Caxias Do Sul

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

Researchers are investigating new treatments for adults with moderately to severely active ulcerative colitis or Crohns disease under a master protocol called Study IIBD. This Phase 2 trial evaluates multiple drugs to understand their safety and effectiveness in managing these conditions. Participants will be assigned to specific sub-studies and randomized to treatment groups, with the study lasting at least 62 weeks. The study includes two treatment periods. In the first period, participants may receive mirikizumab intravenously, or a combination of the oral drug LY4395089 with intravenous mirikizumab. Those who respond to treatment will then enter a second period where they receive mirikizumab through subcutaneous injections. These steps allow researchers to assess different dosing methods and combinations of these drugs. Participants will be monitored regularly throughout the study, including screening tests and laboratory evaluations to ensure eligibility and safety. Researchers will track the number of participants allocated to each treatment group up to day 42 as a primary outcome. The study involves randomization without masking and continues until at least 62 weeks, with ongoing assessments to evaluate treatment effects and monitor health outcomes.

Researchers are conducting a Phase 3 pediatric study to create a framework for evaluating the safety and effectiveness of drugs for managing obesity or overweight conditions in children and teens. The study focuses on participants who have struggled to lose weight despite structured diet and exercise programs. The goal is to assess treatments for long-term weight management in this young population. Participants will receive either the study drug Orforglipron or a placebo orally. The interventions will be detailed in specific substudies, called ISAs, which may start independently as new treatments become available. Results from all ISAs will be reported once all are completed, providing insights into the treatments effects on pediatric obesity or overweight. During the study, participants will be evaluated from baseline to week 72, with the primary outcome measuring the number of participants assigned to each ISA. Participants will undergo assessments including body mass index evaluations based on age- and gender-specific growth charts, and monitoring for weight-related health conditions. Safety and efficacy data will be collected throughout the study duration, which extends to March 2027.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating treatments for participants with KRASNRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer who have previously received chemotherapy. The study compares how long participants remain free of disease progression and the overall survival time when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. This Phase 3 trial focuses on patients who have already undergone prior chemotherapy for their cancer. Participants are randomly assigned to one of two groups. One group receives amivantamab combined with the chemotherapy regimen FOLFIRI, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with the same chemotherapy regimen FOLFIRI. Treatments are given in 28-day cycles and continue until the cancer progresses or other criteria require stopping treatment. During the study, participants undergo regular assessments to monitor disease status, including imaging scans reviewed by independent experts. Researchers measure progression-free survival and overall survival over periods up to several years. Additional outcomes include response rates, duration of response, quality of life assessments, and side effects. Safety and laboratory evaluations are conducted throughout the study, which spans up to four years and four months in total duration.

Researchers are evaluating how long adult participants with KRASNRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer remain disease-free when treated with different combinations of drugs. The study compares amivantamab combined with chemotherapy regimens mFOLFOX6 or FOLFIRI versus cetuximab combined with the same chemotherapy regimens. This phase 3 trial aims to understand which treatment approach may better delay cancer progression. Participants will be randomly assigned to one of two treatment groups. One group receives amivantamab along with chemotherapy cycles consisting of 5-fluorouracil, leucovorin calcium or levoleucovorin, and oxaliplatin or irinotecan hydrochloride, repeated every 28 days. The other group receives cetuximab combined with the same chemotherapy regimens, also in 28-day cycles. Treatments continue until imaging shows disease progression or other criteria require stopping. During the study, participants will undergo regular assessments including radiographic imaging to monitor disease status and treatment effects. Researchers will measure progression-free survival for up to over 4 years, along with other outcomes such as overall survival, response rates, duration and time to response, and quality of life using validated questionnaires. Safety will be monitored through adverse event reporting and laboratory tests, with follow-up continuing for several years to capture long-term results.

Researchers are studying the use of bempedoic acid alone or combined with ezetimibe in adult patients who have primary hypercholesterolemia both heterozygous familial and non-familial types or mixed dyslipidemia. This observational study aims to collect real-world data from Asian and Latin American patients to better understand the risks and benefits of these treatments, as current efficacy and safety information in these populations is limited. Participants in this study receive routine clinical care where they may be treated with bempedoic acid alone or its fixed-dose combination with ezetimibe. No experimental drugs are administered as this is a non-interventional study. The study follows patients for one year after starting the treatment to observe outcomes in their usual care setting. Throughout the one-year follow-up, researchers collect data on patient characteristics, adverse drug reactions, and adverse events related to the treatments. They also assess cardiovascular risk, cholesterol levels including LDL-C, inflammatory markers, uric acid levels, and the attainment of cholesterol goals. This information is gathered from medical records and routine clinical assessments to monitor the safety and effects of the treatments over time.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

This trial investigates the safety and effectiveness of combining a drug called LY4395089, which is a farnesoid X receptor FXR agonist, with mirikizumab compared to using mirikizumab alone in adults who have moderately to severely active Crohns disease. This Phase 2 study is part of a larger research protocol focused on inflammatory bowel diseases and will last about 62 weeks. Participants are assigned to one of two groups. In the first study period, one group receives mirikizumab via intravenous IV infusion, while the other group receives both LY4395089 orally and mirikizumab IV. In the second study period, participants who respond to treatment will stop LY4395089 and receive mirikizumab subcutaneously SC. This design allows comparison of the combined treatment versus mirikizumab alone. Throughout the study, participants will undergo assessments including endoscopic evaluations to measure Crohns disease response up to Week 12, clinical remission checks, and fecal calprotectin tests to monitor inflammation. The study includes regular visits for treatment administration and monitoring, with the total participation lasting approximately 62 weeks. Safety and efficacy are closely observed during the trial.

Researchers are evaluating a combination therapy of finerenone plus empagliflozin compared to usual care in patients hospitalized with heart failure. This international, randomized, controlled, open-label trial aims to assess the effectiveness and safety of this early, intensive treatment approach in managing heart failure during and after hospitalization. Participants will either receive the combination of oral finerenone and empagliflozin or continue with usual care management. The study is designed to compare these two approaches to determine their impact on clinical outcomes. The trial includes a treatment period with these medications given alongside usual management during hospitalization and follow-up. During the study, participants will be monitored over six months for clinical benefits and safety outcomes such as serious adverse events and adverse events leading to discontinuation. Researchers will assess heart failure events, symptom changes using the Kansas City Cardiomyopathy Questionnaire, and time to death or heart failure events. Study visits and evaluations will track participant health and response to treatment over this period.