Nuevo Leon

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are investigating a new treatment approach for children aged 6 months to less than 18 years who have chronic kidney disease (CKD) and proteinuria, a condition where the kidneys leak protein into the urine. CKD causes the kidneys to work less effectively, leading to waste buildup and high blood pressure. Current treatments include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB), which help regulate a system involved in blood pressure and kidney function. However, these treatments do not work for all patients. This study is focused on seeing if adding finerenone to ACEI or ARB can better control this system and improve kidney function. Participants will receive either finerenone or a placebo for about 180 days, alongside their usual ACEI or ARB medication. The study will adjust finerenone doses based on age and body weight. Before starting treatment, participants will attend up to two screening visits within 104 days to check eligibility. During the treatment phase, participants will make at least seven visits to the study site for ongoing care and monitoring. Throughout the study, doctors will measure participants' blood pressure, heart rate, temperature, height, and weight. They will collect blood and urine samples to monitor kidney function and protein levels. Heart health will be checked using electrocardiograms and echocardiography. Participants or their parents will answer questions about medication use, side effects, and how they feel. Researchers will track any medical problems that occur during the study and will follow up about 30 days after treatment ends. The main goal is to see how much the protein in urine changes from the start to day 180.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

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 real-life effectiveness, safety, and usage patterns of Octapharma's factor VIII (FVIII) concentrates Nuwiq, Octanate, and Wilate in patients with severe haemophilia A who have either never been treated or have had minimal previous treatment. This study focuses on previously untreated patients (PUPs), often young children, and minimally treated patients (MTPs), to better understand treatment outcomes and inhibitor development in routine clinical practice. Because haemophilia A is rare and treatment practices vary, especially for PUPs, collecting real-world data is important to improve treatment guidelines and benefit-risk assessments. The study observes patients prescribed Octapharma's FVIII concentrates without changing their treatment, capturing how these products are used in everyday healthcare settings. There are no experimental interventions as this is a non-interventional study. The study includes patients starting or continuing treatment with these FVIII concentrates, monitoring their usage, dosing, and frequency as determined by their healthcare providers. Participants are monitored for effectiveness by tracking the annual rate of breakthrough bleeding episodes and safety by recording adverse drug reactions over 100 exposure days. Data on inhibitor development is also collected. Patients of all ages and genders with severe haemophilia A are eligible if they meet treatment history criteria. Informed consent is obtained before data collection. The study gathers information from routine clinical visits and treatment records without additional procedures or interventions.

Researchers are studying genetic and behavioral factors that might influence the development and outcomes of certain cancers in patients with a cancer history and their relatives. The study aims to identify cancer patients and families with patterns suggesting genetic susceptibility or exposure to cancer-causing agents. It also seeks to understand how heredity and biomarkers affect clinical outcomes such as new cancer occurrences, prognosis, and quality of life in different subgroups of cancer patients. Participants may provide various biological samples including blood, saliva, eyebrow plucks, urine, and stored tumor or healthy tissue samples. The study also involves completing questionnaires as part of ancillary research efforts. These procedures help characterize genetic predisposition and other factors related to cancer development and progression. During the study, researchers will collect and analyze biological samples and questionnaire data to assess cancer risk and identify exploratory biomarkers over a period of up to 10 years. The study includes follow-up to monitor clinical outcomes and disease prognosis. Consent can be obtained from living participants or, for deceased patients, from next of kin to use archived tissue and medical records for genetic research.

Researchers are evaluating how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.