Kazan

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.

Researchers are studying metastatic cancers that express the fibroblast growth factor receptor 1 (FGFR1), focusing on a new targeted treatment using a monoclonal antibody called OM-RCA-01. This Phase 1b/2 clinical trial aims to evaluate how well OM-RCA-01 works and its safety in patients with various types of metastatic tumors such as renal cell carcinoma, non-small cell lung cancer, head and neck cancer, breast cancer, and prostate cancer. The study will help determine the appropriate dosage and observe any medical issues during treatment, while also assessing if the tumor growth slows. All participants will receive the OM-RCA-01 antibody intravenously every two weeks. The antibody works by blocking the activation of FGFR1, which is involved in tumor development. Patients will continue to receive the treatment as long as the disease does not progress and the drug is tolerated. The study uses a basket design enrolling patients based on FGFR1 expression regardless of tumor type, and will include up to 58 patients divided into five tumor-specific groups. During the study, participants will undergo various assessments including tumor evaluations according to RECIST 1.1 criteria, laboratory tests to monitor organ function, and biomarker analysis from tumor tissue samples. Safety and efficacy will be observed over six months for Phase 1b and twelve months for Phase 2. Researchers will monitor for treatment side effects, tumor response, and patient health throughout the trial to gather comprehensive information on the study drug's impact.

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 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 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 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.

Researchers are evaluating the effectiveness, safety, how the body processes and responds to the drug BCD-261, and immune reactions in adults aged 18 to 75 with moderate to severe active Crohn's Disease. This Phase 2 study focuses on patients who have not responded well to previous treatments like glucocorticoids, immunosuppressants, or biologic therapies. The goal is to understand how different doses of BCD-261 affect the disease and to compare these results to a placebo group. Participants will be randomly assigned to five groups, receiving one of four dose levels of BCD-261 (low, medium, high) or a placebo, all given by injection. The study includes an induction phase and a maintenance phase for treatment. After the main assessment at week 14, those initially receiving placebo will switch to the medium dose of BCD-261. This design helps evaluate both short-term and longer-term effects of the drug. Throughout the study, researchers will track clinical remission and endoscopic response at week 14 as primary outcomes. Participants will undergo regular evaluations including symptom assessments and endoscopic exams to monitor disease activity. The study also monitors safety, drug levels, immune responses, and how the drug affects the body over time. Total involvement includes screening, treatment periods, and follow-up assessments to gather comprehensive data on BCD-261 in Crohn's Disease.

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.