Smolensk

Researchers are evaluating the safety and effectiveness of a new biosimilar drug called bevacizumab (made by Mabscale, LLC) compared to the existing drug Avastin4 in treating patients with advanced non-squamous non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has recurred or spread. This is a phase III randomized, double-blind trial designed to show that the new bevacizumab works as well and is as safe as Avastin4. The study also includes assessments of how the body processes the drug (pharmacokinetics). Participants will receive treatment with bevacizumab at 15 mg/kg or Avastin4, combined with chemotherapy drugs paclitaxel (175 mg/m2) and carboplatin (AUC 6). This combination is given as the first-line therapy for advanced NSCLC. The study is conducted across multiple centers and participants are randomly assigned to one of the two treatment groups without knowing which they receive. Throughout the study, participants will be monitored for their response to treatment, specifically measuring the Objective Response Rate at 18 weeks after starting therapy. Researchers will also assess safety and side effects. Various tests including tumor measurements, blood tests, and other evaluations will be done to ensure participants meet criteria and to track treatment effects. The total duration includes screening, treatment, and follow-up visits to monitor health and outcomes.

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 evaluating the safety and effectiveness of two treatments, Indinol Forto400 mg capsules and Visanne 2 mg tablets, for women with endometriosis. This phase 3 study compares these treatments to see if Indinol Forto400 mg is not less effective than Visanne. The study includes females aged 18 to 45 who were diagnosed with endometriosis by surgery within the past 60 months and have experienced at least moderate pelvic pain for at least 2 months. Participants are randomly assigned to take either Indinol Forto 200 mg capsules twice daily or Visanne 2 mg tablets once daily for 24 weeks. Before treatment, there is a one menstrual cycle screening period to assess eligibility. After 24 weeks of treatment with monthly visits, participants enter a one-month post-treatment observation period. Daily pelvic pain, both cyclic and non-cyclic, and vaginal bleeding intensity are recorded using a Visual Analog Scale (VAS). During the study, participants complete daily diaries on pain and bleeding, and their pain scores are closely monitored. The main measure of success is the change in average daily pelvic pain after 24 weeks compared to the screening period. Safety and tolerability are also assessed throughout. The whole study lasts about 7 months, including screening, treatment, and follow-up periods.

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.

Researchers are evaluating the potential effects of repeated use of gadolinium-based contrast agents (GBCAs) on motor and cognitive functions in neurologically normal adults over a period of five years. This Phase 4 study involves adults up to 65 years old who are likely to need at least yearly MRI or other imaging scans. The goal is to compare changes in body movement and mental skills between participants exposed to GBCAs multiple times and a matched group not exposed to GBCAs. Participants will undergo annual motor and cognitive tests to assess their functions. Unenhanced MRI scans of the brain will be performed at the start and after five years to check for abnormalities. Blood and urine samples will be collected yearly to measure gadolinium levels. The GBCAs administered during clinical care include various agents such as Gadoxetate disodium, Gadobenate dimeglumine, Gadodiamide, Gadoterate meglumine, Gadobutrol, and Gadoteridol. The study itself does not assign or control GBCA use; this is based on the participants' medical needs. Over the five-year study, participants will visit the study doctor at least seven times for physical exams, lab tests, and motor and cognitive assessments. Imaging tests like MRI, CT scans, or x-rays will be conducted annually. Researchers will measure changes in motor and cognitive performance compared to baseline and between GBCA-exposed and non-exposed groups. Safety and adverse events will also be monitored throughout the study period.

Researchers are evaluating the efficacy and safety of cariprazine in treating adolescents aged 13 to 17 years with schizophrenia. This Phase 3 study compares cariprazine to a placebo to understand its effects on this population. Participants must have a confirmed diagnosis of schizophrenia based on DSM-5 criteria and meet specific symptom severity requirements. Participants receive either cariprazine or matching placebo capsules once daily by mouth for 6 weeks in a randomized, double-blind, parallel-group design. The study is conducted across multiple international centers to ensure diverse participation and data collection. Throughout the 6-week study, researchers assess changes in schizophrenia symptoms using the PANSS total score from baseline to Week 6. Safety and tolerability are also monitored closely. Participants will undergo clinical evaluations and symptom scoring to track progress and response to treatment during the study period.

Researchers are evaluating the effectiveness and safety of olokizumab (OKZ) compared to a placebo in patients with progressive fibrosing interstitial lung diseases (ILD). This phase 2/3 study uses a double-blind, parallel-group, adaptive design to assess treatment impact on lung function. Progressive fibrosing ILD is confirmed by imaging and lung function tests, with disease progression criteria including declines in lung capacity and worsening symptoms. Participants will receive subcutaneous injections of either 64 mg olokizumab or placebo every 4 weeks during a 48-week double-blind treatment period. The study begins with a 4-week screening period before treatment starts. After completing treatment, all participants enter a 24-week follow-up phase with visits at weeks 52, 60, and 72 to monitor ongoing effects and safety. Throughout the study, patients will undergo lung function tests, imaging reviews, and assessments of respiratory symptoms. Researchers will measure changes in forced vital capacity (FVC) over 48 weeks as the primary outcome. Safety and adverse events will be monitored during treatment and follow-up. The total participation time is about 76 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the effectiveness and safety of Vespireit, prolonged-release tablets (15 mg), compared to Arlevert tablets (40 mg + 20 mg) in patients who have autonomic dysfunction syndrome along with functional vertigo. This Phase 4 trial focuses on adults aged 18 to 65 diagnosed with these conditions. The study addresses chronic functional vertigo symptoms measured by specific scoring systems and aims to provide new insights into treatment options for this population. Participants will be randomly assigned to receive either Vespireit, containing buspirone, or Arlevert, containing dimenhydrinate and cinnarizine. The study medication will be administered during an initial treatment phase lasting 28 days, with precise timing of visits and evaluations. Both drugs are oral tablets, and the comparison includes monitoring the response to therapy over this period. During the study, participants will undergo various assessments including measurement of vertigo scores to track changes from baseline. Safety and efficacy will be closely monitored through scheduled visits, with attention to any adverse events or therapy effectiveness. The primary outcome is the change in mean vertigo score from the start to the end of the initial treatment phase. Participants will be observed and evaluated throughout the treatment period with follow-up as needed, ensuring comprehensive data collection on treatment impact and safety.