Saratov

This research aims to provide ongoing access to treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen studies that include daratumumab. It allows all participants from daratumumab studies and those in daratumumab-containing arms of related studies, which have reached clinical cutoff for final analysis, to continue treatment. The study also collects long-term safety data from these participants. The treatments being evaluated include daratumumab, which is given either intravenously or subcutaneously, carfilzomib administered intravenously, dexamethasone given orally or intravenously, and oral medications lenalidomide and pomalidomide. Participants will continue to receive these treatments as part of this long-term extension study following their previous study treatment. During the study, participants will be monitored for safety, including tracking serious adverse events, adverse events of special interest, pregnancies, and abnormal pregnancies over a period of 3 years and 7 months. Assessments include pregnancy testing for women of childbearing potential and adherence to lifestyle restrictions. Participants must provide informed consent and will be followed closely to evaluate the long-term effects and safety of their treatment.

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.

Researchers are evaluating the effect of AZD0780 tablets on lowering low-density lipoprotein cholesterol (LDL-C) compared with placebo tablets, both given alongside rosuvastatin tablets, in adult Russian participants with dyslipidaemia. AZD0780 is a small molecule aimed at reducing LDL-C in the blood. This Phase II, randomized, double-blind, placebo-controlled study includes adults aged 18 or older with specific LDL-C levels and a history or risk of atherosclerotic cardiovascular disease (ASCVD). Participants will first go through a screening period of up to 14 days, followed by a 28-day run-in period taking rosuvastatin tablets. Then, they will be randomly assigned to receive either AZD0780 or placebo tablets once daily for 12 weeks, continuing rosuvastatin during this time. After treatment, there will be a 10-day safety follow-up. The study will be conducted at approximately 11 centers in Russia and plans to enroll about 76 participants. During the study, participants will undergo various assessments including fasting LDL-C measurements at baseline and after 12 weeks to evaluate the relative change. Safety and tolerability will also be monitored throughout. The total study duration for each participant is up to 136 days, including all periods. Researchers will use these data to understand the effects and safety of AZD0780 when combined with rosuvastatin.

Researchers are evaluating the effects of a combined treatment of zibotentan and dapagliflozin compared to dapagliflozin alone in adults with chronic kidney disease (CKD) who have high levels of protein in their urine. This Phase II, multicenter, randomized, double-blind study aims to assess the efficacy, safety, and tolerability of this combination on top of standard care, including participants with or without type 2 diabetes mellitus (T2DM). The study will provide important clinical data for potential approval of this combination treatment in the Eurasian Economic Union. Participants may undergo a 28-day run-in period with dapagliflozin if they are not already using SGLT2 inhibitors at screening. Following this, they will enter a 12-week double-blind treatment period where they receive either the fixed-dose combination of zibotentan/dapagliflozin or dapagliflozin monotherapy once daily. After completing the treatment phase, all participants will receive open-label dapagliflozin alone during a 4-week safety follow-up period. Throughout the study, researchers will monitor changes in urinary albumin to creatinine ratio (UACR) from baseline at week 12 to evaluate treatment effects. Participants will be assessed regularly for safety, tolerability, and efficacy, with clinical evaluations including laboratory tests and monitoring of adverse events. The total study participation includes the run-in period, 12-week treatment, and a 4-week safety follow-up, ensuring comprehensive observation of treatment impact and participant health.

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 the effectiveness and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma. This open-label Phase 2 study focuses on individuals who have previously received at least two lines of therapy, including specific treatments like proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants must have measurable disease and documented progression according to established criteria. The study treatment involves administering BCD-248 subcutaneously. Patients eligible for the trial will receive this investigational drug during the study period. There are no comparator groups mentioned, and the treatment is given as a single intervention. This trial does not mention additional phases or extension periods. Participants will be monitored for their overall response rate to treatment up to 24 weeks, based on criteria set by the International Myeloma Working Group. Assessments include disease evaluations and safety monitoring. The study involves careful screening to ensure participants meet specific health and prior treatment requirements, with follow-up to track treatment outcomes and adverse events throughout the study duration.

Researchers are evaluating the immunogenicity, reactogenicity, and safety of the drug GNG-DE compared to a reference drug for preventing meningococcal infections caused by serogroups A, C, W, and Y. This Phase 3 study includes participants aged 3 to 55 years and aims to assess how well GNG-DE stimulates an immune response and its safety profile versus the reference vaccine. Participants are divided into two groups: one group of 40 participants will receive a 0.5 mL dose of GNG-DE administered intramuscularly into the deltoid muscle, while the other group of 40 will receive a 0.5 mL dose of the Menactra® vaccine via the same method. Both treatments are given as single doses during the study. During the study, participants will be monitored for immune response by measuring primary immunogenicity parameters around Day 29. Safety and reactogenicity will also be assessed. Participants must attend scheduled visits, complete observation diaries, and comply with study requirements. The study includes screening tests such as SARS-CoV-2 antigen and pregnancy tests when applicable, and participants will be observed for any adverse reactions to the vaccines.

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.

Researchers are conducting a multicenter, double-blind, placebo-controlled, randomized clinical trial to study children aged 3 to 12 years with acute respiratory viral infection (ARVI) symptoms within 24 hours of onset. The trial aims to evaluate the efficacy and safety of Raphamin compared to a placebo in treating ARVI. Enrollment will begin with children aged 6 to 12 years, followed by an interim analysis to decide whether to include younger children aged 3 to 5 years. Patients will be outpatients of either gender during seasonal ARVI incidence. Participants will be randomly assigned to receive either Raphamin tablets or placebo tablets for 5 days. Treatment groups follow the same dosage regimen. Before starting therapy, nasopharyngeal swabs will confirm viral infection through PCR testing. Throughout the trial, an electronic patient diary will be used to record temperature, symptoms, antipyretic use, and any worsening condition. The study includes screening, randomization, treatment, and follow-up periods lasting a total of 14 days. During the study, patients will attend three visits on days 1, 5, and 7, either at a health center or home, plus a phone visit on day 14. At visits, physicians will assess symptom severity, perform examinations, monitor diary completion, and conduct lab tests. The main outcome measured is the time needed for ARVI symptoms to resolve within 14 days. Safety and compliance will be closely monitored, and symptomatic or concomitant therapies are allowed except for prohibited drugs.

Researchers are conducting a large, non-interventional observational study to better understand adults with uncontrolled asthma across Russia. This study aims to gather detailed information on the demographic and clinical characteristics of these patients, the treatments they receive, and how their condition is managed in routine clinical practice. The study focuses on patients not treated with biologics and covers a diverse population from about 50 regions in Russia, reflecting differences in ethnicity, climate, and economic status. The study will include 9,000 adult patients with uncontrolled mild to moderate asthma who are receiving standard care. Data will be collected during 2-3 visits that follow routine clinical practice schedules. At the first visit, information from the previous 52 weeks will be gathered from medical records and patient interviews. The second visit will take place about 12 weeks later to collect follow-up data on treatment changes and clinical outcomes. For a subgroup of 500 patients using a fixed-dose combination of budesonide/salbutamol at the second visit, an additional third visit will occur 12 weeks later to further monitor treatment and outcomes. Participants will be monitored through medical record reviews and interviews during these visits. Researchers will assess baseline characteristics such as blood eosinophil counts, sputum eosinophils, and total IgE levels, along with treatment profiles and clinical outcomes. The study does not involve any experimental interventions beyond standard care and aims to provide comprehensive real-world data on uncontrolled asthma management in Russia. The total study duration for participants includes up to 24 weeks of follow-up for some patients.