Culiacan Rosales

Researchers are evaluating the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of fenebrutinib, an oral drug, in children and adolescents aged 10 to under 18 years with relapsing multiple sclerosis (RMS). This open-label, single-arm Phase 2 study aims to understand how fenebrutinib behaves in the body and its effects in this younger population with RMS, diagnosed according to established pediatric MS criteria and showing active disease signs. The study includes two main periods: a Dose Exploration Period where participants receive fenebrutinib orally and are monitored for drug levels and effects, followed by an Optional Extension Period where eligible participants may continue treatment. Fenebrutinib dosing details and adjustments are guided during the Dose Exploration Period, with ongoing safety and tolerability assessments throughout both periods. Participants will undergo various assessments including blood tests to measure fenebrutinib plasma concentration up to week 96, and MRI scans at week 12 to count new brain lesions enhanced by gadolinium. Safety, tolerability, and disease activity will be closely monitored through clinical evaluations and imaging. The study duration may extend based on participant continuation into the Optional Extension Period, with regular follow-ups and data collection to assess long-term effects and treatment impact.

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

This research focuses on pediatric participants aged 6 to 17 years with obesity or overweight conditions. Its aim is to establish a framework to evaluate the safety and effectiveness of drug treatments for managing chronic weight issues in this population. The study is part of a Phase 3 Master Protocol that includes multiple interventions and will report results when all intervention-specific arms finish. Participants may receive either Orforglipron, a drug given orally, or a placebo, also taken by mouth. Different intervention-specific arms may begin independently as new treatments become available for testing. The study sets clear entry criteria for newly enrolled participants across these intervention arms. During the study, researchers will monitor participants from baseline up to 72 weeks, focusing on the number of participants allocated to each intervention arm. They will also track safety and treatment effectiveness. Participation involves regular assessments of weight, health status, and any side effects, ensuring a thorough evaluation of the chronic weight management interventions over time.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

This research focuses on participants with cancer who were previously enrolled in Genentech and/or F. Hoffmann-La Roche sponsored studies. It aims to provide continued treatment with Roche investigational medicinal products (IMPs) or comparator agents for those who are still receiving study treatment at the time they transition from the parent study and lack access to the treatment locally. The study is an open-label, multicenter phase 3 extension trial designed to offer ongoing therapy for eligible participants. Participants will continue receiving the same Roche IMPs or comparator agents at the doses, schedules, and administration methods that were in effect at the time they stopped treatment in the parent study. Treatments include drugs like Ipatasertib, Tiragolumab combined with Atezolizumab, Atezolizumab alone or in combination, Bevacizumab alone or with Atezolizumab, Entrectinib, Inavolisib, and Divarasib with or without other agents. The first dose in this extension study must be given within 7 days of the allowed treatment interruption from the parent study. During the study, researchers will monitor participants for continued access to the study treatments and track any adverse events using standard criteria for up to about 10 years. Participants must comply with study protocols and will be regularly assessed for safety and ongoing benefit from the treatment. This long-term follow-up is designed to gather data on treatment continuation, safety, and tolerability over an extended period.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

Researchers are evaluating the bioequivalence of two subcutaneous formulations of ocrelizumab in adults with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). This phase II study aims to compare a test formulation of ocrelizumab with the marketed reference formulation to understand if they behave similarly in the body. Participants include those diagnosed based on the revised McDonald criteria, with an Expanded Disability Status Scale (EDSS) score between 0 and 6.5. The study has two phases: a controlled phase where participants receive a single dose of either the test or reference ocrelizumab formulation, followed by a continuation phase where all participants receive the test formulation. Both treatments are administered subcutaneously according to the study schedule. The design is randomized, open-label, parallel group, and multicenter. During the study, researchers will monitor the body's response to the medication by measuring serum concentration levels, including the area under the concentration-time curve and maximum serum concentration over 12 weeks after dosing. Participants undergo screening and evaluations to confirm eligibility and safety. The study excludes those with recent anti-CD20 treatments, certain medical histories, or other conditions that might interfere with the study. The age range for participants is 18 to 65 years, and both genders are eligible.