Port De Sagunt

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the efficacy and safety of iptacopan compared to placebo and standard care in patients with native Complement 3 Glomerulopathy C3G. This Phase 3 pivotal trial aims to assess how iptacopan affects proteinuria levels, kidney function, and kidney tissue changes in both adult and adolescent participants. The study also examines improvements in serum C3 levels as a marker of treatment impact. Participants will be randomly assigned to receive either iptacopan 200 mg twice daily or a matching placebo. Treatment dosing differs slightly for adults and adolescents but follows a twice-daily schedule. The study includes a double-blind treatment period of 12 months, during which kidney biopsies will be performed in adults to evaluate tissue improvements. Vaccinations against certain bacteria are required prior to starting treatment. During the trial, participants will provide urine samples to measure protein levels and have kidney function assessed through estimated glomerular filtration rate eGFR. Safety evaluations include monitoring vital signs, ECGs, and laboratory tests. Fatigue levels will be assessed using a standardized questionnaire. Researchers will follow participants over 6 and 12 months to observe treatment effects and safety, with ongoing assessments during both double-blind and open-label phases.

Researchers are evaluating iptacopan LNP023 alongside standard care to study its effectiveness, safety, and tolerability in adults with active lupus nephritis Class III-IV, with or without Class V. This phase 2 trial is randomized, double-blind, and placebo-controlled, aiming to explore dosing and treatment outcomes in this patient group. Participants receive either iptacopan combined with standard care, placebo matching iptacopan with standard care, or iptacopan with placebo as part of the standard care. Each treatment is taken for 52 weeks. The study proceeds in two parts, with different combination regimens of iptacopan, placebo, and standard care, including oral corticosteroids or their absence. During the study, participants undergo assessments at baseline and weeks 24 and 52 to measure kidney response, protein levels in urine, fatigue, and lupus disease activity using specific scoring tools. Researchers monitor the proportion of patients achieving complete renal response without flares and other kidney and health outcomes. Safety and tolerability are also evaluated over the course of treatment and follow-up.