Krasnodar

Researchers are evaluating the pharmacokinetics, safety, and immune response of two treatments, RPH-030 and Vectibix®, in patients with metastatic colorectal cancer (mCRC) who have wild-type RAS genes. This phase I, multicenter, double-blind, randomized study aims to demonstrate that these treatments have equivalent pharmacokinetic properties when given as first-line therapy in combination with the chemotherapy regimen FOLFIRI. The study also includes a pilot evaluation of the efficacy of these treatments. Participants will be randomly assigned to receive either RPH-030 or Vectibix® intravenously at a dose of 6 mg/kg every two weeks alongside FOLFIRI chemotherapy. Treatment will continue for up to two years or until disease progression, unacceptable toxicity, or withdrawal of consent. The study is divided into several periods: a screening period lasting up to 27 days (extendable to 42 days if biopsy is needed), a 6-month main treatment period, a continued therapy period up to one year, a treatment extension period for responders lasting up to two years, and a follow-up period after treatment ends. During the study, patients will undergo regular tumor assessments approximately every 6 to 8 weeks depending on the study phase. Hospitalizations of at least 24 hours will occur at certain visits for drug administration. Researchers will monitor drug levels in the blood at multiple time points to understand treatment pharmacokinetics. Follow-up will include imaging tests, survival data collection, and safety monitoring until one year after treatment or until patient withdrawal or death. The goal is to assess treatment safety, immune response, effectiveness, and patient well-being throughout the study timeline.

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

This research investigates treatment patterns and the evaluation of homologous recombination repair mutations (HRRm) in circulating tumor DNA (ctDNA) among patients with aggressive high-volume metastatic hormone-sensitive prostate cancer (mHSPC) in the Russian Federation. The study focuses on patients with high-aggressive disease characterized by Gleason scores 8-10 and high-volume disease as defined by specific criteria for bone and visceral metastases. Approximately 400 male patients aged 18 years and older with known tumor HRRm status will participate to better understand demographic and clinical characteristics and treatment approaches in routine practice. The study does not introduce new treatments but observes and collects data as patients receive standard care. Two study visits will occur: the first at baseline to gather medical history, demographic data, and treatment information from diagnosis to enrollment, including routine blood samples for ctDNA and HRRm testing. The second visit will happen at disease progression or after about 12 months to collect follow-up data on progression to metastatic castration-resistant prostate cancer (mCRPC) and subsequent treatments. Blood samples will be analyzed centrally. Participants will have their medical records reviewed and may be interviewed to complete missing information. Data will be entered into electronic records by the study physician. Outcome measures include the proportion of patients receiving various treatments (such as androgen deprivation therapy, chemotherapy, radiation, surgery, and specific inhibitors), duration of therapies, time to progression, mutation presence in ctDNA, testosterone levels, and sites of disease progression over 36 months. Follow-up may be completed by phone if in-person visits are not possible, with the total study duration lasting about 38 months or until data from 400 patients are collected.

Researchers are evaluating the physical impact of multiple sclerosis (MS) from the participant's perspective while providing continued access to the drug ocrelizumab. This Phase 3 extension study focuses on assessing the safety and tolerability of ocrelizumab, a treatment for MS, at approved doses. The study includes participants who were already receiving ocrelizumab in previous Genentech and/or F. Hoffmann-La Roche Ltd sponsored studies and do not have local access to this treatment through other means. Participants will receive ocrelizumab either by intravenous (IV) infusion at 600 milligrams or by subcutaneous (SC) injection at 920 milligrams, following the dosing schedule from their previous parent study. Treatment will begin no earlier than five months after their last dose in the parent study. This open-label, multicenter extension provides ongoing access to ocrelizumab for up to five years. Throughout the study, participants will be monitored for changes in their physical functioning using the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis (PROMISnq PFMS-15a). Researchers will also track the number of participants receiving ocrelizumab during the study and assess safety and tolerability over the long term. Monitoring includes regular evaluations to ensure participant well-being during the extended treatment period.

