Batumi

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.

Researchers are evaluating the safety and effectiveness of efepoetin alfa compared to darbepoetin alfa for treating anemia in adults with chronic kidney disease (CKD) who are on hemodialysis. This Phase III, randomized, investigator-blinded, active-controlled study involves patients with stage 5 CKD receiving stable hemodialysis. The study aims to maintain hemoglobin levels between 10.0 and 12.0 g/dL during the treatment period. Participants will be randomly assigned in a 2:1 ratio to receive either efepoetin alfa or darbepoetin alfa. Before starting treatment, patients will stop any prior erythropoietin drugs. Efepoetin alfa is a novel long-acting drug designed to treat anemia by stimulating red blood cell production, while darbepoetin alfa is a re-engineered erythropoietin with a longer half-life. The study includes a screening period of up to 28 days, followed by the treatment phase, and then a 4-week follow-up via phone contacts up to week 56 or the last patient's visit. Throughout the study, patients will have their hemoglobin levels and other laboratory values regularly monitored to assess treatment effects. The primary measurement is the average change in hemoglobin between weeks 20 and 28. Researchers will also track safety and other health indicators during treatment and follow-up. The total participation time includes screening, treatment, and follow-up periods extending to about 56 weeks.

Researchers are investigating the similarity in pharmacokinetic (PK) profile, effectiveness, safety, and immune response of HLX17 compared to US-sourced Keytruda® in patients who have had surgery for non-small cell lung cancer, melanoma, or renal cell carcinoma. This Phase I, multicenter, randomized, double-blind study aims to compare these two treatments in people with these resected solid tumors to better understand their performance and safety profiles. Participants will receive either HLX17 or US-sourced Keytruda®, each given at a dose of 200 mg on the first day of every 3-week cycle. The study is designed with parallel groups, where each participant receives one of the treatments across multiple cycles. The dosing schedule continues through six cycles, and the two treatments are directly compared under controlled conditions. Throughout the study, participants will be monitored closely with various assessments including laboratory tests and evaluations of organ function to ensure safety. The main outcomes measured are drug exposure over time from the first dose to 21 days after the initial and sixth doses. Participants are expected to have a performance status of 0 and a life expectancy of at least 12 weeks. Safety and immunogenicity will also be evaluated, with follow-up to monitor any side effects or immune responses during and after treatment.

Researchers are evaluating the pharmacokinetics and safety of a subcutaneous injection of durvalumab combined with recombinant human hyaluronidase (rHu) in adults with different types of solid tumors. This Phase I multicenter study aims to find a subcutaneous durvalumab dose that provides drug levels similar to intravenous durvalumab. The study includes participants with non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), and limited-stage small cell lung cancer (LS-SCLC). The study is divided into two parts: Part 1 involves dose escalation with two planned dose levels of subcutaneous durvalumab in participants with NSCLC, HCC, or LS-SCLC. Part 2 focuses on dose expansion in participants with unresectable HCC, starting once the appropriate dose is identified. Durvalumab plus rHu is given under the skin, while intravenous durvalumab and tremelimumab are administered by infusion for some participants. Participants will be monitored from the first dose through approximately 17 months of durvalumab administration. Researchers will measure drug concentrations over time and the lowest concentration before the next dose. Participants will undergo assessments including safety evaluations, organ function tests, and disease measurements. The study also tracks side effects and overall drug exposure to evaluate safety and pharmacokinetics during treatment.

Researchers are evaluating the safety and effectiveness of various new drug combinations, including novel agents combined with standard treatments, for people with advanced or metastatic non-small cell lung cancer (NSCLC). This open-label, multicenter trial focuses on sub-study 2, which examines rilvegostomig combined with standard platinum-based chemotherapy, with or without ramucirumab, in participants with advanced NSCLC. The study aims to identify optimal doses and expand cohorts to better understand treatment safety and tumor response. The trial involves two parts: Part A includes safety run-in groups to test different dose levels of rilvegostomig and establish the recommended Phase 2 dose if not already known. Part B expands to larger groups to assess treatment effects. Rilvegostomig and other study drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, nab-paclitaxel, and ramucirumab are given by intravenous infusion according to the study protocol. Sub-study 1 was canceled and will not take place. Participants will undergo assessments including tumor tissue sampling, disease measurement scans, and laboratory tests to monitor organ function and treatment effects. Researchers will track adverse events, serious adverse events, dose-limiting toxicities, and tumor responses over approximately 46 months. Safety, tolerability, and anti-tumor activity are key outcomes, with follow-up to ensure participant well-being and gather comprehensive data on these novel treatment combinations.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are investigating BI-1206, a monoclonal antibody targeting CD32b (Fc3RIIB), combined with pembrolizumab in adults with advanced solid tumors. This Phase 1/2a, open-label, multicenter trial aims to determine the best dosing and evaluate the treatment's safety and potential effects in patients, including those with uveal melanoma and non-small cell lung cancer (NSCLC). The study involves dose escalation and cohort expansions to find the recommended doses for intravenous (IV) and subcutaneous (SC) administration. Participants will receive BI-1206 either IV or SC every three weeks alongside pembrolizumab administered intravenously at a fixed dose of 200 mg every three weeks. Phase 1 focuses on dose escalation and selection of recommended Phase 2 doses (RP2D) for both IV and SC routes. Phase 2a includes signal-seeking and dose optimization parts, where patients with uveal melanoma and NSCLC receive pembrolizumab and BI-1206 at the SC RP2D. Treatment continues in cycles every three weeks for up to 32 additional cycles or two years if clinical benefit is observed. Throughout the study, participants undergo regular assessments including physical exams, laboratory tests, and monitoring for adverse events (AEs) and serious adverse events (SAEs) up to two years. Researchers also evaluate dose-limiting toxicities during the initial 42-day induction period and monitor tumor response. Biopsies and biomarker analyses are conducted as appropriate. Safety, tolerability, and treatment effects are closely observed during all study phases to better understand the combination therapy's impact.

Researchers are evaluating the safety and effectiveness of calderasib combined with pembrolizumab as a first treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. This Phase 3 trial aims to test if the combination of calderasib and pembrolizumab improves progression-free survival and overall survival compared to pembrolizumab with a placebo. Participants receive oral calderasib tablets or placebo along with pembrolizumab given by intravenous infusion. The study compares these two treatment groups to see which provides better outcomes. Treatments continue during the study, and there are no additional interventions described beyond these drugs. During the trial, participants undergo regular assessments including scans and tests to monitor their cancer's progression and overall health. The main outcomes measured are progression-free survival for up to about 42 months and overall survival for up to about 56 months. Safety is monitored throughout, and participants are followed for several years to evaluate long-term effects of the treatments.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.