achieving complete renal response by week 24 without kidney flares. Participants undergo regular assessments including lab tests and clinical evaluations to track their response and safety. They are followed closely during the 52 weeks of treatment to ensure careful observation of effects and any side effects, supporting an in-depth understanding of iptacopan's role in managing lupus nephritis.