Ulyanovsk

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.

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 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 conducting a multi-center, non-interventional study to observe routine diagnostic and treatment practices for patients with unresectable or inoperable locally advanced non-small cell lung cancer (NSCLC) and limited-stage small cell lung cancer (LS-SCLC) in 50 major oncology centers across Russia. The study will collect data from 2000 patients receiving chemo-radiation therapy (CRT) over two years. The aim is to understand demographic and clinical characteristics, diagnostic procedures, treatment approaches, and short-term outcomes of CRT in these patients, without collecting information on treatments following CRT such as durvalumab. The study involves collecting data at two main points: at the start of CRT (either concurrent or sequential chemo-radiation) and after the last dose of radiation therapy, including results from computed tomography (CT) scans. Data collection will be done from patients' medical records in routine clinical practice, and the second data collection is expected to occur within six months after the first visit. The study follows local regulations for adverse event reporting and does not involve additional interventions or treatments. Participants will be adults aged 18 years or older who have locally advanced NSCLC or LS-SCLC and are currently undergoing radiation therapy as part of CRT. Researchers will gather information on patient demographics, disease stage, histology, and clinical status at baseline. The study will monitor treatment details and short-term outcomes after CRT. All data is collected from existing medical records, ensuring no extra procedures for participants. The total participation duration aligns with routine treatment schedules and follow-up visits.

Researchers are evaluating the real-world use and effectiveness of tezepelumab in adults with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), with or without asthma, in Russia. This observational study collects both past and current data from patients who have started tezepelumab treatment no more than 4 weeks before enrolling. The goal is to understand how tezepelumab works outside of controlled clinical trial settings. The study will take place at about 10 sites across the Russian Federation and will include 110 adult participants aged 18 years or older. Participants will be treated with tezepelumab as prescribed by their doctors. The study is non-interventional, meaning it observes treatment and outcomes without changing patient care. Data collection includes medical records from at least 52 weeks before treatment started. Participants will be monitored for changes in their nasal polyp status and nasal congestion using endoscopic scores and nasal blockage scores at the start of the study and at 4, 24, and 52 weeks after starting tezepelumab. Other assessments include patient questionnaires and clinical evaluations. The study tracks real-world outcomes, safety, and patient-reported experiences over the course of one year.

This research aims to assess the long-term safety of secukinumab in participants who have finished a previous Novartis secukinumab trial and are judged by their investigator to benefit from continued treatment but cannot access the marketed secukinumab form. The study focuses on individuals with autoimmune or inflammatory conditions and is conducted as a Phase 4 trial to monitor treatment safety over an extended period. Participants will receive secukinumab through subcutaneous injections using pre-filled syringes. The study is open-label and multi-center, designed for patients continuing secukinumab therapy after completing a parent study or in cases where the parent study ended prematurely for non-safety reasons. Treatment continuation depends on investigator judgment regarding benefit and risk balance. During the study, participants will be observed for up to two years to evaluate safety by tracking any adverse or serious adverse events. The study includes regular assessments to monitor participant health and treatment effects. Consent and communication with investigators are essential, and participants may sign informed consent or assent forms according to age and local laws. Overall participation duration and detailed safety monitoring are key components of the study.

Researchers are evaluating the effectiveness, safety, how the body processes the drug, its immune response effects, and dosing relationship of BCD-261 in adults aged 18 to 75 with moderate to severe active ulcerative colitis who have not responded well to prior treatments such as steroids, immunosuppressants, or biologics. This Phase 2, randomized, double-blind, placebo-controlled study aims to better understand how BCD-261 works compared to a placebo in this patient group. Participants will be randomly assigned to one of five groups to receive either a low, medium, or high dose of BCD-261 or a placebo via injection during both induction and maintenance treatment periods. After the initial evaluation at week 14, those originally receiving placebo will switch to the medium dose of BCD-261. The study carefully compares different dosing regimens to characterize the drug’s dose-response relationship. During the study, participants will undergo clinical assessments to measure the proportion achieving remission by week 14. Researchers will monitor safety, immune responses, and drug levels throughout. Stable doses of certain medications are maintained before and during screening. The total participation includes treatment, follow-up, and monitoring periods as outlined in the protocol to evaluate the drug’s overall effects and safety in this patient population.

Researchers are evaluating the effectiveness and safety of Raphamin in treating adults aged 18 to 75 years with acute rhinosinusitis, a condition characterized by symptoms such as facial pain and nasal congestion. This multicenter, double-blind, placebo-controlled, randomized clinical trial enrolls patients within 48 hours of symptom onset during the seasonal peak of acute respiratory viral infections. The study uses the Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) to assess symptom severity and quality of life. Participants are randomly assigned to receive either oral Raphamin or a placebo following the same dosing schedule for five days. The trial includes a screening and randomization period of up to one day, a five-day treatment phase, and a follow-up period lasting up to 14 days. Patients attend three in-person visits on days 1, 4, and 7, with an additional phone visit on day 14. During these visits, symptom assessments, physical examinations, and diary reviews are conducted to monitor treatment adherence and safety. Patients keep an electronic diary twice daily to record body temperature and symptom changes according to the MSS. Investigators evaluate symptom progression, adherence, safety, and any complications including the use of antibiotics or hospitalizations. The primary outcome is the percentage of patients showing improvement in acute rhinosinusitis symptoms by day 4. Symptomatic and concomitant disease therapies are allowed except for prohibited medications. Overall, participants are observed for up to 14 days to assess treatment impact and safety.