Novosibirsk

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 evaluating the safety and early effectiveness of vitamin K2 (menaquinone-7, MK-7) supplementation in adults aged 40 to 75 with low bone mineral density, either osteopenia or osteoporosis. The study focuses on patients carrying a specific "unfavorable" variant in the vitamin D receptor (VDR) gene compared to those without this variant. The goal is to see if MK-7 improves bone health more in patients with the VDR variant, who might respond less well to vitamin D alone. Participants will receive a combination of vitamin K2 (100-200 micrograms daily) and vitamin D3 (800-1000 IU daily) for 6 to 9 months. The study compares two groups: those with the homozygous VDR gene variant and those without the variant (wild-type). All participants follow the supplementation regimen throughout the treatment period. During the study, participants will have bone mineral density measured to track changes over 9 months. Researchers will also monitor bone turnover markers and other related biomarkers to assess bone health improvements. Participants are expected to maintain their usual diet and exercise habits, and safety and adherence will be observed throughout the trial.

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 long-term safety of study treatments for participants with pulmonary hypertension (PH) who were treated with specific medications in earlier clinical studies and have no other way to access these treatments. This study is designed for people who have finished their previous parent studies and may continue to benefit from the treatment. It is an open-label, phase 3 platform study that follows participants over an extended period to monitor safety. Participants will receive one of the study drugs they used in their parent study, including oral macitentan, selexipag, or a fixed-dose combination of macitentan and tadalafil. Adults take standard doses, while children aged 2 to under 18 years receive doses adjusted for their body weight to match adult exposure levels. Selexipag is given twice daily with dosing adjusted for body weight in children. This treatment continues as in the parent studies, providing ongoing access to these medications. During the study, participants will be regularly monitored for treatment-emergent adverse events, serious adverse events, and any events leading to discontinuation or death, with follow-up lasting up to 84 months. Female participants of childbearing potential will undergo monthly pregnancy testing and agree to contraceptive use during the study and safety follow-up. The study involves ongoing safety assessments to ensure participant well-being while providing access to the study treatments over the long term.

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.

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 ANB-002, a gene therapy delivered by a single infusion, for its effectiveness, safety, and how it works in adult men with hemophilia B who have low FIX activity (2% or less) and no inhibitors. The study aims to show that ANB-002 is not less effective than the standard preventive treatment using coagulation factor IX (FIX). This is a phase 3, open-label, single-arm study focusing on this specific condition. Participants will first enter a lead-in period lasting at least six months, where they will receive standard FIX preventive treatment without any intervention from the study drug. After this period, they will receive one dose of ANB-002 at the start of the main study phase. This main phase will last 18 months following the infusion. After the main phase, participants will enter a follow-up period where they will be observed and evaluated for up to five years after receiving ANB-002. Throughout the study, researchers will track and compare the participants' annualized bleeding rates before and after receiving ANB-002. This includes monitoring during the lead-in period and from 12 to 18 months after treatment. Participants will also undergo safety checks and pharmacodynamic assessments during the main and follow-up periods to evaluate how the treatment affects their condition over time and to ensure ongoing safety.

Researchers are evaluating the link between persistent Helicobacter pylori infection and the severity of insulin resistance in patients diagnosed with metabolic syndrome. This study focuses on understanding how ongoing H. pylori infection may contribute to worsening insulin resistance, a key factor in metabolic syndrome, which is associated with increased risk of type 2 diabetes, fatty liver disease, and cardiovascular problems. The study aims to clarify the role of chronic inflammation caused by H. pylori in impairing carbohydrate metabolism and increasing systemic inflammation in these patients. The study is a retrospective cohort design including 100 patients with metabolic syndrome, divided evenly into two groups based on H. pylori infection status (infected and non-infected). Researchers assess metabolic parameters, gastro panel markers, and C-reactive protein levels. The main measure is the difference in insulin resistance, evaluated by the HOMA-IR index, between the two groups, with secondary analyses exploring correlations between gastric inflammation and metabolic markers. Participants undergo procedures such as fasting blood draws, breath tests, stool antigen tests, endoscopy with biopsy, and anthropometric measurements. The primary outcome is recorded no more than two days after study inclusion. The study monitors inflammation and metabolic health markers to understand the relationship between H. pylori infection and insulin resistance severity in metabolic syndrome patients aged 18 to 65 years.

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 evaluating early neurological outcomes in patients with atherosclerotic carotid stenosis who undergo carotid artery revascularization using a MicroNet covered stent called CGuard. This study compares two types of embolic protection systems (EPS): a distal filter device and a proximal occlusion device. The background includes previous evidence showing advantages of the CGuard stent with distal EPS, but no high-level evidence comparing distal versus proximal EPS with this stent. Participants will be randomly assigned to receive carotid revascularization using the CGuard stent combined with either the Emboshield NAV6 distal filter EPS or the Mo.Ma proximal occlusion EPS. The study focuses on the procedure involving these devices during carotid artery stenting. These devices are intended to reduce embolic complications during the procedure. During the study, participants will be monitored closely with neurological assessments and brain imaging to identify ischemic lesions within 24 to 48 hours after the procedure. The study requires follow-up visits and imaging assessments as part of the evaluation. Participants must provide informed consent and agree to all follow-up procedures. Safety and neurological outcomes will be carefully tracked throughout the study period.