Izmit

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are studying pirtobrutinib, an oral drug, to understand how well it works and how safe it is for people with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study focuses on participants who have previously received 1 to 3 treatments, including a covalent Bruton tyrosine kinase BTK inhibitor, as well as those with treatment-nafve CLLSLL who have a specific genetic change called 17p deletion. This is a Phase 2 open-label trial sponsored by Loxo Oncology, Inc. The study has two parts. Part 1 tests three different dose levels of pirtobrutinib in participants with relapsed or refractory CLLSLL who have prior treatment experience, lasting about 3 years. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have the 17p deletion, with participation lasting up to 2 years. All doses are given orally. Participants will take the study drug orally and attend visits for up to 3 years in Part 1 or up to 2 years in Part 2. Researchers will monitor how well the disease responds to treatment using overall response rate and how long the response lasts. Safety will be tracked throughout. Participants ability to swallow oral medication and their overall health status will be assessed before and during the study to ensure suitability and safety.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

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.

Researchers are evaluating roxadustat, an oral medicine, for treating anemia in children and teenagers with chronic kidney disease CKD. Anemia involves low red blood cell levels, and current treatments often use injections called erythropoietin stimulating agents ESAs with iron, but these have safety concerns. This Phase 3 open-label study aims to understand how roxadustat affects anemia in this young population, offering a potential alternative to ESA injections. Participants will take roxadustat orally or via gastric tube three times a week for up to 52 weeks. The study begins with a fixed dose for 4 weeks, during which blood hemoglobin levels are regularly checked to adjust dosing as needed to maintain target levels just below normal. The study starts with 10 teenagers and 10 children who receive fixed doses to determine appropriate dosing for others. After this, the remaining children and teenagers will take the optimized dose. Children and teenagers will visit the clinic frequently every 2 weeks during the first month and then every 4 weeks until the treatment ends, with a final visit 4 weeks after stopping roxadustat. At visits, vital signs, fluid status for dialysis patients, blood and urine tests, and medical exams will be conducted, including electrocardiograms at specific intervals. Researchers will monitor hemoglobin, iron levels, safety, growth, and quality of life over the study period, which may last up to 56 weeks including follow-up.

Researchers are evaluating the effects of three drugsfrexalimab, brivekimig, and rilzabrutinibcompared with a placebo in people aged 16 to 75 years who have primary focal segmental glomerulosclerosis FSGS or minimal change disease MCD. This Phase 2a, double-blind study aims to measure changes in proteinuria and how these changes impact remission rates of nephrotic syndrome in this population. Participants will be randomly assigned to one of six groups receiving either active doses of frexalimab, brivekimig, rilzabrutinib, or a matching placebo. The treatment period lasts 24 weeks within an overall study duration of up to 52 weeks. During this time, participants will attend up to 16 visits for treatment administration and monitoring. Throughout the study, participants will undergo regular assessments including measurement of urine protein to creatinine ratio UPCR at baseline and Week 12, evaluation of remission endpoints, and monitoring for adverse events up to Week 48. Blood samples will be taken to measure drug concentrations and check for anti-drug antibodies. The study involves careful safety monitoring and follow-up visits to assess treatment effects and participant well-being.

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents who have a kidney condition known as focal segmental glomerulosclerosis FSGS. This Phase 3 clinical trial aims to determine whether BI 764198 helps improve kidney function in people with primary FSGS or genetic FSGS linked to TRPC6 gene variants. The study is randomized and placebo-controlled, meaning participants are randomly assigned to receive either the medicine or a placebo, and neither the participants nor the researchers know which treatment each person receives. Participants take either BI 764198 tablets or placebo tablets once a day for up to two years, while continuing their usual medication for FSGS. The study involves two groups running in parallel. The main treatment period lasts 104 weeks about two years, during which the participants regularly visit the study site approximately every three months. Both groups are compared to see if BI 764198 affects kidney protein levels and function. During the study, participants provide urine samples regularly to assess their kidney health. Researchers measure changes in urine protein-creatinine ratio and kidney filtration rate from the start to the end of the treatment period. Questionnaires about health-related quality of life are also completed. Doctors monitor participants health and note any side effects throughout the two years. This thorough follow-up helps understand how BI 764198 impacts kidney disease and overall well-being.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are evaluating the effectiveness of Serratus Posterior Superior Intercostal Plane SPSIP block compared to Intercostal Nerve ICN block for managing pain after video-assisted thoracoscopic surgery VATS. This study aims to compare these two methods in terms of controlling postoperative pain, reducing opioid use, minimizing respiratory complications after surgery, and improving patient satisfaction measured by a 5-point Likert scale. In this prospective observational study, patients receive both the SPSIP block and the ICN block for pain relief after surgery. The SPSIP block is done by an anesthesiologist using ultrasound guidance right after skin closure and before the breathing tube is removed. The ICN block is performed by the surgeon under direct vision just before skin closure. During surgery, patients also receive paracetamol and dexketoprofen. After surgery, patients use a patient-controlled analgesia PCA pump with tramadol, and if pain remains high, rescue doses of dexketoprofen are given. Participants will have their pain levels assessed at multiple times up to 24 hours after surgery using the Numerical Pain Rating Scale at rest and while coughing. Researchers will track total opioid use, rescue analgesic use, any complications, and patient satisfaction 24 hours after surgery. This thorough monitoring helps understand the benefits and potential risks of both pain control methods in the early recovery period.