Researchers are conducting a national, multicenter, prospective study in the Russian Federation to collect real-world data on patients with aggressive, advanced endometrial cancer (stages III-IV). The study aims to understand the prevalence of molecular markers such as POLE mutations, dMMR/pMMR, p53 abnormalities, HER2, and PD-L1, as well as to observe first-line postoperative treatment approaches in these patients. Approximately 500 female patients with newly diagnosed aggressive subtypes of advanced endometrial cancer will be enrolled across about 30 sites. The study involves two visits aligned with routine clinical practice. At the first visit, demographic and clinical information will be collected from medical records or patient interviews, along with biopsy or archival tumor samples for molecular testing using immunohistochemistry and genetic sequencing methods. The second visit occurs six months after baseline or at disease progression, whichever is earlier, to gather follow-up data on treatments and disease status. No additional procedures beyond standard care are applied. Participants' data will be securely entered into electronic case report forms by study physicians. Researchers will monitor the rates of molecular markers such as POLE mutation positivity, mismatch repair status, p53 abnormalities, PD-L1 expression, and HER2 expression over 24 months. The overall study duration, from first patient enrollment to final data analysis, is expected to be about 27 months or until all data from 500 patients are collected, including follow-up information.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating transcutaneous electrical stimulation of the auricular vagus nerve (TENS) as a non-invasive method to influence the autonomic nervous system in patients with various health conditions. This technique targets the auricular branch of the vagus nerve using low-frequency electrical impulses applied to the ear, which is a promising, low-cost alternative to invasive vagus nerve stimulation treatments. The study aims to identify a reliable biomarker of successful vagus nerve activation through TENS, focusing on heart rate variability (HRV) measures, specifically the ratio of spectral characteristics known as LF/HF. The study involves TENS applied for 10 minutes, during which HRV parameters will be measured. These measurements will be taken initially at rest before stimulation, during the first and second 5-minute intervals of stimulation, and again after the stimulation ends. This method seeks to clarify the ambiguous effects of TENS on HRV observed in past research, which have shown inconsistent changes in the parasympathetic component of HRV. Participants will undergo monitoring of their heart rate variability dynamics throughout the study session. Researchers will assess changes in the LF/HF ratio as the primary outcome, evaluating these values before, during, and after TENS. The study excludes individuals with certain heart rhythm abnormalities, recent glucocorticosteroid use, use of antiarrhythmic medications (except beta blockers), or severe chronic kidney or liver disease to ensure participant safety and reliable data collection. The overall goal is to advance understanding of TENS as a neuro-immunomodulatory intervention by adhering to international consensus reporting guidelines.

Researchers are investigating the use of auricular vagus nerve stimulation in patients with ST-segment elevation myocardial infarction (STEMI), a serious type of acute coronary syndrome (ACS). Despite advances in invasive treatments like percutaneous coronary intervention (PCI), patients still face high risks of death and disability, partly due to myocardial ischemia reperfusion injury (MIRI) that damages the heart during blood flow restoration. This study explores whether noninvasive stimulation of the vagus nerve can improve long-term outcomes for these patients by reducing heart damage and improving heart function. The study involves using transcutaneous electrical nerve stimulation (TENS) applied to the auricular branch of the vagus nerve. This stimulation starts upon admission for PCI, continues during the PCI procedure, and lasts for 30 minutes afterward. The treatment is delivered using a device designed for this purpose. The goal is to assess if this noninvasive method can protect the heart during and after PCI in patients with STEMI. Participants will be closely monitored from the time of randomization until 30 days afterward. Researchers will track hospital mortality up to 14 days and overall mortality up to 30 days. Throughout the study, patients will undergo evaluations to measure heart function, injury size, and clinical outcomes. Safety and effectiveness of the vagus nerve stimulation will be assessed to determine its potential as a new treatment option for STEMI patients.

Researchers are evaluating the efficacy, safety, pharmacokinetics, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer (TNBC). This Phase 2 study focuses on patients who have received at least one prior systemic therapy and whose cancer has progressed or relapsed. The study aims to better understand how this combination treatment works in later lines of therapy for this aggressive breast cancer subtype. Participants will receive BCD-236 as an intravenous infusion along with chemotherapy, which will be chosen at the investigator's discretion. The study compares this combination treatment's effects and monitors participants over time. The primary outcome measured is the overall response rate at 24 weeks after starting treatment, assessing how well tumors respond to the therapy. Throughout the study, participants will undergo tumor assessments using RECIST 1.1 criteria to measure treatment response. Eligibility requires confirmation of AXL expression in tumor cells from fresh or archival tumor samples. Patients will be monitored for safety and disease progression, with evaluations including physical exams and performance status assessments. The study includes women aged 18 to 74 years with adequate health to participate and a life expectancy of at least four months.

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.